Withdrawal of neurohormonal therapy in patients with non-ischemic cardiomyopathy, no late gadolinium enhancement, and negative genetic testing, who have exhibited super-response to cardiac resynchronization therapy. DRUGLESS-CRT clinical trial.

Start Date16 Dec 2025

Sponsor / Collaborator-

CTIS2025-521470-34-00

/ Not yet recruitingPhase 3IIT

A phase 3 randomized, placebo-controlled, triple blind parallel-group study of candesartan in adults with episodic cluster headache (Episodic CandClus2)

Start Date17 Nov 2025

Sponsor / Collaborator

St. Olavs Hospital HF

CTIS2025-521529-34-00

/ Not yet recruitingPhase 3IIT

A multicenter, phase 3, randomized, placebo-controlled, triple-blind crossover study of candesartan for prevention of chronic cluster headache (Chronic CandClus2)

Start Date17 Nov 2025

Sponsor / Collaborator

St. Olavs Hospital HF

100 Clinical Results associated with Candesartan Cilexetil

100 Translational Medicine associated with Candesartan Cilexetil

100 Patents (Medical) associated with Candesartan Cilexetil

3,803

Literatures (Medical) associated with Candesartan Cilexetil

07 Jan 2026·ACS Chemical Neuroscience

Decoding the Neuroprotective Intervention of Angiotensin Receptor Blockers: A Multimodal Approach Using In Silico Network Pharmacology, Molecular Modeling, and In Vivo Validation of Key Markers

Article

Author: Karmakar, Varnita ; Gorain, Bapi ; Ghosh, Arya ; Deb, Pran Kishore ; Majie, Ankit

Angiotensin receptor blockers (ARBs) have been relatively less explored in the field of neuroprotection and dementia; however, ample preclinical and clinical evidence suggests their potential cognitive benefits. Despite these findings, there remains limited evidence on precise mechanistic pathways involved, highlighting the critical need to bridge the gap. In our previous work, we presented the beneficial effect of azilsartan in a dementia model and observed promising neuroprotective outcomes. Building on these findings, this study sought to compare the activity of azilsartan with other commonly used ARBs, including telmisartan, olmesartan, valsartan, eprosartan, irbesartan, and candesartan, using an integrative network pharmacology approach. Our network analysis identified 12 key target proteins implicated in dementia pathology, which were further subjected to docking studies with the seven ARBs, revealing strong binding affinities of azilsartan, olmesartan, and telmisartan with critical signaling proteins, including AKT1, PIK3CA, and PIK3CB. Molecular dynamics simulations further confirmed the stability and favorable interactions of azilsartan with these targets. To experimentally validate these predictions, in vivo studies were conducted in a scopolamine-induced memory-impaired model, which demonstrated significant restoration of the levels of AKT1 and PIK3CA. These findings clearly demonstrate the PI3K/AKT modulating effects of azilsartan, reinforcing its repurposing potential in dementia and related disorders, thereby expanding novel therapeutic opportunities within this drug class.

01 Jan 2026·ARTERIOSCLEROSIS THROMBOSIS AND VASCULAR BIOLOGY

Inverse Agonist Activity of Angiotensin II Receptor Blocker Is Crucial for Prevention of Progressive Aortic Dilatation in Marfan Syndrome

Article

Author: Saga-Kamo, Akiko ; Akazawa, Hiroshi ; Takada, Tappei ; Takeda, Norifumi ; Yagi, Hiroki ; Umei, Masahiko ; Liu, Qing ; Ueda, Kazutaka ; Matsuoka, Ryo ; Okamura, Shun ; Shindo, Akito ; Ueda, Tomomi ; Kadowaki, Hiroshi ; Komuro, Issei ; Ito, Sayo M.

BACKGROUND::

Marfan syndrome is an inherited disorder caused by FBN1 gene mutations, which can lead to thoracic aortic aneurysm and dissection. Selective AT 1 (angiotensin II type 1) receptor blockade is a preventive option against Marfan syndrome aortopathy, and recent clinical studies demonstrated that the inhibitory effect of an ARB (AT 1 receptor blocker) losartan on aortic aneurysm growth is equivalent to that of β-blockers. At present, several ARBs are clinically available, and they have drug-specific differences in pharmacological properties. Especially, inverse agonism of ARBs has potential benefits for cardiovascular protection, but its impact on Marfan syndrome aortopathy remains poorly understood.

