6 completed, 2 unknown, 1 active not recruiting, 1 approved for marketing. 8 Phase 2, 4 Phase 3, 1 Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 8 | Completed 5, Active not recruiting 1, Recruiting 1, Unknown 1 |
| Phase 3 | 4 | Completed 3, Unknown 1 |
| Phase 1 | 1 | Unknown 1 |
Follow AMX0035: new trials by email Literature Review of AMX0035 trials Research Report on AMX0035
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 |
|---|---|---|---|---|---|---|
| METabolic MODulation to Enhance Insulin Sensitivity and Mitochondrial Function in Type 1 Diabetes (MetMod-T1D) AMX0035, Placebo - Type 1 Diabetes (T1D), Metabolic Diseases | Phase 2 | Recruiting | University of Washington | 60 | 2026-09-01 | 2026-09-15 |
| 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 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 (7) · Neurodegenerative Diseases (3) · Motor Neuron Disease (2) · Nervous System Diseases (2) · Neuromuscular Diseases (2) · Alzheimer Disease (1) · Autoimmune Diseases (1) · Central Nervous System Diseases (1) · Diabetes Mellitus, Type 1 (1) · Endocrine System Diseases (1) · Glucose Metabolism Disorders (1) · Immune System Diseases (1) · Metabolic Diseases (1) · Nutritional and Metabolic Diseases (1) · Spinal Cord Diseases (1)
Amylyx Pharmaceuticals Inc. (10) · University of Washington (1)
United States (10) · France (3) · Germany (3) · Italy (3) · Netherlands (3) · Spain (3) · Belgium (2) · Ireland (2) · Poland (2) · Portugal (2) · Sweden (2) · United Kingdom (2) · Puerto Rico (1)
Patrick Yeramian, MD (2) · Camille Bedrosian, MD (1) · Lahar Mehta, MD (1) · Machelle Manual, PhD (1) · Petter M Bjornstad, MD (1) · Sabrina Paganoni, MD (1) · Sabrina Paganoni, MD, PhD (1)
PMID 35577511, PMID 32877582, PMID 33063909, PMID 35508892, PMID 37941072, PMID 38050066, PMID 39131742