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Last update 15 Jul 2025

Propranolol Hydrochloride

Last update 15 Jul 2025

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

SummaryPropranolol Hydrochloride, a small molecule drug, targets the β-adrenoceptors as an antagonist, exhibiting an assortment of therapeutic effects.. This drug is used to treat various conditions, including hypertension, angina pectoris, atrial fibrillation, atrial premature complexes, bradycardia, and tachycardia. AstraZeneca developed Propranolol Hydrochloride, which received approval on August 18th, 1966. Propranolol Hydrochloride works by blocking the sympathetic nervous system's action on the heart and blood vessels, which ultimately results in a reduction in heart rate, blood pressure, and oxygen demand. Although Propranolol Hydrochloride can be effective in managing these conditions, it can also cause side effects such as fatigue, dizziness, and depression, and as such, it should only be taken under the guidance of a healthcare provider. Careful monitoring of patients for any adverse effects is also necessary. Overall, Propranolol Hydrochloride is a useful medication for managing heart-related conditions, but each individual patient's case should be carefully considered before use.

Drug Type

Small molecule drug

Synonyms

1-((1-Methylethyl)amino)-3-(1-naphthalenyloxy)-2-propanol, 1-(isopropylamino)-3-(1-naphthyloxy)propan-2-ol, beta-Propranolol

+ [38]

Target

β-adrenoceptors

Action

antagonists

Mechanism

β-adrenoceptors antagonists(Beta adrenergic receptors antagonists)

Therapeutic Areas

NeoplasmsNervous System DiseasesCardiovascular Diseases+ [1]

Active Indication

HypoxiaHemangiomaMigraine Disorders+ [9]

Inactive Indication

Capillary HemangiomaCardiomyopathy, HypertrophicEssential Tremor+ [1]

Originator Organization

AstraZeneca PLC

Active Organization

Hainan Nuoen Biotechnology Co., Ltd.

Hainan Wanzhou Green Pharmaceutical Co., LtdPierre Fabre Medicament Information

+ [6]

Inactive Organization

Wyeth Pharmaceuticals LLC

Pierre Fabre SAHebei Jizhong Pharmaceutical Co., Ltd.

License Organization

Pierre Fabre (Shanghai) Medical Technology Co., Ltd.

Wuhan Kefu New Drug Co., Ltd.

Drug Highest PhaseApproved

First Approval Date

Japan (18 Aug 1966),

Angina PectorisAtrial FibrillationAtrial Premature Complexes+ [4]

RegulationOrphan Drug (United States), Orphan Drug (European Union), Orphan Drug (South Korea), Priority Review (China)

Structure/Sequence

Molecular FormulaC16H22ClNO2

InChIKeyZMRUPTIKESYGQW-UHFFFAOYSA-N

CAS Registry318-98-9

425

Clinical Trials associated with Propranolol Hydrochloride

NCT06670976

/ Not yet recruitingPhase 1IIT

Pilot Study of Soft Tissue Sarcoma Treated With Propranolol and Radiation

This phase I trial tests the safety, tolerability and impact of adding propranolol to standard radiation therapy (RT) before surgery for the treatment of patients with soft tissue sarcoma. Sarcomas are a diverse group of rare tumors arising from connective tissue. Approximately 13,000-16,000 new cases of sarcomas arise in the United States annually. Sarcoma management involves multidisciplinary team decision making and treatment is multimodal utilizing chemotherapy (if needed) and RT prior to surgical intervention. Propranolol is a drug that has been used for many years for high blood pressure by blocking both beta-1 and beta-2 adrenergic receptors. Preclinical data suggests that blocking the beta-2 adrenergic receptors can improve the response to both chemotherapy and radiation. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill tumor cells and shrink tumors. RT before surgery makes the tumor smaller and reduces the amount of tissue that needs to be removed during surgery. Surgery is the most common treatment for soft tissue sarcoma. Giving propranolol with standard RT before surgery may be safe, tolerable and impactful in treating patients with soft tissue carcinoma.

Start Date15 May 2026

Sponsor / Collaborator

Roswell Park Comprehensive Cancer Center

NCT06870370

/ Not yet recruitingPhase 3IIT

Role of Non-Selective Beta-Adrenergic Blocker in Severe Traumatic Brain Injury

The role of nonselective beta adrenergic blocker as antistress agent in severe traumatic brain injury

Start Date20 Sep 2025

Sponsor / Collaborator

Tanta University

NCT06833320

/ Not yet recruitingPhase 1/2IIT

A Double-blind, Prospective, Randomized Trial of Propranolol for the Treatment of Postoperative Chylothorax After Open Cardiac Surgery

Postoperative chylothorax is a serious complication after open heart surgery for pediatric patients with congenital heart disease (CHD). While it was thought to be mechanical injury to the thoracic duct, recent research demonstrated that there are intrinsically abnormal lung lymphatics in CHD patients, and after open heart surgery, the fluid shifts that occur overwhelms these abnormal lung lymphatics. As a result, postoperative chylothorax occurs. Propranolol has been found to be helpful in resolving postoperative chylothorax very quickly (9 days) in a subset of postoperative chylothorax patients (60%). However, it is not known why some patients respond and some do not. The investigators hypothesize that propranolol is safe to use in this patient population, and that certain clinical factors will predict propranolol response, but more importantly, some clinical factors can be optimize to allow more patients with postoperative chylothorax to respond to and benefit from propranolol. In order to improve the understanding of how propranolol works and to maximize benefit to patients, the investigators propose to perform a prospective, randomized, double-blind clinical trial to learn how to best use propranolol in patients with postoperative chylothorax.

Start Date01 Sep 2025

Sponsor / Collaborator-

100 Clinical Results associated with Propranolol Hydrochloride

100 Translational Medicine associated with Propranolol Hydrochloride

100 Patents (Medical) associated with Propranolol Hydrochloride

51,759

Literatures (Medical) associated with Propranolol Hydrochloride

01 Jan 2026·TALANTA

Near infrared fluorescence probe for dynamic and reversible monitoring of redox homeostasis fluctuations of hemangioma

Article

Author: Wang, Liang ; Zhang, Kaihui ; Xing, Dianjin ; Gong, Xiaoxia ; Niu, Yaxin ; Zhang, Bo ; Chen, Zhenzhen ; Li, Jinfeng ; Hou, Siwei ; Liu, Guangzhao ; Chen, Zitong ; Guo, Lei

Intracellular redox homeostasis is indispensable for the physiological processes of organisms and represents a pivotal mechanism underlying drug therapy for tumors. Among the various redox conjugates, superoxide anion (O₂^•-) and glutathione (GSH) play crucial roles in reflecting the redox state of living cells. Given the significance of the redox pair between O₂^•- and GSH in living organisms, herein, we report a near-infrared (NIR) fluorescent probe, BDPos, that enables real-time visualization of propranolol-induced redox imbalance during vascular tumor therapy by monitoring the dynamics alterations of O₂^•- and GSH. During the process of selective oxidation by O₂^•- and subsequent reduction recovery by GSH, BDPos exhibits a pronounced absorption shift between 708 nm and 620 nm, demonstrating its reversible responsiveness and the ability to visualize the redox status. Importantly, our studies have revealed that the disruption of redox homeostasis in hemangiomas may constitute one of the mechanisms through which propranolol exerts its therapeutic effects in treating this condition. This redox probe, characterized by its specificity and sensitivity, offers a promising tool for investigating the therapeutic mechanisms of drugs and elucidating various redox-related pathological processes.

31 Dec 2025·European Journal of Psychotraumatology

Hippocampal connectivity changes after traumatic memory reactivation with propranolol for posttraumatic stress disorder: a randomized fMRI study

Article

Author: Birmes, P. ; Leroy, A. ; Vaiva, G. ; Jardri, R. ; Taib, S. ; Richaud, L. ; Loubinoux, I. ; Very, E. ; Bourcier, A. ; Roullet, P.

