Continuous versus Bolus Norepinephrine for Preventing Nausea and Vomiting during Spinal-Epidural Anesthesia for Cesarean Delivery: A Single-Center, Double-Blind, Prospective, Randomized Controlled Trial.

Start Date18 Nov 2025

Sponsor / Collaborator-

ChiCTR2500111048

/ Not yet recruitingPhase 3IIT

Vasopressor-Guided Individualized versus Fixed-Duration Hydrocortisone on Outcomes in Patients with Septic Shock: A Multicenter Randomized Non-Inferiority Trial

Start Date01 Nov 2025

Sponsor / Collaborator-

ChiCTR2500110434

/ Not yet recruitingNot ApplicableIIT

Impact of Intraoperative Norepinephrine versus Phenylephrine Infusion on Postoperative Delirium in Geriatric Hip Fracture Surgery: A Randomized Controlled Trial

Start Date01 Oct 2025

Sponsor / Collaborator-

100 Clinical Results associated with Norepinephrine Bitartrate

100 Translational Medicine associated with Norepinephrine Bitartrate

100 Patents (Medical) associated with Norepinephrine Bitartrate

85,840

Literatures (Medical) associated with Norepinephrine Bitartrate

01 Feb 2026·TALANTA

Current trends in sample preparation for liquid chromatography – mass spectrometry analysis of catecholamines and their metabolites in biological samples

Review

Author: Faistauerová, Klára ; Khalikova, Maria ; Lísa, Miroslav

Catecholamines, including dopamine, norepinephrine, and epinephrine, are essential neurotransmitters and hormones that regulate a wide spectrum of physiological functions, such as stress response, mood, and cardiovascular activity. They are closely associated with various health conditions, making both them and their metabolites of great interest as potential biomarkers for diagnosing and monitoring the treatment of different human diseases. The use of catecholamines and their metabolites in research and clinical practice requires sensitive and accurate determination in various biological matrices, each of which presents unique challenges. In this review, we summarize sample preparation methods for liquid chromatography-mass spectrometry (LC-MS) determination of catecholamines and their metabolites in the most widely studied biological samples. We compare methods from the literature published between 2000 and the present for LC-MS analysis of urine, blood, brain, cerebrospinal fluid, and microdialysate samples. The methods are discussed concerning the specific properties of individual sample types, with special emphasis on method validation. Future trends in sample preparation procedures are outlined, including mainly microextraction techniques and automation of sample preparation procedures.

01 Feb 2026·JOURNAL OF CRITICAL CARE

Septic shock: Past, present, and perspectives

Article

Author: Plata-Menchaca, Erika P ; Pérez-Nieto, Orlando Rubén ; Ferrer, Ricard ; Iba, Toshiaki ; Kattan, Eduardo

Septic shock remains one of the most severe complications of infection, defined by circulatory, cellular, and metabolic dysfunction and associated with persistently high mortality. The concept has evolved markedly, from early descriptions of "blood poisoning" to the recognition of sepsis as a systemic syndrome in the late 20th century. Consensus definitions and large clinical trials, including early goal-directed therapy, led to structured treatment bundles and the launch of the Surviving Sepsis Campaign, which have contributed to gradual improvements in survival. Current management emphasizes rapid recognition, timely antimicrobials, source control, fluid resuscitation, and vasopressor support, with norepinephrine as the first-line agent. Nevertheless, significant heterogeneity among patients complicates decision-making, and debate continues around fluid thresholds, timing of vasopressor initiation, and the use of adjunctive therapies such as corticosteroids or immunomodulators. Looking ahead, precision medicine and emerging technologies promise to refine sepsis care. Machine learning and multi-omic approaches are improving risk prediction, enabling identification of sepsis subphenotypes, and guiding individualized treatment strategies. Bedside tools assessing microcirculatory function and rapid biomarker assays may further enhance prognostication and resuscitation. Effective implementation science and rigorous validation of these tools will be critical for translating innovation into improved outcomes. Septic shock management has advanced substantially, yet further progress requires not only personalization and innovation but also concerted efforts to reduce global disparities in access to timely diagnosis, evidence-based treatment, and long-term survivorship care.

