Trial Profile

A dose-bridging, randomized-controlled, double-blinded, Phase 2/3 clinical trial for the treatment of chronic motor dysfunction due to ischemic stroke

Status: Planning

Phase of Trial: Phase II/III

Latest Information Update: 09 Feb 2026

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At a glance

09 Feb 2026 New trial record
21 Jan 2026 According to a Hopstem biotechnology media release, based on the positive data from the Phase 1 clinical trials in China, FDA has approved Hopstem to initiate a dose-bridging, randomized-controlled, double-blinded, Phase 2 clinical trial in the United States. Hopstem can further determine the key design elements of the Phase 3 clinical trial, such as sample size, in collaboration with the FDA, and then directly expand the Phase 2 trial into the final pivotal 2/3 study.

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