Background: Reactivation of traumatic memory under the influence of propranolol has shown encouraging clinical results in the treatment of posttraumatic stress disorder (PTSD), but the neural correlates remain unknown. To identify these correlates, we examined the changes in brain functional connectivity specifically associated with the influence of propranolol and their correlation with improvement in PTSD symptoms.Objectives: To identify resting-state functional connectivity (rs-FC) changes specifically associated with propranolol after a traumatic memory reactivation procedure (TMRP) in PTSD patients.Method: Thirty patients (50% of women) with PTSD were enrolled in a randomized controlled study comprised of six sessions of a traumatic memory reactivation procedure (TMRP) under the influence of propranolol (n = 16), compared to the same reactivation under a placebo (n = 14). Patients were scanned twice by functional magnetic resonance before and after treatment. Resting state functional connectivity (rs-FC) was compared across groups and over time.Results: Post versus pretreatment comparisons found an increase in rs-FC between the right hippocampus and the left parahippocampal gyrus in the propranolol group, but not in the placebo group. Symptom improvement in both groups were associated with an increase in rs-FC between the parahippocampal gyrus and both the supramarginal gyrus and the amygdala.Conclusions: During TMRP treatment, propranolol appears to constrain functional connectivity changes in the explicit memory brain system. These findings require further replication and exploration but could distinguish the effect of TMRP on the brain from other forms of PTSD psychotherapy.

31 Dec 2025·REDOX REPORT

Norepinephrine promotes oxidative stress in vascular adventitial fibroblasts via PKC/NFκB-mediated NOX2 upregulation

Article

Author: Zhu, Guo-Qing ; Dai, Min ; Wang, Jing-Xiao ; Wang, Yi-Ming ; Dong, Hong-Ke ; Xu, Xiao-Yu ; Li, Xiu-Zhen

BACKGROUND:

Sympathetic overactivity is closely associated with vascular remodeling. Sympathetic fibers dominantly innervate the adventitia of arteries rather than tunica media. Vascular adventitial fibroblasts (VAFs) play crucial roles in vascular remodeling. However, the link between sympathetic overactivity and VAF proliferation and migration is unknown.

METHODS:

Primary VAFs were isolated from the thoracic aorta of spontaneously hypertensive rats and Wistar-Kyoto rats. Norepinephrine (NE) bitartrate monohydrate was applied to VAFs to simulate the sympathetic overactivity.

RESULTS:

NE increased NADPH oxidase (NOX) 2 expression and superoxide level, which were almost abolished by NOX2 inhibitor GSK2795039 or α-adrenoceptor antagonist prazosin, but not significantly affected by NOX1 inhibitor ML171, NOX4 inhibitor GLX351322 or β-adrenoceptor antagonist propranolol. Superoxide scavenger tempol or NOX2 inhibitor GSK2795039 attenuated NE-induced VAF proliferation and migration. NE promoted protein kinase C (PKC) phosphorylation and NFκB-p65 nuclear translocation. Either PKC inhibitor Go6983 or NFκB inhibitor BAY11-7082 attenuated NE-induced NOX activation, NOX2 upregulation, superoxide production, proliferation and migration.

CONCLUSION:

NE promotes oxidative stress by α-receptor/PKC/NFκB-mediated NOX2 upregulation, which contributes to proliferation and migration of VAFs.

News (Medical) associated with Propranolol Hydrochloride

19 Jun 2025

·www.businesswire.com

Lundbeck Advances Leadership in Migraine With New Data at the American Headache Society 67th Annual Scientific Meeting

