Avexitide
- Generic Name
- Avexitide
- Drug Type
- Small Molecule
- Chemical Formula
- C149H234N40O47S
- CAS Number
- 133514-43-9
- Unique Ingredient Identifier
- 5313W10MYT
- Background
Avexitide is under investigation in clinical trial NCT02996812 (Evaluation of Single Ascending Doses of Subcutaneous Exendin 9-39 in Patients With Post-Bariatric Hypoglycemia).
Amylyx Pharmaceuticals Appoints Dan Monahan as Chief Commercial Officer to Spearhead Avexitide Launch
• Amylyx Pharmaceuticals has appointed Dan Monahan as Chief Commercial Officer to lead the commercialization of their product portfolio.
• Monahan will focus on the potential approval and launch of avexitide, a GLP-1 receptor antagonist for post-bariatric hypoglycemia (PBH).
• Amylyx plans to initiate the Phase 3 LUCIDITY trial of avexitide in Q1 2025, with data expected in 2026, to address the unmet need for PBH treatment.
• Monahan brings over 20 years of experience in the biopharmaceutical industry, including successful launches at Otsuka, Novartis, and Sanofi.
Amylyx Announces Phase 3 LUCIDITY Trial for Avexitide in Post-Bariatric Hypoglycemia
• Amylyx Pharmaceuticals initiates Phase 3 LUCIDITY trial for avexitide, a GLP-1 receptor antagonist, targeting post-bariatric hypoglycemia (PBH).
• The trial aims to reduce hypoglycemia events, with participant dosing expected in Q1 2025 and topline results anticipated in 2026.
• LUCIDITY is a multicenter, randomized, double-blind, placebo-controlled study involving 75 participants across 20 U.S. sites.
• Avexitide has received FDA Breakthrough Therapy and Orphan Drug Designations, highlighting the unmet need in PBH treatment.
Amylyx Pharmaceuticals Advances Pipeline with Positive Data and Strategic Acquisitions
• Amylyx reported positive topline data from its Phase 2 HELIOS trial of AMX0035 in Wolfram syndrome, showing improvement or stabilization across key disease measures.
• The company is on track to initiate a Phase 3 program for avexitide in post-bariatric hypoglycemia (PBH) in Q1 2025, following its acquisition and Breakthrough Therapy Designation.
• Amylyx plans to begin the Phase 1 LUMINA clinical trial of AMX0114 in people living with ALS by the end of 2024 or in early 2025 in Canada.
• With $234.4 million in cash reserves, Amylyx anticipates funding operations into 2026, supporting its pipeline development in neurodegenerative diseases and endocrine conditions.
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