SEP-363856

Overview

SEP-363856 is a novel psychotropic drug being investigated for the treatment of schizophrenia. Unlike other drugs used for this condition, SEP-363856 does not bind to the dopamine D2 receptors, but exerts actions on the trace amine–associated receptor 1 (TAAR1) and 5-hydroxytryptamine type 1A (5-HT1A). SEP-363856 was developed by Sunovion pharmaceuticals. An initial clinical study has shown this drug may be effective against both positive and negative symptoms of schizophrenia. Negative symptoms of schizophrenia are more difficult to treat and may include flattened affect, anhedonia, and social withdrawal. Additional clinical trials of SEP-363856 are required to confirm the safety and efficacy of this drug.

Background

Indication

No indication information available.

Associated Conditions

No associated conditions information available.

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
A Trial of the Efficacy and Safety of SEP-363856 in Acutely Psychotic Participants With Schizophrenia	2025/03/25	NCT06894212	Phase 3	Recruiting	Otsuka Pharmaceutical Development & Commercialization, Inc.
A Clinical Study to Learn if SEP-363856 Has Physical Dependence in Adults With Schizophrenia	2023/05/08	NCT05848700	Phase 1	Completed	Otsuka Pharmaceutical Development & Commercialization, Inc.
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	2023/02/23	NCT05741528	Phase 3	ENROLLING_BY_INVITATION	Sumitomo Pharma America, Inc.
A Clinical Study That Will Measure How Well SEP-363856 Works and How Safe it is in Adults With Generalized Anxiety Disorder	2023/02/15	NCT05729373	Phase 2	Recruiting	Otsuka Pharmaceutical Development & Commercialization, Inc.
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	2022/11/28	NCT05628103	Phase 3	Completed	Otsuka Pharmaceutical Development & Commercialization, Inc.
A Trial of the Safety and Efficacy of SEP-363856 in the Treatment of Adults With Major Depressive Disorder	2022/10/25	NCT05593029	Phase 2	Recruiting	Otsuka Pharmaceutical Development & Commercialization, Inc.
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	2022/09/15	NCT05542264	Phase 1	Completed	Otsuka Pharmaceutical Development & Commercialization, Inc.
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	2022/07/19	NCT05463770	Phase 1	Completed	Otsuka Pharmaceutical Development & Commercialization, Inc.
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	2022/06/02	NCT05402111	Phase 1	Completed	Otsuka Pharmaceutical Development & Commercialization, Inc.
A Clinical Trial to Evaluate the Long-term Safety and Tolerability of SEP-363856 in Patients With Schizophrenia in Japan	2022/05/03	NCT05359081	Phase 3	Terminated	Sumitomo Pharma Co., Ltd.

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

Related News

Sumitomo's Novel Schizophrenia Drug Ulotaront Fails to Meet Primary Endpoint in Phase 3 Trials

5 months ago

• Sumitomo Pharma America's ulotaront (SEP-363856), a novel TAAR1 and 5-HT1A agonist, failed to demonstrate statistical significance versus placebo in two Phase 3 trials for acute schizophrenia. • Despite showing favorable safety profile with fewer metabolic side effects compared to current antipsychotics, the drug's efficacy was masked by an unexpectedly high placebo response in the DIAMOND 1 and 2 studies. • The setback occurs amid ongoing development of other promising schizophrenia treatments, including Karuna's KarXT and Minerva's roluperidone, which are advancing toward potential market approval.

BMS Acquires Karuna Therapeutics for $14 Billion, Betting on Novel Schizophrenia Drug KarXT

2 years ago

• Bristol-Myers Squibb has agreed to acquire Karuna Therapeutics for $14 billion, gaining rights to KarXT, a first-in-class muscarinic receptor agonist for schizophrenia awaiting FDA approval. • KarXT represents the first new mechanism of action for schizophrenia treatment in decades, showing promising efficacy without the weight gain side effects common to current antipsychotics. • The strategic acquisition, expected to close in H1 2024, strengthens BMS's neuroscience portfolio with a potential multibillion-dollar drug that has patent protection through mid-2030s.

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