01 Jan 2026·PHYSIOLOGY & BEHAVIOR

β-adrenergic regulation of circadian locomotor activity and anesthetic emergence in mice

Article

Author: Marano, Giuseppe ; Ciano Albanese, Naomi ; Maccari, Sonia ; Ricceri, Laura ; Frassanito, Paolo ; Martinelli, Andrea

β2-adrenergic receptors (β2-ARs) are target of catecholamines such as noradrenaline and belong to the family of G protein-coupled receptors. They are distributed in many organs, including the central nervous system. Genetic and pharmacological tools targeting β2-ARs indicate that they mediate a variety of physiological responses. However, their role in the central nervous system remains elusive. Here, we employed β2-adrenergic receptor-deficient (β2-AR KO) mice to elucidate β2-AR role in regulating circadian locomotor activity as well as emergence from general anesthesia. We found that loss of β2-ARs significantly delayed emergence from anesthesia in β2-AR KO mice of both sexes, indicating involvement of β2-adrenergic signaling pathway in the transition from unconsciousness to complete wakefulness. Behaviorally, general locomotor activity in the dark phase and light-to-dark transitions was significantly lower in β2-AR KO mice than in wild type mice of both sexes, whereas dark to light transitions were decreased in β2-AR KO males only. Given that β-ARs play an important role in regulating cardiovascular function and that changes in cardiac performance may induce changes in locomotor activity, heart rate and systolic function were evaluated by echocardiography. These parameters did not differ significantly between KO and wild type mice, suggesting that altered locomotor behaviors in KO mice are not mediated by changes in cardiac performance. Together, these data reveal the functional importance of β2-adrenergic signaling for anesthetic emergence and circadian locomotor activity suggesting that these processes can be affected by drugs which cross the blood-brain barrier and bind to β2-ARs such as lipophilic, non-selective β-blockers.

News (Medical) associated with Norepinephrine Bitartrate

02 Dec 2025

·www.businesswire.com

Fresenius Kabi Expands Operating Room Portfolio with New Simplist ® Prefilled Syringes

