drug
as of 2026-07-01Ulotaront
SEP-363856SEP-363856 75mgSEP-363856 100mgSEP-363856 50mgSEP-363856 Open LabelSEP363856SEP363856 150 mgSEP-363856 50 mg
MeSH C000705647
at a glance
small molecule
Pre-approval / investigational in the US
24 trials in the graph
Synthesized from structured facts only — each point cited above.
Mechanism & identity
Modality
small molecule
Indications
Investigational (via trials)
Trials
24
A Long-term Administration Trial of SEP-363856 in Patients With Schizophrenia
NCT07225712Phase 3Recruiting
A Trial of the Efficacy and Safety of SEP-363856 in Acutely Psychotic Participants With Schizophrenia
NCT06894212Phase 3Recruiting
An Extension Study to a Clinical Study That Will Continue to Evaluate the Effectiveness and Safety of SEP-363856 in People With Schizophrenia That Switch to SEP-363856 From Their From Their Current Antipsychotic Medication
NCT05741528Phase 3Completed
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
NCT05628103Phase 3Completed
A Clinical Trial to Evaluate the Long-term Safety and Tolerability of SEP-363856 in Patients With Schizophrenia in Japan
NCT05359081Phase 3Terminated
A Clinical Study to Learn if SEP-363856 Has Physical Dependence in Adults With Schizophrenia
NCT05848700Phase 1Completed
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
NCT05542264Phase 1Completed
A Clinical Study to Evaluate the Long-term Safety and Tolerability of an Investigational Drug in People With Schizophrenia
NCT04109950Phase 3Terminated
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
NCT04825860Phase 2, Phase 3Terminated
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
NCT05402111Phase 1Completed
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
NCT05463770Phase 1Completed
A Clinical Trial That Will Study the Efficacy and Safety of an Investigational Drug in Acutely Psychotic People With Schizophrenia
NCT04092686Phase 3Completed
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
NCT04038957Phase 1Completed
A Clinical Trial to Study the Efficacy and Safety of an Investigational Drug in Acutely Psychotic People With Schizophrenia
NCT04072354Phase 3Completed
A Study of the Long-term Safety and Tolerability of an Investigational Drug in People With Schizophrenia.
NCT04115319Phase 3Completed
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.
NCT04865835Phase 1Completed
A Clinical Study to Investigate the Effect of an Investigational Drug on Electrocardiogram Intervals in Adults With Schizophrenia.
NCT04369391Phase 1Completed
Study Assessing the Safety, Tolerability, and Pharmacokinetics of SEP-363856 in Japanese Male and Female Subjects With Schizophrenia
NCT04325737Phase 1Completed
An Extension Study of Safety and Tolerability of SEP-363856 in Adult Subjects With Schizophrenia
NCT02970929Phase 2Completed
Study Assessing the Safety, Tolerability, and Pharmacokinetics of SEP-363856 in Japanese Male and Female Subjects With Schizophrenia in 2 Parts (Part 1 and 2).
NCT03370640Phase 1Completed
A Study to Evaluate the Efficacy and Safety of SEP-363856 in Acutely Psychotic Adults With Schizophrenia
NCT02969382Phase 2Completed
Study Assessing SEP-363856 in Male and Female Volunteers With High or Low Schizotype Characteristics
NCT01972711Phase 1Completed
KOLs & investigators
1
Publications & congress
30
A double-blind study on ulotaront's impact on weight-related parameters in schizophrenia patients with metabolic syndrome and prediabetes: Part II.
Diabetes, obesity & metabolism · 2026 · high-value
Triangulating evidence from the GALENOS living systematic review on trace amine-associated receptor 1 (TAAR1) agonists in psychosis.
The British journal of psychiatry : the journal of mental science · 2025 · high-value
Novel pharmaceutical treatment approaches for schizophrenia: a systematic literature review.
European journal of clinical pharmacology · 2025 · high-value
Trajectory of efficacy and safety across ulotaront dose levels in schizophrenia: a systematic review and dose-response meta-analysis.
The international journal of neuropsychopharmacology · 2025 · high-value
Trace amine-associated receptor 1 (TAAR1) agonism for psychosis: a living systematic review and meta-analysis of human and non-human data.
Wellcome open research · 2024 · high-value
Evaluation of OCT2-mediated drug-drug interactions between ulotaront and metformin in subjects with schizophrenia.
Pharmacology research & perspectives · 2024 · high-value
Second-generation antipsychotics for Parkinson's disease psychosis: A systematic review and network meta-analysis.
General hospital psychiatry · 2024 · high-value
Advancements in Non-Dopaminergic Treatments for Schizophrenia: A Systematic Review of Pipeline Developments.
Pharmacopsychiatry · 2024 · high-value
TAAR1 agonist ulotaront delays gastric emptying of solids in patients with schizophrenia and concurrent metabolic syndrome with prediabetes.
Diabetes, obesity & metabolism · 2024 · high-value
A randomized, single-dose, crossover study of the effects of ulotaront on electrocardiogram intervals in subjects with schizophrenia.
Clinical and translational science · 2023 · high-value
Treatment with the novel TAAR1 agonist ulotaront is associated with reductions in quantitative polysomnographic REM sleep without atonia in healthy human subjects: Results of a post-hoc analysis.
Sleep medicine · 2023 · high-value
A multicenter, double-blind, placebo-controlled, randomized, Phase 1b crossover trial comparing two doses of ulotaront with placebo in the treatment of narcolepsy-cataplexy.
Sleep medicine · 2023 · high-value
Efficacy, safety, and tolerability of ulotaront (SEP-363856, a trace amine-associated receptor 1 agonist) for the treatment of schizophrenia and other mental disorders: a systematic review of preclinical and clinical trials.
Expert opinion on investigational drugs · 2023 · high-value
Effect of TAAR1/5-HT
Translational psychiatry · 2021 · high-value
Depicting Safety Profile of TAAR1 Agonist Ulotaront Relative to Reactions Anticipated for a Dopamine D2-Based Pharmacological Class in FAERS.
Clinical drug investigation · 2021 · high-value
Trace amine-associated receptor 1 (TAAR1): Potential application in mood disorders: A systematic review.
Neuroscience and biobehavioral reviews · 2021 · high-value
Facts & assertions
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relationships
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