The hair-loss solution remains investigational in the U.S. Cosmo targets a U.S. application in Q1 2027 and a European application in Q2 2027. Winlevi's approved 1% acne cream is a different formulation and indication.
Across 1,465 men, Cosmo reports significant hair-count effects in both trials. The patient-reported endpoint is significant in one trial and shows a positive trend in the other; the pooled analysis is significant.
Study-specific safety is not summarized in this timeline entry. See the research notes and primary source; missing safety data do not establish safety.
Study results apply to their own population, dose and analysis. They do not establish a ranking between therapies.
Evidence in the atlas
0 results
Each result belongs to its own study population, dose and analysis. Open a result for its chart, comparator, safety findings and limitations.
sponsor-reported phase 3 topline · 3 Dec 2025
Hair-count endpoints improve; perception is mixed
Across 1,465 men, Cosmo reports significant hair-count effects in both trials. The patient-reported endpoint is significant in one trial and shows a positive trend in the other; the pooled analysis is significant.
The sponsor's 539% and 168% relative-effect headlines are not absolute hairs/cm² or percentage scalp regrowth. The release does not provide the full absolute treatment effects needed to judge the visible size of benefit.
Study-specific safety is not summarized in this timeline entry. See the research notes and primary source; missing safety data do not establish safety.
Detailed trial charts have not been added for this program. See its sourced development timeline and research notes.
Biology & identity
Status in this atlas: The hair-loss solution remains investigational in the U.S. Cosmo targets a U.S. application in Q1 2027 and a European application in Q2 2027. Winlevi's approved 1% acne cream is a different formulation and indication.
Chemical connectivity and stereochemistry of Clascoterone.
Uses, doses and availability depend on the formulation, indication and country. Study doses below describe research; they are not prescribing instructions.
The hair-loss solution remains investigational in the U.S. Cosmo targets a U.S. application in Q1 2027 and a European application in Q2 2027. Winlevi's approved 1% acne cream is a different formulation and indication. The headline relative hair-count percentages do not describe percentage scalp regrowth. Patient-reported results were mixed across the two pivotal trials, and the 12-month extension selected initial responders. Full absolute effects and formulation-specific long-term safety remain important.
Cosmo announces the start of SCALP1 and SCALP2 for men with androgenetic alopecia. The program compares twice-daily 5% solution with vehicle and evaluates hair counts alongside participants' assessment of coverage.
Across 1,465 men, Cosmo reports significant hair-count effects in both trials. The patient-reported endpoint is significant in one trial and shows a positive trend in the other; the pooled analysis is significant.
Actual sponsor topline disclosure. · sponsor-reported phase 3 topline Source
Continued dosing preserves gains in responders
Cosmo reports continued hair-count improvement with ongoing treatment and declining gains after switching to vehicle. Reported tolerability is comparable to vehicle through 12 months.
Actual sponsor 12-month disclosure; extension design checked against both registries. · sponsor-reported extension and safety data SourceSourceSource
Submit the U.S. application
Cosmo targets a U.S. regulatory application in Q1 2027. This is a sponsor filing forecast, not an FDA decision deadline or a launch commitment.
Explicit quarter in Cosmo's July 23, 2026 release; the H1 report describes early 2027. · planned regulatory submission SourceSource
Submit the European application
Cosmo separately targets a European application in Q2 2027. Submission, acceptance, approval and commercial availability are distinct milestones.
Explicit sponsor target in the July 23, 2026 H1 results release. · planned regulatory submission Source
Review the full phase 3 dataset
Cosmo plans publication and congress presentation of the full results. No firm date was verified. Absolute hair-count changes, photographs, patient-reported outcomes and safety will clarify the size and durability of benefit.
Sponsor publication plan without a verified release date; registries checked September 13, 2026. · planned evidence disclosure SourceSourceSource
