Product Description
Revefenacin, a once-daily long-acting muscarinic antagonist for nebulization recently approved by the US FDA for the treatment of patients with COPD, was discovered and developed using "duration and lung selectivity-by-design." This strategy selected a molecule with a high lung-selective index to maximize bronchodilation and limit systemic anti-muscarinic side effects. (Sourced from: https://pubmed.ncbi.nlm.nih.gov/31908443/)
Mechanisms of Action: mAChR Antagonist
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral, Inhalant, Intravenous
FDA Designation: *
Approval Status: Approved
Approved Countries: Egypt | Lebanon | Philippines | Saudi Arabia | Singapore | United Arab Emirates | United States
Approved Indications: None
Known Adverse Events: None
Company: VIATRIS & KG
Company Location:
Company CEO:
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: China, United States
Active Clinical Trial Count: 3
Recent & Upcoming Milestones
- Clinical Outcomes Reported - Theravance Biopharma presented P3 Chronic Obstructive Pulmonary Disease results on 2025-10-21 for Revefenacin
Highest Development Phases
Phase 3: Chronic Obstructive Pulmonary Disease
Phase 2: Respiratory Insufficiency
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
NCT04315558 |
RARICO | P2 |
Completed |
Chronic Obstructive Pulmonary Disease|Respiratory Insufficiency |
2025-01-01 |
12% |
2025-08-14 |
|
NCT05046795 |
REV-3001 | P3 |
Completed |
Chronic Obstructive Pulmonary Disease |
2023-07-26 |
42% |
2023-08-19 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
CTR20212308 |
CTR20212308 | P3 |
Completed |
Chronic Obstructive Pulmonary Disease |
2023-07-26 |
2025-04-29 |
Patient Enrollment|Primary Completion Date|Start Date|Study Completion Date|Treatments|Trial Status |
Recent News Events
Date |
Type |
Title |
|---|---|---|
|
11/20/2025 |
News Article |
Theravance Biopharma to Host Virtual KOL Investor Event to Review Ampreloxetine Phase 3 Clinical Development Program, Ahead of Topline Data in Q1 2026, on December 8, 2025 |
|
11/19/2025 |
News Article |
Theravance Biopharma to Participate in Upcoming Investor Conferences |
|
10/29/2025 |
News Article |
Theravance Biopharma to Present Data on Ampreloxetine at the 36th International Symposium on The Autonomic Nervous System |
|
10/27/2025 |
News Article |
Theravance Biopharma to Report Third Quarter 2025 Financial Results on November 10, 2025 |