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Innovative therapy to effectively improve cognitive impairment was recognized as a breakthrough therapy by the FDA

 Last Update: 2021-06-03
 Source: Internet
 Author: User

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On May 24, 2021, Boehringer Ingelheim (Boehringer Ingelheim) announced that the US FDA has granted an oral investigational therapy BI 425809 Breakthrough Therapy Designation (BTD) for the treatment of schizophrenia-related cognitive impairment (CIAS) .

This breakthrough therapy designation and the initiation of the Phase 3 clinical trial project CONNEX are based on the results of a randomized, double-blind, placebo-controlled Phase 2 clinical trial.

BI 425809 is a new type of Gly-T1 inhibitor developed by Boehringer Ingelheim, which aims to improve the function of N-methyl-D-aspartate (NMDA) receptors by inhibiting Gly-T1, thereby acting as a treatment effect.

The planned Phase 3 clinical trial project will consist of 3 clinical trials.

Note: The original text has been deleted

Reference materials:

[1] Boehringer Ingelheim's Investigational Treatment for Cognitive Impairment Associated with Schizophrenia Receives FDA Breakthrough Therapy Designation.

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Innovative therapy for effectively improving cognitive impairment was recognized by FDA as a breakthrough therapy

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Innovative therapy to effectively improve cognitive impairment was recognized as a breakthrough therapy by the FDA

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Innovative therapy for effectively improving cognitive impairment was recognized by FDA as a breakthrough therapy