Synonyms: example 129 [WO2011069063A2] [6] | SEP-363856 (parent molecule) | SEP-856 | SEP363856
Compound class:
Synthetic organic
Comment: Ulotaront (SEP-363856) is an orally active and brain-penetrant psychotropic agent with a novel mechanism of action. It acts as a trace amine-associated receptor 1 (TAAR1) agonist with additional 5-HT1A receptor agonist activity, and agonism at both of these receptors appears to be required for its clinical effects [2-3]. SEP-363856 is being developed by Sunovion Pharmaceuticals and PsychoGenics, and was granted FDA Breakthrough Therapy Designation as an anti-schizophrenia therapeutic in May 2019. The lack of D2 receptor activity distinguishes SEP-363856 from current antipsychotic medications.
In the Dedic et al. article from 2019 SEP-363856 refers to the hydrochloride salt. We show the parent molecule here. This S enantiomer is more active at TAAR1 compared to the R stereoenantiomer [2]. Ligand Activity Visualisation ChartsThese are box plot that provide a unique visualisation, summarising all the activity data for a ligand taken from ChEMBL and GtoPdb across multiple targets and species. Click on a plot to see the median, interquartile range, low and high data points. A value of zero indicates that no data are available. A separate chart is created for each target, and where possible the algorithm tries to merge ChEMBL and GtoPdb targets by matching them on name and UniProt accession, for each available species. However, please note that inconsistency in naming of targets may lead to data for the same target being reported across multiple charts. ✖ |
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No information available. |
Summary of Clinical Use |
SEP-363856 has progressed to clinical trial as a treatment for schizophrenia [4] and for Parkinson disease-related psychosis [5]. Click here to link to ClinicalTrials.gov's full list of SEP-363856 studies. |
Clinical Trials | |||||
Clinical Trial ID | Title | Type | Source | Comment | References |
NCT02969369 | A Study to Evaluate the Efficacy, Safety and Tolerability of SEP-363856 in Subjects With Parkinson's Disease Psychosis | Phase 2 Interventional | Sunovion | ||
NCT05359081 | A Clinical Trial to Evaluate the Long-term Safety and Tolerability of SEP-363856 in Patients With Schizophrenia in Japan | Phase 3 Interventional | Sumitomo Pharma Co., Ltd. | ||
NCT02969382 | A Study to Evaluate the Efficacy and Safety of SEP-363856 in Acutely Psychotic Adults With Schizophrenia | Phase 2 Interventional | Sunovion | ||
NCT02970929 | An Extension Study of Safety and Tolerability of SEP-363856 in Adult Subjects With Schizophrenia | Phase 2 Interventional | Sunovion | This is an open-label extension study, that recruited patients who had completed participation in the initial 4-week study NCT02969382. | 1 |