A Phase 3, Multi-center, Randomized Withdrawal and Long Term Extension Study of Ampreloxetine for the Treatment of Symptomatic Neurogenic Orthostatic Hypotension in Participants With Multiple System Atrophy

This is a Phase 3, multi-center, randomized withdrawal study to evaluate the efficacy and durability of ampreloxetine in participants with MSA and symptomatic nOH after 20 weeks of treatment. This study includes 4 periods: Screening, open label, randomized withdrawal, and long-term treatment extension (LTE).

Start Date27 Jun 2023

Sponsor / Collaborator

Theravance Biopharma, Inc.

NCT04688632

/ CompletedPhase 1

A Phase 1, Randomized, Double-Blind, Placebo- and Positive-Controlled, Thorough QT Study to Evaluate the Effect of Ampreloxetine on Cardiac Repolarization in Healthy Subjects

A double-blind study to characterize the effect of ampreloxetine on cardiac repolarization in healthy subjects.

Start Date18 Jan 2021

Sponsor / Collaborator

Theravance Biopharma, Inc.

NCT04200573

/ CompletedPhase 1

A Phase 1, Open-Label, Single Dose Study to Evaluate the Pharmacokinetics of Ampreloxetine Following a Single-dose in Subjects With Mild, Moderate, and Severe Hepatic Impairment and in Matching Healthy Subjects

An open-label study to characterize the effects of mild, moderate, and severe Hepatic Impairment (HI) on the pharmacokinetics (PK) of ampreloxetine following a single oral dose in comparison with healthy volunteers with normal hepatic function.

Start Date13 Jan 2020

Sponsor / Collaborator

Theravance Biopharma, Inc.

100 Clinical Results associated with Ampreloxetine hydrochloride

100 Translational Medicine associated with Ampreloxetine hydrochloride

100 Patents (Medical) associated with Ampreloxetine hydrochloride

Literatures (Medical) associated with Ampreloxetine hydrochloride

01 Jul 2024·Clinical pharmacology and therapeutics

Hepatic Dysfunction Quantified by HepQuant DuO Outperforms Child‐Pugh Classification in Predicting the Pharmacokinetics of Ampreloxetine

Article

Author: McRae, Michael P. ; Everson, Gregory T. ; Giovinazzo, Hugh ; Bourdet, David L. ; Kanodia, Jitendra ; Helmke, Steve M. ; Yates, Wayne

HepQuant tests quantify liver function from clearance of deuterium‐ and 13C‐labeled cholates administered either intravenously and orally (SHUNT) or orally (DuO). Hepatic impairment studies have relied on clinical or laboratory criteria like Child‐Pugh classification to categorize the degree of hepatic dysfunction. We compared HepQuant tests with Child‐Pugh classification in predicting the pharmacokinetics of ampreloxetine. Twenty‐one subjects with hepatic impairment (8 Child‐Pugh A, 7 Child‐Pugh B, and 6 Child‐Pugh C), and 10 age‐ and sex‐matched controls were studied. The pharmacokinetics of ampreloxetine were measured after oral administration of a single dose of 10 mg. Disease severity index (DSI), portal‐systemic shunting (SHUNT%), hepatic reserve, and hepatic filtration rates (HFRs) were measured from serum samples obtained after intravenous administration of [24‐13C]‐cholate and oral administration of [2,2,4,4‐2H]cholate. Ampreloxetine plasma exposure (AUC0‐inf) was similar to controls in Child‐Pugh A, increased 1.7‐fold in subjects with Child‐Pugh B, and 2.5‐fold in subjects with Child‐Pugh C and correlated with both Child‐Pugh score and HepQuant parameters. The variability observed in ampreloxetine exposure (AUC0‐inf) in subjects with moderate (Child‐Pugh B) and severe hepatic impairment (Child‐Pugh C) was explained by HepQuant parameters. Multivariable regression models demonstrated that DSI, SHUNT%, and Hepatic Reserve from SHUNT and DuO were superior predictors of ampreloxetine exposure (AUC0‐inf) compared to Child‐Pugh score. HepQuant DSI, SHUNT%, and hepatic reserve were more useful predictors of drug exposure than Child‐Pugh class for ampreloxetine and thus may better optimize dose recommendations in patients with liver disease. The simple‐to‐administer, oral‐only DuO version of the HepQuant test could enhance clinical utility.

11 May 2023·Cureus

Ampreloxetine Versus Droxidopa in Neurogenic Orthostatic Hypotension: A Comparative Review

Review

Author: Hoxhaj, Pranvera ; Goyal, Abhishek ; Razzaq, Waleed ; Khawaja, Imran ; Gupta, Ishita ; Khan, Wajiha ; Botlaguduru, Deepti ; Shah, Shruti ; Collado, Gaudy F ; Sadeghzadegan, Amirali ; Abdin, Zain U ; Singh, Saumya ; Muyolema Arce, Veronica E

Neurogenic orthostatic hypotension (nOH) is a disabling problem of autonomic dysfunction in patients with Parkinson's disease, which is associated with poor quality of life and higher mortality rates. The purpose of this literature review was to explore and compare the efficacy and safety of droxidopa (an existing treatment) and ampreloxetine (a newer medication) in the treatment of nOH. We used a mixed-method literature review that addresses the epidemiology, pathophysiology, and pharmacological and non-pharmacological management of nOH in Parkinson's disease in a general way, with a more exploratory approach to droxidopa- and ampreloxetine-controlled trial studies. We included a total of 10 studies of randomized controlled trials with eight studies focused on droxidopaand two studies focused on ampreloxetine. These two drugs were analyzed and compared based on the collected individual study results. Treatment of nOH in Parkinson's disease patients with droxidopa or ampreloxetine showed clinically meaningful and statistically significant improvements relative to placebo on the components of the OHSA (Orthostatic Hypotension Symptom Assessment) composite score and OHDAS (Orthostatic Hypotension Daily Activity Scale composite scores) composite score. Droxidopa had an improved effect on daily activities, with an associated increase in standing systolic blood pressure (BP), but the long-term efficacy of droxidopa has not been documented. Standing systolic BP was maintained by ampreloxetine and worsened after the withdrawal phase. This highlights the importance of conducting further research which will help us to improve the therapeutic approach for patients with nOH and Parkinson's disease.

01 Dec 2021·Clinical autonomic research : official journal of the Clinical Autonomic Research SocietyQ3 · MEDICINE

Safety and efficacy of ampreloxetine in symptomatic neurogenic orthostatic hypotension: a phase 2 trial

Q3 · MEDICINE

Article

Author: Norcliffe-Kaufmann, Lucy ; Shibao, Cyndya A ; Kanodia, Jitendra ; Haumann, Brett ; Wang, Whedy ; Biaggioni, Italo ; Vickery, Ross ; Kaufmann, Horacio

Abstract:

Purpose:

In neurogenic orthostatic hypotension, blood pressure falls when upright owing to impaired release of norepinephrine, leading to dizziness. Ampreloxetine, a selective norepinephrine reuptake inhibitor, increases circulating norepinephrine levels. This study explored the safety of ampreloxetine and its effect on blood pressure and symptoms in patients with neurogenic orthostatic hypotension.

Methods:

A multicenter ascending-dose trial (range 1–20 mg, Part A) was followed by a 1 day, double-blind, randomized, placebo-controlled study (median dose 15 mg, Part B). Eligible patients then enrolled in a 20-week, open-label, steady-state extension phase (median dose 10 mg, Part C) followed by a 4-week withdrawal. Assessments included the Orthostatic Hypotension Symptom Assessment Scale (item 1), supine/seated/standing blood pressure, and safety.

Results:

Thirty-four patients (age 66 ± 8 years, 22 men) were enrolled. Part A: The proportion of participants with a positive response (i.e., increase from baseline in seated systolic blood pressure of ≥ 10 mmHg) was greater with the 5 and 10 mg ampreloxetine doses than with placebo or other active ampreloxetine doses. Part B: Seated blood pressure increased 15.7 mmHg 4 h after ampreloxetine and decreased 14.2 mmHg after placebo [least squares mean difference (95% CI) 29.9 mmHg (7.6–52.3); P = 0.0112]. Part C: Symptoms of dizziness/lightheadedness improved 3.1 ± 3.0 points from baseline and standing systolic blood pressure increased 11 ± 12 mmHg. After 4 weeks of withdrawal, symptoms returned to pretreatment levels. The effect of ampreloxetine on supine blood pressure was minimal throughout treatment duration.

