Yuyu Pharmaceutical unveiled its plans to conduct U.S. and EU medical trials for utilizing dutasteride to deal with androgenetic alopecia (AGA) in the course of the World Congress for Hair Research 2022 held in Melbourne, Australia, from Friday to Monday.
The trial goals to enhance affected person comfort by decreasing the present dutasteride pill measurement to one-third whereas sustaining the identical 0.5mg dose as the unique drug.
The firm plans to begin medical trials in 2024 after pre-IND conferences with the U.S. Food and Drug Administration and European Medicines Agency in 2023 and launch the improved therapy within the U.S. and EU hair loss therapy markets in 2026.
“Dutasteride, which is prescribed to hair loss patients in Korea and Japan, has not yet received approval for such an indication in the U.S. and EU,” Yuyu CEO Yu Wan-sang stated. “However, the company confirmed that there is a high unmet need as the substance is prescribed off-label in the U.S. and EU.”
Since Yuyu Pharmaceutical is at the moment manufacturing and advertising and marketing dutasteride-based medicines, the corporate believes that it has adequate R&D capabilities to develop such a therapy, Yu added.
The dutasteride element has a hair loss therapy mechanism of motion that inhibits each 5-alpha reductase Type-I and Type-II, which act to vary the male hormone testosterone into Dihydrotestosterone (DHT) hormone that causes hair loss.
The North American hair loss therapy market, valued at $1.8 billion in 2021, is predicted to succeed in $2.9 billion in 2029, recording a compound annual progress price (CAGR) of 5.9 p.c. The EU hair loss therapy market can also be anticipated to have a CAGR of 6.1 p.c and attain $1.39 billion in 2027.