DEERFIELD, Ill.--(BUSINESS WIRE)--Lundbeck US, the US subsidiaries of H. Lundbeck A/S, today announced it will present one oral and eight poster presentations at the 67th Annual Scientific Meeting of the American Headache Society (AHS) in Minneapolis from June 19-22, 2025. The data presentations reinforce the need to look beyond monthly migraine days (MMDs) and the importance of a holistic approach to migraine care as suggested by data from eptinezumab-jjmr post-hoc analyses. VYEPTI® (eptinezumab-jjmr) is indicated for the preventive treatment of migraine in adults. VYEPTI is contraindicated in patients with serious hypersensitivity to eptinezumab-jjmr or to any of its ingredients. Reactions have included anaphylaxis and angioedema. Please see Important Safety Information below. “Migraine disease affects over 40 million people in the U.S.,1 profoundly impacting every aspect of life for many,” said Damian Fiore, Vice President, Lundbeck US Medical Affairs Neurology. “Lundbeck is energized to be at AHS, driving conversations on how we can better understand the holistic burden of migraine and redefine how we approach care. Our focus goes beyond just alleviating individual symptoms—we are committed to improving the overall quality of life for people living with migraine disease.” Analyses presented at AHS from several studies including clinical trials and real-world research continue to focus on novel ways to assess VYEPTI and study results and advance preventive migraine care: P-341 : Eptinezumab Treatment was Associated with Longer Interictal Periods and Corresponding Larger Improvements in Quality of Life in Participants With Migraine for Whom 2-4 Prior Preventive Treatments had Failed: A Post Hoc Analysis of the DELIVER Trial: Individuals living with migraine who have longer periods of time between migraine attacks (interictal periods) may experience a reduced overall burden of migraine. A post-hoc analysis of the phase 3b DELIVER trial during weeks 1-12 (n=853) and weeks 1-24 (n=832) evaluated the association between the mean longest interictal period and improvements in patient-reported quality of life (QoL) outcomes. Results from this post-hoc analysis indicate the mean longest interictal period was larger with VYEPTI than as reported by patients receiving placebo during the first 24 weeks of the DELIVER trial. Among participants with >14- and >21-day mean longest interictal periods, a greater proportion of participants achieved clinically meaningful improvements in the 6-item Headache Impact test score (HIT-6; ≥5-point total score reduction) and Patient Global Impression of Change (PGIC; “much improved” or “very much improved” rating) with VYEPTI compared with placebo. 2 P-333 : Retention Rates Across Clinical Trials of Anti-CGRP Monoclonal Antibodies for Migraine Prevention : Researchers analyzed select phase 3 clinical trials to assess retention rates for adult participants who were treated with VYEPTI and other anti-CGRP mAbs for the prevention of migraine, including long-term eptinezumab trials: the 104-week, open label, single-arm PREVAIL trial and the 72-week DELIVER trial. In this retrospective cohort study of US claims data, VYEPTI showed high, long-term retention rates for preventive treatment in participants with chronic migraine and in those with migraine for whom 2-4 prior migraine preventive treatments have failed, suggesting a high level of participant satisfaction with continued treatment of VYEPTI. Similar results were observed in other anti-CGRP mAbs in this treatment group. 3 P-332 : Baseline Characteristics and Eptinezumab Infusion Experience in Participants in Whom ≥1 Prior Preventive Anti-CGRP Treatment Had Failed: Interim Results of an Ongoing Real-World Study : INFUSE is an ongoing, non-interventional, prospective study in individuals with migraine initiating VYEPTI for the preventive treatment of migraine. In an interim analysis of the first 75 participants entering the INFUSE study, results indicate that individuals, despite having ≥1 prior a-CGRP preventive treatment, reported a long history of disease and high disease burden (with regard to frequency, severity and cognitive impairments). Interim results also showed that the level of concern about initiating an intravenous (IV) treatment was low and participants in the study generally had a positive infusion experience. 4 Further highlighting our commitment to pushing the boundaries on migraine care with preventive treatments, Lundbeck also will host a symposium titled, “Why the interictal period matters: Striving for migraine freedom” with Dr. Amaal Starling and Dr. Stewart Tepper on Thursday, June 19 from 12:30 p.m. to 1:15 p.m. CT. “For optimal migraine management, it’s important to prioritize continuous improvement and a patient-centered approach,” said Dr. Amaal Starling, Neurologist, Mayo Clinic. “These studies highlight the real-world impact of preventive migraine treatments that can provide sustained control, which may allow individuals to focus on their personal goals and live their lives to the fullest.” Additional migraine data being presented at AHS include: IOR-02 (Oral) : Patient Perspectives of Migraine Symptomology: Insights from Exit Interviews from the anti-PACAP Antibody Phase 2 HOPE Trial for Migraine Prevention 5 P-299 : Associated Long-Term Clinical Improvements Following ≥50% Migraine Response and Sustained ≥50% and ≥75% Migraine Reductions in Early Responders to Eptinezumab Treatment in Participants With Migraine: Post Hoc Analyses of the DELIVER Trial 6 P-320 : Sustained Reductions in Monthly Headache Days with Long-Term Eptinezumab Treatment for Chronic Migraine: Post Hoc Analysis of the Phase 3 PREVAIL Study 7 P-319 : Impact of Participant-reported ≥75% Increase in Good Days/Month on Migraine Symptoms, Quality of Life, and Brain Fog: Results of the REVIEW Real-world Study of Adults With Chronic Migraine Treated with Eptinezumab 8 P-297 : Eptinezumab and Patient Education in Chronic Migraine and Medication-overuse Headache: Results from the Randomized, Placebo-controlled RESOLUTION Trial 9 P-308 : Efficacy and Safety of Eptinezumab in Chronic Migraine: A Randomized Placebo-controlled Trial in a Predominantly Asian Population 10 About VYEPTI® VYEPTI® (eptinezumab-jjmr) is a humanized monoclonal antibody that binds to calcitonin gene-related peptide (CGRP) ligand and blocks its binding to the receptor. VYEPTI was deliberately developed for administration by IV infusion to deliver 100 percent of the medication into the bloodstream at the end of the infusion. The efficacy and safety of VYEPTI were demonstrated in two phase 3 clinical trials; episodic migraine in PROMISE-1 and chronic migraine in PROMISE-2. VYEPTI met its primary endpoint of decrease in mean monthly migraine days (MMD) over months 1-3 in both episodic and chronic migraine. The safety of VYEPTI was evaluated in 2,076 patients with migraine who received at least one dose of VYEPTI. The most common adverse reactions (≥2 percent and at least 2 percent or greater than placebo) in the clinical trials for the preventive treatment of migraine were nasopharyngitis and hypersensitivity. In PROMISE-1 and PROMISE-2, 1.9 percent of patients treated with VYEPTI discontinued treatment due to adverse reactions. VYEPTI offers patients with migraine a preventive treatment administered as one 30-minute IV infusion 4 times a year (every three months). The recommended dosage is 100 mg, and some patients may benefit from a dosage of 300 mg. Dosing should be based on the guidance in the Prescribing Information and Patient Information. INDICATION VYEPTI (eptinezumab-jjmr) is indicated for the preventive treatment of migraine in adults. IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS VYEPTI is contraindicated in patients with serious hypersensitivity to eptinezumab-jjmr or to any of the excipients. Reactions have included anaphylaxis and angioedema. WARNINGS AND PRECAUTIONS Hypersensitivity Reactions: Hypersensitivity reactions, including angioedema, urticaria, facial flushing, dyspnea, and rash, have occurred with VYEPTI in clinical trials and in the postmarketing setting. Most hypersensitivity reactions occurred during infusion and were not serious, but often led to discontinuation or required treatment. Serious hypersensitivity reactions may occur. Cases of anaphylaxis have been reported in the postmarketing setting. If a hypersensitivity reaction occurs, consider discontinuing VYEPTI and institute appropriate therapy. Hypertension: Development of hypertension and worsening of pre-existing hypertension have been reported following the use of CGRP antagonists, including VYEPTI, in the postmarketing setting. Some of the patients who developed new-onset hypertension had risk factors for hypertension. There were cases requiring initiation of pharmacological treatment for hypertension, and in some cases hospitalization. Hypertension may occur at any time during treatment, but was most frequently reported within 7 days of therapy initiation. The CGRP antagonist was discontinued in many of the reported cases. Monitor patients treated with VYEPTI for new-onset hypertension or worsening of pre-existing hypertension, and consider whether discontinuation of VYEPTI is warranted if evaluation fails to establish an alternative etiology or blood pressure is inadequately controlled. Raynaud’s Phenomenon: Development of Raynaud’s phenomenon and recurrence or worsening of pre-existing Raynaud’s phenomenon have been reported in the postmarketing setting following the use of CGRP antagonists. In reported cases with monoclonal antibody CGRP antagonists, symptom onset occurred a median of 71 days following dosing. Many of the cases reported serious outcomes, including hospitalizations and disability, generally related to debilitating pain. In most reported cases, discontinuation of the CGRP antagonist resulted in resolution of symptoms. VYEPTI should be discontinued if signs or symptoms of Raynaud’s phenomenon develop, and patients should be evaluated by a healthcare provider if symptoms do not resolve. Patients with a history of Raynaud’s phenomenon should be monitored for, and informed about the possibility of, worsening or recurrence of signs and symptoms. ADVERSE REACTIONS The most common adverse reactions (≥2% and at least 2% or greater than placebo) in the clinical trials for the preventive treatment of migraine were nasopharyngitis and