Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Gefapixant twice daily · 1 trial · 1 indication
24-hour coughs per hour was defined as the average hourly cough frequency based on 24-hour sound recordings using a digital recording device (cough monitor). A longitudinal analysis of covariance (ANCOVA) model was applied to log-transformed cough data to determine geometric mean (GM) 24-hour coughs per hour at baseline and week 24. The GMR (Week 24 GM 24-hour coughs per hour divided by Baseline GM 24-hour coughs per hour) is reported.
Assessment of participants who have at least one AE during the main study period (24 weeks), the treatment extension period (28 weeks), and during 2 weeks of follow-up by telephone.
Assessment of participants who stop study treatment due to an AE during the main study period (24 weeks) or the treatment extension period (28 weeks).
| Arm | Type | Description |
|---|---|---|
| Gefapixant 45 mg BID | EXPERIMENTAL | Participants will receive a gefapixant 45 mg tablet BID during the main study period (24 weeks) and also during the extension period (28 weeks). |
| Gefapixant 15 mg BID | EXPERIMENTAL | Participants will receive a gefapixant 15 mg tablet BID during the main study period (24 weeks) and also during the extension period (28 weeks). |
| Placebo | PLACEBO_COMPARATOR | Participants will receive a matching placebo tablet BID during the 24-week main study period and during the 28-week extension period. |
| Name | Type | Description |
|---|---|---|
| Gefapixant 45 mg twice daily (BID) | DRUG | Gefapixant 45 mg tablet to be administered orally BID |
| Gefapixant 15 mg BID | DRUG | Gefapixant 15 mg tablet to be administered orally BID |
| Placebo | DRUG | Placebo tablet administered orally BID |
| Gefapixant 45 mg BID | DRUG | Gefapixant 45 mg tablet to be administered orally BID |
Inclusion Criteria: * Chest radiograph or computed tomography scan of the thorax (within 5 years of Screening/Visit 1 and after the onset of chronic cough) not demonstrating any abnormality considered to be significantly contributing to the chronic cough or any other clinically significant lung dis...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| GSK plc Sponsored ADR | GSK | 2 | PHASE3 | Camlipixant |
| Trevi Therapeutics, Inc. | TRVI | 1 | PHASE2 | Haduvio (nalbuphine ER) |
Gefapixant twice daily is an investigational oral small molecule being developed by Merck & Company, Inc. (MRK) for the treatment of chronic cough. It is a P2RX3 antagonist and is also known as Gefapixant 45 mg twice daily (BID).
Gefapixant twice daily is being studied for the treatment of chronic cough in adults. It is not yet approved for any indication and remains in clinical development.
Gefapixant twice daily targets P2RX3, a purinergic receptor. It acts as an antagonist at this receptor, which is thought to play a role in cough reflex sensitivity.
Gefapixant twice daily is being developed by Merck & Company, Inc., which trades on the New York Stock Exchange under the ticker MRK.
Gefapixant twice daily is in Phase 3 clinical development. It is an investigational therapy and has not been approved by the FDA or any other regulatory agency.
Gefapixant twice daily has been evaluated in a Phase 3 trial, NCT04525885, titled A Study of Gefapixant (MK-7264) in Adult Participants With Chronic Cough (MK-7264-030)-China Extension. This completed trial enrolled 161 participants in China.