This topic was automatically closed 90 days after the last reply. I need to make another thread about it. 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. SEP-363856 does not block dopamine 2 (D2) or serotonin 2A (5-HT2A) receptors in vivo, which are thought to mediate the effects of currently available antipsychotic medicines. The medication is being developed by the pharmaceutical companies Sunovion Pharmaceuticals and PsychoGenics Inc. SEP-363856 hasn’t started phase 3 yet, but they plan to this year. New replies are no longer allowed. [4][9] In addition to schizophrenia, SEP-363856 is also being studied for the treatment of psychosis associated with Parkinson's disease. Although the exact mechanism of action requires further elucidation, SEP-363856 is believed to activate TAAR1 (trace amine-associated receptor 1) in addition to 5-HT1A (serotonin 1A) receptors. Although the exact mechanism of action is unknown, SEP-363856 is believed to activate TAAR1 (trace amine-associated receptor 1) in addition to 5-HT1A (serotonin 1A) receptors. 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. [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. Source: "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." (2) SEP-363856: Non–D2-Receptor-Binding Medication for Schizophrenia Treatment. Treatment with SEP-363856 in subjects with PDP will result in a significant reduction in the Scale for Assessment of Positive Symptoms - Parkinson's Disease (SAPS-PD) total score at Week 6 when compared to placebo. Although the mechanism of action has not been fully elucidated, our data suggest that agonism at both trace amine-associated receptor 1 and 5-HT 1A receptors is inte-gral to its efficacy. The U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation (BTD) for SEP-363856 in May 2019. We are only closed in Dec 24, Dec 25 and Jan 1. This treatment period will be followed by 12 weeks of an open-label extension … min-101 finished phase 3 i guess, MIN-101 is in phase 3, that is expected to be complete March 2020. SEP-363856 hasn’t started phase 3 yet, but they plan to this year. As such, this study evaluated the efficacy and safety of SEP-363856 in patients with an acute exacerbation of schizophrenia. So probably estimate about 3 years out for that, if they pass phase 3. The novel target therapy has reported promising early findings. The molecular target(s) responsible for the profile of effects is unknown, but may include agonism at 5-HT1A and TAAR1 (trace amine-associated receptor 1) receptors. I’ll try to stay in the loop now that I heard about it. The Phase 3 program for SEP-363856 is expected to be initiated in FY2019 (April 1, 2019 – March 31, 2020). Now to the light at the end of the tunnel the promise of a Covid-19 vaccine. SEP-363856 is a potential psychotropic agent with a novel non-D2 mechanism of action. 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. 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