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A Phase 2b, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Usnoflast Administered to Adult Subjects With ALS

Trial Profile

A Phase 2b, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Usnoflast Administered to Adult Subjects With ALS

Status: Not yet recruiting
Phase of Trial: Phase II

Latest Information Update: 24 Jun 2025

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At a glance

  • Drugs Usnoflast (Primary)
  • Indications Amyotrophic lateral sclerosis
  • Focus Adverse reactions; Therapeutic Use
  • Acronyms UNITE-ALS
  • Sponsors Zydus Lifesciences

Most Recent Events

  • 22 Jan 2025 According to a Zydus Lifesciences media release, company has recently received approval from USFDA to initiate this study.
  • 12 Sep 2024 New trial record
  • 10 Sep 2024 According to a Zydus Lifesciences media release, company is now looking forward to conducting a larger Phase 2b clinical trial in consultation with the regulatory authorities

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