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On March 25, the official website of CDE showed that the clinical application for SEP-363856 tablets of Sumitomo Pharmaceuticals has been accepted by the State Food and Drug Administration.
SEP-363856 is a new type of trace amine related receptor 1 (TAAR1) and serotonin 1A (5-HT1A) receptor agonist.
In April 2020, the results of a key clinical study of SEP-363856 in the treatment of schizophrenia code-named SEP361-201 were published in the New England Journal of Medicine.
The results of the study showed that the total PANSS score of the patients in the SEP-363856 group decreased by 17.
In terms of safety, 7 patients (5.
SEP-363856 is currently undergoing a global Phase III clinical (DIAMOND) project to evaluate its efficacy against other types of schizophrenia.