Drugs / Revefenacin
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed chronic obstructive pulmonary disease 1 milestone | |||||
| Filed | US (FDA) | — | chronic obstructive pulmonary disease | 2017-11-13 | “today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration ( FDA ) for revefenacin (TD-4208)” theravance.com ↗ |
| Approved Indication not stated 1 milestone | |||||
| Approved | US (FDA) | YUPELRI | — | 2018-11-09 | fda.gov ↗ |
Trials 17
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 16 trials | ||||||
| Phase 1 | NCT05207111 | Sep 2021 | — | Mylan Pharma UK Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT02820311 | May → Jul 2016 | — | Mylan Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02578082 | Dec 2015 → May 2016 | impaired renal function disease | Mylan Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02581592 | Nov 2015 → Apr 2016 | — | Mylan Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02772159 | Jun 2015 → Apr 2016 | chronic obstructive pulmonary disease | Mylan Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00555022 | Dec 2007 → Apr 2008 | chronic obstructive pulmonary disease | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 25 trials · 3 met primary | ||||||
| Phase 2 | NCT04315558 | Nov 2020 → Jan 2025 | acute respiratory failure, chronic obstructive pulmonary disease | University of California, Los Angeles | Completed | No outcome recorded |
| Phase 2 | NCT02040792 | May → Jul 2014 | chronic obstructive pulmonary disease | Mylan Inc. | Completed | Met primary |
| Phase 2 | NCT02109172 | Apr → Sep 2014 | chronic obstructive pulmonary disease | Mylan Inc. | Completed | No outcome recorded |
| Phase 2 | NCT01704404 | Dec 2012 → Nov 2013 | chronic obstructive pulmonary disease | Mylan Inc. | Completed | Met primary |
| Phase 2 | NCT03064113 | May → Oct 2011 | chronic obstructive pulmonary disease | Mylan Inc. | Completed | Met primary |
| Phase 34 trials · 1 met primary · 1 missed | ||||||
| Phase 3 | NCT05046795 | Nov 2021 → Jul 2023 | chronic obstructive pulmonary disease | Mylan Pharma UK Ltd. | Completed | Met primary |
| Phase 3 | NCT03573817 | May → Sep 2018 | chronic obstructive pulmonary disease | Mylan Inc. | Completed | No outcome recorded |
| Phase 3 | NCT03095456 | Mar → Nov 2017 | chronic obstructive pulmonary disease | Mylan Inc. | Completed | Missed primary |
| Phase 3 | NCT02518139 | Sep 2015 → Jun 2017 | chronic obstructive pulmonary disease | Mylan Inc. | Completed | No outcome recorded |
| Phase 42 trials · 1 missed | ||||||
| Phase 4 | NCT05165485 | Jan 2022 → Nov 2023 | chronic obstructive pulmonary disease | Theravance Biopharma | Completed | Missed primary |
| Phase 4 | NCT04655170 | Dec 2020 → Jan 2023 overdue | chronic obstructive pulmonary disease | University of Tennessee Graduate School of Medicine | Recruiting | No outcome recorded |
| Comparator or background therapy3 trials | ||||||
| Phase 3 | NCT02459080 Comparator | Sep 2015 → Aug 2016 | chronic obstructive pulmonary disease | Mylan Inc. | Completed | No outcome recorded |
| Phase 3 | NCT02512510 Comparator | Sep 2015 → Aug 2016 | chronic obstructive pulmonary disease | Mylan Inc. | Completed | No outcome recorded |
| Phase 4 | NCT07133880 Comparator | Dec 2023 → Dec 2025 overdue | chronic obstructive pulmonary disease | University of Tennessee Graduate School of Medicine | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 15
| Date | Issuer | Release |
|---|---|---|
| 2026-05-18 | Lupin Limited | Regulatory Lupin Receives Tentative Approval from U.S. FDA for Revefenacin Inhalation Solution lupin.com ↗
Mumbai, India, Naples, Fla, May 18, 2026: Global pharma major, Lupin Limited (Lupin) today announced that it has received tentative approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Revefenacin Inhalation Solution, 175 mcg/3 mL Unit-Dose Vials. |
| 2025-10-14 | Theravance Biopharma | Results Theravance Biopharma to Present New Analyses Highlighting YUPELRI® (revefenacin) Outcomes in COPD at the 2025 CHEST Annual Meeting theravance.com ↗
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 |
| 2025-06-26 | Theravance Biopharma | Regulatory Theravance Biopharma Announces Approval of YUPELRI® (revefenacin) by China's NMPA theravance.com ↗
YUPELRI approved by China's NMPA as the first once-daily nebulized LAMA for maintenance treatment of COPD |
| 2024-10-18 | Theravance Biopharma | Results Theravance Announces Publication of YUPELRI® (revefenacin) Area Under the Curve Spirometry Analysis in the International Journal of Chronic Obstructive Pulmonary Disease theravance.com ↗
These data and analyses, published in the International Journal of Chronic Obstructive Pulmonary Disease , reinforce that YUPELRI provides consistent and durable improvements in lung function, as compared with placebo, over a full 24-hours. |
| 2024-01-05 | Theravance Biopharma | Results Theravance Biopharma Announces Results from the Phase 4 YUPELRI® PIFR-2 Study in Patients with Severe to Very Severe Chronic Obstructive Pulmonary Disease (COPD) theravance.com ↗
The study did not show a statistically significant difference between YUPELRI and Spiriva HandiHaler on the primary endpoint, change from baseline in trough forced expiratory volume in one second (FEV 1 ) at Day 85. |
