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CB-03-01
CB-03-01 is a selective androgen receptor modulator (SARM) that inhibits 5-alpha reductase to reduce DHT-driven androgenetic alopecia.
CB-03-01 is a selective androgen receptor modulator (SARM) that inhibits 5-alpha reductase to reduce DHT-driven androgenetic alopecia. Used for Androgenetic alopecia (male pattern hair loss).
At a glance
| Generic name | CB-03-01 |
|---|---|
| Also known as | clascoterone, cortexolone 17α-propionate |
| Sponsor | Intrepid Therapeutics, Inc. |
| Drug class | 5-alpha reductase inhibitor |
| Target | 5-alpha reductase |
| Modality | Small molecule |
| Therapeutic area | Dermatology |
| Phase | Phase 2 |
Mechanism of action
CB-03-01 works by blocking the enzyme 5-alpha reductase, which converts testosterone to dihydrotestosterone (DHT), the primary driver of male pattern hair loss. By reducing local DHT levels in hair follicles, it aims to prevent hair loss and potentially promote regrowth. This mechanism differs from systemic hormonal approaches by targeting the biochemical pathway directly involved in androgenetic alopecia.
Approved indications
- Androgenetic alopecia (male pattern hair loss)
Common side effects
- Sexual dysfunction
- Decreased libido
- Gynecomastia
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)
- An Evaluation of the Adrenal Suppression Potential and Pharmacokinetic Properties of CB-03-01 Cream in Subjects With Acne Vulgaris (PHASE2)
- 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 CI brief — competitive landscape report
- CB-03-01 updates RSS · CI watch RSS
- Intrepid Therapeutics, Inc. portfolio CI