Breakthrough designation for Boehringer's drug for cognitive impairment associated with schizophrenia

24 May 2021
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The US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation (BTD) for Boehringer Ingelheim’s BI 425809 for the treatment of cognitive impairment associated with schizophrenia (CIAS).

The privately-held German company also announced the planned initiation of the innovative CONNEX Phase III trial assessing the safety and efficacy of BI 425809 for improving cognition in adults with schizophrenia.

BI 425809, a glycine transporter-1 (GlyT1) inhibitor, forms a key component of Boehringer's Mental Health research program.

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