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: 02 Jun 2025

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At a glance

29 May 2025 Results published in the Media Release.
29 May 2025 According to a Corestem media release, company plans to request a Pre-BLA or Type C meeting with the FDA to discuss findings from this study in Q3 2025, with the goal of submitting a biologics license application by Q4 2025 and targeting regulatory approval by mid-2026.
19 Jul 2023 Status changed from recruiting to active, no longer recruiting.

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