Amylyx Pharmaceuticals Inc. (NASDAQ: AMLX) announced the launch of a U.S. Expanded Access Program for up to 250 adults with post-bariatric hypoglycemia to provide treatment access to avexitide, an investigational glucagon-like peptide-1 receptor antagonist.

The program allows U.S. physicians to request avexitide for adults with post-bariatric hypoglycemia following Roux-en-Y gastric bypass surgery who have a serious unmet medical need, are unable to participate in an ongoing clinical trial, and have exhausted available management options. Initial eligible patients include individuals who have completed the Phase 3 LUCIDITY clinical trial and participants in a prior trial of avexitide.

"The experiences shared by those living with PBH underscore the profound unmet medical need they face every day," said Camille L. Bedrosian, Chief Medical Officer at Amylyx.

Avexitide has not been approved by the U.S. Food and Drug Administration for any indication. The drug is currently being evaluated in the Phase 3 LUCIDITY clinical trial, a 16-week, multicenter, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of avexitide in adults with post-bariatric hypoglycemia following gastric bypass surgery.

The trial has enrolled 78 participants, with topline data anticipated in the third quarter of 2026. If approved, commercial launch of avexitide is anticipated in 2027, according to the company statement.

Post-bariatric hypoglycemia is estimated to affect approximately 8% of people in the U.S. who have undergone sleeve gastrectomy and Roux-en-Y gastric bypass surgery, representing approximately 160,000 people. The condition causes recurrent drops in blood glucose levels and can manifest as neuroglycopenia, which may cause confusion, cognitive dysfunction, loss of consciousness, and seizures.

There are currently no FDA-approved therapies for post-bariatric hypoglycemia.