Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Benzonatate · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Placebo Control |
| Benzonatate | EXPERIMENTAL | Benzonatate Active |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | Placebo - single dose at start of each treatment period |
| Benzonatate - 400 mg | DRUG | Benzonatate - 400 mg single dose |
| Benzonatate - 600 mg | DRUG | Benzonatate - 600 mg single dose |
Inclusion Criteria: * Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG,...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| GSK plc Sponsored ADR | GSK | 2 | PHASE3 | Camlipixant |
| Trevi Therapeutics, Inc. | TRVI | 1 | PHASE2 | Haduvio (nalbuphine ER) |
Benzonatate is an oral small molecule developed for cough, a respiratory condition. It has been studied in a Phase 1 dose tolerance trial in healthy adult volunteers. The drug is investigational in this development program and is not described as approved for cough.
Benzonatate is developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. Pfizer is the sponsor associated with the clinical development program for this cough asset.
Benzonatate is in Phase 1 clinical development for cough. One Phase 1 trial has been completed, and no trials are currently active. The program enrolled a total of 9 participants across its clinical work to date.
Benzonatate has been studied in the Phase 1 Benzonatate Dose Tolerance Study, registered as NCT01690975. That trial was completed, enrolled 9 participants, was randomized, double blind, and placebo controlled, and was conducted in the United States with healthy adult volunteers.