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Sodium phenylbutyrate/ursodoxicoltaurine - Amylyx Pharmaceuticals

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Drug Profile

Sodium phenylbutyrate/ursodoxicoltaurine - Amylyx Pharmaceuticals

Alternative Names: ALBRIOZA; AMX-0035; PB/TURSO; RELYVRIO; Sodium phenylbutyrate/tauroursodeoxycholic acid; Sodium phenylbutyrate/taurursodiol; Tauroursodeoxycholic acid/sodium phenylbutyrate; Ursodoxicoltaurine

Latest Information Update: 04 Sep 2025

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At a glance

  • Originator Amylyx Pharmaceuticals
  • Class Alcohols; Amides; Amines; Antidementias; Antineoplastics; Antivirals; Cholanes; Cyclohexanols; Electrolytes; Gallstone therapies; Hepatoprotectants; Neuroprotectants; Phenylbutyrates; Small molecules; Sulfonic acids
  • Mechanism of Action Ammonia scavengers; Histone deacetylase inhibitors; Phosphotransferase inhibitors
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Amyotrophic lateral sclerosis; Wolfram syndrome
  • New Molecular Entity No

Highest Development Phases

  • Registered Amyotrophic lateral sclerosis
  • Phase II Alzheimer's disease; Wolfram syndrome
  • No development reported Friedreich's ataxia
  • Discontinued Progressive supranuclear palsy

Most Recent Events

  • 27 Aug 2025 Discontinued - Phase-III for Progressive supranuclear palsy in USA, Germany, France, Spain, Italy (PO)
  • 27 Aug 2025 Amylyx Pharmaceuticals terminates a phase IIb/III ORION trial in Progressive supranuclear palsy due to poor week 24 efficacy results
  • 08 Aug 2025 Efficacy data from the phase I/II HELIOS trial in Wolfram Syndrome were presented by Amylyx Pharmaceuticals

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