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A Double-blind, Randomized, Multicenter, Placebo-Controlled, Parallel, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Lenzumestrocel(Neuronata-R® Inj.) in Patients With Amyotrophic Lateral Sclerosis

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Trial Profile

A Double-blind, Randomized, Multicenter, Placebo-Controlled, Parallel, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Lenzumestrocel(Neuronata-R® Inj.) in Patients With Amyotrophic Lateral Sclerosis

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 09 Oct 2025

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At a glance

  • Drugs Lenzumestrocel (Primary) ; Riluzole
  • Indications Amyotrophic lateral sclerosis
  • Focus Registrational; Therapeutic Use
  • Acronyms ALSummit
  • Sponsors CORESTEM; Corestemchemon

Most Recent Events

  • 17 Sep 2025 According to a Corestemchemon media release, the company plans to request a Type-C meeting with the USFDA in Q4 2025 to discuss the dataset and biomarker-driven subgroup efficacy from this study. Submission of BLA is planned within 2026 aiming to pursue an accelerated approval pathway.
  • 17 Sep 2025 Results presented in the Corestemchemon Media Release.
  • 17 Sep 2025 According to a Corestemchemon media release, Professor Ki-Uk Oh (Department of Neurology, Advanced Regenerative Medicine Center, Hanyang University Hospital, and principal investigator of the ALSUMMIT trial), formally presented the full Phase 3 clinical trial results in a second session at the PACTALS 2025 congress in Melbourne, Australia.

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