Conclusion:

Ampreloxetine was well tolerated and improved orthostatic symptoms and seated/standing blood pressure with little change in supine blood pressure.

Trial registration:

NCT02705755 (first posted March 10, 2016).

News (Medical) associated with Ampreloxetine hydrochloride

29 Oct 2025

·investor.theravance.com

Theravance Biopharma to Present Data on Ampreloxetine at the 36th International Symposium on The Autonomic Nervous System

Ampreloxetine clinical development program to be featured in four presentations at the upcoming International Symposium on The Autonomic Nervous System Topline results from the ongoing Phase 3 CYPRESS study of ampreloxetine anticipated in Q1 2026 DUBLIN, Oct. 29, 2025 /PRNewswire/ -- Theravance Biopharma, Inc. (NASDAQ: TBPH) today announced that it will be participating at the 36th International Symposium on the Autonomic Nervous System, organized by the American Autonomic Society (AAS), taking place November 5-8, 2025, in Clearwater Beach, FL. The Company will have one platform presentation and three poster presentations on its clinical development program for ampreloxetine, a potential first-in-class norepinephrine reuptake inhibitor in development for the treatment of symptomatic neurogenic orthostatic hypotension (nOH) symptoms due to multiple system atrophy (MSA). "We are excited to have a strong presence at the upcoming International Symposium on the Autonomic Nervous System. Our platform presentation will highlight results from the previous REDWOOD trial, where we observed a durable symptomatic nOH benefit with improvement in activities of daily living in the pre-specified subgroup analysis in patients with MSA treated with ampreloxetine1," commented Lucy Norcliffe-Kaufmann, Ph.D., Theravance Biopharma's Executive Director of Clinical Science. "Additionally, we are pleased to share the rigorous methodologies we developed based on our previous trial experience to support enrollment and patient retention. By applying these insights, we were well positioned to successfully address the executional challenges associated with clinical studies in rare and severe neurodegenerative diseases." Presentations information and key findings: Platform presentation: Precision therapy with ampreloxetine for neurogenic orthostatic hypotension in multiple system atrophy Presenter: Lucy Norcliffe-Kaufmann, Ph.D.; Theravance Biopharma's Executive Director of Clinical Science and Associate Professor, New York University Langone Health Dysautonomia Center Session date and time: Saturday, November 8, 2025, at 8:30 am ET The following three posters will be presented at Poster Session II, taking place on Thursday, November 6, 2025, at 7:00-8:30 pm ET: Poster title: The impact of ampreloxetine on supine hypertension: an ambulatory blood pressure monitoring study Presenter: Lucy Norcliffe-Kaufmann, Ph.D.; Theravance Biopharma's Executive Director of Clinical Science and Associate Professor, New York University Langone Health Dysautonomia Center Poster number: 9 Poster title: Retention strategies in rare disease clinical trials: a case study of symptomatic treatment for multiple system atrophy Presenter: Molly Szpyhulsky, MBA, BSN, RN; Theravance Biopharma U.S. Poster number: 15 Poster title: Enrollment strategies in a phase III trial for MSA-related nOH: insights from global investigators Presenter: Molly Szpyhulsky, MBA, BSN, RN; Theravance Biopharma U.S. Poster number: 10 About Ampreloxetine Ampreloxetine, an investigational, once-daily, selective norepinephrine reuptake inhibitor in development for the treatment of symptomatic neurogenic orthostatic hypotension (nOH) in patients with multiple system atrophy (MSA). The unique benefits of ampreloxetine treatment reported in MSA patients from Study 0170 included an increase in norepinephrine levels, a favorable impact on blood pressure, clinically meaningful and durable symptom improvement, and no signal for worsening of supine hypertension. In the US, the Company has been granted an Orphan Drug Designation for ampreloxetine for the treatment of symptomatic nOH in patients with MSA and, if results from the ongoing Phase 3 CYPRESS study are supportive, plans to file an NDA for full approval in this indication. About the Phase 3 CYPRESS (Study 0197) Study The CYPRESS Study (NCT05696717) is a registrational Phase 3, multi-center, randomized withdrawal study to evaluate the efficacy and durability of ampreloxetine in participants with MSA and symptomatic nOH after 20 weeks of treatment; the primary endpoint of the study is change in the Orthostatic Hypotension Symptom Assessment (OHSA) composite score. The Study includes four periods: screening, open label (12-week period, participants will receive a single daily 10 mg dose of ampreloxetine), randomized withdrawal (eight-week period, double-blind, placebo-controlled, participants will receive a single daily 10 mg dose of placebo or ampreloxetine), and a long-term treatment extension. Secondary outcome measures include change from baseline in Orthostatic Hypotension Daily Activity Scale (OHDAS) item 1 (activities that require standing for a short time) and item 3 (activities that require walking for a short time). About the Phase 3 SEQUOIA (Study 0169) and REDWOOD (Study 0170) Studies Study 0169 (NCT03750552) was a Phase 3, 4-week, multi-center, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of ampreloxetine compared to placebo in patients with symptomatic nOH (n=195). Patients from Study 0169 were eligible to enter into Study 0170 (NCT03829657), a Phase 3, multi-center, 22-week study comprising a 16-week open-label period and a 6-week double-blind, placebo-controlled, randomized withdrawal period to evaluate the sustained benefit in efficacy and safety of ampreloxetine in patients with symptomatic nOH. The primary endpoint for Study 0170 of treatment failure at week 6 was defined as a worsening of both Orthostatic Hypotension Symptom Assessment Scale (OHSA) question #1 and Patient Global Impression of Severity (PGI-S) scores by 1.0 point. After Study 0169 did not meet its primary endpoint, the Company took actions to close out the ongoing clinical program including Study 0170. The study was more than 80% enrolled (n=128/154 planned) despite stopping early. The primary endpoint was not statistically significant for the overall population of patients, which included patients with Parkinson's disease, pure autonomic failure and MSA (odds ratio=0.6; p-value=0.196). The pre-specified subgroup analysis by disease type suggests the benefit seen in patients receiving ampreloxetine was largely driven by MSA patients (n=40). An odds ratio of 0.28 (95% CI: 0.05, 1.22) was observed in MSA patients indicating a 72% reduction in the odds of treatment failure with ampreloxetine compared to placebo. The benefit to MSA patients was observed in multiple endpoints including OHSA composite, Orthostatic Hypotension Daily Activities Scale (OHDAS) composite, Orthostatic Hypotension Questionnaire (OHQ) composite and OHSA #1.1 About Multiple System Atrophy (MSA) and Symptomatic Neurogenic Orthostatic Hypotension (nOH) MSA is a progressive brain disorder that affects movement and balance and disrupts the function of the autonomic nervous system. The autonomic nervous system controls body functions that are mostly involuntary. One of the most frequent autonomic symptoms associated with MSA is a sudden drop in blood pressure upon standing (nOH).2 There are approximately 50,000 MSA patients in the US3 and 70-90% of MSA patients experience nOH symptoms.4 Despite available therapies, many MSA patients remain symptomatic with nOH.5 Neurogenic orthostatic hypotension (nOH) is a rare disorder defined as a fall in systolic blood pressure of ⩾20 mm Hg or diastolic blood pressure of ⩾10 mm Hg, within 3 minutes of standing. Severely affected patients are unable to stand for more than a few seconds because of their decrease in blood pressure, leading to cerebral hypoperfusion and syncope. A debilitating disorder, nOH results in a range of symptoms including dizziness, lightheadedness, fainting, fatigue, blurry vision, weakness, trouble concentrating, and head and neck pain. About Theravance Biopharma Theravance Biopharma, Inc.'s focus is to deliver Medicines that Make a Difference® in people's lives. In pursuit of its purpose, Theravance Biopharma leverages decades of expertise, which has led to the development of FDA-approved YUPELRI® (revefenacin) inhalation solution indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). Ampreloxetine, its late-stage investigational once-daily norepinephrine reuptake inhibitor in development for symptomatic neurogenic orthostatic hypotension (nOH) in patients with Multiple System Atrophy (MSA), has the potential to be a first in class therapy effective in treating a constellation of cardinal symptoms in MSA patients. The Company is committed to creating/driving shareholder value. For more information, please visit www.theravance.com. THERAVANCE BIOPHARMA®, THERAVANCE® and the Cross/Star logo are registered trademarks of the Theravance Biopharma group of companies (in the U.S. and certain other countries). YUPELRI® is a registered trademark of Viatris Specialty