Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Revefenacin in · 1 trial · 1 indication
Change from Baseline (Day 1, pre-dose) trough FEV1 on Day 85
Sensitivity analysis results of change from baseline in trough FEV1 (mL) on Day 85 with missing data imputed by last observation carried forward
| Arm | Type | Description |
|---|---|---|
| Revefenacin inhalation solution 175 mcg QD. | EXPERIMENTAL | Revefenacin inhalation solution 175 mcg QD. |
| Placebo inhalation solution QD. | PLACEBO_COMPARATOR | Placebo inhalation solution QD. |
| Name | Type | Description |
|---|---|---|
| Revefenacin 175 mcg in 3 ML Inhalation Solution | DRUG | Revefenacin |
| Placebo inhalation solution QD | DRUG | Placebo |
Inclusion Criteria: * Key inclusion criteria include: * Males and females of Chinese ethnicity, at least 40 years of age. Females may be of either childbearing or non-childbearing potential. All females of childbearing potential must be using an acceptable, highly effective method of contracepti...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| GSK plc Sponsored ADR | GSK | 5 | PHASE3 | Depemokimab |
| Sanofi SA Sponsored ADR | SNY | 7 | PHASE3 | Itepekimab |
| AstraZeneca PLC | AZN | 14 | PHASE3 | Tezepelumab |
| Grifols, S.A. Sponsored ADR Class B | GRFS | 1 | PHASE3 | Alpha-1 MP |
| Pfizer Inc. | PFE | 1 | PHASE2 | PF-07275315 dose 1 |
| Merck & Co., Inc. | MRK | 2 | PHASE2 | Frespaciguat |
| Upstream Bio, Inc. | UPB | 1 | PHASE2 | Verekitug |
| Sunshine Biopharma Incorporated | SBFM | 1 | PHASE3 | 611 |
| Generate Biomedicines, Inc. | GENB | 1 | PHASE1 | GB-0895 |
| United Therapeutics Corporation | UTHR | 1 | PHASE2 | Treprostinil |
| Pulmonx Corp. | LUNG | 3 | - | Undisclosed |
| Baxter International Inc. | BAX | 1 | N/A | Undisclosed |
| Catalyst Pharmaceuticals, Inc. | CPRX | 1 | EARLY_PHASE1 | Undisclosed |
Revefenacin is an investigational small molecule being developed for the treatment of Chronic Obstructive Pulmonary Disease (COPD). It is being studied in patients with moderate to very severe COPD, including those with low peak inspiratory flow rate. The drug is administered as an inhalation solution.
Revefenacin is being developed by Viatris Inc. (NASDAQ: VTRS). The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with Chronic Obstructive Pulmonary Disease (COPD).
Revefenacin is in Phase 3 clinical development for Chronic Obstructive Pulmonary Disease (COPD). Multiple Phase 3 trials have been completed, including studies in the United States and China. The drug is investigational and has not been approved by regulatory authorities.
Revefenacin has completed several clinical trials, including NCT03095456, a Phase 3 study in COPD patients with low peak inspiratory flow rate; NCT03573817, a safety study of Revefenacin and formoterol in COPD; and NCT05046795, a Phase 3 study in Chinese subjects with COPD. A Phase 1 bioavailability study, NCT05207111, was also completed.
No, Revefenacin is not the same as formoterol. They are different drugs that have been studied together in a clinical trial (NCT03573817) to evaluate their safety when administered in sequence and as a combination in patients with Chronic Obstructive Pulmonary Disease.