METHODS::

Candesartan-7H is a candesartan derivative that lacks the carboxyl group critical for inverse agonist activity and works as a neutral antagonist for the AT 1 receptor. Candesartan cilexetil (1 mg/kg per day), candesartan-7H (1 or 20 mg/kg per day), or vehicle was administered to Fbn1C1041G/+ mice, and aortic dilatation was analyzed using echocardiography, histological staining, and in situ MMP (matrix metalloproteinase) assay. Activation of TGF-β (transforming growth factor β) signaling and mechanosensitive signaling was studied using Western blot and immunohistochemical analysis.

RESULTS::

Candesartan cilexetil (1 mg/kg per day) and candesartan-7H (20 mg/kg per day) lowered blood pressures equally in Fbn1C1041G/+ mice. Progressive dilatation of the aorta in association with aortic wall thickening, degeneration of elastic fibers, deposition of collagen, MMP activation, and TGF-β signaling activation in Fbn1C1041G/+ mice was significantly suppressed by treatment with candesartan cilexetil (1 mg/kg per day), but not by candesartan-7H, even at 20 mg/kg per day. In addition, candesartan cilexetil, but not candesartan-7H, suppressed activation of mechanosensitive signaling involving focal adhesion kinase, p38 mitogen-activated protein kinase, and early growth response-1 in the ascending aorta of Fbn1C1041G/+ mice.

CONCLUSIONS::

Our findings support a crucial role of inverse agonist activity of ARB for the prevention of mechanical stress-induced AT 1 receptor activation and aortic aneurysm progression in Marfan syndrome mice.

31 Dec 2025·BLOOD PRESSURE

A systematic review of commencing full-dose antihypertensives in newly diagnosed hypertension

Review

Author: Karavadra, Babu ; Shantsila, Alena ; Lip, Gregory Y.H. ; Shantsila, Eduard ; d′Elia, Alexander

BACKGROUND:

Hypertension is the UK's most common treatable cause of mortality and morbidity, including cardiovascular disease (CVD), renal disease and dementia.

OBJECTIVE:

This systematic review has explored the efficacy and safety of commencing full-dose antihypertensive treatment in individuals with essential hypertension.

METHOD:

Method16 randomised controlled trials (RCTs) were eligible for inclusion, with some RCTs assessing more than one treatment. The review assessed commonly used antihypertensive drugs (perindopril 8 mg, ramipril 10 mg, amlodipine 10 mg, losartan 100 mg, irbesartan 300 mg, candesartan 16 mg and candesartan 32 mg) compared to low starting doses or placebo RCTs. Eligible studies included 12 RCTs that compared full vs low doses and 19 RCTs that compared full starting doses vs placebo. The primary outcome was the difference in blood pressure reduction compared to controls (reported or calculated). ResultsUsing full doses compared to low doses led to better BP reduction (overall, 3.9/2.2 mmHg lower achieved BP) without an increase in adverse effects. This notion is supported by the changes achieved with full-dose treatment initiation compared to placebo (average over all studies: 11.4 [4.4]/6.5 [2.9] mmHg).

CONCLUSIONS:

This review indicates that initiating full-dose antihypertensives for essential hypertension may be beneficial and safe. The available data are limited, and further RCTs are required to assess this in specific patient groups to assess safety and efficac.