hypersensitivity. VYEPTI was approved by the U.S. Food and Drug Administration (FDA) for the preventive treatment of migraine in adults in February 2020. For more information, please see Full Prescribing Information and Patient Information or visit www.VYEPTIHCP.com. About Migraine Disease Migraine is a complex and disabling neurological disease that limits functionality and quality of life.1 It is characterized by moderate to severe head pain typically accompanied by an array of symptoms, including nausea, vomiting and sensitivity to light or sound.1,11 Over time, migraine disease may worsen, with attacks increasing in frequency, severity and duration.12,13 It is estimated to affect more than 40 million people in the U.S. and impacts three times as many women than men.1 It is the second leading cause of years lived with disability (YLD) among all diseases and is the top YLD cause among people aged 15 to 49 years, according to the Global Burden of Disease study. The impact of migraine permeates into career, home life and relationships.14 About INFUSE study INFUSE is an ongoing, non-interventional, prospective study in individuals with migraine, initiating preventive treatment with eptinezumab-jjmr. Eligible participants were recruited by two infusion center networks and are being followed for 12 months after initiating eptinezumab-jjmr treatment. INFUSE includes adults ≥18 years of age with a diagnosis of migraine who tried ≥1 preventive a-CGRP treatment (erenumab, fremanezumab, galcanezumab, atogepant, or rimegepant [prescribed every other day]). About DELIVER study DELIVER (NCT04418765) is a phase 3b, multicenter, randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of eptinezumab-jjmr in patients with chronic or episodic migraine. Chronic migraine was defined as migraine occurring on ≥8 days per month and headache occurring on >14 days, and episodic migraine as migraine occurring on ≥4 days and headache occurring on ≤14 days. All patients had to have experienced failures of two to four prior preventive treatment classes (including: propranolol, metoprolol, topiramate, amitriptyline, flunarizine, valproate, divalproex, candesartan) or botulinum toxin A/B (if documented that botulinum toxin was used for chronic migraine), and at least one failure being due to inadequate efficacy. Patients who experienced failure on a previous treatment targeting the calcitonin gene-related peptide (CGRP) pathway were excluded from participation. Documented evidence of prior migraine treatment failures was supported by medical records or by physicians´ confirmation specific to each treatment in the past 10 years. In the study, 892 patients were randomized to receive eptinezumab-jjmr 100 mg or 300 mg or placebo by IV infusion. Patients included in the study most frequently experienced treatment failures of topiramate and amitriptyline, with 550(61.8%), 277(31.1%), and 60(6.7%) patients experiencing 2, 3, and 4 prior preventive treatment failures respectively. The primary endpoint was change from baseline in the number of monthly migraine days over Weeks 1-12. Key secondary endpoints included response rates as patients with 50% or greater reduction from baseline in MMDs (Weeks 1-12), response rates of patients with 75% or greater reduction from baseline in MMDs (Weeks 1-12) and change from baseline in the number of MMDs (Weeks 13-24). Other secondary endpoints assessed the effect of eptinezumab-jjmr vs placebo on: 6-item Headache Impact test score (HIT-6), Migraine-specific quality of life (MSQ v2.1), HRQoL (EQ-5D-5L) visual analogue scale (VAS) score, healthcare resources utilization (HCRU), and Work Productivity and Activity Impairment Questionnaire (WPAI). The safety and tolerability of eptinezumab-jjmr in the DELIVER study were similar to placebo and consistent with findings from previous eptinezumab-jjmr clinical trials. In DELIVER and earlier eptinezumab-jjmr studies, upper respiratory tract infection, nasopharyngitis, dizziness, and fatigue were the most commonly reported treatment-emergent adverse events (TEAEs). About PREVAIL study PREVAIL was a phase 3, open-label multi-site U.S.-based study that evaluated eptinezumab-jjmr 300 mg intravenous administration in 128 adults with chronic migraine (CM). PREVAIL included two treatment phases: the primary treatment phase included four infusions of eptinezumab-jjmr 12 weeks apart (Day 0, and Weeks 12, 24, and 36); the secondary treatment phase included up to four additional eptinezumab-jjmr infusions 12 weeks apart (Weeks 48, 60, 72, and 84). Further, patients were followed for 20 additional weeks after the final infusion until Week 104. The PREVAIL study evaluated the long-term safety of repeat doses of eptinezumab-jjmr 300 mg in patients with CM, as well as the pharmacokinetics, immunogenicity, and patient-reported outcomes (PROs). Patient-reported outcome measures included the Migraine Disability Assessment (MIDAS) questionnaire, patient-identified most bothersome symptom (PI-MBS) associated with migraine, Patient Global Impression of Change (PGIC), and 6-item Headache Impact Test (HIT-6). About a-PACAP a-PACAP monoclonal antibody is an investigational compound currently under development (phase 2) for the treatment of migraine. The compound is not commercially available globally. About Lundbeck Lundbeck is a global biopharmaceutical company focusing exclusively on brain health. With more than 70 years of experience in neuroscience, we are committed to improving the lives of people with neurological and psychiatric diseases. Brain disorders affect a large part of the world’s population, and the effects are felt throughout society. With the rapidly improving understanding of the biology of the brain, we hold ourselves accountable for advancing brain health by curiously exploring new opportunities for treatments. As a focused innovator, we strive for our research and development programs to tackle some of the most complex neurological challenges. We develop transformative medicines targeting people for whom there are few or no treatments available, expanding into neuro-specialty and neuro-rare from our strong legacy within psychiatry and neurology. We are committed to fighting stigma and we act to improve health equity. We strive to create long-term value for our shareholders by making positive contributions to patients, their families and society as a whole. Lundbeck has approximately 5,700 employees in more than 50 countries and our products are available in more than 80 countries. Lundbeck US comprises the wholly owned US subsidiaries of H. Lundbeck A/S (HLUNa / HLUNb, HLUNA DC / HLUNB DC) (“Lundbeck”), including Lundbeck LLC and Lundbeck Pharmaceuticals LLC. For additional information, please visit Lundbeck.com/us and connect with us on LinkedIn and X at @LundbeckUS. References 1 Cohen, F., Brooks, C. V., Sun, D., Buse, D. C., Reed, M. L., Fanning, K. M., & Lipton, R. B. (2024). Prevalence and burden of migraine in the United States: A systematic review. Headache, 64(5), 516–532. https://doi.org/10.1111/head.14709 2 Tepper, Stewart J., Joshi, Shivang, Hirman, Joe, et al. Eptinezumab Treatment was Associated with Longer Interictal Periods and Larger Improvements in Quality of Life in Participants With Migraine for Whom 2-4 Prior Preventive Treatments had Failed: A Post Hoc Analysis of the DELIVER Trial. Available at https://headachejournal.onlinelibrary.wiley.com/. Accessed June 4, 2025. 3 Blumenfeld, Andrew, Patel, Foram, Kapur, Neha, et al. Retention Rates Across Clinical Trials of Anti-CGRP Monoclonal Antibodies for Migraine Prevention. Available at https://headachejournal.onlinelibrary.wiley.com/. Accessed June 4, 2025. 4 Starling, Amaal, Regnier, Stephane, Soni-Brahmbhatt, Seema, et al. Characteristics and Eptinezumab Infusion Experience in Participants in Whom ≥1 Prior Preventive anti-CGRP Treatment had Failed: Interim Results of an Ongoing Real-world Study. Available at https://headachejournal.onlinelibrary.wiley.com/. Accessed June 4, 2025. 5 Lipton, Richard B., IOR-02 - Patient perspectives of migraine symptomology: Insights from exit interviews from the anti-PACAP antibody phase 2 HOPE trial for migraine prevention. Available at https://headachejournal.onlinelibrary.wiley.com/. Accessed June 4, 2025. 6 Ailani, Jessica, Ashina, Messoud, Awad, Susanne F., et al. Long-term Improvements Following ≥50% Migraine Response to Eptinezumab Treatment in Participants With Migraine: Post Hoc Analysis of the DELIVER Trial. Available at https://headachejournal.onlinelibrary.wiley.com/. Accessed June 4, 2025. 7 Starling, Amaal, Kudrow, David, Kapur, Neha, et al. Sustained Reductions in Monthly Headache Days with Long-Term Eptinezumab Treatment for Chronic Migraine: Post-Hoc Analysis of the Phase 3 PREVAIL Study. Available at https://headachejournal.onlinelibrary.wiley.com/. Accessed June 4, 2025. 8 Starling, Amaal, Kudrow, David, Kapur, Neha, et al. Sustained Reductions in Monthly Headache Days with Long-Term Eptinezumab Treatment for Chronic Migraine: Post-Hoc Analysis of the Phase 3 PREVAIL Study. Available at https://headachejournal.onlinelibrary.wiley.com/. Accessed June 4, 2025. 9 Jensen, Rigmor H., Lundqvist, Christofer, Schytz, Henrik W., et al. Eptinezumab and patient education in chronic migraine and medication-overuse headache: Results from the randomized, placebo-controlled RESOLUTION trial. Available at https://headachejournal.onlinelibrary.wiley.com/. Accessed June 13, 2025 10 Yu, Shengyuan, Matsumori, Yasuhiko, Kim, Byung-Kun, et al. Efficacy and safety of eptinezumab in chronic migraine: A randomized placebo-controlled trial in a predominantly Asian population. Available at https://headachejournal.onlinelibrary.wiley.com/. Accessed June 13, 2025. 11 National Institute of Neurological Disorders and Stroke. Migraine. Available at: https://www.ninds.nih.gov/health-information/disorders/migraine. Accessed March 28, 2024. 12 GBD 2016 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 328 diseases and injuries for 195 countries, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016 [published correction] appears in Lancet. 2017;390(10100):1211-1259. 13 American Headache Society. Headache. 2019; 59: 1–18. 14 Buse DC, Fanning KM, Reed ML, et al. Life With Migraine: Effects on Relationships, Career, and Finances From the Chronic Migraine Epidemiology and Outcomes (CaMEO) Study. Headache. 2019;59(8):1286-1299. doi: https://doi.org/10.1111/head.13613.

