Drugs / SEP-380135
last change May 2026 re-read 2 minutes ago

SEP-380135

also known as 14C-SEP-380135
Developed for
schizophrenia · bipolar disorder · major depressive disorder
Investigated by
Otsuka Pharmaceutical Development & Commercialization, Inc.

Trials 3 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 1 NCT07455084 Mar → Apr 2026 overdue schizophrenia Otsuka Pharmaceutical Development & Commercialization, Inc. Not yet recruiting No outcome recorded
Phase 1 NCT07305779 Mar → May 2025 schizophrenia Otsuka Pharmaceutical Development & Commercialization, Inc. Completed No outcome recorded
Phase 1 NCT07549581 Nov 2024 → Sep 2025 bipolar disorder, major depressive disorder, schizophrenia Otsuka Pharmaceutical Development & Commercialization, Inc. Completed No outcome recorded

Press releases naming this drug 1 release

DateIssuerRelease
2024-03-15 Otsuka Pharmaceutical Development & Commercialization, Inc. Otsuka and Sumitomo Revise License Agreement- Otsuka holds exclusive rights to develop, manufacture, and commercialize ulotaront and SEP-380135 worldwide - otsuka.co.jp

Evidence & citations 3 cited values

Every value below carries the sentence it was read from. 3 sources stand behind the page.

FieldValueCited text
Known as SEP-380135 ClinicalTrials.gov intervention name — accepted as the source's own label NCT07305779
2

NCT07455084

NCT07549581

Known as 14C-SEP-380135 “Participants receive a single oral administration of 14C-SEP-380135 on Day 1.” NCT07455084
Route Oral Oral capsules.” NCT07305779