I have covered the novel androgen receptor antagonist Breezula® (clascoterone) for 11 years across numerous posts. The product was originally known as CB-03-01, and manufactured by a company named Cassiopea (Italy). The latter was acquired by Cosmo Pharmaceuticals (Ireland) in December 2021.
Interestingly, Cosmo did not use the word “Breezula” even once in the press release. It does not show up on the company’s pipeline page either. And the Breezula page on their site is not working at present. I really hope they do not change the name yet again. My blog post “categories” about this company and product are already too numerous.
Key notes from the press release:
A massive 1,465 patients were randomized into the two identical clinical studies: Scalp 1 (NCT05910450) and Scalp 2 (NCT05914805). I covered these in detail here and here.
Both studies reached statistically significant endpoints in Target-Area Hair Count (TAHC). The first reached 539% relative improvement compared to placebo; and the second reached 168% relative improvement to placebo.
The safety profile across both studies for positive.
The way they present these numbers is a bit strange and may exaggerate the efficacy. And the large gap between 539% and 168% is very surprising. In the successful 6-month interim Phase 2 trial results that were presented in 2018, they chose to compare Breezula results with finasteride.
Cosmo will complete the required 12-month safety follow-up in spring 2026. Thereafter, Cosmo plans to promptly pursue parallel regulatory submissions in the United States and Europe.
“Clascoterone 5% topical solution is positioned to become the first topical androgen receptor inhibitor ever approved for AGA, subject to regulatory authorization.”
This development also bodes favorably for China-based Kintor Pharma’s androgen receptor antagonist KX-826 (Pyrilutamide). It is currently in Phase 3 trials. A number of other such products are currently in trials or have been released as weaker cosmeceuticals.
On a related note, Cosmo Pharma released Winlevi clascoterone 1% cream in 2020, and it has since become the number 1 most prescribed topical acne brand in the US. Some people were trying to use Winlevi off-label on their scalps in the past, but I suspect that the dose is too low. Moreover, scalp absorption of the cream might be totally different from scalp absorption of the solution.
Also of interest, an August 2025 study concluded that Breezula promotes dermal papilla inductivity and hair matrix keratinocyte proliferation to a similar extent as minoxidil. In addition, Breezula also reduces the secretion of hair growth inhibitor IL-6 in balding skin samples. Some of the scientists involved in this research are affiliated with Cosmo.
Years ago, I mentioned how a hair transplant surgeon raved to me about Breezula based on a presentation (with photos) that he witnessed at an ISHRS conference. Fingers crossed that we finally have a third FDA-approved hair loss treatment by the end of 2027 (30 years after finasteride was approved, and 39 years after minoxidil was approved)!
There are 50 locations across 4 countries (US, Georgia, Germany and Poland) for Breezula Phase 3 Trials. If you are in the US, please search for your state (or nearby state) in both the SCALP1 and SCALP2 breakouts on this page.
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. This despite the fact that these trials started in June 2023. As of March 2024:
348 out of a planned 726 patients have been recruited in study CB-03-01/37.
507 out of a planned 726 patients have been recruited in study CB-03-01/38.
One reason for this slow pace of recruitment is that the inclusion and exclusion criteria are quite stringent.
While both the clinical trial page links below say that only men above 18 are allowed, our own “Yoda” tried to get in and was told that men abve 55 are also not allowed.
Only men who have mild to moderate androgenetic alopecia (AGA) in the temple and vertex regions (ranging from III to V on the Norwood-Hamilton Scale) are eligible. They must also have ongoing hair loss.
You have to revisit the center several times over 6 months, and apply the topical clascoterone solution on a daily basis.
You need to have not taken finasteride or dutasteride within 6 months of visit 2. And not taken topical minoxidil within 12 weeks of visit 2. They need to be able to figure out only Breezula hair growth results via its androgen receptor (AR) antagonist mechanism of action. This requirement may dissuade a majority of hair loss sufferers from participating.
There are a total of 8 inclusion criteria and 14 exclusion criteria that you must read before deciding to volunteer.
Another major issue is that there are various Breezula clinical trial URLs floating around, and past company announcements were a bit confusing about locations. Moreover, even in the below two links, the location section is a scroll-through box where you can only see one location on the screen at a time.
So I am pasting all the 50 locations (across 4 countries) below in the hopes that I can help at least slightly speed up recruitement.
Arkansas Locations North Little Rock, Arkansas, United States, 72116 The Petrus Center for Aesthetic Surgery and Hair Transplantation Contact: Gary Petrus, MD Contact: Terri Kim Rogers +1 501-614-3052 Kim@DrPetrus.com
California Locations San Diego, California, United States, 92123 Therapeutics Clinical Research Contact: Neal Bhatia, MD Contact: Hector A Bailon +1 858-571-6800 hbailon@therapeuticsresearch.com
Florida Locations Jacksonville, Florida, United States, 32224 Mayo Clinic, Department of Dermatology Contact: Alison Bruce, MD Contact: Matthew Dwarika +1 904-953-3551 Dwarika.Matthew@mayo.edu
Miami, Florida, United States, 33125 University of Miami Contact: Mariya Miteva, MD Contact: Olumide Ojoola, MD +1 305-243-8205 oxo160@med.miami.edu
Louisiana Locations Baton Rouge, Louisiana, United States, 70809 DelRicht Research Contact: Ira Thorla, MD +1 225-412-0316 info@delricht.com
New Orleans, Louisiana, United States, 70115 DelRicht Research Contact: Sarah Jackson, MD +1 504-336-2667 info@delricht.com
Michigan Locations Detroit, Michigan, United States, 48202 Henry Ford Health Contact: Linda Stein Gold, MD Contact: Fanar Razoky +1 248-219-4304 frazoky1@hfhs.org
Minnesota Locations Minneapolis, Minnesota, United States, 55455 University of Minnesota Contact: Maria Hordinsky, MD Contact: Jaime Nugent +1 612-625-8625 speck007@umn.edu
Nevada Locations Las Vegas, Nevada, United States, 89148 JDR Dermatology Research Contact: James Del Rosso, MD Contact: Melissa Jacobson +1 702-964-2425 mj.drdr@gmail.com
New Jersey Locations Berlin, New Jersey, United States, 08009 Hassman Research Institute Contact: Michael Hassman, MD Michael.Hassman@cenexel.com Contact: Mark Capichana +1 856-753-7335 m.capichana@cenexel.com
New York Locations New York, New York, United States, 10022 Diane S. Berson MD, PLLC Contact: Diane S Berson, MD Contact: Kiera Murphy +1 212-355-3511 staff@dianebersonmd.com
Stony Brook, New York, United States, 11790 Derm Research Center of New York, Inc. Contact: Elyse Rafal, MD Contact: Dawn D’Angelo +1 631-880-9660 ddangelo@drcny.com
North Carolina Locations Charlotte, North Carolina, United States, 28277 On Site Clinical Solutions Contact: Catherine Pointon, MD Contact: Alexandra Perez +1 704-995-1198 aperez@onsiteclinical.com
Tbilisi, Georgia, 0159 Kanveni National Center of Dermatology and Venerology Contact: George Galdava, MD Contact: Victoria Sulava +995 593 324 578 sulavav@yahoo.com
Tbilisi, Georgia, 0159 Tbilisi Cancer Center Contact: Lally Mekokishvili, MD Contact: Nino Kapanadze +995 577 79 78 06 Ninucakap@yahoo.com
Arizona Locations Scottsdale, Arizona, United States, 85255 Investigate MD Contact: Brenda LaTowsky, MD +1 480-440-5985 research@investigatemd.com
Florida Locations Hollywood, Florida, United States, 33021 Physician’s Institute of Cosmetic and Reconstructive Surgery Contact: Jonathan Weiser, MD Contact: Wanda Bargot +1 945-964-4113 wandabargot@yahoo.com
Georgia Locations Atlanta, Georgia, United States, 30329 DelRicht Research Contact: Robert Springer, MD +1 770-417-4454 info@delricht.com
Michigan Locations Troy, Michigan, United States, 48084 Revival Research Institute Contact: Ali Moiin, MD Contact: Sikar Grewal +1 248-564-1485 grewal@rev-research.com
Warren, Michigan, United States, 48088 Grekin Skin Institute Contact: Steven Grekin, MD Contact: Claudia Attala +1 586-759-5525 claudia.attala@adcsclinics.com
Missouri Locations Wildwood, Missouri, United States, 63040 DelRicht Research Contact: Christopher Kling, MD +1 504-336-2667 info@delricht.com
North Carolina Locations Huntersville, North Carolina, United States, 28078 Piedmont Plastic Surgery and Dermatology Contact: Nicole Seminara, MD Contact: Jeffrey Decker +1 980-900-9229 Jdecker@onsiteclinical.com
South Carolina Locations Spartanburg, South Carolina, United States, 29307 Advanced Dermatology & Cosmetic Surgery Contact: Amylynne Frankel, MD Contact: Ashley Davis +1 864-574-0017 ashley.davis@adcsclinics.com
Tennessee Locations Thompson’s Station, Tennessee, United States, 37179 DelRicht Research Contact: Pezhman Shoureshi, MD +1 629-895-1775 info@delricht.com
Texas Locations Pflugerville, Texas, United States, 78660 Austin Institute for Clinical Research Contact: Edward Lain, MD Contact: Xiomara Duarte +1 512-279-2545 XDuarte@atxresearch.com
Washington Locations Spokane, Washington, United States, 99202 Premier Clinical Research Contact: William P Werschler, MD Contact: Celeste Gray +1 509-505-1815 CGray@PremierClinicalResearch.com
Germany
Berlin, Germany, 10117 Clinical Research Center for Hair and Skin Science, Dept. of Dermatology, Venereology and Allergology, Charité – Universitätsmedizin Berlin Contact: Ulrike Blume-Peytavi, MD Contact: Annette Andruck +49 30 450 518 458 annette.andruck@charite.de
Mainz, Germany, 55131 Department of Dermatology and Allergy, Johannes Gutenberg-Universität KöR Contact: Petra Staubach, MD Contact: Evelyn Mueller +49 (0) 6131-17-2944 evelyn.mueller@unimedizin-mainz.de
Poland
Katowice, Poland, 40-081 Centrum Medyczne Pratia Contact: Kamila Płaczek, MD Contact: Paulina Majka +48 721 201 421 paulina.majka@pratia.com
Kraków, Poland, 31-011 Centrum Nowoczesnych Terapii Dobry Lekarz Contact: Malgorzata Dyczek, MD Contact: Katarzyna Gajda +48 690 000 367 katarzyna.gajda@dobrylekarz.com.pl
Kraków, Poland, 31-559 Diamond Clinic Sp. z o.o. Contact: Barbara Rewerska, MD Contact: Aleksandra Kubajewska +48 571 241 412 a.kubajewska@diamondclinic.eu
Lublin, Poland, 20-412 Pro Life Medica Contact: Agnieszka Sajdak-Wojtaluk, MD Contact: Agnieszka Saja-Górecka +48 537 827 727 a.saja-gorecka@etg-network.com
Warszawa, Poland, 02-637 Narodowy Instytut Geriatrii, Reumatologii iRehabilitacji im. prof. dr hab. med. Eleonory Reicher Contact: Mariusz Sikora, MD Contact: Marta Kurek +48 603 315 033 marta.kurek@spartanska.pl
