Relyvrio FDA Approval History
Last updated by Judith Stewart, BPharm on April 7, 2024.
FDA Approved: Yes (Discontinued) (First approved September 29, 2022)
Brand name: Relyvrio
Generic name: sodium phenylbutyrate and taurursodiol
Dosage form: Powder for Oral Suspension
Previous Name: AMX0035
Company: Amylyx Pharmaceuticals, Inc.
Treatment for: Amyotrophic Lateral Sclerosis
Relyvrio (sodium phenylbutyrate and taurursodiol) is a neuroprotective therapy for the treatment of amyotrophic lateral sclerosis (ALS).
On April 4, 2024, Amylyx Pharmaceuticals, Inc. announced the Company has started a process with the U.S. Food and Drug Administration (FDA) and Health Canada to voluntarily discontinue the marketing authorizations for Relyvrio/Albrioza (sodium phenylbutyrate and taurursodiol) and remove the product from the market in the U.S. and Canada based on topline results from the Phase 3 PHOENIX trial. Relyvrio/Albrioza will no longer be available for new patients. Patients currently on therapy in the U.S. and Canada who, in consultation with their physician, wish to stay on treatment can be transitioned to a free drug program.
- Relyvrio (also known as AMX0035 and Albrioza) is a proprietary oral fixed-dose combination of two small molecules: sodium phenylbutyrate (PB), which is a small molecular chaperone designed to reduce the unfolded protein response (UPR), preventing cell death resulting from the UPR; and taurursodiol (TURSO; also known as ursodoxicoltaurine), which is a Bax inhibitor designed to reduce cell death through apoptosis. PB and TURSO were combined in a fixed-dose formulation in an effort to reduce neuronal death and dysfunction. Relyvrio is designed to target the endoplasmic reticulum and mitochondrial-dependent neuronal degeneration pathways in ALS and other neurodegenerative diseases.
- Relyvrio is administered orally once daily for the first three weeks, then twice daily thereafter.
- Common adverse reactions include diarrhea, abdominal pain, nausea, and upper respiratory tract infection.
Development timeline for Relyvrio
Further information
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