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SCH 486757 · 2 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| SCH 486757 | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| SCH 486757 | DRUG | SCH 486757 2 x 50-mg capsule twice daily orally for 2 weeks followed by a 2-week washout period and 2 weeks of crossover treatment |
| Placebo Dose 1 | DRUG | Matching placebo capsules twice daily orally for 2 weeks followed by a 2 week washout period and 2 weeks of crossover treatment |
Inclusion Criteria: * Male and female subjects, 18 to \<65 years old, with a history of a dry cough for \>6 months. * By history, evaluation of gastroesophageal reflux disease was done and ruled out by a minimum of an 8-week trial of antacid therapy (with a proton-pump inhibitor \[PPI\] given twice...
SCH 486757 is an investigational small molecule being developed for the treatment of cough. It has been studied in patients with persistent postviral cough and chronic cough. The drug is in Phase 2 clinical development and is not yet approved by regulatory authorities.
SCH 486757 is being developed by Merck & Company, Inc., which trades on the New York Stock Exchange under the ticker symbol MRK. The company is conducting clinical trials to evaluate the drug's efficacy and safety in patients with cough.
SCH 486757 is in Phase 2 clinical development. It has completed two Phase 2 trials, one in persistent postviral cough and one in chronic cough. The drug is investigational and has not been approved by the FDA or other regulatory agencies.
SCH 486757 has completed two Phase 2 clinical trials. The first, NCT00230230, compared the drug to codeine and placebo in 91 subjects with persistent postviral cough. The second, NCT00506987, studied its efficacy and safety in 31 subjects with chronic cough. Both trials were randomized, double-blind, and placebo-controlled.
No, SCH 486757 is not FDA approved. It is an investigational drug currently in Phase 2 clinical development. The completed trials have evaluated its use in cough, but the drug has not received marketing approval from the FDA or any other regulatory body.