This is a multicenter, randomized, double-blind, parallel-group, flexibly-dosed, study evaluating the efficacy and safety of SEP-363856 in acutely psychotic adult subjects with schizophrenia using SEP-363856 (50 or 75 mg/day [ie, once daily]) versus placebo over a 4-week treatment period. 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. Our Journal Club #6 will discuss the following topics: (1) Mechanism of Action for SEP-363856. SEP-363856 is also currently being studied as a treatment for Parkinson’s disease psychosis. min-101 more effective for negative symptoms i guess. 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. 2020-11-23. 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-HT2A) receptors, which are thought to mediate the effects of currently available antipsychotic medicines. The nation's vaccine czar says the first Americans could get it in just three weeks, and in the meantime a major step forward in treating covet patients. 2 Likes. ITI-007 (Lumateperone) may be available … [4] This mechanism of action is unique among available antipsychotics, which generally antagonize dopamine receptors (especially dopamine receptor D2). The participants were randomized to receive SEP-363856 or placebo treatment for four weeks. 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. 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. 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 atypical antipsychotic medicines. This topic was automatically closed 90 days after the last reply. SEP-363856 hasn’t started phase 3 yet, but they plan to this year. 13 May 2020 SEP 363856 is in phase I development for Schizophrenia in Japan (Dainippon Sumitomo Pharmaceutical pipeline, May 2020) 30 Apr 2020 Sunovion Pharmaceuticals plans a phase I trial for Schizophrenia (In adults, In the elderly) in USA in May 2020 (PO, Tablet) (NCT04369391) Wow, good to know. 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. The text of the entry was as follows: Did you know... that the investigational drug SEP-363856 may represent a new class of antipsychotics? 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. Efficacy and Safety of Sep-363856, A Novel Psychotropic Agent with a Non-D2 Mechanism of Action, in the Treatment of Schizophrenia: A 4-Week, Randomized, Placebo-Controlled Trial", "SEP-363856, a Novel Psychotropic Agent with a Unique, Non-D2 Receptor Mechanism of Action", "Drug Receives FDA's Breakthrough Therapy Designation for Treating Individuals with Schizophrenia", https://en.wikipedia.org/w/index.php?title=SEP-363856&oldid=960240427, Short description is different from Wikidata, Pages using collapsible list with both background and text-align in titlestyle, Articles containing unverified chemical infoboxes, Creative Commons Attribution-ShareAlike License, This page was last edited on 1 June 2020, at 21:51. So probably estimate about 3 years out for that, if they pass phase 3. For the past 50 years, the clinical efficacy of antipsychotic medications has relied on blockade of dopamine D2 receptors. An oral compound, SEP-363856, that does not act on dopamine D2 receptors but has agonist activity at trace amine–associated receptor 1 (TAAR1) and 5-hydroxytryptamine type 1A (5-HT1A) receptors, may represent a new class of psychotropic agent for the treatment of psychosis in schizophrenia. SEP-363856 hasn’t started phase 3 yet, but they plan to this year. 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 antipsychotic medicines. 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. New replies are no longer allowed. 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