News (Medical) associated with Candesartan Cilexetil

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

09 Aug 2023

·www.prnewswire.com

China Pharma's Candesartan Hypertension Product Passes the Quality and Efficacy Consistency Evaluation of Generic Drugs

HAIKOU, China, Aug. 9, 2023 /PRNewswire/ -- China Pharma Holdings, Inc. (NYSE American: CPHI) ("China Pharma," the "Company" or "We"), a specialty pharmaceutical company, today announced that its wholly-owned subsidiary Hainan Helpson Medical & Biotechnology Co., Ltd. (hereinafter referred to as "Helpson") has received the "Drug Supplementary Application Approval Notice" for its candesartan tablets by National Medical Products Administration of China (hereinafter referred to as NMPA"), indicating that the Company's candesartan tablets have passed the quality and efficacy consistency evaluation of generic drugs. The consistency evaluation of generic drugs evaluates approved generic drugs based on the principle that generic drugs need to reach the same level of quality and efficacy as the innovator drug, and can replace the innovator drug in clinical practice. This not only saves medical expenses, but also ensures the safety and effectiveness of public medication. Candesartan is an angiotensin II antagonist (ARB), suitable for primary hypertension, and is the smallest dose of sartan drugs. The dosage is 4-16mg, once a day. It is the most stable and strongest receptor binding sartan drug. It is tightly bound to four sites of AT1 receptor, with high affinity and slow dissociation characteristics. It is used to maintain stable blood pressure control for 24 hours; reduce the risk of morning spikes caused by blood pressure fluctuations; reduce target organ damage caused by blood pressure fluctuations; help to reduce the hospitalization risk and mortality rate of patients with chronic heart failure, and improve symptoms and exercise ability. According to the 2023 edition of the China Cardiovascular Disease Report compiled by the National Center for Cardiovascular Disease in China, there are currently 290 million cardiovascular disease patients in China, including 270 million hypertensive patients. According to data from Mi Nei Net, the sales of candesartan tablets in urban, county-level public hospitals, and urban retail pharmacies in China in 2021 were RMB226 million (USD$35 million) and RMB173 million (USD$27 million), respectively. Ms. Zhilin Li, China Pharma's Chairman and CEO, commented, "Candesartan tablets have long been one of our flagship products. We are excited that it passed generic-drug-consistency-evaluation. Such achievement not only shows that the quality and efficacy of our Candesartan have been recognized by the NMPA, indicating its ability to replace the innovator drug in clinical practice, but also signifies that it has the qualification to participate in China's national centralized procurement, which will greatly enhance our competitiveness in the field of government procurement." About China Pharma Holdings, Inc. China Pharma Holdings, Inc. is a specialty pharmaceutical company that develops, manufactures and markets a diversified portfolio of products, focusing on conditions with high incidence and high mortality rates in China, including cardiovascular, CNS, infectious, and digestive diseases. The Company's cost-effective business model is driven by market demand and supported by new GMP-certified product lines covering the major dosage forms. In addition, the Company has a broad and expanding nationwide distribution network across all major cities and provinces in China. The Company's wholly-owned subsidiary, Hainan Helpson Medical & Biotechnology Co., Ltd., is located in Haikou City, Hainan Province. For more information about China Pharma Holdings, Inc., please visit . The Company routinely posts important information on its website. Safe Harbor Statement Certain statements in this press release constitute forward-looking statements for purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995. Any statements set forth above that are not historical facts are forward-looking statements that involve risks and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties may include, but are not limited to: the achievability of financial guidance; success of new product development; unanticipated changes in product demand; increased competition; downturns in the Chinese economy; uncompetitive levels of research and development; and other information detailed from time to time in the Company's filings and future filings with the United States Securities and Exchange Commission. The forward-looking statements made herein speak only as of the date of this press release and the Company undertakes no duty to update any forward-looking statement to conform the statement to actual results or changes in the Company's expectations, except as required by applicable law or regulation. For more information, please contact Investor Relations: China Pharma Holdings, Inc. Ms. Diana Na Huang Phone: +86-898-6681-1730 (China) Email: [email protected] SOURCE China Pharma Holdings, Inc.