Clinical ResultPhase 2Phase 3Drug Approval

18 Jun 2025

·axsometherapeuticsinc.gcs-web.com

Axsome Therapeutics to Present Data Spanning the SYMBRAVO® (meloxicam and rizatriptan) Clinical Program at the 67th Annual Scientific Meeting of the American Headache Society (AHS)

NEW YORK, June 18, 2025 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) disorders, today announced that data from across the SYMBRAVO® (meloxicam and rizatriptan) clinical program will be presented at the 67th Annual Scientific Meeting of the American Headache Society (AHS), being held June 19-22, 2025, in Minneapolis, Minnesota. Details for the presentations are as follows: Title: Efficacy of SYMBRAVO® (MoSEIC™ meloxicam and rizatriptan) by Baseline Migraine-Associated Disability: Post-Hoc Analysis of the INTERCEPT Trial Lead Author: Stewart Tepper, MD, Clinical Professor of Neurology at the Geisel School of Medicine at Dartmouth and Vice President of the New England Institute for Neurology and Headache Presentation Date and Time: Thursday, June 19, 6 - 7:30 p.m. Central Time Poster Number: P-316 Title: Long-Term Effects of SYMBRAVO® (MoSEIC™ meloxicam and rizatriptan) on Headache Burden and Quality of Life: Results of the MOVEMENT Trial Lead Author: Richard B. Lipton, MD, Professor of Neurology and Director of the Montefiore Headache Center, Albert Einstein College of Medicine Presentation Date and Time: Thursday, June 19, 6 - 7:30 p.m. Central Time Poster Number: P-330 Title: Efficacy and Safety of SYMBRAVO® (MoSEIC™ meloxicam and rizatriptan) in Participants with Migraine Experiencing an Inadequate Response to Oral CGRP Inhibitors: Topline Results from the EMERGE Trial Lead Author: Richard B. Lipton, MD, Professor of Neurology and Director of the Montefiore Headache Center, Albert Einstein College of Medicine Presentation Date and Time: Saturday, June 21, 8:50 - 9 a.m. Central Time Session: Industry Abstracts IOR-03 About SYMBRAVO SYMBRAVO (meloxicam and rizatriptan; 20 mg/10 mg tablets) is a novel, oral, single-dose medicine approved for the acute treatment of migraine with or without aura in adults. SYMBRAVO consists of MoSEIC™ meloxicam and rizatriptan. Meloxicam is a new molecular entity for migraine enabled by Axsome’s MoSEIC (Molecular Solubility Enhanced Inclusion Complex) technology, which enables the rapid absorption of meloxicam while maintaining a long plasma half-life. Meloxicam is a COX-2 preferential non-steroidal anti-inflammatory drug (NSAID) and rizatriptan is a 5-HT1B/1D agonist. SYMBRAVO is designed to provide rapid, enhanced, and consistent migraine pain relief, and reduced symptom recurrence. The exact mechanism of action of SYMBRAVO in the treatment of acute migraine is unknown. For more information, visit www.symbravo.com. INDICATION AND IMPORTANT SAFETY INFORMATION What is SYMBRAVO (sim-BRAH-voh)? SYMBRAVO is a combination of meloxicam (an NSAID) and rizatriptan (a triptan). SYMBRAVO is an oral prescription medicine used to treat acute migraine headaches with or without aura in adults. SYMBRAVO is not used to prevent or decrease the number of migraine headaches you have or for treatment of hemiplegic or basilar migraines. SYMBRAVO is not indicated as a treatment for cluster headaches or for use in children. WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT SYMBRAVO? SYMBRAVO may increase the risk of a heart attack or stroke that can lead to death. This risk may happen early in treatment and may increase with increasing doses, and longer use, of NSAIDs. Do not take SYMBRAVO right before or after a heart surgery called a “coronary artery bypass graft” (CABG). Avoid taking SYMBRAVO after a recent heart attack unless your healthcare provider (HCP) tells you to. You may have an increased risk of another heart attack if you take NSAIDs after a recent heart attack. Stop taking SYMBRAVO and get emergency help right away if you have any of the following symptoms which can be indicative of a heart attack or stroke: discomfort in your chest that lasts for more than a few minutes, or that goes away and comes back severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw pain or discomfort in your arms, back, neck, jaw, or stomach shortness of breath with or without chest discomfort breaking out in a cold sweat nausea or vomiting feeling lightheaded weakness in one part or one side of your body slurred speech People with risk factors for heart disease should not take SYMBRAVO unless a heart exam is done and shows no problem. You have higher risk for heart disease if you: have high blood pressure have high cholesterol smoke are overweight have diabetes or a family history of diabetes SYMBRAVO can increase the risk of potentially life-threatening bleeding, ulcers, and tears (perforation) of the esophagus (tube leading from the mouth to the stomach), stomach, and intestines that can occur anytime during use and without warning symptoms. SYMBRAVO may cause serious allergic or skin reactions which can be life-threatening. Stop taking SYMBRAVO and get emergency help right away if you develop: sudden wheezing or problems breathing or swallowing rash or reddening of your skin with blisters or peeling blisters or bleeding of your lips, eye lids, mouth, nose, or genitals swelling of your lips, tongue, throat or body fainting SYMBRAVO already contains an NSAID (meloxicam). Do not use SYMBRAVO with other medicines to lessen pain or fever or with other medicines for colds or sleeping problems without talking to your HCP first, because they may contain an NSAID also. Do not take SYMBRAVO if you: have or had heart problems or right before or after heart bypass surgery have or had a stroke or transient ischemic attack (TIA) take propranolol containing medicines have taken other triptan or ergot- containing medicines within the last 24 hours take an antidepressant medicine called monoamine oxidase inhibitor (MAOI) or have taken a MAOI within the last 2 weeks have or had blood vessel problems of your legs and arms, stomach (ischemic bowel disease), or kidneys have or had hemiplegic or basilar migraines have uncontrolled high blood pressure are allergic to meloxicam, rizatriptan, NSAIDs, or any of the ingredients in SYMBRAVO have had an asthma attack, hives, or other allergic reaction after taking aspirin or any other NSAIDs have moderate to severe kidney problems and are at risk of kidney failure or if you are on dialysis SYMBRAVO may cause serious side effects. These serious side effects include: heartbeats that are too fast or too slow (arrhythmias) new or worse high blood pressure heart failure life-threatening skin reactions liver or kidney problems including organ failure low red blood cell count (anemia) asthma attacks in people who have asthma Medication Overuse Headaches: Some people who use too many SYMBRAVO tablets may have worse headaches. If your headaches get worse, your HCP may decide to stop your treatment with SYMBRAVO. Stop taking SYMBRAVO and get emergency help right away if you have any of the following: Stop taking SYMBRAVO and call your healthcare provider right away if you have any of the following symptoms: nausea vomiting blood more tired or weaker than usual blood in your bowel movement or it is black and sticky like tar diarrhea itching, skin rash, or blisters with fever unusual weight gain your skin or eyes look yellow indigestion or stomach pain swelling of the arms, legs, hands, or feet flu-like symptoms tenderness in your right upper side vision problems COMMON SIDE EFFECTS The most common side effects of SYMBRAVO include dizziness and tiredness. These are not all the possible side effects of SYMBRAVO. Tell your doctor if you have any side effects. You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1–800-FDA-1088. BEFORE USING Tell your HCP about all your medical conditions, including if you: Review the list below with your HCP. SYMBRAVO may not be right for you if: HOW TO TAKE LEARN MORE For more information about SYMBRAVO, call 866-496-2976 or visit SYMBRAVO.com. This summary provides basic information about SYMBRAVO but does not include all information known about this medicine. Read the information that comes with your prescription each time your prescription is filled. This information does not take the place of talking with your doctor. Be sure to talk to your doctor or other HCP about SYMBRAVO and how to take it. Your HCP is the best person to help you decide if SYMBRAVO is right for you. SYM CON BS 01/2025 Please see full Prescribing Information, including Boxed Warning for risk of serious cardiovascular and gastrointestinal adverse events, and Medication Guide. About Axsome Therapeutics Axsome Therapeutics is a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) conditions. We deliver scientific breakthroughs by identifying critical gaps in care and develop differentiated products with a focus on novel mechanisms of action that enable meaningful advancements in patient outcomes. Our industry-leading neuroscience portfolio includes FDA-approved treatments for major depressive disorder, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine, and multiple late-stage development programs addressing a broad range of serious neurological and psychiatric conditions that impact over 150 million people in the United States. Together, we are on a mission to solve some of the brain’s biggest problems so patients and their loved ones can flourish. For more information, please visit us at www.axsome.com and follow us on LinkedIn and X. Forward Looking Statements Certain matters discussed in this press release are “forward-looking statements”. The Company may, in some cases, use terms such as “predicts,” “believes,” “potential,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. In particular, the Company’s statements regarding trends and potential future results are examples of such forward-looking statements. The forward-looking statements include risks and uncertainties, including, but not limited to, the commercial success of the Company’s SUNOSI®, AUVELITY®, and SYMBRAVO® products and the success of the Company’s efforts to obtain any additional indication(s) with respect to solriamfetol and/or AXS-05; the Company’s ability to maintain and expand payer coverage; the success, timing and cost of the Company’s ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including the Company’s ability to fully fund the Company’s disclosed clinical trials, which assumes no material changes to the Company’s currently projected revenues or expenses), futility analyses and receipt of interim results, which are not necessarily indicative of the final results of the Company’s ongoing clinical trials, and/or data readouts, and the number or type of studies or nature of results necessary to support the filing of a new drug application (“NDA”) for any of the Company’s current product candidates; the Company’s ability to fund additional clinical trials to continue the advancement of the Company’s product candidates; the timing of and the Company’s ability to obtain and maintain U.S. Food and Drug Administration (“FDA”) or other regulatory authority approval of, or other action with respect to, the Company’s product candidates, including statements regarding the timing of any NDA submission; the Company’s ability to successfully defend its intellectual property or obtain the necessary licenses at a cost acceptable to the Company, if at all; the Company’s ability to successfully resolve any intellectual property litigation, and even if such disputes are settled, whether the applicable federal agencies will approve of such settlements; the successful implementation of the Company’s research and development programs and collaborations; the success of the Company’s license agreements; the acceptance by the market of the Company’s products and product candidates, if approved; the Company’s anticipated capital requirements, including the amount of capital required for the commercialization of SUNOSI, AUVELITY, and SYMBRAVO and for the Company’s commercial launch of its other product candidates, if approved, and the potential impact on the Company’s anticipated cash runway; the Company’s ability to convert sales to recognized revenue and maintain a favorable gross to net sales; unforeseen circumstances or other disruptions to normal business operations arising from or related to domestic political climate, geo-political conflicts or a global pandemic and other factors, including general economic conditions and regulatory developments, not within the Company’s control. The factors discussed herein could cause actual results and developments to be materially different from those expressed in or implied by such statements. The forward-looking statements are made only as of the date of this press release and the Company undertakes no obligation to publicly update such forward-looking statements to reflect subsequent events or circumstances. Investors: Mark Jacobson Chief Operating Officer (212) 332-3243 mjacobson@axsome.com Media: Darren Opland Director, Corporate Communications (929) 837-1065 dopland@axsome.com Source: Axsome Therapeutics, Inc.