LLC. Trademarks, trade names or service marks of other companies appearing on this press release are the property of their respective owners. Forward-Looking Statements This press release will contain certain "forward-looking" statements as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding, among other things, statements relating to goals, plans, objectives, expectations and future events. Theravance Biopharma, Inc. (the "Company") intends such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995. Examples of such statements include statements relating to: the Company's expectations regarding its future profitability, expenses and uses of cash, the Company's goals, designs, strategies, plans and objectives, future growth of YUPELRI sales, future royalty payments, the ability to provide value to shareholders, the Company's regulatory strategies and timing of clinical studies, possible safety, efficacy or differentiation of our investigational therapy, the status of patent infringement litigation initiated by the Company and its partner against certain generic companies in federal district courts; contingent payments due to the Company from the sale of the Company's TRELEGY ELLIPTA royalty interests to Royalty Pharma, and expectations around the use of OHSA scores as endpoints for clinical trials. These statements are based on the current estimates and assumptions of the management of Theravance Biopharma as of the date of this press release and the conference call and are subject to risks, uncertainties, changes in circumstances, assumptions and other factors that may cause the actual results of Theravance Biopharma to be materially different from those reflected in the forward-looking statements. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, among others, risks related to: factors that could increase the Company's cash requirements or expenses beyond its expectations and any factors that could adversely affect its profitability, whether the milestone thresholds can be achieved, delays or difficulties in commencing, enrolling or completing clinical studies, the potential that results from clinical or non-clinical studies indicate the Company's product candidates or product are unsafe, ineffective or not differentiated, risks of decisions from regulatory authorities that are unfavorable to the Company, dependence on third parties to conduct clinical studies, delays or failure to achieve and maintain regulatory approvals for product candidates, risks of collaborating with or relying on third parties to discover, develop, manufacture and commercialize products, and risks associated with establishing and maintaining sales, marketing and distribution capabilities with appropriate technical expertise and supporting infrastructure, the ability of the Company to protect and to enforce its intellectual property rights, volatility and fluctuations in the trading price and volume of the Company's shares, and general economic and market conditions. Other risks affecting the Company are in the Company's Form 10-Q filed with the SEC on August 13, 2025, and other periodic reports filed with the SEC. In addition to the risks described above and in Theravance Biopharma's filings with the SEC, other unknown or unpredictable factors also could affect Theravance Biopharma's results. No forward-looking statements can be guaranteed, and actual results may differ materially from such statements. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Theravance Biopharma assumes no obligation to update its forward-looking statements on account of new information, future events or otherwise, except as required by law. Contact: investor.relations@theravance.com 650-808-4045 1 Freeman R, et al. Precision therapy with ampreloxetine for neurogenic orthostatic hypotension in multiple system atrophy. MedRxiv. https://www.medrxiv.org/content/10.1101/2025.08.12.25332833v1. 2https://medlineplus.gov/genetics/condition/multiple-system-atrophy/ 3 UCSD Neurological Institute (25K-75K, with ~10K new cases per year); NIH National Institute of Neurological Disorders and Stroke (15K-50K). 4 Delveinsight MSA Market Forecast (2023); Symptoms associated with orthostatic hypotension in pure autonomic failure and multiple systems atrophy, CJ Mathias (1999). 5 Data on file. MSA Natural History Statistics, NYU September 2019. View original content to download multimedia:https://www.prnewswire.com/news-releases/theravance-biopharma-to-present-data-on-ampreloxetine-at-the-36th-international-symposium-on-the-autonomic-nervous-system-302597901.html SOURCE Theravance Biopharma, Inc.

