6 completed, 2 active not recruiting, 2 unknown, 1 approved for marketing. 7 Phase 2, 5 Phase 3, 2 Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 7 | Completed 5, Active not recruiting 1, Unknown 1 |
| Phase 3 | 5 | Completed 3, Active not recruiting 1, Unknown 1 |
| Phase 1 | 2 | Recruiting 1, Unknown 1 |
Follow Amylyx Pharmaceuticals Inc.: new trials by email
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Avexitide for Treatment of Post-Bariatric Hypoglycemia Avexitide, Placebo - Post Bariatric Hypoglycemia | Phase 3 | Active not recruiting | Amylyx Pharmaceuticals Inc. | 75 | 2025-04-29 | 2026-08-24 |
| AMX0114 in Adult Participants With Amyotrophic Lateral Sclerosis AMX0114, Placebo - ALS | Phase 1 | Recruiting | Amylyx Pharmaceuticals Inc. | 48 | 2025-04-07 | 2026-04-14 |
| AMX0035 and Progressive Supranuclear Palsy AMX0035, Placebo - Progressive Supranuclear Palsy, PSP | Phase 2 / Phase 3 | Completed | Amylyx Pharmaceuticals Inc. | 139 | 2023-12-21 | 2026-04-30 |
| AMX0035 in Adult Patients With Wolfram Syndrome AMX0035 - Wolfram Syndrome | Phase 2 | Active not recruiting | Amylyx Pharmaceuticals Inc. | 12 | 2023-03-03 | 2026-04-14 |
| Extension Study Evaluating The Safety And Tolerability of AMX0035 AMX0035 - Amyotrophic Lateral Sclerosis | Phase 3 | Completed | Amylyx Pharmaceuticals Inc. | 352 | 2022-12-29 | 2025-01-13 |
| Phase III Trial of AMX0035 for Amyotrophic Lateral Sclerosis Treatment Placebo, AMX0035 - Amyotrophic Lateral Sclerosis | Phase 3 | Unknown | Amylyx Pharmaceuticals Inc. | 664 | 2021-10-28 | 2024-08-14 |
| Pharmacokinetic and Pharmacodynamic Study of AMX0035 in Patients With ALS AMX0035 - ALS | Phase 1 / Phase 2 | Unknown | Amylyx Pharmaceuticals Inc. | 14 | 2021-08-05 | 2023-07-24 |
| A Compassionate Use Protocol of AMX0035 for Treatment of Patients With Amyotrophic Lateral Sclerosis (ALS) AMX0035 - Amyotrophic Lateral Sclerosis | Phase 2 / Phase 3 | Completed | Amylyx Pharmaceuticals Inc. | 28 | 2020-11-22 | 2023-04-07 |
| Study to Assess the Safety and Biological Activity of AMX0035 for the Treatment of Alzheimer's Disease AMX0035, Placebo - Alzheimer Disease | Phase 2 | Completed | Amylyx Pharmaceuticals Inc. | 95 | 2018-09-14 | 2025-03-07 |
| Open Label Extension Study of AMX0035 in Patients With ALS AMX0035 - Amyotrophic Lateral Sclerosis, ALS | Phase 2 | Completed | Amylyx Pharmaceuticals Inc. | 90 | 2018-03-29 | 2025-08-13 |
| AMX0035 in Patients With Amyotrophic Lateral Sclerosis (ALS) AMX0035, Placebo - Amyotrophic Lateral Sclerosis, Motor Neuron Disease | Phase 2 | Completed | Amylyx Pharmaceuticals Inc. | 137 | 2017-06-22 | 2024-05-16 |
| An Expanded Access Protocol to Provide Avexitide in Patients With Post-Bariatric Hypoglycemia Avexitide - Post-bariatric Hypoglycemia | Available | Amylyx Pharmaceuticals Inc. | 2026-07-14 | |||
| An Intermediate Size Expanded Access Protocol of AMX0035 for ALS AMX0035 - Amyotrophic Lateral Sclerosis | Approved for marketing | Amylyx Pharmaceuticals Inc. | 2022-10-18 |
Amyotrophic Lateral Sclerosis (8) · Motor Neuron Disease (3) · Neurodegenerative Diseases (3) · Hypoglycemia (2) · Nervous System Diseases (2) · Neuromuscular Diseases (2) · Alzheimer Disease (1) · Central Nervous System Diseases (1) · Spinal Cord Diseases (1) · Supranuclear Palsy, Progressive (1) · TDP-43 Proteinopathies (1) · Wolfram Syndrome (1)
sodium phenylbutyrate and taurursodiol (10) · 4-phenylbutyric acid (4) · exendin (9-39) (2) · ursodoxicoltaurine (2)
United States (12) · France (3) · Germany (3) · Italy (3) · Spain (3) · Belgium (2) · Ireland (2) · Netherlands (2) · Poland (2) · Portugal (2) · Sweden (2) · United Kingdom (2) · Canada (1) · Puerto Rico (1)
Patrick Yeramian, MD (2) · Camille Bedrosian, MD (1) · Lahar Mehta, MD (1) · Machelle Manual, PhD (1) · Sabrina Paganoni, MD (1) · Sabrina Paganoni, MD, PhD (1)
PMID 35577511, PMID 32877582, PMID 33063909, PMID 35508892, PMID 37941072, PMID 38050066, PMID 39131742