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CB-03-01 cream, 1%
CB-03-01 is an androgen receptor antagonist that blocks the effects of androgens in the skin to reduce sebum production and inflammation associated with acne.
CB-03-01 is an androgen receptor antagonist that blocks the effects of androgens in the skin to reduce sebum production and inflammation associated with acne. Used for Acne vulgaris.
At a glance
| Generic name | CB-03-01 cream, 1% |
|---|---|
| Also known as | cortexolone 17α-propionate, clascoterone (USAN, INN) |
| Sponsor | Cassiopea SpA |
| Drug class | Androgen receptor antagonist |
| Target | Androgen receptor (AR) |
| Modality | Small molecule |
| Therapeutic area | Dermatology |
| Phase | Phase 3 |
Mechanism of action
CB-03-01 selectively inhibits androgen receptor signaling in sebaceous glands and skin, thereby reducing sebum production and the inflammatory cascade that drives acne pathogenesis. By blocking local androgen effects without systemic hormonal suppression, it offers a topical approach to treating acne vulgaris with a potentially favorable safety profile compared to systemic anti-androgens.
Approved indications
- Acne vulgaris
Common side effects
- Application site irritation
- Erythema
- Dryness
Key clinical trials
- A Study to Evaluate the Safety and Efficacy of CB-03-01 Cream, 1% in Subjects With Facial Acne Vulgaris (26) (PHASE3)
- An Evaluation of the Adrenal Suppression Potential and PK of CB-03-01 Cream in Pediatric Patients With Acne Vulgaris (PHASE2)
- A Study to Evaluate the Safety and Efficacy of CB-03-01 Cream, 1% in Subjects With Facial Acne Vulgaris (25) (PHASE3)
- An Open-Label, Long-Term Extension Study to Evaluate the Safety of CB-03-01 Cream, 1% in Participants With Acne Vulgaris (PHASE3)
- A Phase 2 Dose Escalating Study to Evaluate the Safety and Efficacy of CB-03-01 Cream in Subjects With Facial Acne Vulgaris (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:
- CB-03-01 cream, 1% CI brief — competitive landscape report
- CB-03-01 cream, 1% updates RSS · CI watch RSS
- Cassiopea SpA portfolio CI