LAKE ZURICH, Ill.--(BUSINESS WIRE)--Fresenius Kabi, part of the global healthcare company Fresenius, and a leading provider of essential medicines and medical technologies, announced today it has introduced two new products in its Simplist® portfolio of ready-to-administer prefilled syringes: Simplist® Ephedrine Sulfate Injection, USP and Simplist® Succinylcholine Chloride Injection, USP. Both medications are used in anesthesia and critical care, and their introduction extends the Simplist line’s use into operating rooms, supporting clinicians with safe, efficient and reliable medication delivery. Fresenius Kabi has expanded its Simplist® ready-to-administer portfolio, introducing new presentations that extend its use into operating rooms and support clinicians in anesthesia and critical care. Simplist Succinylcholine Chloride Injection, USP, is a paralytic used in addition to general anesthesia for intubation and during mechanical ventilation in pediatric and adult patients. Simplist Ephedrine Sulfate Injection, USP is indicated for the treatment of clinically important hypotension (low blood pressure) during anesthesia. “As part of our commitment to simplify medication delivery and improve patient safety, the expansion of our Simplist portfolio into the operating room demonstrates how we’re supporting anesthesiologists and nurse anesthetists in their vital work,” said Arun Verma, president of Fresenius Kabi Region U.S. and member of the Executive Leadership Team at Fresenius Kabi AG. “These ready-to-administer medications are designed to help clinicians throughout the hospital by helping to reduce complexity, help minimize waste, and reduce the number of drug-preparation steps where errors can occur.” About the Products: Simplist Succinylcholine Chloride Injection, USP is available in 100 mg per 5 mL (20 mg per mL) and 200 mg per 10 mL (20 mg per mL) strengths. It offers an 18-month shelf life and is stored in a refrigerator at 36°F (2°C) to 46°F (8°C). The single dose prefilled syringes are stable for up to 14 days at room temperature without loss of potency. Simplist Ephedrine Sulfate Injection, USP is available in 25 mg per 5 mL (5 mg per mL) and 50 mg per 10 mL (5 mg per mL) presentations. It can be stored at room temperature and has a 24-month shelf life. Both prefilled syringes are manufactured and prepared by Fresenius Kabi, eliminating the need for assembly or dilution at the point of care to simplify medication administration, enhance workflow efficiency, and support best practices in medication administration safety. To learn more about Fresenius Kabi’s expanding manufacturing and other operations in the U.S., visit www.MoreInAmerica.com. IMPORTANT SAFETY INFORMATION Succinylcholine Chloride Injection, USP WARNING: VENTRICULAR DYSRHYTHMIAS, CARDIAC ARREST, AND DEATH FROM HYPERKALEMIC RHABDOMYOLYSIS IN PEDIATRIC PATIENTS CONTRAINDICATIONS In patients with skeletal muscle myopathies In patients with known hypersensitivity to succinylcholine After the acute phase of injury following major burns, multiple trauma, extensive denervation of skeletal muscle, or upper motor neuron injury In patients with a personal or familial history or suspected genetic susceptibility to malignant hyperthermia WARNINGS AND PRECAUTIONS Anaphylaxis: Severe anaphylactic reactions to neuromuscular blocking agents, including succinylcholine, have been reported. Some cases have been life-threatening and fatal. Take necessary precautions, such as the immediate availability of appropriate emergency treatment. Risk of Death due to Medication Errors: Unintended administration of Succinylcholine Chloride Injection may result in paralysis, respiratory arrest and death. Confirm proper selection of intended product and avoid confusion with other injectable solutions that are present in critical care and other clinical settings. Hyperkalemia: Succinylcholine Chloride Injection may induce serious cardiac arrhythmias or cardiac arrest due to hyperkalemia. Malignant Hyperthermia: Malignant hyperthermia may occur, especially in individuals with known or suspected susceptibility based on genetic factors or family history. Discontinue triggering agents, administer intravenous dantrolene sodium, and apply supportive therapies. Bradycardia: Intravenous bolus administration may result in profound bradycardia or, rarely asystole. The incidence is higher following a second dose of succinylcholine. Pretreatment with anticholinergic agents (e.g. atropine) may reduce the occurrence of bradyarrhythmias. ADVERSE REACTIONS Adverse reactions reported with succinylcholine are cardiac arrest, malignant hyperthermia, arrhythmias, bradycardia, tachycardia, hypertension, hypotension, hyperkalemia, prolonged respiratory depression or apnea. To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176, option 5, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. DRUG INTERACTIONS Drugs that May Enhance the Neuromuscular Blocking Action of Succinylcholine: promazine, oxytocin, aprotinin, certain non-penicillin antibiotics, quinidine, β-adrenergic blockers, procainamide, lidocaine, trimethaphan, lithium carbonate, magnesium salts, quinine, chloroquine, isoflurane, desflurane, metoclopramide, terbutaline, and drugs that reduce plasma cholinesterase activity. INDICATIONS AND USAGE Succinylcholine Chloride Injection is a depolarizing neuromuscular blocker indicated in adults and pediatric patients: As an adjunct to general anesthesia To facilitate