This section highlights FDA-related milestones and regulatory updates for drugs developed by Theravance Biopharma (TBPH).
Over the past two years, Theravance Biopharma has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
Ampreloxetine and YUPELRI. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Ampreloxetine - FDA Regulatory Timeline and Events
Ampreloxetine is a drug developed by Theravance Biopharma for the following indication: Symptomatic neurogenic orthostatic hypotension.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Ampreloxetine
- Announced Date:
- May 9, 2025
- Indication:
- Symptomatic neurogenic orthostatic hypotension
Announcement
Theravance Biopharma, Inc. announced presentation of analyses of its previous Phase 3 program evaluating ampreloxetine, an investigational medicine for the treatment of symptomatic neurogenic orthostatic hypotension (nOH) at the International MSA Congress, taking place May 9-11 in Boston, Massachusetts.
AI Summary
Theravance Biopharma announced that it will present detailed analyses of its earlier Phase 3 program for ampreloxetine at the International MSA Congress in Boston from May 9–11, 2025. The data comes from a subgroup analysis of the REDWOOD 0170 study, a placebo-controlled, double-blind, randomized withdrawal trial. This study evaluated ampreloxetine in patients with Multiple System Atrophy (MSA) suffering from symptomatic neurogenic orthostatic hypotension (nOH).
The analysis highlighted that patients who received 16 weeks of open-label ampreloxetine showed meaningful improvements in their nOH symptoms measured by the OH Symptom Assessment (OHSA) composite score. Importantly, while patients on ampreloxetine maintained stable symptoms after week 6, those who switched to placebo experienced worsening. These findings support the potential of ampreloxetine to offer durable relief for nOH symptoms in MSA patients, reinforcing its promise as an effective treatment option.
Read Announcement- Drug:
- Ampreloxetine
- Announced Date:
- April 10, 2024
- Indication:
- Symptomatic neurogenic orthostatic hypotension
Announcement
Theravance Biopharma, Inc announced it will host a virtual KOL event on Thursday, May 23, 2024 from 10:00 AM to 11:30 AM ET, featuring Horacio Kaufmann, MD, FAAN (Felicia B. Axelrod Professor of Neurology and Professor of Medicine at New York University Grossman School of Medicine) and Italo Biaggioni, MD (Professor of Medicine and Pharmacology Director, Vanderbilt Autonomic Dysfunction Center), who will discuss the unmet need and current treatment landscape for MSA patients with symptomatic nOH.
AI Summary
Theravance Biopharma, Inc. has announced a virtual Key Opinion Leader (KOL) event scheduled for Thursday, May 23, 2024, from 10:00 AM to 11:30 AM ET. The event will focus on addressing the unmet needs and current treatment landscape for multiple system atrophy (MSA) patients who experience symptomatic neurogenic orthostatic hypotension (nOH). Experts Horacio Kaufmann, MD, FAAN, and Italo Biaggioni, MD, will share their insights during a detailed discussion on this pressing issue. Dr. Kaufmann, a renowned professor from New York University Grossman School of Medicine, and Dr. Biaggioni, a trusted authority at Vanderbilt University, will both contribute their extensive clinical and research knowledge to help advance understanding of MSA and nOH. The event aims to provide valuable updates for healthcare professionals, fostering a collaborative approach to improving patient care in this challenging therapeutic area.
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YUPELRI (Revefenacin) - FDA Regulatory Timeline and Events
YUPELRI (Revefenacin) is a drug developed by Theravance Biopharma for the following indication: Chronic obstructive pulmonary disease (COPD).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- YUPELRI (Revefenacin)
- Announced Date:
- June 26, 2025
- Indication:
- Chronic obstructive pulmonary disease (COPD)
Announcement
Theravance Biopharma, Inc announced that Viatris Inc. ("Viatris"), has secured regulatory approval from China's National Medical Products Administration (NMPA) for YUPELRI® (revefenacin) inhalation solution, the first once–daily nebulized long–acting muscarinic antagonist (LAMA) approved for maintenance treatment of chronic obstructive pulmonary disease (COPD) in China.
AI Summary
Theravance Biopharma, Inc. announced that Viatris Inc. has received regulatory approval from China’s National Medical Products Administration (NMPA) for YUPELRI® (revefenacin) inhalation solution. This makes YUPELRI the first once–daily nebulized long–acting muscarinic antagonist (LAMA) approved in China for the maintenance treatment of chronic obstructive pulmonary disease (COPD). This milestone approval triggers a one-time payment of $7.5 million from Viatris to Theravance Biopharma, expected in Q3 2025. Additionally, Theravance is eligible for further sales-based milestones of up to $37.5 million and tiered royalties ranging from 14% to 20% on net sales in China. Under this agreement, Viatris will handle all aspects of development, launch, and commercialization of YUPELRI in China, ensuring the product reaches patients in need while supporting Theravance’s diversified financial strategy.
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