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a Phase 2/3 clinical study of NUZ-001, for the treatment of Amyotrophic Lateral Sclerosis (ALS) as part of the HEALEY ALS Platform Trial

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Trial Profile

a Phase 2/3 clinical study of NUZ-001, for the treatment of Amyotrophic Lateral Sclerosis (ALS) as part of the HEALEY ALS Platform Trial

Status: Not yet recruiting
Phase of Trial: Phase II/III

Latest Information Update: 16 Oct 2025

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At a glance

  • Drugs Monepantel (Primary)
  • Indications Amyotrophic lateral sclerosis
  • Focus Therapeutic Use
  • Acronyms HEALEY ALS

Most Recent Events

  • 06 Oct 2025 According to the Neurizon Therapeutics Media Release, with IND now active, company anticipates Mass General Hospital (MGH) filing a protocol amendment to their IND for the HEALEY ALS Platform Trial to incorporate our specific protocol regimen early in the coming weeks. Company expects to initiate patient enrollment in the HEALEY ALS Platform Trial in Q4 CY2025.
  • 06 Oct 2025 According to the Neurizon Therapeutics Media Release, company announced U.S. Food and Drug Administration (FDA) has lifted the clinical hold on NUZ-001. This decision marks a pivotal regulatory milestone for Neurizon and the ALS community, clearing the way for Phase 2/3 development of NUZ-001 as part of the HEALEY ALS Platform Trial, expected to commence Q4 CY2025.
  • 10 Jul 2025 According to the Neurizon Therapeutics Media Release, FDA has provided positive written feedback on strategy to resolve the clinical hold for NUZ001. The two preclinical pharmacokinetic studies requested have been completed ahead of schedule, and the study reports are being finalized. Company expects to submit complete responses in coming weeks and anticipate that the clinical hold will be lifted in August 2025. The Company expects to start this trial in Q4 2025.

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