CAMBRIDGE, Mass. — Amylyx Pharmaceuticals has launched a U.S. Expanded Access Program for eligible adults with post-bariatric hypoglycemia, giving some patients access to the company’s investigational drug avexitide while it continues late-stage clinical development.
The program will allow 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, have exhausted available management options and meet other eligibility criteria.
Amylyx said the program will include up to 250 adults. Initial eligible patients include people who have completed the pivotal Phase 3 LUCIDITY clinical trial and participants in a prior trial of avexitide in post-bariatric hypoglycemia following Roux-en-Y gastric bypass surgery.
Avexitide is an investigational, first-in-class glucagon-like peptide-1 receptor antagonist. It has not been approved by the U.S. Food and Drug Administration for any indication.
“Listening to the PBH community is central to our work, and this dialogue directly informed our approach to the U.S. Expanded Access Program for avexitide,” said Camille L. Bedrosian, MD, Chief Medical Officer at Amylyx. “The experiences shared by those living with PBH underscore the profound unmet medical need they face every day. This program reflects our commitment to providing a potential option for eligible individuals as we continue to advance avexitide through clinical development.”
Amylyx is evaluating avexitide in the Phase 3 LUCIDITY clinical trial, a 16-week, multicenter, randomized, double-blind, placebo-controlled study assessing the drug’s safety and efficacy in adults with post-bariatric hypoglycemia following Roux-en-Y gastric bypass surgery.
Participants who complete the double-blind portion of the study are eligible to enter a 32-week open-label extension period. The trial has enrolled 78 participants, and Amylyx said topline data are expected in the third quarter of 2026.
If approved, Amylyx expects to commercially launch avexitide in 2027.
