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.
Select a button below to view the list of FDA events for that drug.
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:
- March 3, 2026
- Indication:
- Symptomatic neurogenic orthostatic hypotension
Announcement
Theravance Biopharma, Inc. announced topline results from the Phase 3 CYPRESS study evaluating the efficacy and safety of ampreloxetine in patients with symptomatic neurogenic orthostatic hypotension (nOH) due to multiple system atrophy (MSA), a rare disease.
AI Summary
Theravance Biopharma announced topline results from the Phase 3 CYPRESS study of ampreloxetine in patients with symptomatic neurogenic orthostatic hypotension (nOH) due to multiple system atrophy (MSA), a rare neurodegenerative disorder that causes dangerous drops in blood pressure on standing. The CYPRESS trial evaluated ampreloxetine’s efficacy and safety in this specific patient population as a potential treatment for nOH symptoms that reduce quality of life and increase fall risk.
The company said it will present an overview of the ongoing CYPRESS study, explaining strategic design choices that were informed by positive findings in the earlier REDWOOD study. Management will also summarize ampreloxetine’s commercial opportunity and go-to-market strategy, followed by a live question-and-answer session for investors and clinicians. Further details will be available from Theravance when they publish full data.
Read Announcement- Drug:
- Ampreloxetine
- Announced Date:
- October 29, 2025
- Target Action Date:
- Q1 2026
- Estimated Target Date Range:
- January 1, 2026 - March 31, 2026
- Indication:
- Symptomatic neurogenic orthostatic hypotension
Announcement
Theravance Biopharma, Inc. announced that the Topline results from the ongoing Phase 3 CYPRESS study of ampreloxetine anticipated in Q1 2026
AI Summary
Theravance Biopharma said that topline results from its Phase 3 CYPRESS study of ampreloxetine are expected in the first quarter of 2026. The CYPRESS study is a multi-center, registrational trial in patients with multiple system atrophy (MSA) who have symptomatic neurogenic orthostatic hypotension (nOH). It includes a 12-week open-label period where all participants receive 10 mg of ampreloxetine daily, followed by an eight-week randomized withdrawal comparing ampreloxetine to placebo.
The main goal is to measure changes in the Orthostatic Hypotension Symptom Assessment composite score after 20 weeks. Secondary measures include daily activity scales that assess standing and walking. Key insights from earlier trials showed durable symptom improvement and no worsening of hypertension. If the CYPRESS results support safety and efficacy, Theravance plans to file for full approval of ampreloxetine in this indication. The company plans to share these results at upcoming meetings and in regulatory filings.
Read Announcement- Drug:
- Ampreloxetine
- Announced Date:
- October 29, 2025
- Indication:
- Symptomatic neurogenic orthostatic hypotension
Announcement
Theravance Biopharma, Inc. 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.
AI Summary
Theravance Biopharma will participate at the 36th International Symposium on the Autonomic Nervous System, organized by the American Autonomic Society, November 5–8, 2025, in Clearwater Beach, FL. It will showcase four presentations on ampreloxetine, a potential first-in-class norepinephrine reuptake inhibitor for symptomatic neurogenic orthostatic hypotension (nOH) in multiple system atrophy (MSA).
The platform presentation, led by Lucy Norcliffe-Kaufmann, Ph.D., will highlight results from the REDWOOD trial, showing durable symptomatic benefits and improved activities of daily living in MSA patients treated with ampreloxetine. Theravance will also share rigorous trial methodologies developed for rare and severe neurodegenerative diseases to support enrollment and patient retention.
On November 6, three poster presentations will cover ampreloxetine’s impact on supine hypertension, trial retention strategies, and global enrollment tactics for MSA-related nOH studies. Topline results from the ongoing Phase 3 CYPRESS study are expected in Q1 2026.
Read Announcement- Drug:
- Ampreloxetine
- Announced Date:
- August 25, 2025
- Indication:
- Symptomatic neurogenic orthostatic hypotension
Announcement
Theravance Biopharma, Inc. announced completion of enrollment in the open-label portion of its pivotal Phase 3 CYPRESS study in patients with symptomatic neurogenic orthostatic hypotension (nOH) due to multiple system atrophy (MSA), a rare and progressive neurodegenerative disorder.
AI Summary
Theravance Biopharma announced that it has finished enrolling patients in the open-label portion of its pivotal Phase 3 CYPRESS study of ampreloxetine for symptomatic neurogenic orthostatic hypotension (nOH) due to multiple system atrophy (MSA). MSA is a rare, progressive brain disorder causing sudden drops in blood pressure upon standing. Affected patients experience dizziness, fainting and blurry vision, which can lead to falls, disability and loss of independence.
In CYPRESS, patients receive daily ampreloxetine for 12 weeks in the open-label phase. Those who respond are then randomly assigned to continue the drug or switch to placebo for eight weeks. The main measure is the change in the Orthostatic Hypotension Symptom Assessment (OHSA) composite score over that period.
Topline results are expected in the first quarter of 2026. If data are positive, Theravance plans an expedited New Drug Application (NDA) submission. Ampreloxetine has U.S. Orphan Drug Designation and could become the first durable treatment for about 40,000 U.S. patients with MSA-related nOH.
Read Announcement- 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
YUPELRI (Revefenacin) FDA Regulatory 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:
- October 14, 2025
- Indication:
- Chronic obstructive pulmonary disease (COPD)
Announcement
Theravance Biopharma, Inc. 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.
AI Summary
Theravance Biopharma, Inc. announced it will present two rapid-fire sessions at CHEST 2025, the annual meeting of the American College of Chest Physicians, held October 19–22, 2025, in Chicago, IL.
In the first presentation, a retrospective cohort study showed that COPD patients who stuck to their once-daily nebulized YUPELRI treatment after hospital discharge had significantly fewer and less severe exacerbations in the following three months. These adherent patients also incurred notably lower healthcare use and costs compared to non-adherent patients. The second presentation reports post-hoc analyses of a 52-week Phase 3 safety study, finding that YUPELRI led to a significantly lower incidence and severity of moderate-to-severe acute exacerbations compared to tiotropium.
Presentation details:
Title: Exacerbation Rates in COPD Patients: A Retrospective Analysis of the Nebulized Once Daily Long-Acting Muscarinic Antagonist Revefenacin in a 52-Week Safety Study
Presenter: Edmund J. Moran, Ph.D. – October 21, 2025, 10:56–11:00 AM CT
Title: Adherence to Revefenacin Associated with Reductions in Exacerbations and Healthcare Costs Following a COPD-Related Hospitalization
Presenter: Grace Leung, MPH – October 21, 2025, 2:15–2:19 PM CT
Read Announcement- 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.
Read Announcement
