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Clinical Trials and Expanded Access

At Neurizon Therapeutics, we are committed to advancing innovative research in neurodegenerative diseases, including amyotrophic lateral sclerosis (ALS). Our clinical development programs are designed to rigorously evaluate the safety and investigational profile of NUZ-001 through ethically conducted and regulator-approved clinical trials.

Consistent with our commitment to scientific integrity and regulatory compliance, participation in authorised clinical trials is currently the only pathway through which NUZ-001 may be accessed. Clinical trials are conducted under carefully controlled conditions to ensure appropriate oversight, participant safety, and reliable data generation.

NUZ-001 is being evaluated as a regimen “I” within the HEALEY ALS Platform Trial, an adaptive Phase 2/3 study led by the Healey & AMG Center for ALS at Mass General Brigham in collaboration with the Network for Excellence in ALS (NEALS). The trial is conducted across multiple specialist clinical sites, with patient enrolment anticipated in Q1 2026.

As NUZ-001 is being evaluated within the HEALEY ALS Platform Trial infrastructure, Neurizon does not manage site-level recruitment or determine patient eligibility. Those interested in participating in a clinical trial should speak with their treating neurologist or healthcare provider.

Individuals and healthcare professionals seeking information about trial locations, eligibility criteria, and enrolment status should refer to the official listing on clinicaltrials.gov

Healthcare professionals seeking scientific information about NUZ-001 may contact Neurizon via our general enquiries page or email us at enquiries@neurizon.com.

Expanded Access

“Expanded Access” (sometimes referred to as compassionate use) is a pathway that may allow use of investigational therapies outside of a clinical trial, usually for severe or life-threatening conditions. At this time, Neurizon does not have an Expanded Access Program for NUZ-001. NUZ-001 remains an investigational therapy and the only way to access is participation in an authorised clinical trial.

About the HEALEY ALS Platform Trial

Mass General Brigham’s HEALEY ALS Platform Trial is a multicenter, double-blind, placebo-controlled, adaptive trial for ALS created in partnership with the Network of Excellence for ALS (NEALS). The goal of the HEALEY ALS Platform trial is to accelerate the development of potential new ALS therapies. The trial tests and evaluates multiple investigational drugs simultaneously, shares infrastructure across trial sites, and improves start-up and enrollment efficiencies, allowing for fast results.

For more information, please visit Sean M. Healey & AMG Center for ALS