tracheal intubation To provide skeletal muscle relaxation during surgery or mechanical ventilation This Important Safety Information does not include all the information needed to use Succinylcholine Chloride Injection, USP safely and effectively. Please see full prescribing information, including BOXED WARNING, for Succinylcholine Chloride Injection, USP 100 mg per 5 mL and 200 mg per 10 at www.fresenius-kabi.com/us. Ephedrine Sulfate Injection, USP WARNINGS AND PRECAUTIONS Pressor Effects with Concomitant Use with Oxytocic Drugs: Pressor effect of sympathomimetic pressor amines is potentiated. Tachyphylaxis and Tolerance: Repeated administration of ephedrine may cause tachyphylaxis. ADVERSE REACTIONS Most common adverse reactions during treatment: nausea, vomiting, and tachycardia. To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176, option 5, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. DRUG INTERACTIONS Interactions that Augment Pressor Effect: clonidine, oxytocin and oxytocic drugs, propofol, monoamine oxidase inhibitors (MAOIs), and atropine. Monitor blood pressure. Interactions that Antagonize the Pressor Effect: Antagonistic effects with α-adrenergic antagonists, β-adrenergic antagonists, reserpine, quinidine, mephentermine. Monitor blood pressure. Guanethidine: Ephedrine may inhibit the neuron blockage produced by guanethidine, resulting in loss of antihypertensive effectiveness. Monitor blood pressure and adjust the dosage of pressor accordingly. Rocuronium: Ephedrine may reduce the onset time of neuromuscular blockade when used for intubation with rocuronium if administered simultaneously with anesthetic induction. Be aware of this potential interaction. No treatment or other interventions are needed. Epidural anesthesia: Ephedrine may decrease the efficacy of epidural blockade by hastening the regression of sensory analgesia. Monitor and treat the patient according to clinical practice. Theophylline: Concomitant use of ephedrine may increase the frequency of nausea, nervousness, and insomnia. Monitor patient for worsening symptoms and manage symptoms according to clinical practice. Cardiac glycosides: Giving ephedrine with a cardiac glycoside, such as digitalis, may increase the possibility of arrhythmias. Carefully monitor patients on cardiac glycosides who are also administered ephedrine. INDICATIONS AND USAGE Ephedrine Sulfate Injection is an alpha- and beta-adrenergic agonist and a norepinephrine-releasing agent that is indicated for the treatment of clinically important hypotension occurring in the setting of anesthesia. This Important Safety Information does not include all the information needed to use Ephedrine Sulfate Injection, USP safely and effectively. Please see full prescribing information, for Ephedrine Sulfate Injection, USP at www.fresenius-kabi.com/us.” About Fresenius Kabi As a global healthcare company, Fresenius Kabi is Committed to Life. The company’s products, technologies, and services are used for the therapy and care of patients with critical and chronic conditions. With more than 41,000 employees and present in more than 100 countries, Fresenius Kabi’s expansive product portfolio focuses on providing access to high-quality and lifesaving essential medicines and technologies. In Biopharma, Fresenius Kabi offers cutting-edge biosimilars for autoimmune diseases and oncology. With leading market positions in Clinical Nutrition, a broad portfolio of enteral and parenteral products makes a distinct difference in patients’ nutritional status. In MedTech, the company provides vital infusion pumps, cell and gene therapy devices, disposables, and more. Fresenius Kabi is a global leader in supplying blood collection bags and devices, supporting blood banks and health care facilities worldwide. The company’s I.V. Generics and Fluids for infusion therapy help save millions of lives every year, in emergency medicine, surgery, oncology, and intensive care. Fresenius Kabi takes a holistic approach to health care and uniquely combines experience, expertise, innovation, and dedication – making a difference in the lives of 450 million patients annually. With the #FutureFresenius strategy, the company is developing, producing, and selling new products and technologies and aspires to expand its position as a leading global provider of therapies, improve patient care, generate sustainable value for stakeholders – shaping the future of healthcare. Fresenius Kabi is part of the Fresenius Group, founded in 1912, along with Helios and Quirónsalud. As ONE team, the companies in the Fresenius Group are committed to providing lifesaving and life-changing healthcare solutions on a global scale. For more information, please visit www.fresenius-kabi.com/us. To learn about U.S. career opportunities at Fresenius Kabi, visit us at www.fresenius-kabi.com/us/join-us and follow us on LinkedIn and Facebook. This release contains forward-looking statements that are subject to various risks and uncertainties. Future results could differ materially from those described in these forward-looking statements due to certain factors, e.g., changes in business, economic and competitive conditions, regulatory reforms, results of clinical trials, foreign exchange rate fluctuations, uncertainties in litigation or investigative proceedings, and the availability of financing. Fresenius Kabi does not undertake any responsibility to update the forward-looking statements in this release.