Phase 3Orphan DrugClinical Result

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

14 Oct 2025

·investor.theravance.com

Theravance Biopharma to Present New Analyses Highlighting YUPELRI® (revefenacin) Outcomes in COPD at the 2025 CHEST Annual Meeting

A retrospective cohort study of claims data demonstrated that following hospital discharge, patients adherent to YUPELRI experienced significantly fewer, and less severe, exacerbations and had significantly lower healthcare costs than non-adherent patients Post-hoc analyses of a Phase 3 safety study showed that patients taking YUPELRI had significantly lower incidence of moderate-to-severe acute exacerbations, and overall, less severe exacerbations, than patients taking tiotropium DUBLIN , Oct. 14, 2025 /PRNewswire/ -- Theravance Biopharma , Inc. (" Theravance Biopharma " or the "Company") (NASDAQ: TBPH), today announced that it will be presenting two rapid-fire presentations at CHEST 2025, the annual meeting of the American College of Chest Physicians taking place from October 19-22, 2025 , in Chicago, IL. "We are pleased to share new analyses on YUPELRI at the upcoming CHEST Annual Meeting. The findings of the retrospective database analysis of claims data evaluating exacerbations in the 3 months following hospital discharge demonstrates that adherent patients to YUPELRI had significantly fewer exacerbations, and particularly less severe ones, compared to non-adherent patients," commented Antonio Anzueto , M.D., Professor of Medicine, Pulmonary/Critical Section, University of Texas , Health San Antonio. "The analysis not only showed that exacerbations were lower in adherent patients, but also their healthcare-related use and costs were significantly lower, highlighting the dual benefit of YUPELRI on patient outcomes. We are also presenting additional insights from the post-hoc analyses of the 52-week Phase 3 safety study highlighted that the YUPELRI exacerbation profile over 1 year is at least as effective as tiotropium. Taken together, the new analyses further strengthen the already compelling evidence for YUPELRI's use as a once-daily nebulized maintenance treatment for patients with COPD." Details on the presentations are as follows: Title: Exacerbation Rates in COPD Patients: A Retrospective Analysis of the Nebulized Once Daily Long-Acting Muscarinic Antagonist Revefenacin in a 52-Week Safety StudyPresenter: Edmund J Moran, Ph.D., Theravance Biopharma Date and time: October 21, 2025 ; 10:56 – 11:00 AM CT ; Emerging Trends in COPD Title: Adherence to Revefenacin Associated with Reductions in Exacerbations and Healthcare Costs Following a COPD-Related HospitalizationPresenter: Grace Leung, MPH, Zavicus Consulting Date and time: October 21, 2025 ; 2:15 – 2:19 PM CT ; Current Updates in COPD About Theravance Biopharma Theravance Biopharma, Inc.'s focus is to deliver Medicines that Make a Difference® in people's lives. In pursuit of its purpose, Theravance Biopharma leverages decades of expertise, which has led to the development of FDA-approved YUPELRI® (revefenacin) inhalation solution indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). Ampreloxetine, its late-stage investigational once-daily norepinephrine reuptake inhibitor in development for symptomatic neurogenic orthostatic hypotension (nOH) in patients with Multiple System Atrophy (MSA), has the potential to be a first-in-class therapy effective in treating a constellation of cardinal symptoms in MSA patients. The Company is committed to creating/driving shareholder value. For more information, please visit www.theravance.com. THERAVANCE BIOPHARMA ®, THERAVANCE® and the Cross/Star logo are registered trademarks of the Theravance Biopharma group of companies (in the U.S. and certain other countries). YUPELRI® is a registered trademark of Viatris Specialty LLC . Trademarks, trade names or service marks of other companies appearing on this press release are the property of their respective owners. About Theravance Biopharma / Viatris Collaboration Theravance Biopharma and Viatris Inc. and their respective affiliates have established a strategic collaboration to develop and commercialize nebulized revefenacin products for COPD. Forward-Looking Statements This press release contains certain "forward-looking" statements as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding, among other things, statements relating to goals, plans, objectives, expectations and future events. Theravance Biopharma, Inc. (the "Company") intends such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995. Examples of such statements include statements relating to: the Company's expectations regarding its future profitability, expenses and uses of cash, the Company's goals, designs, strategies, plans and objectives, future growth of YUPELRI sales, future royalty payments, the ability to provide value to shareholders, the Company's regulatory strategies and timing of clinical studies, possible safety, efficacy or differentiation of our investigational therapy, the status of patent infringement litigation initiated by the Company and its partner against certain generic companies in federal district courts, contingent payments due to the Company from the sale of the Company's TRELEGY ELLIPTA royalty interests to Royalty Pharma, and expectations around the use of OHSA scores as endpoints for clinical trials. These statements are based on the current estimates and assumptions of the management of Theravance Biopharma as of the date of this press release and are subject to risks, uncertainties, changes in circumstances, assumptions and other factors that may cause the actual results of Theravance Biopharma to be materially different from those reflected in the forward-looking statements. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, among others, risks related to: factors that could increase the Company's cash requirements or expenses beyond its expectations and any factors that could adversely affect its profitability, whether the milestone thresholds can be achieved, delays or difficulties in commencing, enrolling or completing clinical studies, the potential that results from clinical or non-clinical studies indicate the Company's product candidates or product are unsafe, ineffective or not differentiated, risks of decisions from regulatory authorities that are unfavorable to the Company, dependence on third parties to conduct clinical studies, delays or failure to achieve and maintain regulatory approvals for product candidates, risks of collaborating with or relying on third parties to discover, develop, manufacture and commercialize products, and risks associated with establishing and maintaining sales, marketing and distribution capabilities with appropriate technical expertise and supporting infrastructure, the ability of the Company to protect and to enforce its intellectual property rights, volatility and fluctuations in the trading price and volume of the Company's shares, and general economic and market conditions. Other risks affecting the Company are in the Company's Form 10-Q filed with the SEC on August 13, 2025 , and other periodic reports filed with the SEC . In addition to the risks described above and in Theravance Biopharma's filings with the SEC , other unknown or unpredictable factors also could affect Theravance Biopharma's results. No forward-looking statements can be guaranteed, and actual results may differ materially from such statements. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Theravance Biopharma assumes no obligation to update its forward-looking statements on account of new information, future events or otherwise, except as required by law. Contact:investor.relations@theravance.com650-808-4045 View original content to download multimedia:https://www.prnewswire.com/news-releases/theravance-biopharma-to-present-new-analyses-highlighting-yupelri-revefenacin-outcomes-in-copd-at-the-2025-chest-annual-meeting-302583065.html SOURCE Theravance Biopharma, Inc.