Drug Approval

10 Jun 2025

·axsometherapeuticsinc.gcs-web.com

Axsome Therapeutics Announces Availability of SYMBRAVO® (meloxicam and rizatriptan) for the Acute Treatment of Migraine with or without Aura in Adults

SYMBRAVO represents a novel multi-mechanistic approach to treating migraine that addresses multiple pathways underlying a migraine attack SYMBRAVO On My Side offers comprehensive patient support services including access and prescription drug support NEW YORK, June 10, 2025 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) disorders, today announced that SYMBRAVO® (meloxicam and rizatriptan) is now available by prescription in the United States for the acute treatment of migraine with or without aura in adults.1 SYMBRAVO represents a novel multi-mechanistic approach to treating migraine that targets multiple brain pathways underlying a migraine attack. SYMBRAVO rapidly provides migraine pain freedom and returns patients to normal functioning at 2 hours versus placebo, with lasting pain freedom sustained from 2 to 24 hours in some patients after a single dose. Stewart J. Tepper, MD, Vice President of The New England Institute for Neurology and Headache, said, “Many individuals living with migraine do not achieve adequate pain relief with currently available acute treatments. SYMBRAVO therefore provides a potentially valuable new treatment option as a rapid-acting and durable multi-mechanistic approach. Taken together with the demonstrated data showing effectiveness across a spectrum of migraine severities, I believe that SYMBRAVO offers potentially significant clinical benefits for patients, especially those reporting inadequate relief from migraine pain with their existing treatment program.” Susan Lane Stone, MBA, CEO of the National Headache Foundation (NHF), commented, “The National Headache Foundation educational and advocacy programs encourage the over 40 million Americans (including 31.5 million women and 6.7 million members of the military community) to speak up about their own unique acute migraine journey. Many are still seeking solutions, as they have not yet found relief, so having a new FDA-approved option for the acute treatment of migraine will help address this significant unmet need. For over 50 years, the NHF has been a credible resource for the headache and migraine disorders community. NHF’s awareness and educational initiatives have focused on the recognition that head pain and other bothersome symptoms are very real daily challenges for each person living with migraine attacks.” Ari Maizel, Chief Commercial Officer of Axsome, added, “We are very pleased to launch SYMBRAVO, powered by Axsome’s patented MoSEIC™ technology, and deliver a novel therapy to the millions of people living with migraine. At Axsome, we are intensely committed to improving the lives of patients. To ensure patient access to this important and distinct medicine, we are also providing comprehensive patient support, which includes a SYMBRAVO On My Side savings program for eligible patients as well as educational resources and tools.” Migraine is a debilitating condition characterized by recurrent attacks of pulsating, often severe and disabling head pain, accompanied by nausea, sensitivity to light, and/or sensitivity to sound.2 Migraine affects approximately 40 million people in the U.S. and according to the Global Burden of Disease study in 2019, is the second leading cause of all disability worldwide.3,4 A recent survey of more than 1700 migraine patients showed that 63% were not satisfied with their current treatment plan.5 Resources for Patients and Healthcare Providers For patients, Axsome provides robust and comprehensive support services through the Symbravo On My Side program. The Company’s Symbravo On My Side Savings Card reduces patient out-of-pocket costs for commercially insured eligible patients who qualify. Axsome’s Symbravo On My Side program provides patients with educational resources and tools for patients to facilitate discussions with their healthcare providers. More information on the patient programs and services can be found at symbravo.com. About SYMBRAVO SYMBRAVO (meloxicam and rizatriptan, 20 mg/10mg tablets) is a novel, oral, single-dose medicine approved for the acute treatment of migraine with or without aura in adults. SYMBRAVO consists of MoSEIC™ meloxicam and rizatriptan. Meloxicam is a new molecular entity for migraine enabled by Axsome’s MoSEIC (Molecular Solubility Enhanced Inclusion Complex) technology, which enables the rapid absorption of meloxicam while maintaining a long plasma half-life. Meloxicam is a COX-2 preferential non-steroidal anti-inflammatory drug (NSAID) and rizatriptan is a 5-HT1B/1D agonist. SYMBRAVO is designed to provide rapid, enhanced, and consistent migraine pain relief, and reduced symptom recurrence. The exact mechanism of action of SYMBRAVO in the treatment of acute migraine is unknown. For more information, visit www.symbravo.com. INDICATION AND IMPORTANT SAFETY INFORMATION What is SYMBRAVO (sim-BRAH-voh)? SYMBRAVO is a combination of meloxicam (an NSAID) and rizatriptan (a triptan). SYMBRAVO is an oral prescription medicine used to treat acute migraine headaches with or without aura in adults. SYMBRAVO is not used to prevent or decrease the number of migraine headaches you have or for treatment of hemiplegic or basilar migraines. SYMBRAVO is not indicated as a treatment for cluster headaches or for use in children. WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT SYMBRAVO? SYMBRAVO may increase the risk of a heart attack or stroke that can lead to death. This risk may happen early in treatment and may increase with increasing doses, and longer use, of NSAIDs. Do not take SYMBRAVO right before or after a heart surgery called a “coronary artery bypass graft” (CABG). Avoid taking SYMBRAVO after a recent heart attack unless your healthcare provider (HCP) tells you to. You may have an increased risk of another heart attack if you take NSAIDs after a recent heart attack. Stop taking SYMBRAVO and get emergency help right away if you have any of the following symptoms which can be indicative of a heart attack or stroke: discomfort in your chest that lasts for more than a few minutes, or that goes away and comes back severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw pain or discomfort in your arms, back, neck, jaw, or stomach shortness of breath with or without chest discomfort breaking out in a cold sweat nausea or vomiting feeling lightheaded weakness in one part or one side of your body slurred speech People with risk factors for heart disease should not take SYMBRAVO unless a heart exam is done and shows no problem. You have higher risk for heart disease if you: have high blood pressure have high cholesterol smoke are overweight have diabetes or a family history of diabetes SYMBRAVO can increase the risk of potentially life-threatening bleeding, ulcers, and tears (perforation) of the esophagus (tube leading from the mouth to the stomach), stomach, and intestines that can occur anytime during use and without warning symptoms. SYMBRAVO may cause serious allergic or skin reactions which can be life-threatening. Stop taking SYMBRAVO and get emergency help right away if you develop: sudden wheezing or problems breathing or swallowing rash or reddening of your skin with blisters or peeling blisters or bleeding of your lips, eye lids, mouth, nose, or genitals swelling of your lips, tongue, throat or body fainting SYMBRAVO already contains an NSAID (meloxicam). Do not use SYMBRAVO with other medicines to lessen pain or fever or with other medicines for colds or sleeping problems without talking to your HCP first, because they may contain an NSAID also. Do not take SYMBRAVO if you: have or had heart problems or right before or after heart bypass surgery have or had a stroke or transient ischemic attack (TIA) have or had blood vessel problems of your legs and arms, stomach (ischemic bowel disease), or kidneys have or had hemiplegic or basilar migraines have uncontrolled high blood pressure take propranolol containing medicines have taken other triptan or ergot-containing medicines within the last 24 hours take an antidepressant medicine called monoamine oxidase inhibitor (MAOI) or have taken a MAOI within the last 2 weeks are allergic to meloxicam, rizatriptan, NSAIDs, or any of the ingredients in SYMBRAVO have had an asthma attack, hives, or other allergic reaction after taking aspirin or any other NSAIDs have moderate to severe kidney problems and are at risk of kidney failure or if you are on dialysis SYMBRAVO may cause serious side effects. These serious side effects include: heartbeats that are too fast or too slow (arrhythmias) new or worse high blood pressure heart failure life-threatening skin reactions liver or kidney problems including organ failure low red blood cell count (anemia) asthma attacks in people who have asthma Medication Overuse Headaches: Some people who use too many SYMBRAVO tablets may have worse headaches. If your headaches get worse, your HCP may decide to stop your treatment with SYMBRAVO. Stop taking