First-In-Human Clinical Trial Evaluating AI-09, A Novel Long-Lasting Ready-To-Use Liquid Injectable Neuromodulator For The Treatment Of Glabellar Lines
July 2025
in “
Journal of Investigative Dermatology
”
TLDR AI-09 is safe, effective, and reduces wrinkles for up to 6 months.
The first-in-human clinical trial of AI-09, a novel liquid injectable neuromodulator for glabellar lines, involved 96 participants aged 20-70 and demonstrated that AI-09 is safe, well-tolerated, and effective. The trial tested seven dose levels, with the highest dose showing significant efficacy, achieving an 87% response rate in reducing wrinkles to Absent or Mild at Week 4 compared to 7% for the vehicle. The median duration of response was 6 months. Adverse events were mostly mild or moderate, with no serious events linked to the treatment. These results suggest AI-09 as a promising long-lasting alternative to current neuromodulators, warranting further research.