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NCT05286372
An Intermediate Size Expanded Access Protocol of AMX0035 for ALS
trial testing AMX0035 in Amyotrophic Lateral Sclerosis. Approved for marketing.
Quick facts
| Lead sponsor | Amylyx Pharmaceuticals Inc. |
|---|---|
| Status | APPROVED FOR MARKETING |
| Study type | EXPANDED_ACCESS |
| Sites | 21 locations across Puerto Rico, United States |
Drugs / interventions tested
- AMX0035 — full drug profile →
Conditions studied
- Amyotrophic Lateral Sclerosis — all drugs for Amyotrophic Lateral Sclerosis →
Sponsor
Amylyx Pharmaceuticals Inc. — full company profile →
Who can join
18 and older, any sex, with Amyotrophic Lateral Sclerosis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The Expanded Access Program will provide access and assess the safety of AMX0035 for the treatment of people living with ALS.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Emerging Roles of Bile Acids and TGR5 in the Central Nervous System: Molecular Functions and Therapeutic Implications.
Romero-Ramírez L, Mey J. · · 2024 · cited 14× · PMID 39273226 · DOI 10.3390/ijms25179279 -
Axonopathy Underlying Amyotrophic Lateral Sclerosis: Unraveling Complex Pathways and Therapeutic Insights.
Luan T, Li Q, Huang Z, Feng Y, et al · · 2024 · cited 9× · PMID 39097850 · DOI 10.1007/s12264-024-01267-2 -
Emerging Roles of Bile Acids in Neuroinflammation.
Butcher EL, Arthur S. · · 2025 · cited 1× · PMID 41373461 · DOI 10.3390/ijms262311301
Verify or expand the search:
- PubMed search for NCT05286372
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of AMX0035
Trials testing the same drug.
- NCT06122662 — AMX0035 and Progressive Supranuclear Palsy · Phase 2, PHASE3 · active not recruiting
- NCT05676034 — AMX0035 in Adult Patients With Wolfram Syndrome · Phase 2 · active not recruiting
- NCT05619783 — Extension Study Evaluating The Safety And Tolerability of AMX0035 · Phase 3 · completed
- NCT05021536 — Phase III Trial of AMX0035 for Amyotrophic Lateral Sclerosis Treatment · Phase 3 · active not recruiting
- NCT04516096 — A Compassionate Use Protocol of AMX0035 for Treatment of Patients With Amyotrophic Lateral Sclerosis (ALS) · Phase 2, PHASE3 · completed
Other recruiting trials for Amyotrophic Lateral Sclerosis
Currently open trials in the same condition.
- NCT07502677 — Diagnostic Accuracy of SleepImage Technology for Detecting Respiratory Failure in Patients With Amyotrophic Lateral Scle · recruiting
- NCT07478172 — Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease · NA · recruiting
- NCT07204977 — Acamprosate in C9orf72 Hexanucleotide Repeat Expansion Amyotrophic Lateral Sclerosis (ACALS) · Phase 1 · active not recruiting
- NCT07290062 — A Study to Investigate the Safety and Pharmacodynamics of a Single Intrathecal Injection (IT) of INS1202 in Participants · Phase 1 · recruiting
- NCT07259980 — A Study to Learn More About the Long-Term Safety of Tofersen (Qalsody) in Participants With Superoxide Dismutase 1 (SOD- · recruiting
Other Amylyx Pharmaceuticals Inc. trials
Trials by the same sponsor.
- NCT06122662 — AMX0035 and Progressive Supranuclear Palsy · Phase 2, PHASE3 · active not recruiting
- NCT05676034 — AMX0035 in Adult Patients With Wolfram Syndrome · Phase 2 · active not recruiting
- NCT05619783 — Extension Study Evaluating The Safety And Tolerability of AMX0035 · Phase 3 · completed
- NCT05021536 — Phase III Trial of AMX0035 for Amyotrophic Lateral Sclerosis Treatment · Phase 3 · active not recruiting
- NCT04516096 — A Compassionate Use Protocol of AMX0035 for Treatment of Patients With Amyotrophic Lateral Sclerosis (ALS) · Phase 2, PHASE3 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05286372 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Amylyx Pharmaceuticals Inc.
- Last refreshed: 18 October 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05286372.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing