SEP-363856

Phase 3Small molecule

Otsuka

SEP-363856 is one of 60 small molecule programs targeting Schizophrenia. It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

Pipeline

Status by Indication[3][1]

Indication

SchizophreniaCompleted

Generalized Anxiety DisorderCompleted

SchizophreniaPhase 3

Completed

Generalized Anxiety DisorderPhase 3

Completed

Competition

Competitive Landscape

174 competitors in Schizophrenia

#DrugCompanyPhaseTrials

SEP-363856

Otsuka

Phase 3

21 2

Ozempic

Novo Nordisk

Preclinical

1 3

Resotran

Takeda

Preclinical

1 4

Inapsine

Jazz Pharmaceuticals

Preclinical

1 5

Depakote

Ibrance

Lunesta

3 8

Luvox

SSolvay Pharmaceuticals

Preclinical

1 9

Catapres

Boehringer Ingelheim

Preclinical

1 10

Rapamune

PPrism Pharmaceuticals

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 3Recruiting

Schizophrenia

NCT06894212

Q1 2028

Phase 3Recruiting

Schizophrenia

NCT07225712

Q4 2028

Phase 3Recruiting

Generalized Anxiety Disorder

NCT07767903

Phase 3Recruiting

Generalized Anxiety Disorder

NCT07759128

Q2 2029

Phase 3Not yet recruiting

Generalized Anxiety Disorder

NCT07786454

Clinical

Trials by Indication[1]

Schizophrenia21 trials

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).

Completed·SSumitomo Pharma Co., Ltd.·Phase 1·NCT03370640·24 enrolled

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

Completed· Otsuka logo

Otsuka·Phase 3·NCT05741528·75 enrolled

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

Completed· Otsuka logo

Otsuka·Phase 1·NCT05463770·15 enrolled

Show 18 more trials

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

Completed· Otsuka logo

Otsuka·Phase 1·NCT05402111·31 enrolled

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

Terminated·SSumitomo Pharma Co., Ltd.·Phase 2/3·NCT04825860·83 enrolled

A Clinical Trial to Study the Efficacy and Safety of an Investigational Drug in Acutely Psychotic People With Schizophrenia

Completed· Otsuka logo

Otsuka·Phase 3·NCT04072354·463 enrolled

A Clinical Trial That Will Study the Efficacy and Safety of an Investigational Drug in Acutely Psychotic People With Schizophrenia

Completed· Otsuka logo

Otsuka·Phase 3·NCT04092686·464 enrolled

Study Assessing the Safety, Tolerability, and Pharmacokinetics of SEP-363856 in Male and Female Subjects With Schizophrenia

Completed· Otsuka logo

Otsuka·Phase 1·NCT01994473·48 enrolled

A Study to Evaluate the Efficacy and Safety of SEP-363856 in Acutely Psychotic Adults With Schizophrenia

Completed· Otsuka logo

Otsuka·Phase 2·NCT02969382·245 enrolled

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

Completed· Otsuka logo

Otsuka·Phase 1·NCT05542264·19 enrolled

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

Completed· Otsuka logo

Otsuka·Phase 1·NCT04038957·22 enrolled

A Study Assessing the Safety, Tolerability, and Pharmacokinetics of SEP-363856 in Male and Female Subjects With Schizophrenia

Completed· Otsuka logo

Otsuka·Phase 1·NCT01940159·48 enrolled

A Long-term Administration Trial of SEP-363856 in Patients With Schizophrenia

Recruiting· Otsuka logo

Otsuka·Phase 3·NCT07225712·100 enrolled

A Clinical Study to Learn if SEP-363856 Has Physical Dependence in Adults With Schizophrenia

Completed· Otsuka logo

Otsuka·Phase 1·NCT05848700·60 enrolled

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

Completed· Otsuka logo

Otsuka·Phase 3·NCT05628103·101 enrolled

Study Assessing the Safety, Tolerability, and Pharmacokinetics of SEP-363856 in Japanese Male and Female Subjects With Schizophrenia

Completed·SSumitomo Pharma Co., Ltd.·Phase 1·NCT04325737·13 enrolled

An Extension Study of Safety and Tolerability of SEP-363856 in Adult Subjects With Schizophrenia

Completed· Otsuka logo

Otsuka·Phase 2·NCT02970929·157 enrolled

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.

Completed· Otsuka logo

Otsuka·Phase 1·NCT04865835·21 enrolled

A Clinical Trial to Evaluate the Long-term Safety and Tolerability of SEP-363856 in Patients With Schizophrenia in Japan

Terminated·SSumitomo Pharma Co., Ltd.·Phase 3·NCT05359081·68 enrolled

A Clinical Study to Evaluate the Long-term Safety and Tolerability of an Investigational Drug in People With Schizophrenia

Terminated· Otsuka logo

Otsuka·Phase 3·NCT04109950·463 enrolled

A Phase 3, Randomized, Double-blind, Parallel-group, Placebo-controlled, Multicenter Trial to Evaluate the Efficacy and Safety of SEP-363856 in Acutely Psychotic Participants With Schizophrenia

Recruiting· Otsuka logo

Otsuka·Phase 3·NCT06894212·522 enrolled

Generalized Anxiety Disorder4 trials

A Clinical Study That Will Measure How Well SEP-363856 Works and How Safe it is in Adults With Generalized Anxiety Disorder

Completed· Otsuka logo

Otsuka·Phase 2/3·NCT05729373·434 enrolled

A Phase 3, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Multicenter Trial to Compare the Efficacy and Safety of a Fixed Dose of SEP-363856 to Placebo in the Treatment of Adults With Generalized Anxiety Disorder

Recruiting· Otsuka logo

Otsuka·Phase 3·NCT07767903·384 enrolled

A Phase 3, Multicenter, Open-Label Extension Trial to Evaluate the Safety and Tolerability of SEP-363856 in the Treatment of Adults With Generalized Anxiety Disorder

Not yet recruiting· Otsuka logo

Otsuka·Phase 3·NCT07786454·1,120 enrolled

Show 1 more trial

A Phase 3, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Multicenter Trial to Compare the Efficacy and Safety of Fixed Doses of SEP-363856 to Placebo in the Treatment of Adults With Generalized Anxiety Disorder

Recruiting· Otsuka logo

Otsuka·Phase 3·NCT07759128·576 enrolled

Major Depressive Disorder1 trial

A Trial of the Safety and Efficacy of SEP-363856 in the Treatment of Adults With Major Depressive Disorder

Completed· Otsuka logo

Otsuka·Phase 2·NCT05593029·929 enrolled

Psychosis1 trial

A Study to Evaluate the Efficacy, Safety and Tolerability of SEP-363856 in Subjects With Parkinson's Disease Psychosis

Completed· Otsuka logo

Otsuka·Phase 2·NCT02969369·39 enrolled

Female1 trial

Study Assessing SEP-363856 in Male and Female Volunteers With High or Low Schizotype Characteristics

Completed· Otsuka logo

Otsuka·Phase 1·NCT01972711·105 enrolled

Sources

References

[1]
ClinicalTrials.gov — 28 trial records for SEP-363856. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — SEP-363856 compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for SEP-363856. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Otsuka company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: Otsuka

SEP-363856

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2028

Q4 2028

Q2 2029

Trials by Indication[1]

Schizophrenia21 trials

Generalized Anxiety Disorder4 trials

Major Depressive Disorder1 trial

Psychosis1 trial

Female1 trial

References

Drug Info

Quick Facts

Related News