25 Nov 2025

·www.otsuka.co.jp

Otsuka Pharmaceutical Submits New Drug Application to U.S. FDA for Centanafadine for the Treatment of ADHD in Children, Adolescents, and Adults

RSS Centanafadine is an investigational compound for the treatment of ADHD in children, adolescents, and adults. It is a first-in-class norepinephrine, dopamine, and serotonin reuptake inhibitor (NDSRI). In four pivotal Phase 3 clinical trials evaluating the efficacy and safety of centanafadine across pediatric and adult patient populations, centanafadine demonstrated statistically significant efficacy for the core symptoms of inattention and hyperactivity-impulsivity in ADHD. Clinical and preclinical data suggest centanafadine showed a favorable safety and tolerability profile and a low potential for abuse and dependence. ADHD is a chronic neurodevelopmental disorder characterized primarily by impairments in attention, hyperactivity, and impulsivity. Although historically seen as a childhood disorder, research suggests that many individuals diagnosed with ADHD in childhood continue to experience symptoms into adulthood, with some patients experiencing significant impairment. ADHD is often not diagnosed until adulthood, with an estimated 15.5 million adults in the U.S. currently diagnosed. Otsuka Pharmaceutical Co., Ltd. (Otsuka) and Otsuka Pharmaceutical Development & Commercialization, Inc. announce the filing of a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for centanafadine, once daily extended release capsules, a novel norepinephrine, dopamine, and serotonin reuptake inhibitor (NDSRI), for the treatment of attention-deficit hyperactivity disorder (ADHD) in children, adolescents, and adults. The NDA submission is supported by results from four pivotal Phase 3 clinical trials evaluating the efficacy and safety of centanafadine across patient populations1,2,3. "As an innovator in mental health, we are pleased to take this important step forward in the hope of providing a novel treatment option to patients living with ADHD," said John Kraus, M.D., Ph.D., executive vice president and chief medical officer, Otsuka Pharmaceutical Development & Commercialization, Inc. "Centanafadine represents a first in class mechanism of action among available ADHD therapies, and if approved, may expand the range of options available to those managing this complex condition. We are grateful to the patients and caregivers for their participation in these trials." In Phase 3 clinical studies with children, adolescents, and adults, centanafadine demonstrated statistically significant and clinically meaningful improvements in ADHD symptoms compared with placebo, as measured by the ADHD Rating Scale-5 (ADHD-RS-5) in adolescents and children, and the ADHD Investigator Symptom Rating Scale (AISRS) in adults. Centanafadine was generally well tolerated across studies, with the most common adverse events including decreased appetite, nausea, rash, fatigue, abdominal pain, and somnolence in children and adolescents, and decreased appetite and headache in adults1,2,3. About the Phase 3 Clinical Trial Program The Phase 3 program for centanafadine provides a robust clinical evaluation of the first investigational NDSRI ADHD therapy. The clinical program consists of four different pivotal Phase 3 trials that evaluated the efficacy and safety of centanafadine across children, adolescents, and adults1,2,3. The pivotal Phase 3 trial in children (NCT05428033) was a randomized, double-blind, three-arm, fixed-dose study evaluating the efficacy, safety, and tolerability of centanafadine in children aged 4 to 12 years with ADHD. Participants received a weight-based high dose, low dose, or placebo for 6 weeks. The primary endpoint was the change from baseline in ADHD-RS-5 total score at Week 6. The high-dose group demonstrated statistically significant improvement versus placebo, while the low-dose group did not reach statistical significance. Centanafadine showed a favorable safety and tolerability profile and a low potential for abuse and dependence, with the most frequently reported adverse events including decreased appetite, rash, and vomiting1. The pivotal Phase 3 trial in adolescents (NCT05257265) was a randomized, double-blind, three-arm, fixed-dose study designed to evaluate the efficacy, safety, and tolerability of centanafadine in adolescents aged 13 to 17 years with ADHD. Participants received either a high dose, low dose, or placebo over a 6-week treatment period. The primary endpoint was change from baseline in the ADHD Rating Scale-5 (ADHD-RS-5) total score at Week 6. The high-dose group achieved statistically significant and clinically meaningful reductions in ADHD symptoms compared with placebo. Centanafadine showed a favorable safety and tolerability profile and a low potential for abuse and dependence, with the most common adverse events including decreased appetite, nausea, headache, and rash2. The two pivotal Phase 3 trials in adults (NCT03605680, NCT03605836) were randomized, double-blind, placebo-controlled studies designed to evaluate the efficacy, safety, and tolerability of centanafadine sustained-release (SR) tablet in adults aged 18 to 55 years with ADHD. Participants received either centanafadine 200 mg/day, 400 mg/day, or placebo over a 6-week treatment period. The primary endpoint was the change from baseline in the Adult ADHD Investigator Symptom Rating Scale (AISRS) total score at Week 6. Both centanafadine dose groups demonstrated statistically significant and clinically meaningful improvements versus placebo. In both studies, centanafadine showed a favorable safety and tolerability profile and a low potential for abuse and dependence, with the most common adverse events including decreased appetite and headache3. About Attention-Deficit Hyperactivity Disorder (ADHD) ADHD is a chronic neurodevelopmental disorder characterized primarily by impairments in attention, hyperactivity, and impulsivity4. It affects approximately 7 million children in the U.S. and an estimated 15.5 million adults, according to the Centers for Disease Control and Prevention (CDC)5,6. About Centanafadine Centanafadine is a first-in-class norepinephrine, dopamine, and serotonin reuptake inhibitor (NDSRI). Clinical studies have shown that centanafadine significantly reduces core symptoms of ADHD in children, adolescents, and adults, with a favorable safety and tolerability profile and low potential for abuse. About Otsuka Otsuka Pharmaceutical Co., Ltd. is a total healthcare company that focuses on each individual's potential to enhance their well-being. Our medical-related business provides treatments and diagnostics for both physical and mental health. Our nutraceutical business supports daily health maintenance and improvement. Otsuka's unique products and services are based on scientific evidence, under the guidance of our corporate philosophy: Otsuka-people creating new products for better health worldwide. For further information, please visit www.otsuka.co.jp/en/ 1 References 1 Ward, Caroline L., et al. "Efficacy and safety of centanafadine for ADHD treatment in children: A randomized clinical trial." Pediatrics Open Science, vol. 1, no. 3, 1 July 2025, pp. 1-11, https://doi.org/10.1542/pedsos.2024-000349. 2 Ward, Caroline L., Ann C. Childress, et al. "Centanafadine for attention-deficit/hyperactivity disorder in adolescents: A randomized clinical trial." Journal of the American Academy of Child & Adolescent Psychiatry, July 2025, https://doi.org/10.1016/j.jaac.2025.06.023. 3 Adler, Lenard A., et al. "Efficacy, safety, and tolerability of Centanafadine sustained-release tablets in adults with attention-deficit/hyperactivity disorder." Journal of Clinical Psychopharmacology, vol. 42, no. 5, 2 June 2022, pp. 429-439, https://doi.org/10.1097/jcp.0000000000001575. 4 American Psychiatric Association (2022). Diagnostic and Statistical Manual of Mental Disorders (5th ed., text rev). 5"Data and Statistics on ADHD." Centers for Disease Control and Prevention, Centers for Disease Control and Prevention, www.cdc.gov/adhd/data/index.html. 6 "Facts about ADHD in Adults." Centers for Disease Control and Prevention, Centers for Disease Control and Prevention, www.cdc.gov/adhd/php/adults/.

