Approval Probability
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NUZ-001 · 1 trial · 1 indication
Change in disease severity over time as measured by the Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R) total score and survival. Each type of function is scored from 4 (normal) to 0 (no ability), with a maximum total score of 48 and a minimum total score of 0. Patients with higher scores have more physical function.
| Arm | Type | Description |
|---|---|---|
| NUZ-001 | EXPERIMENTAL | NUZ-001 |
| Matching Placebo | PLACEBO_COMPARATOR | Placebo Comparator: Matching Placebo |
| Name | Type | Description |
|---|---|---|
| NUZ-001 | DRUG | NUZ-001 is administered orally once daily for 36 weeks. |
| Matching placebo | DRUG | Matching placebo is administered orally once daily for 36 weeks. |
Inclusion Criteria: * No additional inclusion criteria beyond the inclusion criteria specified in the Master Protocol (NCT NCT04297683). Exclusion Criteria: * The following exclusion criteria are in addition to the exclusion criteria specified in the Master Protocol (NCT NCT04297683). 1. Clini...
NUZ-001 is an investigational small molecule being studied for the treatment of amyotrophic lateral sclerosis (ALS), a progressive neurodegenerative disease. It is currently in Phase 2 clinical development and has not been approved by the FDA.
NUZ-001 is being developed by Merit Medical Systems, Inc., a company traded on the NASDAQ under the ticker symbol MMSI. The company is conducting a Phase 2 clinical trial of NUZ-001 in patients with ALS.
NUZ-001 is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The ongoing Phase 2 trial is designed to evaluate the drug in patients with amyotrophic lateral sclerosis (ALS).
NUZ-001 is being evaluated in the HEALEY ALS Platform Trial, Regimen I, under the clinical trial identifier NCT07410806. This Phase 2 trial is enrolling by invitation in the United States and plans to enroll 160 participants with amyotrophic lateral sclerosis (ALS).
Yes, NUZ-001 is being studied in a randomized, double-blind, placebo-controlled Phase 2 clinical trial. The trial is part of the HEALEY ALS Platform Trial and includes biomarker-selected patients with amyotrophic lateral sclerosis (ALS).