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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: Suspended
Phase of Trial: Phase II/III

Latest Information Update: 26 Sep 2025

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At a glance

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

Most Recent Events

  • 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.
  • 24 Mar 2025 According to the Neurizon Therapeutics Media Release, Following the latest round of testing, updates to the Master Protocol have been included to enhance and optimise future learning within the trial based on data collected from the first 5 regimens. These changes allow to finalise its RSA under the Master Protocol for submission to the FDA as soon as the clinical hold on NUZ-001 has been lifted. Further information on the RSA for NUZ-001 will be provided following FDA acceptance in H2 CY2025.
  • 24 Mar 2025 According to the Neurizon Therapeutics Media Release, Company will continue to work towards finalising participation in the HEALEY trial, with entry expected during H2 CY2025, which will include completing the two short-term pharmacokinetic studies required to lift the FDA clinical hold.

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