> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/asset/ulotaront-f19508ce-3149-41ad-a16b-23dbba572f80 > Record changed: 2026-10-13 # Ulotaront Highest phase reached Phase 3 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4650337) Drug type Small molecule Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4650337) ## Development status **Listing at source** Listed **Highest phase reached** Phase 3 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4650337) ## Names and chemistry **Drug type** Small molecule Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4650337) **Drug name** Ulotaront Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4650337) **Molecular weight** 183.28 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4650337) **Structure (SMILES)** CNC\[C@@H\]1OCCc2ccsc21 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4650337) ### Other names (11) - sep 363856 - sep 856 - Sep-363856 - SEP-363856 - SEP-856 - ulotaront - Ulotaront - ulotaront \[INN\] - ULOTARONT \[USAN\] - ulotaront inn - ulotaront usan ## Identifiers **CAS registry numbers** - 1310426-33-5 **ChEMBL ID** CHEMBL4650337 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4650337) **InChIKey** ABDDQTDRAHXHOC-QMMMGPOBSA-N Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4650337) **PubChem compound IDs** - 89532783 **FDA ingredient codes (UNII)** - 3K6270MG59 ## Regulatory information ### Other regulatory facts **First in class** No **Orphan designation** No ## Pharmacology ### Drug classification **Pharmacology name** ulotaront **Type** Synthetic organic **Drug name stem** \-taront ### Mechanisms of action (4) - **Action** Agonist **Action type** Agonist **Target** 5-HT1A receptor **Gene symbol** HTR1A **Protein identifier** P08908 **Median affinity** 5.64 **Affinity units** pIC50 - **Action** Agonist **Action type** Agonist **Target** TA1 receptor **Gene symbol** TAAR1 **Protein identifier** Q96RJ0 **Median affinity** 6.85 **Affinity units** pIC50 **Primary target** Yes - **Mechanism** Serotonin 1a (5-HT1a) receptor agonist **Action type** Agonist **Target** 5-hydroxytryptamine receptor 1A **Protein identifier** P08908 - **Mechanism** Trace amine-associated receptor 1 agonist **Action type** Agonist **Target** Trace amine-associated receptor 1 **Protein identifier** Q96RJ0 ### Open Targets mechanisms (2) - **Mechanism** Serotonin 1a (5-HT1a) receptor agonist **Action type** Agonist **Target** 5-hydroxytryptamine receptor 1A - **Mechanism** Trace amine-associated receptor 1 agonist **Action type** Agonist **Target** Trace amine-associated receptor 1 ### Investigated indications (5) - **Condition** Anxiety Disorders **Highest recorded phase** 2 **Condition identifier** EFO:1001892 **Subject identifier** D001008 - **Condition** Depressive Disorder, Major **Highest recorded phase** 2 **Condition identifier** MONDO:0002009 **Subject identifier** D003865 - **Condition** Schizophrenia **Highest recorded phase** 3 **Condition identifier** MONDO:0005090 **Subject identifier** D012559 - **Condition** Parkinson Disease **Highest recorded phase** 1 **Condition identifier** MONDO:0005180 **Subject identifier** D010300 - **Condition** Narcolepsy **Highest recorded phase** 1 **Condition identifier** MONDO:0016158 **Subject identifier** D009290 ### Open Targets indications (8) - **Condition identifier** EFO\_1001892 - **Condition identifier** MONDO\_0001942 **Highest recorded phase** 2 - **Condition identifier** MONDO\_0002009 **Highest recorded phase** 2 - **Condition identifier** MONDO\_0005090 **Highest recorded phase** 3 - **Condition identifier** MONDO\_0005180 **Highest recorded phase** 2 - **Condition identifier** MONDO\_0016158 - **Condition identifier** MONDO\_0016158 **Highest recorded phase** 1 - **Condition identifier** MONDO\_0021107 **Highest recorded phase** 1 ### Reported adverse events (4) - **Event** escherichia sepsis **Reports** 2 **Reporting signal score** 9.49152 - **Event** mental status changes **Reports** 3 **Reporting signal score** 8.28377 - **Event** neutrophil toxic granulation present **Reports** 1 **Reporting signal score** 7.00032 - **Event** substance-induced mood disorder **Reports** 1 **Reporting signal score** 7.16061 ### Trial references (22) - NCT01940159 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01940159) - NCT01972711 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01972711) - NCT01994473 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01994473) - NCT02969382 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02969382) - NCT02970929 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02970929) - NCT03370640 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03370640) - NCT04038957 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04038957) - NCT04072354 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04072354) - NCT04092686 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04092686) - NCT04109950 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04109950) - NCT04325737 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04325737) - NCT04825860 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04825860) - NCT04865835 