Drugs / AMX0035
Drug research

AMX0035

Open a linked trial to see its study details and recorded changes, or check the regulatory events below and follow their sources.

Drug identity checked against registry records

Also recorded as Proprietary formulation of taurursodiol and sodium phenylbutyrate; RELYVRIO; Sodium Phenylbutyrate (PB) and Taurursodiol (TURSO, also known as Ursodoxicoltaurine or Tauroursodeoxycholic Acid [TUDCA]); Sodium Phenylbutyrate (PB) and Taurursodiol (TURSO; also known as Tauroursodeoxycholic Acid [TUDCA])

A drug appearing in a clinical trial does not mean it is FDA-approved. Check the original regulatory source for any approval claim.

Included trials

TrialSponsorPhaseStatusPrimary completion
Study to Assess the Safety and Biological Activity of AMX0035 for the Treatment of Alzheimer's DiseaseNCT03533257AMLXPhase 2Completed2020-10-22Actual
AMX0035 and Progressive Supranuclear PalsyNCT06122662AMLXPhase 2, Phase 3Completed2025-09-30Actual
Phase III Trial of AMX0035 for Amyotrophic Lateral Sclerosis TreatmentNCT05021536AMLXPhase 3Unknown2024-01-19Actual
AMX0035 in Adult Patients With Wolfram SyndromeNCT05676034AMLXPhase 2Active not recruiting2024-07-23Actual
AMX0035 in Patients With Amyotrophic Lateral Sclerosis (ALS)NCT03127514AMLXPhase 2Completed2019-09-25Actual
Open Label Extension Study of AMX0035 in Patients With ALSNCT03488524AMLXPhase 2Completed2021-03-01Actual
Extension Study Evaluating The Safety And Tolerability of AMX0035NCT05619783AMLXPhase 3Completed2024-10-16Actual

Regulatory dates and decisions

No regulatory events match this view.Try another date range or view. Events appear after automated source checks. This does not mean no FDA events have occurred. Dates that a source does not disclose stay undisclosed.