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(49)

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 200

Caulfield South, Australia, Australia

Zydus 201

Sydney, New South Wales, Australia

Zydus 202

Southport, Australia

Zydus 110

Leuven, Belgium, Belgium

Zydus 101

Toronto, Ontario, Canada

Zydus 100

Québec, Quebec, Canada

Zydus 124

Clermont-Ferrand, France, France

Zydus 122

Limoges, France, France

Zydus 123

Montpellier, France, France

Zydus 125

Nice, France, France

Zydus 120

Paris, France, France

Zydus 121

Tours, France, France

Zydus 130

Dresden, Germany, Germany

Zydus 133

Hanover, Germany, Germany

Zydus 134

Jena, Germany, Germany

Zydus 131

Lübeck, Germany, Germany

Zydus 132

Rostock, Germany, Germany

Zydus 135

Ulm, Germany, Germany

Zydus 140

Dublin, Ireland, Ireland

Zydus 154

Genova, Italy, Italy

Zydus 153

Milan, Italy, Italy

Zydus 151

Modena, Italy, Italy

Zydus 152

Naples, Italy, Italy

Zydus 150

Brescia, Italy

Zydus 160

Utrecht, Netherlands, Netherlands

Zydus 170

Krakow, Poland, Poland

Zydus 171

Warsaw, Poland, Poland

Zydus 180

Alicante, Spain, Spain

Zydus 181

Barcelona, Spain, Spain

Zydus 182

Málaga, Spain, Spain

Zydus 183

Valencia, Spain, Spain

Zydus 191

Malmö, Sweden, Sweden

Zydus 190

Stockholm, Sweden, Sweden

Zydus 192

Umeå, Sweden, Sweden

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NCT07023835

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Usnoflast Neuromuscular Investigation for Treatment Efficacy in Amyotrophic Lateral Sclerosis

Conditions

Summary

Eligibility

Plain Language Summary

Interventions

Locations(49)

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