RecruitingPhase 2NCT07023835

Usnoflast Neuromuscular Investigation for Treatment Efficacy in Amyotrophic Lateral Sclerosis

A Phase 2b, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Usnoflast Administered to Adult Subjects With ALS

Sponsor

Zydus Therapeutics Inc.

Enrollment

240 participants

Start Date

Sep 17, 2025

Study Type

INTERVENTIONAL

Conditions

Amyotrophic Lateral Sclerosis(ALS)

Summary

Usnoflast Neuromuscular Investigation for Treatment Efficacy in Amyotrophic Lateral Sclerosis

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called 50 mg Usnoflast, a drug called 75 mg Usnoflast, and others for people with amyotrophic lateral sclerosis(als). The study is currently recruiting participants at 17 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUG50 mg Usnoflast

50 mg Usnoflast (50 mg Usnoflast capsules and matching placebo of 25 mg capsule)

DRUG75 mg Usnoflast

75 mg Usnoflast (25 mg + 50 mg Usnoflast capsules)

DRUGPlacebo

Matching placebo of 25 mg and 50 mg

Locations(17)

Zydus US015

La Jolla, California, United States

Zydus US008

Orange, California, United States

Zydus US013

San Francisco, California, United States

Zydus US005

New Britain, Connecticut, United States

Zydus US012

Tampa, Florida, United States

Zydus US007

Atlanta, Georgia, United States

Zydus US010

Boston, Massachusetts, United States

Zydus US006

Detroit, Michigan, United States

Zydus US014

Lincoln, Nebraska, United States

Zydus US003

Winston-Salem, North Carolina, United States

Zydus US009

Pittsburgh, Pennsylvania, United States

Zydus US001

Dallas, Texas, United States

Zydus US002

Houston, Texas, United States

Zydus US004

Richmond, Virginia, United States

Zydus US011

Seattle, Washington, United States

Zydus 101

Toronto, Ontario, Canada

Zydus 100

Québec, Quebec, Canada

View Full Details on ClinicalTrials.gov

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NCT07023835

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