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Clascoterone 5% solution
Clascoterone is an androgen receptor antagonist that blocks androgen signaling in skin to reduce sebum production and acne lesions.
Clascoterone is an androgen receptor antagonist that blocks androgen signaling in skin to reduce sebum production and acne lesions. Used for Acne vulgaris.
At a glance
| Generic name | Clascoterone 5% solution |
|---|---|
| Also known as | CB-03-01 5% solution |
| Sponsor | Cassiopea SpA |
| Drug class | Androgen receptor antagonist |
| Target | Androgen receptor (AR) |
| Modality | Small molecule |
| Therapeutic area | Dermatology |
| Phase | Phase 3 |
Mechanism of action
Clascoterone selectively inhibits androgen receptor activity in sebaceous glands and skin, thereby reducing sebum production and the proliferation of acne-causing bacteria. By acting as a topical antiandrogen, it addresses one of the key pathogenic factors in acne without systemic hormonal effects. This mechanism makes it particularly useful for acne patients who cannot tolerate or do not respond to conventional treatments.
Approved indications
- Acne vulgaris
Common side effects
- Application site irritation
- Erythema
- Dryness
Key clinical trials
- A Study to Evaluate the Efficacy and Safety of Clascoterone Solution in Treatment of Male Pattern Hair Loss (PHASE3)
- A Study to Evaluate the Efficacy and Safety of Clascoterone Solution in Treatment of Male Pattern Hair Loss (SCALP2) (PHASE3)
- A Phase 2 Study to Evaluate the Safety and Efficacy of CB-03-01 Solution, a Comparator Solution and Vehicle Solution in Males With Androgenetic Alopecia (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Clascoterone 5% solution CI brief — competitive landscape report
- Clascoterone 5% solution updates RSS · CI watch RSS
- Cassiopea SpA portfolio CI