Huons Global said Tuesday that it has completed domestic phase 3 clinical trials for Hutox, its botulinum toxin (BTX) strain.
The company received the investigational new drug (IND) approval for the phase 3 clinical trial for Hutox in treating moderate or severe improvement in forehead wrinkles, from the Ministry of Food and Drug Safety (MFDS) last year.
In March, Huons managed to complete early patient registration and started a large-scale clinical trial at three hospitals, including Chung-Ang University Hospital and Konkuk University Medical Center.
The company managed to achieve meaningful results in improving forehead wrinkles through the clinical trial and aims to launch the product from the second half of next year after receiving approval from the authorities concerned.
BTX is used worldwide for the treatment of eyelid seizures, strabismus, hyperhidrosis, muscle stiffness after stroke, as well as cosmetic purposes such as wrinkle improvement.
In addition to improving the appearance of wrinkles, the company has also received approval from the ministry last year for a domestic phase 1 and 3 clinical trials for using Hutox in improving visible angle wrinkles. The company expects to expand the implication by 2020.
“Hutox's phase 3 clinical trials have been completed as expected, and domestic release is expected in the second half of next year,” Huons Global CEO Kim Wan-sup said. “After the domestic launch, we expect the product will have a strong growth momentum through merger sales and marketing with Elravie Premier, a hyaluronic acid filler.”
Huons will also increase its market share in the global botulinum toxin market, Kim added.
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