Drugs / Revefenacin
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | YUPELRI | — | 2018-11-09 | fda.gov ↗ |
Trials 17 · a red edge is where a trial was stopped
| 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 | ||||||
| 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 | No outcome recorded |
| 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 | No outcome recorded |
| Phase 2 | NCT03064113 | May → Oct 2011 | chronic obstructive pulmonary disease | Mylan Inc. | Completed | No outcome recorded |
| Phase 34 trials | ||||||
| Phase 3 | NCT05046795 | Nov 2021 → Jul 2023 | chronic obstructive pulmonary disease | Mylan Pharma UK Ltd. | Completed | No outcome recorded |
| 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 | No outcome recorded |
| Phase 3 | NCT02518139 | Sep 2015 → Jun 2017 | chronic obstructive pulmonary disease | Mylan Inc. | Completed | No outcome recorded |
| Phase 42 trials | ||||||
| Phase 4 | NCT05165485 | Jan 2022 → Nov 2023 | chronic obstructive pulmonary disease | Theravance Biopharma | Completed | No outcome recorded |
| Phase 4 | NCT04655170 | Dec 2020 → Jan 2023 overdue | chronic obstructive pulmonary disease | University of Tennessee Graduate School of Medicine | Recruiting | No outcome recorded |
Also used as a comparator or background therapy in 3 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 32 trials | ||||||
| Phase 3 | NCT02512510 Comparator | Sep 2015 → Aug 2016 | chronic obstructive pulmonary disease | Mylan Inc. | Completed | No outcome recorded |
| Phase 3 | NCT02459080 Comparator | Sep 2015 → Aug 2016 | chronic obstructive pulmonary disease | Mylan Inc. | Completed | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT07133880 Comparator | Dec 2023 → Dec 2025 overdue | chronic obstructive pulmonary disease | University of Tennessee Graduate School of Medicine | Recruiting | No outcome recorded |
Press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2023-11-13 | Pfizer's Upjohn has merged with Mylan to form Viatris Inc. | 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 ↗ |
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 NCT02109172 ↗ |
| 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 ↗ |