Drug Approval

01 Nov 2021

·endpts.com

AstraZeneca sells two COPD drugs to a familiar partner as Pascal Soriot's oncology push marches on

As CEO Pascal Soriot continues his long-running pivot toward oncology, AstraZeneca is offloading another pair of respiratory drugs. The drugmaker is selling off two medicines containing the active ingredient aclidinium bromide to Covis Pharma Group, the companies announced Monday morning, and receiving $270 million in return. Covis will also cover ongoing development costs for the drugs, which are marketed as Tudorza and Duaklir in the US. Both medicines treat chronic obstructive pulmonary disease and are delivered using the same device. Tudorza was first approved by the FDA in 2012 and Duaklir in 2019. The meds brought in a combined $143 million in sales last year, AstraZeneca said. Soriot has made oncology AstraZeneca’s new R&D mission as his company continues to push high-profile cancer drugs such as Tagrisso and Imfinzi. The former is AstraZeneca’s best-selling blockbuster, having brought in nearly $2.5 billion in sales in the first half of 2021. Imfinzi didn’t do too bad itself, however, bringing in $1.16 billion. But such an evolution ostensibly requires some small sacrifices, as Soriot has engaged in numerous divestitures in recent years. Most notably, AstraZeneca bid farewell to its one-time megablockbuster Crestor last December, selling rights to German firm Grünenthal for $320 million upfront and $30 million in milestones. That price couldn’t hold a candle to the drug’s former peak sales, when Crestor tallied $6.6 billion in 2011 and $5 billion as recently as 2015. But generics had sharply cut into Crestor sales by 2016, with AstraZeneca failing to block FDA approval in a last-ditch court effort. AstraZeneca had also sold two heart failure and hypertension drugs, Atacand and Atacand Plus, to Cheplapharm for $400 million in October 2020. AstraZeneca’s patents for the drugs in Monday’s deal don’t expire until 2029, according to a public records search of the FDA’s Orange Book, but it’s not clear when their market exclusivity ends. It’s also not the first time Covis has acquired drugs from the big British-Swedish pharma company. In November 2018, AstraZeneca gave Covis global rights to three respiratory drugs for $350 million after selling US rights a year earlier. The drugs were Alvesco, a maintenance therapy for asthma, and Omnaris and Zetonna, nasal sprays for seasonal and perennial rhinitis. The moves fit into Covis’ larger strategy of acquiring several brand name and generic drugs from major biopharmas, as the Swiss firm now says it’s a top 10 global respiratory company. Though the earlier AstraZeneca deal had brought Covis’ only such drugs before Monday’s deal, its portfolio also includes the heartburn drug Prilosec, the cholesterol med Altoprev and the ALS generic drug riluzole.

Generic Drug

100 Deals associated with Candesartan Cilexetil

External Link

KEGG	Wiki	ATC	Drug Bank
D00626	Candesartan Cilexetil	C09CA06	DB00796

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Essential Hypertension	China	Takeda Pharmaceutical Co., Ltd.	12 Sep 2002
Parenchymal renal hypertension	Japan	T’s Pharma Co., Ltd.	12 Mar 1999
Heart Failure	Australia	AstraZeneca Pty Ltd.	29 Jul 1998
Left ventricular systolic dysfunction	Australia	AstraZeneca Pty Ltd.	29 Jul 1998
Hypertension	United States	ANI Pharmaceuticals, Inc.	04 Jun 1998

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Aortic Valve Stenosis	Phase 3	Finland	AstraZeneca PLC	01 May 2009
Migraine With Aura	Phase 3	Norway	AstraZeneca PLC	01 Apr 2009
Migraine Without Aura	Phase 3	Norway	AstraZeneca PLC	01 Apr 2009
Diabetes Mellitus	Phase 3	Germany	Takeda Pharma GmbH	29 Oct 2007
Cardiotoxicity	Phase 3	Netherlands	AstraZeneca PLC	01 Jun 2007
HER2 Positive Breast Cancer	Phase 3	Netherlands	AstraZeneca PLC	01 Jun 2007
Acute myocardial infarction	Phase 3	United States	AstraZeneca PLC	01 Jul 2005
Diabetic Ketoacidosis	Phase 3	United States	AstraZeneca PLC	01 Jul 2005
Stroke	Phase 3	Norway	AstraZeneca PLC	01 Jun 2005
Stroke	Phase 3	Norway	Takeda Pharmaceutical Co., Ltd.	01 Jun 2005

