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 the treatment of androgenetic alopecia, a common form of hair loss in men. It is a small molecule being developed by GSK plc for this dermatological condition. The drug is currently in Phase 3 clinical development and is being studied in a randomized, double-blind, placebo-controlled trial.
Finasteride active targets the enzyme 5-alpha-reductase, which converts testosterone to dihydrotestosterone (DHT). By inhibiting this enzyme, the drug reduces DHT levels, which is believed to slow hair loss and promote hair regrowth in men with androgenetic alopecia. This mechanism is the basis for its use in treating this condition.
Finasteride active is being developed by GSK plc, a global pharmaceutical company listed on the stock exchange under the ticker GSK. The company is conducting clinical trials to evaluate the drug's safety and efficacy for the treatment of androgenetic alopecia in men.
Finasteride active is in Phase 3 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The Phase 3 trial, identified as NCT01231607, has been completed and involved 917 male participants with androgenetic alopecia.
Finasteride active has one completed Phase 3 clinical trial, NCT01231607, titled 'Dutasteride Versus Placebo and Finasteride in Men With Androgenetic Alopecia.' This randomized, double-blind, placebo-controlled study enrolled 917 men aged 20 years and older across multiple countries, including Argentina, Chile, Japan, Mexico, Peru, Philippines, Russia, Taiwan, and Thailand.
Finasteride active is a formulation of finasteride, a well-known medication for androgenetic alopecia. In the clinical trial NCT01231607, finasteride was used as an active comparator against dutasteride and placebo. The drug is being developed by GSK plc and is currently in Phase 3 development for this indication.