Breezula phase 3. Apr 11, 2024 · CB-03-01 has undergone three Phase II trials, which have informed the dosage for an upcoming Phase III trial that is expected to be completed in 2025. This anti-androgen is made by Cosmo Pharmaceuticals (Italy), formerly Cassiopea. New York hair-loss specialist Dr. Breezula Phase 3 Clinical Trials In my recent post about Cosmo Pharmaceuticals’ update on Breezula’s Phase 3 clinical trials, we learnt that the enrollment is still less than 60% compelete. Trial Design: Two identical Phase 3 trials (SCALP1 and SCALP2), each with two 6-month stages: initial randomized, double-blind, vehicle-controlled study, followed by a single-blind treatment phase. Dec 5, 2020 · Breezula (clascoterone), a topical androgen receptor inhibitor in Phase III trials, shows promise for androgenetic alopecia — especially in men. On June 18, 2023, a phase 3 trial listing of a 5% clascoterone solution (aka Breezula) treating male AGA was posted on the official clinical trials website. Dec 4, 2025 · Topical androgen receptor inhibitor Breezula® (clascoterone 5% solution) has met its co-primary endpoints in two Phase III trials, showing substantial improvements in scalp hair count over vehicle — raising hopes for a new non-systemic therapy for pattern hair loss. This despite the fact that these trials started in June 2023. The first Phase II trial was a proof-of-concept study conducted in 2014 with 95 males with androgenetic alopecia. The SCALP1 study will comprise 726 participants and will involve 4 treatment groups. Oct 15, 2022 · Breezula, also known by the generic name Clascoterone, is a new pattern hair loss treatment. Dennis Porto comments on the promising data and what it could mean for patients. Dec 3, 2025 · Cosmo announces breakthrough Phase III Topline results from Scalp 1 and Scalp 2 for Clascoterone 5% Solution in male hair loss, showing up to 539% relative improvement in Target-Area Hair Count vs placebo; US and EU submissions are underway. Previous Findings: Phase 2 trials Jan 21, 2026 · Cosmo Pharmaceuticals just announced breakthrough Phase III trial topline results for Clascoterone 5% solution (Breezula) in treating male pattern hair loss. It should be starting phase 3 clinical trials soon. Mar 21, 2024 · Breezula (Clascoterone) Phase 3 clinical trials just started in the US in 2023. Source: Cosmo Pharmaceuticals. This trial evaluates the safety and efficacy of Breezula, a promising treatment for hair loss conditions such as androgenetic alopecia. We would like to show you a description here but the site won’t allow us. As of March 2024: 348 out of a planned 726 patients have been recruited in . 1,465 patients were randomized into the two identical-in-design clinical studies Scalp 1 ( NCT05910450) and Scalp 2 (NCT05914805) Both studies reached Jul 10, 2023 · Treatment: Breezula®, a topical 5% clascoterone solution for male pattern hair loss. Enrollment: Recruitment began in June 2023; completion expected by early 2025. Dec 2, 2025 · Breezula Phase 3 Clinical Trials. Jun 7, 2025 · The Breezula Phase 3 trial is a crucial step in the process of obtaining regulatory approval for a new drug. aztl tpt mlozk sdcdj ltusds