AMX0035 in ALS (CENTAUR / PHOENIX)

Phase 3 Completed

ALS (no genetic stratification)

NCT ID NCT05021536 ↗

Phase Phase 3

Status Completed

Sponsor Amylyx

Enrolment n = 664

Last updated 2026-04-30

Registered 2026-04-30

Target intervention

AMX0035 (sodium phenylbutyrate + taurursodiol)

Primary endpoint

ALSFRS-R change at 48 weeks

Summary

PHOENIX failed primary; Relyvrio voluntarily withdrawn April 2024. Triggered post-hoc reflection on Phase 2 effect-size inflation.

Protocol timeline

Phase I

Phase II

Phase III

Phase IV

Current status Completed

Enrolled n = 664

View on ClinicalTrials.gov ↗

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