Clascoterone
- Generic Name
- Clascoterone
- Brand Names
- Winlevi
- Drug Type
- Small Molecule
- Chemical Formula
- C24H34O5
- CAS Number
- 19608-29-8
- Unique Ingredient Identifier
- XN7MM8XG2M
- Background
Clascoterone (cortexolone 17α-propionate, CB-03-01) is a novel antagonist of androgen receptors. It binds to androgen receptors with high affinity. By competing with androgens for binding to androgen receptors, clascoterone works by blocking the androgen receptor signalling cascades that promote acne pathogenesis, such as sebaceous gland proliferation, excess sebum production, and inflammatory pathways. In August 2020, FDA approved clascoterone for the first-in-class topical treatment of acne (acne vulgaris) in male and female patients 12 years and older. Clascoterone is also being investigated as a novel treatment for androgenetic alopecia.
- Indication
Clascoterone is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.
- Associated Conditions
- Acne Vulgaris
A Study to Evaluate the Efficacy and Safety of Clascoterone Solution in Treatment of Male Pattern Hair Loss (SCALP2)
- Conditions
- Alopecia, Androgenetic
- Interventions
- Drug: Vehicle solution
- First Posted Date
- 2023-06-22
- Last Posted Date
- 2024-02-12
- Lead Sponsor
- Cassiopea SpA
- Target Recruit Count
- 726
- Registration Number
- NCT05914805
- Locations
- 🇵🇱
Diamond Clinic Sp. z o.o., Kraków, Poland
🇺🇸Austin Institute for Clinical Research, Pflugerville, Texas, United States
🇩🇪Eurofins | bioskin, Hamburg, Germany
A Study to Evaluate the Efficacy and Safety of Clascoterone Solution in Treatment of Male Pattern Hair Loss
- Conditions
- Alopecia, Androgenetic
- Interventions
- Drug: Vehicle solution
- First Posted Date
- 2023-06-18
- Last Posted Date
- 2024-08-22
- Lead Sponsor
- Cassiopea SpA
- Target Recruit Count
- 726
- Registration Number
- NCT05910450
- Locations
- 🇺🇸
The Petrus Center for Aesthetic Surgery and Hair Transplantation, North Little Rock, Arkansas, United States
🇺🇸Mayo Clinic, Department of Dermatology, Jacksonville, Florida, United States
🇬🇪LTD Health, Batumi, Georgia
Clascoterone for Steroid-related Acne Vulgaris in Transgender Male Patients Receiving Masculinizing Hormone Therapy
- First Posted Date
- 2023-06-07
- Last Posted Date
- 2025-05-18
- Lead Sponsor
- Stanford University
- Target Recruit Count
- 18
- Registration Number
- NCT05891795
- Locations
- 🇺🇸
Stanford University, Stanford, California, United States
A Study to Investigate the Effects of Cortexolone 17α-propionate (and Its Metabolites) on Healthy Volunteers' Heart
- Conditions
- Healthy Volunteers
- Interventions
- Drug: Placebo
- First Posted Date
- 2018-09-11
- Last Posted Date
- 2019-02-04
- Lead Sponsor
- Cassiopea SpA
- Target Recruit Count
- 32
- Registration Number
- NCT03665194
- Locations
- 🇬🇧
Richmond Pharmacology Ltd, London, United Kingdom
An Evaluation of the Adrenal Suppression Potential and PK of CB-03-01 Cream in Pediatric Patients With Acne Vulgaris
- First Posted Date
- 2016-03-28
- Last Posted Date
- 2020-11-20
- Lead Sponsor
- Cassiopea SpA
- Target Recruit Count
- 27
- Registration Number
- NCT02720627
- Locations
- 🇺🇸
Site 103, Fort Smith, Arkansas, United States
🇺🇸Site 101, San Diego, California, United States
🇺🇸Site 102, Houston, Texas, United States
An Evaluation of the Adrenal Suppression Potential and Pharmacokinetic Properties of CB-03-01 Cream in Subjects With Acne Vulgaris
- First Posted Date
- 2013-04-15
- Last Posted Date
- 2020-12-02
- Lead Sponsor
- Intrepid Therapeutics, Inc.
- Target Recruit Count
- 42
- Registration Number
- NCT01831960
- Locations
- 🇺🇸
Shideler Clinical Research Center, Carmel, Indiana, United States
🇺🇸Michigan Center for Research Corp., Clinton Township, Michigan, United States
🇺🇸Northwest Clinical Trials, Inc., Boise, Idaho, United States
A Phase 2 Dose Escalating Study to Evaluate the Safety and Efficacy of CB-03-01 Cream in Subjects With Facial Acne Vulgaris
- First Posted Date
- 2012-06-29
- Last Posted Date
- 2020-11-16
- Lead Sponsor
- Intrepid Therapeutics, Inc.
- Target Recruit Count
- 363
- Registration Number
- NCT01631474
- Locations
- 🇺🇸
Dermatology Research Associates, Los Angeles, California, United States
🇺🇸Marina I. Peredo, M.D., PC, Smithtown, New York, United States
🇺🇸Clinical Partners, LLC, Johnston, Rhode Island, United States
Drug Development Updates
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