Clinical ResultPhase 3NDA

20 Oct 2025

·www.fiercepharma.com

Theravance stands up nOH physician education campaign ahead of pivotal data

Its latest campaign is the most recent in a series of actions by Theravance to lay the groundwork for its ampreloxetine. Theravance Biopharma is stepping up efforts to educate physicians about a rare disease, launching its “Power in the Periphery” campaign in the run-up to publication of phase 3 data in the indication.The awareness campaign is focused on the drivers and symptoms of neurogenic orthostatic hypotension (nOH) associated with multiple system atrophy (MSA), a progressive brain disorder. According to Theravance, 70% to 90% of the 50,000 MSA patients in the U.S. have symptoms of nOH, a condition defined by drops in blood pressure after standing, which can lead to lightheadedness, fainting and fatigue.The company used the International Congress of Parkinson’s Disease and Movement Disorders this month to launch its healthcare professional-focused nOH awareness campaign, which also features an accompanying website.The campaign name, “Power in the Periphery,” reflects evidence that MSA mainly affects the central nervous system, while peripheral nerves remain functional and continue producing the neurotransmitter norepinephrine. The website includes text and graphics about different drivers of nOH, explaining that the form of the condition seen in MSA patients is caused by central nervous degeneration. Another section of the website describes how norepinephrine prevents dizziness and fainting. The campaign is the latest in a series of actions by Theravance to lay the groundwork for its ampreloxetine. The molecule is designed to selectively inhibit norepinephrine reuptake, thereby improving standing blood pressure and reducing nOH symptoms. For one, the company surveyed 200 neurologists and cardiologists late last year as part of its launch preparation efforts. More recently, management discussed disease state education, targeted stakeholder engagement and talks with payers on an earnings call in May and provided an update on the activities in August.Theravance is educating physicians and payers in anticipation of phase 3 data on ampreloxetine in nOH due to MSA. The company completed enrollment in the open-label portion of a phase 3 trial in August, putting it on track to report data in the first quarter of 2026. Theravance plans to seek FDA approval if the data are positive.The company began the study in patients with MSA and nOH after a phase 3 trial in a broader population missed its primary endpoint. Theravance initially tested ampreloxetine in patients with nOH linked to a range of conditions, including Parkinson's disease. While that phase 3 trial missed its primary endpoint, the company identified an efficacy signal in a prespecified subgroup of MSA patients.

