May 5, 2026 — Leads & Copy —
Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) has launched a U.S. Expanded Access Program (EAP) for up to 250 adults with post-bariatric hypoglycemia (PBH). The program aims to provide treatment access to avexitide, an investigational glucagon-like peptide-1 (GLP-1) receptor antagonist.
The EAP enables U.S. physicians to request avexitide for adults with PBH following Roux-en-Y gastric bypass (RYGB) surgery who have a serious unmet medical need. To be eligible, patients must be unable to participate in an ongoing clinical trial, have exhausted available management options, and meet all other eligibility criteria. Initial eligible patients include those who have completed the Phase 3 LUCIDITY clinical trial and participants in a prior trial of avexitide in PBH following RYGB surgery.
According to Dr. Camille L. Bedrosian, Chief Medical Officer at Amylyx, the U.S. Expanded Access Program for avexitide was informed by dialogue with the PBH community. Bedrosian added that the program reflects Amylyx’s commitment to providing a potential option for eligible individuals as the company continues to advance avexitide through clinical development.
Avexitide is currently under investigation and has not been approved by the U.S. Food and Drug Administration (FDA) for any indication. It is being evaluated in the Phase 3 LUCIDITY clinical trial, a 16-week, multicenter, randomized, double-blind, placebo-controlled trial assessing its efficacy and safety in adults with PBH following RYGB surgery. Participants who complete the 16-week double-blind period can enter a 32-week open-label extension period. The trial has enrolled 78 participants, with topline data readout anticipated in Q3 2026. If approved, commercial launch of avexitide is anticipated in 2027.
Individuals with PBH who are interested in potential access to avexitide through the EAP should consult their physician or care team to determine eligibility. Access to avexitide through the EAP is limited, may change over time, and participation is not guaranteed. Additional information about the EAP is available at amylyx.com/global-access-policy.
Avexitide has been evaluated in five Phase 1 and Phase 2 clinical trials for PBH and has also been studied in congenital hyperinsulinism (HI). The FDA has granted avexitide Breakthrough Therapy Designation for both indications, Rare Pediatric Disease Designation in congenital HI, and Orphan Drug Designation for the treatment of hyperinsulinemic hypoglycemia (which includes PBH and congenital HI).
PBH is estimated to affect approximately 8% of people in the U.S. who have undergone sleeve gastrectomy and Roux-en-Y gastric bypass. PBH is thought to be driven by an exaggerated glucagon-like peptide-1 (GLP-1) response, leading to recurrent drops in blood glucose, known as hypoglycemia. Hypoglycemia can manifest as neuroglycopenia, causing confusion, cognitive dysfunction, loss of consciousness, and seizures. There are currently no FDA-approved therapies for PBH.
The LUCIDITY trial (NCT06747468) is a 78-participant, multicenter, randomized, double-blind, placebo-controlled Phase 3 clinical trial evaluating the efficacy and safety of avexitide in participants with PBH following RYGB surgery. Participants were randomized 3:2 to receive either 90 mg of avexitide subcutaneously once daily or placebo. The primary efficacy objective is to evaluate the reduction in the composite of Level 2 and Level 3 hypoglycemic events through Week 16.
Amylyx Pharmaceuticals is focused on developing therapies for diseases with high unmet needs. The company is currently focused on four investigational therapies across several endocrine conditions and neurodegenerative diseases.
Source: Amylyx Pharmaceuticals
