Clascoterone is a synthetic steroidal androgen receptor inhibitor and pharmaceutical active pharmaceutical ingredient (API). It is also known chemically as cortexolone 17α-propionate and by the development code CB-03-01.
Clascoterone acts by competing with androgens for binding to the androgen receptor, thereby inhibiting androgen receptor signaling. It is used as a topical pharmaceutical active ingredient, including in products for the treatment of acne vulgaris.
| Parameter | Details |
|---|---|
| Product Name | Clascoterone |
| Generic Name | Clascoterone |
| Chemical Name / Synonym | Cortexolone 17α-propionate |
| CAS Number | 19608-29-8 |
| Molecular Formula | C₂₄H₃₄O₅ |
| Molecular Weight | 402.52 g/mol |
| Chemical Class | Steroidal compound |
| Pharmacological Class | Androgen receptor inhibitor |
| Therapeutic Application | Topical dermatological |
| Physical Form | Powder / crystalline solid |
| Appearance | White to almost-white powder |
| Water Solubility | Practically insoluble |
FDA's drug-substance review gives the same chemical identity, formula, molecular weight and physical description.
Clascoterone is used as a topical androgen receptor inhibitor. The FDA-approved product WINLEVI contains clascoterone 1% cream for topical treatment of acne vulgaris.
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 0.1% |
| Residue on Ignition | NMT 0.5% |
| Total Impurities | NMT 2.0% |
| Water Content | NMT 1.0% |
| Melting Point | -100° to -80° |