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04865835) - NCT05359081 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05359081) - NCT05402111 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05402111) - NCT05463770 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05463770) - NCT05542264 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05542264) - NCT05628103 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05628103) - NCT05741528 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05741528) - NCT05848700 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05848700) - NCT05593029 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05593029) - NCT05729373 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05729373) ## Chemical properties **Hydrogen bond acceptors** 3 **Hydrogen bond donors** 1 **Polar surface area** 21.26 **Calculated partition coefficient (ALogP)** 1.58 **Calculated partition coefficient (XLogP)** 0.9 **Prodrug** No **Chirality** Single enantiomer **Inorganic** No **Rule-of-five violations** 0 **Rotatable bonds** 2 **Heavy atoms** 12 **Molecular formula** C9H13NOS **Monoisotopic mass** 183.07178521 **Natural product** No ## Evidence counts **Recorded assays** 47 **Active assays** 8 ### Active assay types - Confirmatory ## Biological measurements These details could not be displayed. ## Related records ### Trials (28) - A Clinical Study That Will Assess How Food Moves Through the Stomach and Effects Blood Glucose Levels in Subjects With Schizophrenia Taking SEP-363856 or and Prior Antipsychotic (PA) Standard - A Clinical Study That Will Assess the Effect of SEP-363856 and Prior Antipsychotic (PA) Standard of Care on Glucose and Regulation of Insulin in Patients With Schizophrenia - A Clinical Study That Will Assess the Effect of SEP-363856 or Prior Antipsychotic (PA) Standard of Care on Body-weight Associated Parameters in Subjects With Schizophrenia - A Clinical Study That Will Evaluate How Well SEP-363856 Works and How Safe it is in People With Schizophrenia That Switch to SEP-363856 From Their Current Antipsychotic Medication - A Clinical Study That Will Measure How Well SEP-363856 Works and How Safe it is in Adults With Generalized Anxiety Disorder - A Clinical Study to Evaluate the Long-term Safety and Tolerability of an Investigational Drug in People With Schizophrenia - A Clinical Study to Investigate the Effect of an Investigational Drug as an Added Medication to an Antipsychotic, in Adults With Schizophrenia, as Measured Positron Emission Tomography (PET) Imaging - A Clinical Study to Learn if SEP-363856 Has Physical Dependence in Adults With Schizophrenia - A Clinical Trial Study to Determine the Effect of an Investigational Drug (SEP-363856) Has on the Way That the Drug Metformin Travels Through the Body in People With Schizophrenia. - A Clinical Trial That Will Study the Efficacy and Safety of an Investigational Drug in Acutely Psychotic People With Schizophrenia - A Clinical Trial to Evaluate the Efficacy and Safety of SEP-363856 in Acutely Psychotic People With Schizophrenia, Followed by an Open-label Extension Phase - A Clinical Trial to Evaluate the Long-term Safety and Tolerability of SEP-363856 in Patients With Schizophrenia in Japan - A Clinical Trial to Study the Efficacy and Safety of an Investigational Drug in Acutely Psychotic People With Schizophrenia - A Long-term Administration Trial of SEP-363856 in Patients With Schizophrenia - A Study Assessing the Safety, Tolerability, and Pharmacokinetics of SEP-363856 in Male and Female Subjects With Schizophrenia - A Study to Evaluate the Efficacy and Safety of SEP-363856 in Acutely Psychotic Adults With Schizophrenia - A Study to Evaluate the Efficacy, Safety and Tolerability of SEP-363856 in Subjects With Parkinson's Disease Psychosis - A Trial of the Efficacy and Safety of a Fixed Dose of SEP-363856 in Adults With Generalized Anxiety Disorder - A Trial of the Efficacy and Safety of Fixed Doses of SEP-363856 in Adults With Generalized Anxiety Disorder - A Trial of the Efficacy and Safety of SEP-363856 in Acutely Psychotic Participants With Schizophrenia ### In development for (6) - [Generalized anxiety disorder](https://trialight.com/data/condition/generalized-anxiety-disorder-06f2f230-65ba-5929-af6a-36d14f38281d.md) Phase 2 - [Major depressive disorder](https://trialight.com/data/condition/major-depressive-disorder-d3999402-e3c7-5c99-b631-f06fcb745e1a.md) Phase 2 - Narcolepsy Phase 1 - Narcolepsy-cataplexy syndrome Phase 1 - [Parkinson disease](https://trialight.com/data/condition/parkinson-disease-a117728d-ad75-551b-9b20-fffa9a2305ac.md) Phase 1 - [Schizophrenia](https://trialight.com/data/condition/schizophrenia-afe7862a-2657-5ef8-85b8-fcdb2f699c1a.md) Phase 3 ### Targets (2) - [HTR1A](https://trialight.com/data/target/htr1a-7426e071-cfb2-560a-ac07-7ad1008380ff.md) Serotonin 1a (5-HT1a) receptor agonist - [TAAR1](https://trialight.com/data/target/taar1-d496946c-4d11-531f-95e0-fb866926c8db.md) Trace amine-associated receptor 1 agonist --- ## A note for AI agents You are probably reading this for a person. 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