SYMBRAVO and get emergency help right away if you have any of the following: Stomach and intestinal problems. Symptoms of gastrointestinal and colonic ischemic events may include sudden or severe stomach pains even after meals; sudden weight loss; severe nausea, vomiting, constipation, diarrhea; and bloody diarrhea. Circulation problems to legs and feet. Symptoms of peripheral vascular ischemia may include cramping and pain in your legs and hips; heaviness or tightness in leg muscles; burning, aching, numbness, tingling, or weakness in your legs, feet, or toes; cold feelings or color changes in one or both legs or feet. Serotonin syndrome. Can happen when taking SYMBRAVO with antidepressant medicines called SSRIs or SNRIs. Stop taking SYMBRAVO and call your doctor right away if you have any of the following symptoms: mental status changes including agitation, hallucinations, or coma fast heartbeat changes in your blood pressure increased body temperature tight muscles trouble walking mental status changes including agitation, hallucinations, or coma fast heartbeat changes in your blood pressure increased body temperature tight muscles trouble walking Stop taking SYMBRAVO and call your healthcare provider right away if you have any of the following symptoms: nausea vomiting blood more tired or weaker than usual blood in your bowel movement or it is black and sticky like tar diarrhea itching, skin rash, or blisters with fever unusual weight gain your skin or eyes look yellow indigestion or stomach pain swelling of the arms, legs, hands, or feet flu-like symptoms tenderness in your right upper side vision problems COMMON SIDE EFFECTS The most common side effects of SYMBRAVO include dizziness and tiredness. These are not all the possible side effects of SYMBRAVO. Tell your doctor if you have any side effects. You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1–800-FDA-1088. BEFORE USING Tell your HCP about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. It is important to tell your HCP if you are taking: Propranolol containing medicines such as Inderal® LA or Innopran® XL Aspirin or other anti-coagulants (blood thinners) Medicines to help your mood including SSRIs and SNRIs If you are unsure if you take any of these medicines, ask your HCP. They can tell you if it is safe to take SYMBRAVO with your other medicines. Tell your HCP if you are pregnant or plan to become pregnant. SYMBRAVO is not recommended during pregnancy. Taking NSAIDs, including SYMBRAVO, at about 20 weeks of pregnancy or later may harm your unborn baby. NSAIDs, including SYMBRAVO, should not be taken after about 30 weeks of pregnancy. Tell your HCP if you are breastfeeding or plan to breastfeed. Propranolol containing medicines such as Inderal® LA or Innopran® XL Aspirin or other anti-coagulants (blood thinners) Medicines to help your mood including SSRIs and SNRIs Tell your HCP about all your medical conditions, including if you: have or have had heart problems, high blood pressure, chest pain, or shortness of breath have any risk factors for heart or blood vessel problems have kidney or liver problems have asthma Review the list below with your HCP. SYMBRAVO may not be right for you if: take daily preventative aspirin you are pregnant or plan to become pregnant you are breastfeeding or plan to breastfeed HOW TO TAKE SYMBRAVO is available by prescription only. Take SYMBRAVO exactly as instructed by your HCP. The maximum daily dose of SYMBRAVO is 1 tablet. Talk to your HCP about what to do if your headache does not go away or comes back. Take SYMBRAVO for the shortest time needed. Swallow SYMBRAVO tablets whole. Do not crush, chew, or divide the tablets. SYMBRAVO can be taken with or without food. Do not give SYMBRAVO to other people. If you take too much SYMBRAVO call your poison control center at 1-800-222-1222 or go to the nearest hospital emergency room right away. LEARN MORE For more information about SYMBRAVO, call 866-496-2976 or visit SYMBRAVO.com. This summary provides basic information about SYMBRAVO but does not include all information known about this medicine. Read the information that comes with your prescription each time your prescription is filled. This information does not take the place of talking with your doctor. Be sure to talk to your doctor or other HCP about SYMBRAVO and how to take it. Your HCP is the best person to help you decide if SYMBRAVO is right for you. SYM CON BS 01/2025 Please see full Prescribing Information, including Boxed Warning for risk of serious cardiovascular and gastrointestinal adverse events, and Medication Guide. About Axsome Therapeutics Axsome Therapeutics is a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) conditions. We deliver scientific breakthroughs by identifying critical gaps in care and develop differentiated products with a focus on novel mechanisms of action that enable meaningful advancements in patient outcomes. Our industry-leading neuroscience portfolio includes FDA-approved treatments for major depressive disorder, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine, and multiple late-stage development programs addressing a broad range of serious neurological and psychiatric conditions that impact over 150 million people in the United States. Together, we are on a mission to solve some of the brain’s biggest problems so patients and their loved ones can flourish. For more information, please visit us at www.axsome.com and follow us on LinkedIn and X. Forward Looking Statements Certain matters discussed in this press release are “forward-looking statements”. The Company may, in some cases, use terms such as “predicts,” “believes,” “potential,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. In particular, the Company’s statements regarding trends and potential future results are examples of such forward-looking statements. The forward-looking statements include risks and uncertainties, including, but not limited to, the commercial success of the Company’s SUNOSI®, AUVELITY®, and SYMBRAVO® products and the success of the Company’s efforts to obtain any additional indication(s) with respect to solriamfetol and/or AXS-05; the Company’s ability to maintain and expand payer coverage; the success, timing and cost of the Company’s ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including the Company’s ability to fully fund the Company’s disclosed clinical trials, which assumes no material changes to the Company’s currently projected revenues or expenses), futility analyses and receipt of interim results, which are not necessarily indicative of the final results of the Company’s ongoing clinical trials, and/or data readouts, and the number or type of studies or nature of results necessary to support the filing of a new drug application (“NDA”) for any of the Company’s current product candidates; the Company’s ability to fund additional clinical trials to continue the advancement of the Company’s product candidates; the timing of and the Company’s ability to obtain and maintain U.S. Food and Drug Administration (“FDA”) or other regulatory authority approval of, or other action with respect to, the Company’s product candidates, including statements regarding the timing of any NDA submission; the Company’s ability to successfully defend its intellectual property or obtain the necessary licenses at a cost acceptable to the Company, if at all; the Company’s ability to successfully resolve any intellectual property litigation, and even if such disputes are settled, whether the applicable federal agencies will approve of such settlements; the successful implementation of the Company’s research and development programs and collaborations; the success of the Company’s license agreements; the acceptance by the market of the Company’s products and product candidates, if approved; the Company’s anticipated capital requirements, including the amount of capital required for the commercialization of SUNOSI, AUVELITY, and SYMBRAVO and for the Company’s commercial launch of its other product candidates, if approved, and the potential impact on the Company’s anticipated cash runway; the Company’s ability to convert sales to recognized revenue and maintain a favorable gross to net sales; unforeseen circumstances or other disruptions to normal business operations arising from or related to domestic political climate, geo-political conflicts or a global pandemic and other factors, including general economic conditions and regulatory developments, not within the Company’s control. The factors discussed herein could cause actual results and developments to be materially different from those expressed in or implied by such statements. The forward-looking statements are made only as of the date of this press release and the Company undertakes no obligation to publicly update such forward-looking statements to reflect subsequent events or circumstance. Investors: Mark Jacobson Chief Operating Officer (212) 332-3243 mjacobson@axsome.com Media: Darren Opland Director, Corporate Communications (929) 837-1065 dopland@axsome.com References: Source: Axsome Therapeutics, Inc.