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03640312 (QUARTET USA, Pubmed \| Hypertens Res) Manual	Phase 2	Hypertension Add-on	62	candesartanandesartan 2 mg, amlodipine 1.25 mg, indapamide 0.625 mg, and bisoprolol 2.5 mg)	xblngzwftp(gjadlhemug) = comicyomgu ongtbqpdvy (licmglbgpy ) View more	Positive	08 Apr 2024
				candesartan 8 mgcandesartan 8 mg	-
NCT04138316 (CandeSpartan, Pubmed \| Cephalalgia) Manual	Not Applicable	Migraine Disorders	86	Candesartan	yxsotorgck(wyukfsdtpo) = ycifhsvvqv joauqsczyh (wyiuxzmqin ) View more	Positive	01 Apr 2024
NCT02646982 (CEDAR, CTgov)	Phase 2	Alzheimer Disease \| Mild cognitive disorder	77	Candesartan (Candesartan)	khlofcvdbq = bjuktlrnnu mxlmvdrfui (igykxpmkap, drzbskbzmg - irbxcufyuk) View more	-	29 Sep 2022
				Placebo (Placebo)	khlofcvdbq = omyvkflhew mxlmvdrfui (igykxpmkap, uppopkhevf - kryvxrzhsu) View more
NCT02646982 (Pubmed \| Brain Commun)	Phase 2	Alzheimer Disease	77	Candesartan	kbmfprqvqi(haekahutiz) = ceqbmdrzcp bogyrbgrmr (gykluabiey, 313.27 - 2110.63) View more	-	01 Jan 2022
NCT01678794 (CTgov)	Phase 1/2	Cardio-Renal Syndrome	33	Candesartan (Candesartan)	fptajvlult(aadctkmhkx) = vbdczcucsd vbhxnbciaw (knlxyfchgm, tfgrwgfnxg - aabjlmjwvp) View more	-	18 Nov 2021
				Placebo (Placebo)	fptajvlult(aadctkmhkx) = izbgulowoz vbhxnbciaw (knlxyfchgm, nhnwsyvlml - dcotgzscer) View more
NCT01434134 (PRADA, Pubmed \| Circulation)	Phase 2	Breast Cancer Adjuvant	120	Candesartan cilexetil	qihmpcckfi(viconyfwpx) = gghaaxcdmq lvqooudsll (zfcqnnmcii, 0.5 - 2.8)	-	16 May 2021
				Metoprolol succinate	qihmpcckfi(viconyfwpx) = dzsiynmxdd lvqooudsll (zfcqnnmcii, 0.4 - 2.7)
NCT01984164 (CALIBREX, CTgov)	Phase 2	Mild cognitive disorder \| Hypertension	176	Candesartan (Candesartan)	sjbmnbbncx(qcsfhynrjz) = nlwxyvcppj xdnibvripz (kqddjjdbwp, 5.46) View more	-	21 Feb 2021
				Lisinopril (Lisinopril)	sjbmnbbncx(qcsfhynrjz) = rhrfdspzfm xdnibvripz (kqddjjdbwp, 5.89) View more
NCT01984164 (CALIBREX, AAIC2020)	Phase 2	Mild cognitive disorder	176	Candesartan	opoyvrzadk(baewzcavrf) = cjqmhmjegp lzmkdaiadg (tuzknsptvn ) View more	Positive	07 Dec 2020
				Lisinopril	opoyvrzadk(baewzcavrf) = xynqpyjegg lzmkdaiadg (tuzknsptvn ) View more
NCT01984164 (Pubmed \| JAMA Netw Open)	Phase 2	Mild cognitive disorder	176	Candesartan	qnqkhvjlsj(yanoryrmud): ES = -12.8 (95% CI, -22.5 to -3.1) View more	-	03 Aug 2020
				Lisinopril
NCT00634400 (CHARM, Pubmed \| Contemp Clin Trials)	Phase 3	Heart Failure	-	Candesartan	tjbcwovouy(pokjxgaobk): hazard ratio = 0.91	-	01 Mar 2020
				Placebo

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