Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Finasteride active · 1 trial · 1 indication
The primary target area HC was based on the nonvellus hair (\>=30 micrometers \[μm\] in width; thick and noticeable hair) count within a target 2.54 cm (1 inch) diameter circle at the vertex (crown, topmost part of the head). A cosmetic ink dot was placed by tattoo at BL so that the same area could be identified at BL and post-BL. If the ink dot faded, it was re-done in exactly the same location to ensure visibility for subsequent photographs. For the MT, hair was clipped before each photograph; HC was based on hair follicles in the photographs. Change from BL=Week 24 value minus the BL value.
| Arm | Type | Description |
|---|---|---|
| 1mg Finasteride | ACTIVE_COMPARATOR | 1mg finasteride active plus dutasteride placebo, by mouth once daily |
| 0.02mg Dutasteride | ACTIVE_COMPARATOR | 0.02mg dutasteride active plus finasteride placebo, by mouth once daily |
| 0.1mg Dutasteride | ACTIVE_COMPARATOR | 0.1mg dutasteride active plus finasteride placebo, by mouth once daily |
| 0.5mg Dutasteride | ACTIVE_COMPARATOR | 0.5mg dutasteride active plus finasteride placebo, by mouth once daily |
| Placebo | PLACEBO_COMPARATOR | 1mg finasteride placebo plus dutasteride placebo, by mouth once daily |
| Name | Type | Description |
|---|---|---|
| 1mg Finasteride active | DRUG | 1mg finasteride active, by mouth once daily |
| 0.02mg dutasteride | DRUG | 0.02mg dutasteride active, by mouth once daily |
| 0.1mg dutasteride | DRUG | 0.1mg dutasteride active, by mouth once daily |
| 0.5mg dutasteride | DRUG | 0.5mg dutasteride active, by mouth once daily |
| Finasteride placebo | DRUG | finasteride placebo, by mouth once daily |
| Dutasteride placebo | DRUG | dutasteride placebo, by mouth once daily |
Inclusion Criteria: * Norwood-Hamilton Type III vertex, IV, or V Exclusion Criteria: * History or evidence of hair loss other than androgenetic alopecia * Scarring of the scalp * Use of dutasteride in previous 18 months * Use of finasteride within previous 12 months * Hair transplantation or hair...
Finasteride active is used for androgenetic alopecia, a form of hair loss in men. It is a small molecule developed by GSK plc (ticker: GSK) and is in Phase 3 clinical development. The drug is designed to treat male pattern baldness.
Finasteride active targets SRD5A2, also known as 5-alpha-reductase type 2. It acts as an inhibitor of this enzyme. By inhibiting SRD5A2, the drug is intended to reduce the conversion of testosterone to dihydrotestosterone, a hormone implicated in androgenetic alopecia.
Finasteride active is being developed by GSK plc, which trades under the ticker GSK. GSK is the company responsible for advancing this small molecule through clinical development for androgenetic alopecia.
Finasteride active is in Phase 3 clinical development. It is an investigational drug and has not been approved by the FDA for androgenetic alopecia. The Phase 3 trial has been completed, but regulatory approval has not been granted.
Finasteride active has been studied in one completed Phase 3 trial, NCT01231607, titled "Dutasteride Versus Placebo and Finasteride in Men With Androgenetic Alopecia." This randomized, double-blind, placebo-controlled trial enrolled 917 male participants aged 20 years and older across multiple countries.