Hugel "Liquid Botulinum Toxin 'HG102' Phase 3 Plan Approved"

For Patients with Moderate or Severe Glabellar Lines
Scheduled for Completion in October 2025

Hugel announced on the 13th that it has received approval from the Ministry of Food and Drug Safety for the Phase 3 clinical trial plan (IND) of its next-generation botulinum toxin product, 'HG102.'

Hugel logo. [Image provided by Hugel]

HG102 is Hugel's next-generation product that transforms the existing freeze-dried powder form of botulinum toxin into a liquid form with the addition of the local anesthetic lidocaine hydrochloride.

The Phase 3 clinical trial will be conducted at Sinchon Severance Hospital, Seoul National University Hospital, and Asan Medical Center, targeting 272 patients with moderate to severe glabellar lines. The study will compare the HG102 treatment group (test group) and AbbVie's Botox treatment group (control group) by administering the same dose once and evaluating the improvement of glabellar lines and safety.

The existing powder form of botulinum toxin requires slow injection of sterile saline for dissolution and dilution, and the reconstituted drug must be used within 24 hours, which is inconvenient. Additionally, there is a risk of additional infection during saline injection, and if foaming or similar vigorous agitation occurs during dilution, the drug may become denatured.

HG102, in liquid form, is expected to enhance convenience for medical staff, improve procedural safety and precision, and also provide economic benefits by reducing drug costs, according to Hugel.

A Hugel representative stated, "The Phase 3 clinical trial of HG102 is expected to be completed by October 2025," adding, "Hugel will continue sustainable growth by developing various new products that meet the needs of both medical professionals and patients based on excellent research and development (R&D) capabilities."

This content was produced with the assistance of AI translation services.