NCT03370640 is a Phase 1 clinical trial of SEP-363856 in Schizophrenia, sponsored by Sumitomo Pharma Co., Ltd..

Who is sponsoring NCT03370640?

NCT03370640 is sponsored by Sumitomo Pharma Co., Ltd..

What drugs are being tested in NCT03370640?

Interventions in NCT03370640: SEP-363856.

What condition does NCT03370640 study?

NCT03370640 studies Schizophrenia.

Is NCT03370640 still recruiting?

NCT03370640 is currently completed. Last updated 12 April 2022.

Last reviewed 2022-04-12 · How we verify

NCT03370640

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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 Phase 1 Last updated 12 April 2022

What this trial tests

Phase 1 trial testing SEP-363856 in Schizophrenia in 24 participants. Completed in 20 September 2018.

Timeline

29 November 2017

Primary endpoint
20 September 2018

20 September 2018

Quick facts

Lead sponsor	Sumitomo Pharma Co., Ltd.
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	24
Start date	29 November 2017
Primary completion	20 September 2018
Estimated completion	20 September 2018
Sites	8 locations across Japan

Drugs / interventions tested

SEP-363856 — full drug profile →

Conditions studied

Schizophrenia — all drugs for Schizophrenia →

Sponsor

Sumitomo Pharma Co., Ltd. — full company profile →

Who can join

Adults 18 to 55, any sex, with Schizophrenia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a multiple oral dose, open-label study to assess the safety, tolerability, and pharmacokinetics of SEP-363856 in Japanese subjects with schizophrenia.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

G protein-coupled receptors in neurodegenerative diseases and psychiatric disorders.
Wong TS, Li G, Li S, Gao W, et al · · 2023 · cited 113× · PMID 37137892 · DOI 10.1038/s41392-023-01427-2
Unlocking the Therapeutic Potential of Ulotaront as a Trace Amine-Associated Receptor 1 Agonist for Neuropsychiatric Disorders.
Kuvarzin SR, Sukhanov I, Onokhin K, Zakharov K, et al · · 2023 · cited 17× · PMID 37509616 · DOI 10.3390/biomedicines11071977

Verify or expand the search:

Other trials of SEP-363856

Trials testing the same drug.

NCT06894212 — A Trial of the Efficacy and Safety of SEP-363856 in Acutely Psychotic Participants With Schizophrenia · Phase 3 · recruiting
NCT05848700 — A Clinical Study to Learn if SEP-363856 Has Physical Dependence in Adults With Schizophrenia · Phase 1 · completed
NCT05741528 — An Extension Study to a Clinical Study That Will Continue to Evaluate the Effectiveness and Safety of SEP-363856 in Peop · Phase 3 · completed
NCT05729373 — A Clinical Study That Will Measure How Well SEP-363856 Works and How Safe it is in Adults With Generalized Anxiety Disor · Phase 2, PHASE3 · completed
NCT05628103 — A Clinical Study That Will Evaluate How Well SEP-363856 Works and How Safe it is in People With Schizophrenia That Switc · Phase 3 · completed

Other recruiting trials for Schizophrenia

Currently open trials in the same condition.

NCT07424404 — A Study to Evaluate the Long-term Safety and Tolerability of KarXT and KarX-EC for the Treatment of Schizophrenia and Au · Phase 3 · recruiting
NCT07467993 — Study to Assess the Safety, Tolerability, and Treatment Response of GXV813 in Hospitalized Adults With Schizophrenia · Phase 2 · recruiting
NCT07379827 — Effectiveness and Adverse-effect Switch Evaluation of Xanomeline and Trospium Chloride (KarXT) · recruiting
NCT06758414 — CBT-CP for Veterans With SMI · NA · recruiting
NCT07395206 — Acceptability, Feasibility and Preliminary Outcomes of the Kiso Mind App for Outpatients With Schizophrenia Spectrum Dis · NA · recruiting

Other Sumitomo Pharma Co., Ltd. trials

Trials by the same sponsor.

NCT06460064 — First-in-human Study to Assess the Safety, Tolerability and Immunogenicity of the Adjuvanted Universal Influenza Vaccine · Phase 1 · completed
NCT05435729 — A Pharmacodynamics and Safety Study of DSP-9632P in Patients With Levodopa-Induced Dyskinesia in Parkinson's Disease · Phase 1 · completed
NCT05359081 — A Clinical Trial to Evaluate the Long-term Safety and Tolerability of SEP-363856 in Patients With Schizophrenia in Japan · Phase 3 · terminated
NCT04825860 — A Clinical Trial to Evaluate the Efficacy and Safety of SEP-363856 in Acutely Psychotic People With Schizophrenia, Follo · Phase 2, PHASE3 · terminated
NCT04325737 — Study Assessing the Safety, Tolerability, and Pharmacokinetics of SEP-363856 in Japanese Male and Female Subjects With S · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03370640 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Sumitomo Pharma Co., Ltd.
Last refreshed: 12 April 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03370640.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing