NCT07023835

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 240 (estimated)
• Sponsor: Zydus Therapeutics Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Usnoflast Neuromuscular Investigation for Treatment Efficacy in Amyotrophic Lateral Sclerosis

Detailed description

A phase 2b, randomized, double-blind, placebo-controlled, parallel-group, multicenter 36 weeks study to evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of Usnoflast administered to adult subjects with Amyotrophic Lateral Sclerosis followed by 16 weeks open label extension study. This Open Label Extension will be a multicenter, 16-week, single arm study to confirm the long-term safety and efficacy of Usnoflast in subjects with ALS. Eligible subjects of all three arms of the main study will be recruited in the OLE phase and will receive Usnoflast (75 mg) for a total of 16 weeks BID (oral capsule administration).

Conditions

• Amyotrophic Lateral Sclerosis (ALS)

Interventions

Type	Name	Description
DRUG	50 mg Usnoflast	50 mg Usnoflast (50 mg Usnoflast capsules and matching placebo of 25 mg capsule)
DRUG	75 mg Usnoflast	75 mg Usnoflast (25 mg + 50 mg Usnoflast capsules)
DRUG	Placebo	Matching placebo of 25 mg and 50 mg

Timeline

• Start date: 2025-09-17
• Primary completion: 2028-03-01
• Completion: 2028-10-01
• First posted: 2025-06-17
• Last updated: 2026-02-05

Locations

17 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study