Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Revefenacin · 1 trial · 2 indications
Reduction in total inspiratory resistance across the airways and ventilator circuit measured by the change in Static Resistance (Rstat) at the time of drug trough
| Arm | Type | Description |
|---|---|---|
| Revefenacin | EXPERIMENTAL | Revefenacin will be delivered once daily via nebulizer. In order to allow for full blinding and steady Q6 hours regimen in control arm, at hours 6, 12 and 18 after the Revefenacin dose, nebulized normal saline will be delivered. |
| Ipratropium | ACTIVE_COMPARATOR | Nebulized ipratropium will be delivered via nebulizer Q6 hours. |
| Name | Type | Description |
|---|---|---|
| Revefenacin Inhalation Solution [Yupelri] | DRUG | nebulized drug comparison |
| Ipratropium Bromide | DRUG | nebulized drug comparison |
Inclusion Criteria: * Adults ≥ 40 years of age * Acute respiratory failure requiring invasive mechanical ventilation * Documented history of COPD based on spirometric evidence of FEV1/FVC\<70% * Smoking history \>10 years (current or prior) * Invasive mechanical ventilation for \< 96 hours Exclusi...
| 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 |
| Merck & Co., Inc. | MRK | 3 | PHASE2 | Frespaciguat |
| Grifols, S.A. Sponsored ADR Class B | GRFS | 1 | PHASE3 | Alpha-1 MP |
| Pfizer Inc. | PFE | 1 | PHASE2 | PF-07275315 dose 1 |
| 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 |
| ResMed Inc. | RMD | 1 | - | Undisclosed |
| Baxter International Inc. | BAX | 1 | N/A | Undisclosed |
| Catalyst Pharmaceuticals, Inc. | CPRX | 1 | EARLY_PHASE1 | Undisclosed |
| my mhealth Ltd | UBX | 1 | - | Undisclosed |
Revefenacin is an investigational small molecule being studied for the treatment of COPD. It is being evaluated in patients with COPD who also have acute respiratory insufficiency. The drug is currently in Phase 2 clinical development and is not yet approved for any use.
Revefenacin is being developed by Theravance Biopharma, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol TBPH. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with COPD.
Revefenacin is in Phase 2 clinical development. A Phase 2 trial has been completed, and the drug remains investigational. It has not been approved by regulatory authorities, and its safety and efficacy have not been fully established.
Revefenacin has been studied in a completed Phase 2 clinical trial with the identifier NCT04315558. The trial, titled "Revefenacin in Acute Respiratory Insufficiency in COPD," enrolled 21 participants with COPD and acute respiratory failure in the United States. The trial was randomized, double-blind, and active-controlled.
Revefenacin is the drug name used in clinical development. No alternative names have been reported for this investigational compound. It is being studied specifically for its potential role in treating COPD with acute respiratory insufficiency.