CUTIA-B (02487) announced that its Investigational New Drug application for CU-40104, a topical dutasteride formulation, has received implied clinical trial approval from China's National Medical Products Administration. The treatment is indicated for androgenetic alopecia.

CU-40104 is a proprietary topical dutasteride developed by the company. As a competitive inhibitor of both type I and type II 5-alpha reductase enzymes, dutasteride works by inhibiting the conversion of testosterone to dihydrotestosterone in the scalp, thereby treating androgenetic alopecia.

The company is developing a topical formulation designed to deliver dutasteride directly to the application site on the scalp. Compared with oral dutasteride, which has already been approved for treating androgenetic alopecia in multiple countries, the topical formulation is expected to reduce systemic exposure and associated side effects.

CUTIA-B believes that CU-40104 will further enrich its portfolio of hair disorder treatments and provide valuable complementary and synergistic benefits alongside CU-40102, a topical finasteride spray already approved for marketing in China by the NMPA.