---
title: "CUTIA-B: CU-40104 (topical dutasteride formulation) new drug clinical trial application has obtained implied approval for clinical trials from the National Medical Products Administration"
type: "News"
locale: "en"
url: "https://longbridge.com/en/news/279178370.md"
description: "CUTIA-B announced that its new drug clinical trial application for CU-40104 (topical dutasteride formulation) has received implied approval from the National Medical Products Administration, with the indication for the treatment of androgenetic alopecia. CU-40104 is an independently developed topical medication aimed at reducing systemic exposure and side effects, and is expected to enrich the company's product line for hair diseases, creating a synergistic effect with the approved CU-40102"
datetime: "2026-03-16T00:33:05.000Z"
locales:
  - [zh-CN](https://longbridge.com/zh-CN/news/279178370.md)
  - [en](https://longbridge.com/en/news/279178370.md)
  - [zh-HK](https://longbridge.com/zh-HK/news/279178370.md)
---

# CUTIA-B: CU-40104 (topical dutasteride formulation) new drug clinical trial application has obtained implied approval for clinical trials from the National Medical Products Administration

According to the Zhitong Finance APP, CUTIA-B (02487) announced that the clinical trial application (IND) for the group's CU-40104 (topical dutasteride formulation) has received implicit approval from the National Medical Products Administration of the People's Republic of China (NMPA) for clinical trials, with the indication for the treatment of androgenetic alopecia.

CU-40104 is a topical dutasteride independently developed by the group. Dutasteride, as a specific competitive inhibitor of type I and II 5α-reductase, inhibits the conversion of testosterone to dihydrotestosterone in the scalp, which can treat androgenetic alopecia. The topical formulation being developed by the group allows for the direct application of dutasteride to the action site on the scalp, which is expected to reduce systemic exposure and side effects compared to oral dutasteride (which has been approved for the treatment of androgenetic alopecia in multiple countries worldwide).

The group believes that CU-40104 will further enrich its product matrix for hair diseases and serve as a valuable complement and synergistic effect to CU-40102 (topical finasteride spray), which has already received marketing approval from the NMPA

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