Cutia Therapeutics (HKG: 2487), a dermatology-focused pharmaceutical company, has announced the submission of a New Drug Application (NDA) for its proprietary CU-40102 (external einasteride spray) for the treatment of androgenic alopecia to the Department of Health of Hong Kong, China.
CU-40102 is positioned as the world’s first and currently only clinical-stage drug of its kind. The drug is a specific type II 5α-reductase competitive inhibitor, designed to prevent the conversion of testosterone to dihydrotestosterone in the scalp, which is a primary cause of androgenic alopecia in male patients. The topical formulation of CU-40102 allows for direct application to the scalp, ensuring a high concentration of the drug at the site of application while minimizing systemic exposure. This targeted approach is expected to reduce the side effects commonly associated with oral administration of einasteride.
As Cutia Therapeutics awaits regulatory decisions in Hong Kong, the drug is also under review for approval in mainland China, indicating a potential expansion of the company’s market reach.- Flcube.com