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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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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: Planning
Phase of Trial: Phase II/III

Latest Information Update: 23 Dec 2024

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At a glance

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

    • Most Recent Events

    • 18 Dec 2024 According to the Neurizon Therapeutics Media Release, Pending FDA clearance of the IND application, Neurizon anticipates Massachusetts General Hospital (MGH) filing a protocol amendment to their IND for the HEALEY ALS Platform Trial to incorporate our regimen specific appendix in Q1 CY2025. Neurizon expects to initiate patient enrollment in the HEALEY ALS Platform Trial in H1 CY2025.
    • 18 Dec 2024 According to the Neurizon Therapeutics Media Release, announce the filing of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for its lead candidate, NUZ-001. This milestone is a pivotal step in enabling the commencement of a Phase 2/3 clinical trial within the HEALEY ALS Platform Trial framework. The FDA has a period of 30 days to review the IND application.
    • 14 Nov 2024 New trial record

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