Sodium phenylbutyrate/tauroursodeoxycholic acid - Amylyx Pharmaceuticals

Drug Profile

Sodium phenylbutyrate/tauroursodeoxycholic acid - Amylyx Pharmaceuticals

Alternative Names: AMX 0035; Tauroursodeoxycholic acid/sodium phenylbutyrate

Latest Information Update: 10 Apr 2018

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At a glance

  • Originator Amylyx Pharmaceuticals
  • Class Antidementias
  • Mechanism of Action Undefined mechanism
  • Orphan Drug Status

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

    Yes - Amyotrophic lateral sclerosis
  • New Molecular Entity Yes

Highest Development Phases

  • Phase II Amyotrophic lateral sclerosis
  • Preclinical Alzheimer's disease; Friedreich's ataxia

Most Recent Events

  • 29 Mar 2018 Amylyx Pharmaceuticals initiates enrolment in the CENTAUR-OLE open label extension trial for Amyotrophic lateral sclerosis (In children, In adults, In the elderly) in USA (PO) (NCT03488524)
  • 24 Oct 2017 Amylyx Pharmaceuticals plans the phase II PEGASUS trial for Alzheimer's disease in 1H 2018 (PO) (CTP#289683) (NCT03533257)
  • 19 Sep 2017 Sodium phenylbutyrate/tauroursodeoxycholic acid receives Orphan Drug status for Amyotrophic lateral sclerosis in USA
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