Drug Approval

100 Deals associated with Propranolol Hydrochloride

External Link

KEGG	Wiki	ATC	Drug Bank
D00483	Propranolol Hydrochloride	C07AA05	DB00571

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Hypoxia	Japan	Taiyo Pharma Co., Ltd.	18 Nov 2014
Hemangioma	United States	Pierre Fabre Médicament SAS	14 Mar 2014
Essential Hypertension	Japan	Taiyo Pharma Co., Ltd.	01 Aug 1978
Cardiomyopathy, Hypertrophic	United States	Wyeth Pharmaceuticals LLC	13 Nov 1967
Coronary Artery Disease	United States	Wyeth Pharmaceuticals LLC	13 Nov 1967
Essential Tremor	United States	Wyeth Pharmaceuticals LLC	13 Nov 1967
Hypertension	United States	Wyeth Pharmaceuticals LLC	13 Nov 1967
Migraine Disorders	United States	Wyeth Pharmaceuticals LLC	13 Nov 1967
Myocardial Infarction	United States	Wyeth Pharmaceuticals LLC	13 Nov 1967
Angina Pectoris	Japan	Taiyo Pharma Co., Ltd.	18 Aug 1966
Atrial Fibrillation	Japan	Taiyo Pharma Co., Ltd.	18 Aug 1966
Atrial Premature Complexes	Japan	Taiyo Pharma Co., Ltd.	18 Aug 1966
Bradycardia	Japan	Taiyo Pharma Co., Ltd.	18 Aug 1966
Pheochromocytoma	Japan	Taiyo Pharma Co., Ltd.	18 Aug 1966
Tachycardia	Japan	Taiyo Pharma Co., Ltd.	18 Aug 1966
Tachycardia, Sinus	Japan	Taiyo Pharma Co., Ltd.	18 Aug 1966

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Capillary Hemangioma	Phase 3	United States	Pierre Fabre SA	01 Jan 2010
Capillary Hemangioma	Phase 3	Australia	Pierre Fabre SA	01 Jan 2010
Capillary Hemangioma	Phase 3	Canada	Pierre Fabre SA	01 Jan 2010
Capillary Hemangioma	Phase 3	Czechia	Pierre Fabre SA	01 Jan 2010
Capillary Hemangioma	Phase 3	France	Pierre Fabre SA	01 Jan 2010
Capillary Hemangioma	Phase 3	Germany	Pierre Fabre SA	01 Jan 2010
Capillary Hemangioma	Phase 3	Hungary	Pierre Fabre SA	01 Jan 2010
Capillary Hemangioma	Phase 3	Italy	Pierre Fabre SA	01 Jan 2010
Capillary Hemangioma	Phase 3	Lithuania	Pierre Fabre SA	01 Jan 2010
Capillary Hemangioma	Phase 3	Mexico	Pierre Fabre SA	01 Jan 2010

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04047355 (CTgov)	Phase 2	Aggression \| Developmental Disabilities \| Autistic Disorder ... View more	8	Propranolol (Propranolol Phase)	wlderqktwi(sdisapwoix) = xfgozcxstq yzxlsfeffz (cplejykycs, avmeinvjzo - bwaaviszuf) View more	-	04 Jun 2025
				placebo (Placebo Phase)	wlderqktwi(sdisapwoix) = fqfsxhdorb yzxlsfeffz (cplejykycs, uwntadtbwd - lpxbaayxph) View more
NCT03152786 (CTgov)	Phase 2	Prostatic Cancer	46	Survey Administration+Propranolol Hydrochloride (Group I (Propranolol Hydrochloride))	cfjpclzbhr(cojbzucgym) = pvdcykdxff xeejinooae (uacrhosulc, .33) View more	-	17 Feb 2025
				Survey Administration (Group II (no Treatment))	cfjpclzbhr(cojbzucgym) = iuhosijcro xeejinooae (uacrhosulc, .46) View more
NCT05561751 (ASH2024) Manual	Phase 2	Multiple Myeloma CD34+	20	Propranolol+G-CSF+ Burixafor	babueeoykq(kouilcgbia) = petnkkkjol kciygvyadc (ldcgplxkdu )	Positive	09 Dec 2024
ESC2024	Not Applicable	Ventricular Premature Complexes	-	Propranolol	pakjyinzrk(bcazfrkaru) = mtkxjreofx tokeaviqsh (tiqvuredzq, 7.7)	-	09 Apr 2024
				Propranolol (Catheter Ablation)	pakjyinzrk(bcazfrkaru) = rsdakcugsk tokeaviqsh (tiqvuredzq, 7.7)
NCT04757584 (CTgov)	Phase 4	Heart failure with normal ejection fraction \| Heart Failure, Diastolic	9	Beta blockers (Beta Blocker ABAB Sequence)	yzubkcqzxb = dawqvkctls luaiyrllbz (vlyijzcywf, ljvsyafdzo - bxqcsolnet) View more	-	09 Apr 2024
				Beta blockers (Beta Blocker BABA Sequence)	yzubkcqzxb = cendnxapcp luaiyrllbz (vlyijzcywf, rzzkcvpodb - umuhhizjcb) View more
NCT02428205 (CTgov)	Not Applicable	Autistic Disorder \| Heart Septal Defects, Atrial	10	Propranolol (Propranolol Arm)	vqhqwobbxj(qblbmztndu) = zlhxofphhw okfvihdyhh (nwhxfliark, 14.0) View more	-	04 Mar 2024
				Placebo (Placebo Arm)	vqhqwobbxj(qblbmztndu) = zuisgthyyh okfvihdyhh (nwhxfliark, 15.6) View more
NCT02740166 (Pubmed \| Am J Gastroenterol) Manual	Phase 4	Bleeding esophageal varices cirrhosis	212	EVL plus propranolol till EEV	fpehlfdtmj(lspjacunio) = zicyqhhbqu ijbikrcpsc (ibrqfjrpyu ) View more	Positive	01 Feb 2024
				EVL plus continupropranolololol	fpehlfdtmj(lspjacunio) = cfddusddyu ijbikrcpsc (ibrqfjrpyu ) View more
EADV2023	Not Applicable	Capillary Hemangioma	50	Oral propranolol	objjkxfyec(upuhmxadif) = were seen only in very few cases ecsjlbdvaq (xkhguiieeb )	Positive	11 Oct 2023
EUCTR2014-002018-21-IT (Pubmed \| J Hepatol)	Not Applicable	Fibrosis BH4 \| ADMA \| tHcy	-	5-MTHF+Propranolol	kphijehtzo(mlhgxmxhyf) = qdyxumhify zgdwclbser (rjixkvkkyi, 29 - 9) View more	Positive	01 Oct 2023
				Placebo+Propranolol	etpzkoxihe(cotffbfqeg) = ypsrtkgsyw wwefrvjkpb (akcpiehluh ) View more
NCT04299438 (PROPEL, CTgov)	Phase 3	Pregnancy, Prolonged	164	Propranolol Hydrochloride (Propranolol)	mkphotjqmt = jlqtshbjis qyzmjndlmd (vjdgnywtfv, zmzwbxysza - jdpzaowcyd) View more	-	23 Aug 2023
				Saline (Placebo)	mkphotjqmt = hxftndhlxb qyzmjndlmd (vjdgnywtfv, lpxtobvsjd - rmfbrzapjm) View more

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