Huons Biopharma Receives Approval for Phase 3 Clinical Trial Plan of 'Liztox' for Square Jaw Treatment

Huons Biopharma announced on the 15th that it has received approval for the clinical phase 3 trial plan (IND) for the improvement of "benign masseter hypertrophy (square jaw)" using its self-developed botulinum toxin product "Liztox" (export name: Hutox).

Liztox Injection. [Image provided by Huons Biopharma]

Huons Biopharma obtained approval from the Ministry of Food and Drug Safety for the phase 3 clinical trial of Liztox for benign masseter hypertrophy and plans to evaluate safety and efficacy through four institutions, including Chung-Ang University Hospital, targeting 176 adults aged 19 and older who require improvement of benign masseter hypertrophy.

Previously, Huons Biopharma clinically confirmed the improvement effect of Liztox on benign masseter hypertrophy through a phase 2 clinical trial completed in the first half of last year. It is a relatively simple procedure that directly injects the botulinum toxin into the masseter muscle using a minimally invasive method, which can be used as an alternative to conservative or surgical treatments.

Currently, Liztox holds indications for improving glabellar wrinkles and periorbital wrinkles in the aesthetic field. Through this phase 3 clinical trial, the company plans to acquire additional indications to further enhance its competitiveness.

A representative of Huons Biopharma stated, "We are striving to expand the indications and production volume of Liztox in response to the demands of the botulinum toxin market," adding, "We plan to actively respond to the increasing demand for botulinum toxin through the phase 3 clinical trial for post-stroke upper limb muscle spasticity treatment and the expansion of a new factory."