Treatment

sodium phenylbutyrate and taurursodiol

WITHDRAWN · Relyvrio, Albrioza, AMX0035

WITHDRAWNAlso searchable as: NO LONGER MARKETED

Key facts

Generic name
sodium phenylbutyrate and taurursodiol
Brand name(s)
Relyvrio, Albrioza, AMX0035
Gene requirement
Not gene-specific / no known gene requirement
Genetic confirmation
Not required by this record
ALS population
Adults with ALS in the original approval and study programs
Category
Historical ALS disease-targeting treatment
Regulatory status
WITHDRAWN
FDA approval date
09-29-2022
Approval pathway
Accelerated approval
Country / availability
State-level / commercial availability not verified
Route(s)
Oral
Administration
Administration details depend on formulation and individual care plan.

What is it?

Previously FDA-approved for ALS, later withdrawn from the U.S. and Canadian markets for new patients.

Indication: Previously FDA-approved for ALS; not currently available for new patients in the United States.

Who is it for?

Adults with ALS in the original approval and study programs

How does it work?

Mechanism: Not stated in the official study record.

Target: Not stated in the official study record.

How is it administered?

Oral

The route and formulation should be reviewed with the treating clinician.

Available formulations

What evidence supported approval?

The historical approval, PHOENIX results, and market-removal decision are documented by the linked FDA and manufacturer sources.

What is known about benefit?

The FDA snapshot describes the original CENTAUR study results. The later PHOENIX Phase 3 trial did not meet its prespecified primary or secondary endpoints.

Important safety information

Historical safety information remains available in the official sources but should not be interpreted as a current treatment option.

This page does not provide dosing, prescribing, or individualized medical advice.

Related research

Research opportunities are separate from treatment availability. Eligibility, recruitment, and study status must be confirmed in the Research record.

  • No linked research record in the Research database.

Historical timeline

  1. FDA approval for ALS.

  2. PHOENIX Phase 3 did not meet prespecified primary or secondary endpoints.

  3. Amylyx announced voluntary discontinuation of marketing authorizations and removal from the U.S. and Canadian markets; it was no longer available for new patients.

Official Sources

Last verified: 09-30-2026

Treatment information is provided for education and navigation and does not replace medical advice. Whether a treatment is appropriate depends on the individual’s diagnosis, genetic status, symptoms, health status, and other clinical factors. Treatment decisions should be made with the person’s ALS care team.

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