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
Efficacy and Safety of Topical Clascoterone (WINLEVI) Cream 1% in Patients With Facial Acneiform Rosacea
- Conditions
- Papular-pustular RosaceaPapulopustular Rosacea (PPR)Papulopustular Rosacea
- Interventions
- First Posted Date
- 2025-05-01
- Last Posted Date
- 2025-05-06
- Lead Sponsor
- Narrows Institute for Biomedical Research
- Target Recruit Count
- 20
- Registration Number
- NCT06952517
- Locations
- 🇺🇸
New York Harbor VA Brooklyn Campus, Brooklyn, New York, United States
Pharmacokinetics, Safety and Tolerability of Clascoterone Cream 1% in Healthy Chinese Adult Subjects
- First Posted Date
- 2024-06-12
- Last Posted Date
- 2025-01-28
- Lead Sponsor
- Zhejiang Sunshine Mandi Pharmaceutical Co.,Ltd.
- Target Recruit Count
- 12
- Registration Number
- NCT06454708
- Locations
- 🇨🇳
Huashan Hospital, Fudan University, London, China
A Study to Assess Sebaceous Gland Changes and Constituents of Sebum (Skin Oil) Induced by Clascoterone 1% Cream in Acne Patients
- Conditions
- Acne Vulgaris
- Interventions
- First Posted Date
- 2024-05-23
- Last Posted Date
- 2025-02-17
- Lead Sponsor
- Sun Pharmaceutical Industries Limited
- Target Recruit Count
- 10
- Registration Number
- NCT06425900
- Locations
- 🇺🇸
Dermatology Consulting Services, PLLC, High Point, North Carolina, United States
A Study to Evaluate the Impact of Clascoterone 1% Cream on Skin Barrier Properties in Acne Prone Patients
- First Posted Date
- 2024-05-16
- Last Posted Date
- 2025-03-04
- Lead Sponsor
- Sun Pharmaceutical Industries Limited
- Target Recruit Count
- 50
- Registration Number
- NCT06415292
- Locations
- 🇺🇸
Dermatology Consulting Services, PLLC, High Point, North Carolina, United States
A Study Evaluating the Efficacy and Safety of Clascoterone Cream 1% in Skin of Color Patients With Acne
- First Posted Date
- 2024-05-16
- Last Posted Date
- 2025-05-07
- Lead Sponsor
- Sun Pharmaceutical Industries Limited
- Target Recruit Count
- 10
- Registration Number
- NCT06415305
- Locations
- 🇺🇸
Skin Sciences, PLLC, Louisville, Kentucky, United States
A Study to Evaluate the Reduction in Sebum (Skin Oil) Induced by Clascoterone Cream 1% in Acne Patients
- First Posted Date
- 2024-05-16
- Last Posted Date
- 2025-04-15
- Lead Sponsor
- Sun Pharmaceutical Industries Limited
- Target Recruit Count
- 40
- Registration Number
- NCT06415279
- Locations
- 🇺🇸
Dermatology Consulting Services, PLLC, High Point, North Carolina, United States
Efficacy and Safety of Clascoterone Cream 1% in Facial Acne Vulgaris
- First Posted Date
- 2024-05-08
- Last Posted Date
- 2024-06-05
- Lead Sponsor
- Zhejiang Sunshine Mandi Pharmaceutical Co.,Ltd.
- Target Recruit Count
- 692
- Registration Number
- NCT06403501
- Locations
- 🇨🇳
Huashan Hospital, Fudan University, Shanghai, China
A Study Assessing the Efficacy of Combined Use of Clascoterone 1% Cream and Adapalene 0.3% for the Treatment of Acne
- Conditions
- Acne Vulgaris
- Interventions
- First Posted Date
- 2024-03-29
- Last Posted Date
- 2025-04-06
- Lead Sponsor
- Sun Pharmaceutical Industries Limited
- Target Recruit Count
- 20
- Registration Number
- NCT06336603
- Locations
- 🇺🇸
Skin Sciences, PLLC, Louisville, Kentucky, United States
A Study Assessing the Efficacy of Combined Use of Clascoterone 1% Cream and Duac Gel (Benzoyl Peroxide/Clindamycin) for the Treatment of Acne
- First Posted Date
- 2024-03-29
- Last Posted Date
- 2024-10-21
- Lead Sponsor
- Sun Pharmaceutical Industries Limited
- Target Recruit Count
- 10
- Registration Number
- NCT06336629
- Locations
- 🇺🇸
Skin Sciences, PLLC, Louisville, Kentucky, United States
Topical Anti-Androgens in Pilonidal Sinus Disease
- Conditions
- Pilonidal CystPilonidal Disease of Natal CleftPilonidal SinusPilonidal Disease
- Interventions
- Drug: Vehicle Cream
- First Posted Date
- 2024-02-29
- Last Posted Date
- 2025-01-20
- Lead Sponsor
- University of Pennsylvania
- Target Recruit Count
- 75
- Registration Number
- NCT06286397
- Locations
- 🇺🇸
University of Pennsylvania, Philadelphia, Pennsylvania, United States
Drug Development Updates
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