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. NUZ-001 is an investigational therapy and has not been approved for commercial use in any jurisdiction.
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).
Enrolment into Regimen I is now complete, with 250 participants enrolled across 78 activated clinical sites in the United States.
As NUZ-001 is being evaluated within the HEALEY ALS Platform Trial infrastructure, Neurizon does not manage site-level recruitment or determine patient eligibility.
Individuals and healthcare professionals seeking further information about the current study status and participating locations, 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 people with serious or life-threatening conditions to access an investigational therapy outside of a clinical trial.
The Sean M. Healey & AMG Center for ALS at Mass General Brigham has received funding from the U.S. National Institutes of Health (NIH) to conduct an Expanded Access Program (EAP) for NUZ-001 in people living with ALS who are otherwise ineligible to participate in clinical trials (FAIN U01NS153995). The program is supported through an NIH expanded-access research program established under the Accelerating Access to Critical Therapies for ALS Act (ACT for ALS).
The program is expected to provide access to NUZ-001 for up to 200 people living with ALS in the U.S. for up to 96 weeks. The EAP will be led by the Healey & AMG Center, with Neurizon supplying NUZ-001 and supporting the program as regulatory sponsor.
The program is currently in the start-up phase and is not yet enrolling participants. Further information regarding enrolment, eligibility and participating sites will be provided by the Healey & AMG Center as it becomes available.
NUZ-001 remains an investigational therapy and the only way to access is participation an authorized 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
