Amylyx Pharmaceuticals
- Country
- 🇺🇸United States
- Ownership
- Public
- Established
- 2014-01-01
- Employees
- 384
- Market Cap
- $145M
- Website
- http://www.amylyx.com
Clinical Trials
27
Trial Phases
3 Phases
Drug Approvals
1
Drug Approvals
Clinical Trials
Distribution across different clinical trial phases (26 trials with phase data)• Click on a phase to view related trials
Avexitide for Treatment of Post-Bariatric Hypoglycemia
- First Posted Date
- 2024-12-24
- Last Posted Date
- 2025-07-02
- Lead Sponsor
- Amylyx Pharmaceuticals Inc.
- Target Recruit Count
- 75
- Registration Number
- NCT06747468
- Locations
- 🇺🇸
Stanford Health Care - Endocrinology Clinic, Stanford, California, United States
🇺🇸University of Colorado Health Anschutz Medical Campus, Aurora, Colorado, United States
🇺🇸East Coast Institute for Research, Jacksonville, Florida, United States
AMX0114 in Adult Participants With Amyotrophic Lateral Sclerosis
- First Posted Date
- 2024-10-30
- Last Posted Date
- 2025-07-08
- Lead Sponsor
- Amylyx Pharmaceuticals Inc.
- Target Recruit Count
- 48
- Registration Number
- NCT06665165
- Locations
- 🇺🇸
University of California, San Diego, La Jolla, California, United States
🇺🇸Orlando Regional Medical Center, Orlando Health Neuroscience Institute, Orlando, Florida, United States
🇺🇸Georgetown University Hospital Pasquerilla Healthcare Center, Washington, District of Columbia, United States
AMX0035 and Progressive Supranuclear Palsy
- Conditions
- Neurodegenerative DiseasesAtypical ParkinsonismPSPProgressive Supranuclear Palsy
- Interventions
- Other: Placebo
- First Posted Date
- 2023-11-08
- Last Posted Date
- 2024-12-20
- Lead Sponsor
- Amylyx Pharmaceuticals Inc.
- Target Recruit Count
- 110
- Registration Number
- NCT06122662
- Locations
- 🇺🇸
Mayo Clinic, Scottsdale, Arizona, United States
🇺🇸University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States
🇺🇸Parkinson's & Movement Disorder Institute, Fountain Valley, California, United States
AMX0035 in Adult Patients With Wolfram Syndrome
- First Posted Date
- 2023-01-09
- Last Posted Date
- 2025-04-02
- Lead Sponsor
- Amylyx Pharmaceuticals Inc.
- Target Recruit Count
- 12
- Registration Number
- NCT05676034
- Locations
- 🇺🇸
Washington University, Saint Louis, Missouri, United States
Extension Study Evaluating The Safety And Tolerability of AMX0035
- First Posted Date
- 2022-11-17
- Last Posted Date
- 2025-01-13
- Lead Sponsor
- Amylyx Pharmaceuticals Inc.
- Target Recruit Count
- 352
- Registration Number
- NCT05619783
- Locations
- 🇧🇪
University Hospitals Leuven, Leuven, Belgium
🇫🇷Hospices Civils de Lyon Hôpital Neurologique Pierre Wertheimer Cellule Mutualisée de Recherche Clinique (CMRC), Bron, France
🇫🇷Hopital Gabriel Montpied Service de Neurologie, Clermont-Ferrand, France
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News
FDA Grants Historic Approval to Biogen's Qalsody for Rare Genetic Form of ALS
Biogen's Qalsody (tofersen) receives FDA accelerated approval as the first therapy for SOD1-mutated ALS, marking a significant breakthrough in genetic-specific ALS treatment.
FDA Lifts Clinical Hold on Amylyx's AMX0114 Phase 1 ALS Trial, Paving Way for LUMINA Study
The FDA has lifted the clinical hold on Amylyx Pharmaceuticals' Phase 1 trial of AMX0114, an antisense oligonucleotide for ALS treatment.
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.
Pharmaceutical R&D Highlights of 2024: GLP-1s, CRISPR, and More
• GLP-1 receptor agonists like semaglutide and tirzepatide showed potential beyond diabetes and weight loss, including cardiovascular and mental health benefits. • CRISPR gene editing entered the market with Casgevy for sickle cell disease and β-thalassemia, though uptake has been slow due to complex treatment requirements. • Protein-folding algorithms developed by Nobel laureates revolutionized biochemical research and found applications in pharmaceutical drug discovery. • Antibody-drug conjugates (ADCs) saw major investment, with firms focusing on novel linker chemistries to enhance their efficacy and target specificity.
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).
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.
AMX0035 Shows Sustained Improvements in Wolfram Syndrome Patients in Phase 2 Trial
Amylyx Pharmaceuticals' AMX0035 demonstrated sustained improvements in pancreatic function in adults with Wolfram syndrome in a Phase 2 trial.
Amylyx's AMX0035 Shows Promise in Alzheimer's Disease Biomarker Study
Amylyx Pharmaceuticals published exploratory analyses from the Phase 2 PEGASUS trial showing AMX0035 reduced key Alzheimer's disease biomarkers in cerebrospinal fluid samples.
Amylyx Acquires Phase 3-Ready GLP-1 Receptor Antagonist Avexitide for Hyperinsulinemic Hypoglycemia
Amylyx Pharmaceuticals acquired avexitide from Eiger BioPharmaceuticals for $35.1 million, gaining a first-in-class GLP-1 receptor antagonist with FDA Breakthrough Therapy Designation for post-bariatric hypoglycemia and congenital hyperinsulinism.
Relyvrio Fails Phase 3 Trial, Amylyx Considers Market Withdrawal
Amylyx Pharmaceuticals' Relyvrio failed to demonstrate significant benefit in the Phase 3 PHOENIX trial for ALS, raising concerns about its efficacy.