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On March 24, the official website of CDE showed that Boehringer Ingelheim's new drug BI 425809 has been approved for clinical use by default and is intended to be used for the treatment of cognitive symptoms of schizophrenia.
The abnormality of the glutamatergic pathway caused by the low function of the N-methyl-D-aspartate receptor is the pathological cause of the onset of schizophrenia and Alzheimer's disease.
In March 2021, the results of a Phase II (NCT02832037) study of BI 425809 in the treatment of schizophrenia were published in The Lancet·Psychiatry.
From April 25, 2018 to October 4, 2019, a total of 509 patients received treatment (BI 425809 2 mg, n=85; 5 mg, n=84; 10 mg, n=85; 25 mg, n=85 ; Placebo, n=170), 444 patients (87%) completed 12 weeks of treatment.
The incidence of adverse reactions in each group was similar, namely: BI 425809 2 mg (59%), 5 mg (52%), 10 mg (41%), 25 mg (42%), and placebo (44%).
