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# FDA OK’s Hugel’s Frown Lines Neurotoxin
- URL: https://www.fdaweb.com/fda-oks-hugels-frown-lines-neurotoxin/
- Published: 2024-03-04T12:00:00.000Z
- Updated: 2026-09-14T14:24:28.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5156474

FDA has approved Hugel’s Letybo (botulinum toxin), a neurotoxin for treating moderate-to-severe glabellar (frown) lines in adults. Approval was based on data from three Phase 3 trials that enrolled more than 1,000 subjects in the U.S. and Europe (BLESS I [NCT02677298](https://clinicaltrials.gov/study/NCT02677298?term=NCT02677298&rank=1&ref=fdaweb.com), BLESS II [NCT02677805](https://clinicaltrials.gov/study/NCT02677805?term=NCT02677805&rank=1&ref=fdaweb.com) and BLESS III [NCT03985982](https://clinicaltrials.gov/study/NCT03985982?term=NCT03985982&rank=1&ref=fdaweb.com)). According to Hugel, the data showed a greater proportion of patients who received Letybo saw improvements compared with those receiving a placebo.

“This botulinum toxin type A has been the leading neurotoxin brand in South Korea…,” the company says. It expects to launch the product by mid year.