Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Terbinafine · 2 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Terbinafine Hydrochloride Tablets 250 mg |
| 2 | ACTIVE_COMPARATOR | Lamisil® Tablets 250 mg |
| Name | Type | Description |
|---|---|---|
| Terbinafine Hydrochloride Tablets 250 mg | DRUG | 250mg, single dose fasting |
| Lamisil® Tablets 250 mg | DRUG | 250mg, single dose fasting |
Inclusion Criteria: 1. Age: 18 years and older. 2. Sex: Male and/or non-pregnant, non-lactating female. 1. Women of childbearing potential must have negative serum beta human chorionic gonadotropin (beta-HCG) pregnancy tests performed within 14 days prior to the start of the study and on the ev...
Terbinafine is a small molecule drug developed by Viatris Inc. (ticker VTRS). It is also known as Terbinafine Hydrochloride Tablets 250 mg. The drug has been studied in Phase 1 clinical trials, with two completed trials involving a total of 72 healthy volunteers.
Terbinafine is made by Viatris Inc., which trades under the ticker symbol VTRS. Viatris is the developer of the Terbinafine Hydrochloride Tablets 250 mg formulation.
Terbinafine is in Phase 1 clinical development. Two Phase 1 trials have been completed, and there are currently no active trials. The drug is investigational and has not been approved by the FDA for any indication.
Terbinafine has been evaluated in two completed Phase 1 trials: NCT00648713, a fed study comparing Terbinafine Hydrochloride Tablets 250 mg to Lamisil 250 mg, and NCT00647647, a fasting study comparing the same formulations. Both enrolled 36 healthy volunteers in the United States.