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: Completed

Phase of Trial: Phase III

Latest Information Update: 05 May 2026

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At a glance

30 Apr 2026 Status changed from active, no longer recruiting to completed.
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.

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