Clinical ResultPhase 3Drug Approval

100 Deals associated with Ampreloxetine hydrochloride

External Link

KEGG	Wiki	ATC	Drug Bank
D11688	-	-	DB15348

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Multiple system atrophy, Parkinson's variant	Phase 3	United States	Theravance Biopharma, Inc.	27 Jun 2023
Multiple system atrophy, Parkinson's variant	Phase 3	Argentina	Theravance Biopharma, Inc.	27 Jun 2023
Multiple system atrophy, Parkinson's variant	Phase 3	Australia	Theravance Biopharma, Inc.	27 Jun 2023
Multiple system atrophy, Parkinson's variant	Phase 3	Austria	Theravance Biopharma, Inc.	27 Jun 2023
Multiple system atrophy, Parkinson's variant	Phase 3	Brazil	Theravance Biopharma, Inc.	27 Jun 2023
Multiple system atrophy, Parkinson's variant	Phase 3	Canada	Theravance Biopharma, Inc.	27 Jun 2023
Multiple system atrophy, Parkinson's variant	Phase 3	Denmark	Theravance Biopharma, Inc.	27 Jun 2023
Multiple system atrophy, Parkinson's variant	Phase 3	Estonia	Theravance Biopharma, Inc.	27 Jun 2023
Multiple system atrophy, Parkinson's variant	Phase 3	France	Theravance Biopharma, Inc.	27 Jun 2023
Multiple system atrophy, Parkinson's variant	Phase 3	Germany	Theravance Biopharma, Inc.	27 Jun 2023