| 2023-11-13 | Pfizer's Upjohn has merged with Mylan to form Viatris Inc. | Results Viatris and Theravance Biopharma Announce Positive Top-Line Results from YUPELRI® (revefenacin) Phase III Trial in China for the Treatment of Chronic Obstructive Pulmonary Disease (COPD) viatris.com ↗
Top-line results showed that YUPELRI met its primary efficacy endpoint demonstrating a statistically significant increase in trough FEV 1 (forced expiratory volume in one second) versus placebo. |
| 2019-05-20 | Theravance Biopharma | Results Theravance Biopharma and Mylan Present Additional YUPELRI® (revefenacin) Phase 3 Data Analysis at the 2019 ATS International Conference theravance.com ↗
The results suggest the use of YUPELRI with LABA or ICS/LABA may provide additional COPD symptom control particularly in patients with more severe disease, though additional studies are needed to confirm any such benefit. |
| 2018-11-09 | Theravance Biopharma | Regulatory Theravance Biopharma and Mylan Receive FDA Approval for YUPELRI™ (revefenacin) in Adults with Chronic Obstructive Pulmonary Disease theravance.com ↗
YUPELRI, a long-acting muscarinic antagonist (LAMA), is the first and only once-daily, nebulized bronchodilator approved for the treatment of COPD in the US. |
| 2018-10-11 | Theravance Biopharma | Results Theravance Biopharma and Mylan Report Positive New Data from Multiple Studies of YUPELRI™ (revefenacin) at the 2018 CHEST Annual Meeting theravance.com ↗
In the intent-to-treat population, the YUPELRI group showed improvements in trough FEV 1 and trough FVC on day 29 compared with tiotropium group; however, these differences did not reach statistical significance. |
| 2018-09-17 | Theravance Biopharma | Results Theravance Biopharma and Mylan Report New Data from Phase 3 Studies of YUPELRI™ (revefenacin) in Oral Presentation at the European Respiratory Society International Congress theravance.com ↗
Presented data showed reductions in the rates of chronic obstructive pulmonary disease (COPD) exacerbations ranging from 15% to 18% in moderate to very severe COPD patients administered once-daily YUPELRI for up to 52 weeks as compared to placebo and tiotropium (Spiriva ® HandiHaler ® ). |
| 2018-02-27 | Theravance Biopharma | Results Theravance Biopharma, Inc. Reports Fourth Quarter and Full Year 2017 Financial Results and Provides Business Update theravance.com ↗
In the pre-specified subgroup of severe and very severe (GOLD 3/4) COPD patients (representing approximately 80% of the patients in the study), revefenacin demonstrated nominally statistically significant and clinically relevant improvements in FEV1 versus tiotropium |
| 2018-01-29 | Theravance Biopharma | Regulatory Theravance Biopharma and Mylan Announce FDA Acceptance of New Drug Application for Revefenacin (TD-4208) in Adults with Chronic Obstructive Pulmonary Disease theravance.com ↗
The acceptance of our NDA moves us closer to providing COPD patients with access to once-daily, nebulized LAMA therapy. |
| 2017-11-13 | Theravance Biopharma | Regulatory Theravance Biopharma and Mylan Submit New Drug Application to FDA for Revefenacin (TD-4208) in Adults with Chronic Obstructive Pulmonary Disease theravance.com ↗
This submission represents a key step in our efforts to bring the first once-daily nebulized LAMA to the COPD patient community. |
| 2017-11-01 | Theravance Biopharma | Results Theravance Biopharma and Mylan Report Additional Positive Phase 3 Data for Revefenacin (TD-4208) in Multiple Presentations at 2017 CHEST Annual Meeting theravance.com ↗
Results demonstrated statistically significant and clinically meaningful improvements for revefenacin over placebo in trough forced expiratory volume in one second (FEV 1 ) at all time points measured in each study over 24 hours post-dose. |
| 2017-05-23 | Theravance Biopharma | Results Theravance Biopharma and Mylan Report Additional Phase 3 Data for Revefenacin (TD-4208) in Several Presentations at 2017 ATS theravance.com ↗
The improvements in trough FEV 1 , the primary efficacy endpoint, versus placebo for the intent-to-treat populations across both studies were 118 mL and 145 mL for 88 mcg and 175 mcg, respectively (p ≤ 0.001). |
All press releases naming this drug 22 releases
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 22 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | revefenacin | “Revefenacin (TD-4208) is a potent, lung-selective, long-acting muscarinic antagonist currently in development as a once-daily nebulized therapy for chronic obstructive...” PMID 28987804 ↗ Oct 2017 |
| Known as | GSK1160724 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00555022 ↗ |
| Known as | Revefenacina | ChEMBL registry synonym — accepted as the source's own label CHEMBL3833319 ↗ |
| Known as | Revefenacine | ChEMBL registry synonym — accepted as the source's own label CHEMBL3833319 ↗ |
| Known as | TD-4208 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02772159 ↗ |
| Known as | Yupelri | “Revefenacin (YUPELRI) & Formoterol (Perforomist)” NCT04655170 ↗1“Revefenacin Inhalation Solution [Yupelri]” NCT04315558 ↗ |
| Action | Inhibit | “Muscarinic acetylcholine receptor M3 antagonist” CHEMBL3833319 ↗1“GSK1160724 is a potent mAChR antagonist” NCT00555022 ↗ |
| Modality | Small molecule | — CHEMBL3833319 ↗ |
| Route | Inhaled | “GSK1160724 will be available with dosing strengths of 10, 50 and 125 micrograms/blister for inhalation using the DISKUS inhaler.” NCT00555022 ↗ |
| Target | CHRM3 | “Muscarinic acetylcholine receptor M3 antagonist” CHEMBL3833319 ↗ |