On Mar. 4, 2024, Hugel America announced it received U.S. Food and Drug Administration (FDA) approval on its neurotoxin, Letybo to treat moderate-to-severe glabellar (frown) lines in adults.

The FDA approval was supported by positive results from three completed phase III trials that enrolled more than 1,000 subjects in the U.S. and Europe. Hugel has sold over 26 million vials in 50+ different countries including Australia, Canada, and Europe.

Hugel planned to accelerate its transition for approved medical use with the goal of launching to aesthetic clinicians in the second half of 2024.