Phase 3Phase 2

100 Deals associated with Norepinephrine Bitartrate

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KEGG	Wiki	ATC	Drug Bank
D05206	Norepinephrine Bitartrate	C01CA03	DB00368

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Indication	Country/Location	Organization	Date
Shock	Japan	Long Grove Pharmaceuticals LLC	24 Apr 1984
Anesthesia	United States	Hospira, Inc.	13 Jul 1950
Heart Arrest	United States	Hospira, Inc.	13 Jul 1950
Hypotension	United States	Hospira, Inc.	13 Jul 1950
Myocardial Infarction	United States	Hospira, Inc.	13 Jul 1950
Pheochromocytoma	United States	Hospira, Inc.	13 Jul 1950
Poliomyelitis	United States	Hospira, Inc.	13 Jul 1950
Sepsis	United States	Hospira, Inc.	13 Jul 1950

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06158022 (Pubmed \| Drug Des Devel Ther)	Not Applicable	-	60	Norepinephrine	ivwqlafhuk(pwqajieyjh) = loxwysraom tbgouaaewr (zodtxuzsnc, 0.07 - 0.08)	Positive	01 Nov 2025
				Phenylephrine	ivwqlafhuk(pwqajieyjh) = bospakxhjq tbgouaaewr (zodtxuzsnc, 0.85 - 0.95)
NCT05997303 (Pubmed \| Br J Anaesth)	Phase 4	High-Risk Pregnancy	71	Continuous norepinephrine infusion	ubjyvchtem(otyygboikl): P-Value = <0.001	Positive	01 Oct 2025
				Manual bolus norepinephrine administration
NCT05506319 (Pubmed \| Med Intensiva (Engl Ed))	Phase 4	Shock, Septic	-	Norepinephrine reduction	flffxbonby(nbzrytvbvi) = newehqgiwy rbyetykkib (kdyezvqhps )	-	01 Oct 2025
				Vasopressin reduction	flffxbonby(nbzrytvbvi) = crznhcedbn rbyetykkib (kdyezvqhps )
NCT05521152 (Pubmed \| Anaesth Crit Care Pain Med)	Phase 3	Biliary Atresia	-	Norepinephrine infusion	mbjiavlrsd(vazlbyzbvl) = lwippggsfg nsmtmlxmbd (lkqetgyufa )	Positive	01 May 2025
				Placebo saline infusion	mbjiavlrsd(vazlbyzbvl) = kmhdvtpxxo nsmtmlxmbd (lkqetgyufa )
NCT05931601 (EU CT ID 2023-504584-16-00, Pubmed \| Scand J Trauma Resusc Emerg Med)	Phase 3	Shock \| Hypotension	320	Early initiated noradrenaline	lruowgfefs(hntuudmigt) = sebmdyieay hwnfotqqvn (quopvyopgk ) View more	Positive	07 Apr 2025
NCT04501861 (CTgov)	Phase 3	Heart Diseases	153	Vasopressin (The Use of Vasopressin)	jozmnggzjp(oxutmcgasf) = rpxohkfoij levlkdrhno (hwfzktgtvs, 0.086) View more	-	09 Jan 2025
				Norepinephrine (The Use of Norepinephrine)	jozmnggzjp(oxutmcgasf) = hodsvdjkmt levlkdrhno (hwfzktgtvs, 0.094) View more
NCT05133817 (Pubmed) Manual	Not Applicable	Anesthesia \| Hypotension	-	Prophylactic norepinephrine 0 µg/kg/min	hewksrypzs(ucsrvbdhzf) = upgbqhlsht wdmefseycg (mrtwadqask ) View more	Positive	01 Jun 2024
				prophylactic norepinephrine 0.025 µg/kg/min	hewksrypzs(ucsrvbdhzf) = sblvaeshgz wdmefseycg (mrtwadqask )
NCT04701190 (Pubmed \| J Clin Med)	Phase 4	Hypotension	192	Zero-Bolus High-Infusion (Group ZBHI)	ygseipzjmp(nfzrhqpuaa) = fiuutgfidj agihhshypx (jyfpwcabbi )	Positive	10 Oct 2023
NCT03822091 (Pubmed \| Indian J Gastroenterol)	Phase 3	Hepatorenal Syndrome	-	Terlipressin	yxecehxgea(ucpzueftft) = ktpytsoqrx sjwgevcshp (vtllqsryvf ) View more	-	05 May 2023
				Terlipressin and Noradrenaline	yxecehxgea(ucpzueftft) = kcctgyubzo sjwgevcshp (vtllqsryvf ) View more
NCT03849508 (Pubmed \| Anesth Analg)	Phase 4	Anesthesia Maintenance	124	Norepinephrine	tqozszxsli(tbdiffkqkr): ARD = -2.4 (95% CI, -4.4 to -0.5) View more	Positive	24 Oct 2022
				Phenylephrine

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