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On July 11, Kaifeng Pharmaceutical announced that the Phase II clinical trial application of Freitan (KX-826) for the treatment of androgenetic alopecia has been approved by the US FDA
.
Androgenic alopecia (androgenic alopecia, AGA) is one of the most common hair loss diseases in which hair follicles are miniaturized
.
The population of androgenetic alopecia is huge, accounting for more than 90% of the overall alopecia, and it is increasing year by year and becoming younger
The current treatment methods for androgenetic alopecia include systemic medication, topical medication, hair transplantation, mesotherapy, and low-energy laser therapy
.
The main drug treatments are minoxidil and finasteride
The difference in the mechanism of action between Phraytaen and Finasteride (Source: Prospectus of Kaifeng Pharmaceutical)
Freetarin is a small molecule AR antagonist and one of the two core products of Pioneer Pharmaceutical
.
Public information shows that Kaixing Pharmaceutical started the preclinical research of Freitan in July 2011, and obtained Freitan in China and the United States in April 2018 and June 2018, respectively, for the treatment of androgenetic alopecia.
IND approval
The Phase II clinical trial approved by the FDA is a randomized, double-blind, placebo-controlled, parallel group study, which aims to explore the effectiveness and safety of Freitan in the treatment of male subjects with androgenetic alopecia
.
The primary endpoint of the clinical trial was the change in the number of non-vellus hairs in the target area compared to the baseline at the end of the 24th week compared with the placebo group