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Also known as Clascoterone 5% solution
Clascoterone 5% · 2 trials · 1 indication
Changes from Pivotal Part 1 Baseline in non-vellus Total Area Hair Count (TAHC) at Month 6.
MAA-PRO item 8, a hair coverage-specific PGI-C, as the co-primary endpoint. The clinically meaningful change (threshold) is defined as a response of "1", "2", or "3". Note that the item 2 responder threshold was used as a criterion for subjects to qualify for Part 2 enrollment.
| Arm | Type | Description |
|---|---|---|
| Clascoterone Part 1 and Part 2 | EXPERIMENTAL | Subjects treated for 12 months with Clascoterone 5% solution (both in double-blind Part 1 and in the single-blind Part 2 of the study). |
| Clascoterone Part 1 + Vehicle Part 2 | OTHER | Subjects treated for the first 6 months Part 1 in double-blind with Clascoterone 5% solution followed by 6 months Part 2 in the single-blind label with Vehicle. |
| Vehicle Part 1 + Clascoterone Part 2 | OTHER | Subjects treated for the first 6 months Part 1 in double-blind with Vehicle followed by 6 months Part 2 in the single-blind label with Clascoterone 5% solution. |
| Vehicle Part 1 and Part 2 | PLACEBO_COMPARATOR | Subjects treated for 12 months with Vehicle (both in double-blind Part 1 and in the single-blind Part 2 of the study). |
| Name | Type | Description |
|---|---|---|
| Clascoterone 5% solution | DRUG | Topical application of 1.5 ml of clascoterone solution 5%, twice a day, to balding areas of the scalp (vertex and temples) |
| Vehicle solution | DRUG | Topical application of 1.5 ml of vehicle, twice a day, to balding areas of the scalp (vertex and temples) |
Inclusion Criteria: Subject can participate in this clinical study if all the following criteria are met: 1. Subject who is male ≥18 years old. 2. Subject who has provided written informed consent. 3. Subject who has mild to moderate AGA in temple and vertex region, rating III vertex to V on the M...
Clascoterone 5% is an investigational small molecule being developed for the treatment of androgenetic alopecia, commonly known as male pattern hair loss. It is a topical solution intended for use in adult males. The drug is currently in Phase 3 clinical trials to evaluate its efficacy and safety for this condition.
Clascoterone 5% is a small molecule that acts by targeting androgen receptors in the scalp. By blocking these receptors, it is designed to counteract the effects of androgens that contribute to hair loss in androgenetic alopecia. This mechanism aims to prevent further hair thinning and promote hair regrowth in affected areas.
Clascoterone 5% is being developed by Icon Plc, a company publicly traded under the ticker symbol ICLR. The company is conducting Phase 3 clinical trials to evaluate the drug's efficacy and safety for the treatment of male pattern hair loss.
Clascoterone 5% is currently in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Two Phase 3 trials have been conducted, one of which is completed and the other is active but not recruiting participants.
Clascoterone 5% is being studied in two Phase 3 trials for male pattern hair loss. NCT05910450 is active but not recruiting, with 703 participants in the United States and Georgia. NCT05914805, known as SCALP2, is completed with 762 participants in the United States, Germany, and Poland. Both are randomized, double-blind, placebo-controlled studies.
Yes, Clascoterone 5% is also known as Clascoterone 5% solution. The drug is being developed as a topical solution for the treatment of androgenetic alopecia in males. Both names refer to the same investigational product currently in Phase 3 clinical trials.