US EditionFDA Clears NUZ-001 for Entry Into HEALEY ALS Platform Trial
The FDA’s approval allows Neurizon to begin clinical activities for NUZ-001 in the HEALEY ALS trial, aiming to accelerate treatment options for amyotrophic lateral sclerosis.
- On Dec. 12, 2025, the U.S. Food and Drug Administration accepted the protocol for NUZ-001 as Regimen I in the HEALEY ALS Platform Trial.
- The HEALEY ALS Platform Trial is a multicenter, double-blind, placebo-controlled adaptive trial created with the Network of Excellence for ALS to accelerate new therapy development.
- Neurizon Therapeutics Limited's NUZ-001 shows favourable oral bioavailability, central nervous system penetration, an encouraging safety profile, early signs of potential clinical benefit, and is not approved for commercial use.
- Acceptance allows the Sean M. Healey & AMG Center for ALS IND to begin Institutional Review Board submissions, activation of clinical trial sites and investigators, and study start-up toward trial activation.
- First patients are expected to be enrolled early in 2026, and Neurizon said this milestone strengthens its pathway toward advancing a potential new ALS treatment aligned with its strategy to accelerate access to ALS treatments.
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FDA Clears NUZ-001 for Entry into HEALEY ALS Platform Trial
Highlights:
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