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03829657 (S9.002, AAN2025)	Phase 3	Hypertension	186	Ampreloxetine 10 mg/day	rccdmwmxug(qxxezokhcw) = nsqanuntcd ysxjhqhdmc (buwtkaepwo, 16.9)	Positive	07 Apr 2025
				Placebo	rccdmwmxug(qxxezokhcw) = spbsmodkhl ysxjhqhdmc (buwtkaepwo, 17.0)
NCT03829657 (S9.001, AAN2025)	Phase 3	Neurogenic Orthostatic Hypotension	203	Ampreloxetine 10 mg/day	pbghmmgqnz(uwhthtisce) = yvqpkuurrv ukefnrstjq (vxxcycsxnp )	Positive	07 Apr 2025
MDS2023	Phase 3	Multiple System Atrophy	68	Ampreloxetine	fqucimosky(cxcyxwbnqd) = cclkhjjxqs rnfvajznjr (ijnhifygqb )	Positive	27 Aug 2023
MDS2023	Phase 3	-	72	Ampreloxetine	xudttlhytv(ddedqjytbl) = gwhpwsqggd phndbameee (crxhowyarv )	Positive	27 Aug 2023
				Placebo	xudttlhytv(ddedqjytbl) = qiipfassix phndbameee (crxhowyarv )
NCT03829657 (S9.002 \| S9.001 \| REDWOOD, CTgov)	Phase 3	Pure Autonomic Failure \| Multiple System Atrophy \| Neurogenic Orthostatic Hypotension ... View more	203	placebo (RW Treatment Period: Placebo)	qujputhpry(blrnxykewk) = hfqyfvpxbm zzrfqzvdrd (tqevudsizw, 0.068) View more	-	20 Jan 2023
				Ampreloxetine (RW Treatment Period: Ampreloxetine)	qujputhpry(blrnxykewk) = kqxrktiabg zzrfqzvdrd (tqevudsizw, 0.065) View more
NCT04095793 (OAK, CTgov)	Phase 3	Pure Autonomic Failure \| Orthostatic hypertension \| Neurogenic Orthostatic Hypotension	110	ampreloxetine	lzlwwuqleq = melvniwrml cfbcdjztjq (wzvhqdrqdp, vwutzyhsrg - saxifqjxst) View more	-	30 Nov 2022
NCT03829657 (REDWOOD, Corporate Publications) Manual	Phase 3	Neurogenic Orthostatic Hypotension	-	Ampreloxetine	lplggtlvuv(xrmzhfgnda): difference = -1.6 (95% CI, -2.7 to -0.5) View more	Positive	02 Nov 2022
				Placebo
NCT02705755 (CTgov)	Phase 2	Pure Autonomic Failure \| Neurogenic Orthostatic Hypotension \| Parkinson Disease ... View more	34	TD-9855 (Part A: TD-9855 1 mg)	zkhbqiqjhk(gbnmonirdg) = drjyfuzwct utjjmwmaic (yugoliugmt, 18.58) View more	-	26 Sep 2022
				TD-9855 (Part A: TD-9855 2.5 mg)	zkhbqiqjhk(gbnmonirdg) = bumrrudtrr utjjmwmaic (yugoliugmt, 20.27) View more
NCT03750552 (SEQUOIA, CTgov)	Phase 3	Pure Autonomic Failure \| Orthostatic hypertension \| Neurogenic Orthostatic Hypotension	195	ampreloxetine (Ampreloxetine)	vvovrbwlrx(qokiqpjzhr) = eqbtntafmc etmbtyjknk (nmisfwwckx, 0.290) View more	-	14 Sep 2022
				Placebo (Placebo)	vvovrbwlrx(qokiqpjzhr) = gjyrqoghfd etmbtyjknk (nmisfwwckx, 0.293) View more
NCT01458340 (CTgov)	Phase 2	Attention Deficit Disorder With Hyperactivity	295	Placebo	kvemxlgxta(alvloadbpc) = sxkglieqlf xamvmjxmgf (acgrorvacw, 1.21) View more	-	14 Mar 2022

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