The U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation (BTD) for SEP-363856 in May 2019. For the past 50 years, the clinical efficacy of antipsychotic medications has relied on blockade of dopamine D2 receptors. SEP-363856 does not bind to dopamine 2 (D2) or serotonin 2A (5-HT2A) receptors, which are thought to mediate the eects of currently available atypical antipsychotic medicines. [4], As of 2018, Sunovion, the maker of another antipsychotic called lurasidone (Latuda), is conducting clinical trials on SEP-363856 in partnership with the preclinical research company PsychoGenics. SEP-363856 is a novel psychotropic agent, with a non-D2 mechanism, that had previously shown broad efficacy in animal models of schizophrenia and depression. SEP-363856 is a novel psychotropic agent, with a non-D2 mechanism, that had previously shown broad efficacy in animal models of schizophrenia and depression. [3], The mechanism of action of SEP-363856 in the treatment of schizophrenia is unclear. min-101 finished phase 3 i guess, MIN-101 is in phase 3, that is expected to be complete March 2020. SEP-363856 was developed as a new class of psychotropic agents with a non-D2-receptor binding mechanism of action for the treatment of psychosis in schizophrenia. The nomination discussion and review may be seen at … Although the exact mechanism of action requires further elucidation, SEP-363856 is believed to activate TAAR1 … New replies are no longer allowed. SEP-363856 is a novel psychotropic agent with a novel mechanism of action that does not involve dopamine or serotonin receptor antagonism and is therefore distinct from currently available antipsychotic agents. SEP-363856 is a potential psychotropic agent with a novel non-D2 mechanism of action. 2 Likes. The mechanism of action of SEP-363856 does not involve serotonin- or dopamine-receptor antagonism and is therefore different from currently available antipsychotic agents, they explain in a news release announcing the results. SEP-363856 is a potential psychotropic agent with a novel non-D2 mechanism of action. anyone have information about this drugs? SEP-363856 does not bind to dopamine 2 (D2) or serotonin 2A (5-HT2A) receptors, which are thought to mediate the effects of currently available antipsychotic medicines. This topic was automatically closed 90 days after the last reply. The FDA granted Breakthrough Therapy Designation for SEP-363856 based on pivotal, Phase 2 data from Study SEP361-201, which were presented by Sunovion at the 57^th Annual Meeting of the … As such, this study evaluated the efficacy and safety of SEP-363856 in patients with an acute exacerbation of schizophrenia. SEP-363856 does not bind to dopamine 2 (D2) or serotonin 2A (5-HT 2A) receptors, which are thought to mediate the effects of currently available atypical antipsychotic medicines. SEP-363856 (also known as SEP-856)[1] is an investigational antipsychotic that is undergoing clinical trials for the treatment of schizophrenia and Parkinson's disease psychosis. Perhaps sometime this summer. Following an initial screening, patients will be randomly assigned to either SEP-363856 oral capsules at 25, 50, or 75 mg once daily, or to a matching placebo, for six weeks. SEP-363856 hasn’t started phase 3 yet, but they plan to this year. SEP-363856 (also known as SEP-856) is an investigational antipsychotic that is undergoing clinical trials for the treatment of schizophrenia and Parkinson's disease psychosis. However, it is thought to be an agonist at the trace amine-associated receptor 1 (TAAR1) and serotonin-1A receptor (5-HT1A) receptors. 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