trial

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

NCTId NCT05628103
as of 2026-07-01
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at a glance
Phase 3 · Completed
Enrollment 101 (actual)
Sponsored by Otsuka Pharmaceutical Development & Commercialization, Inc.
Primary completion 2024-04-01
Synthesized from structured facts only — each point cited above.

Design & status

Phase
Phase 3
Status
Completed
Enrollment
101 (actual)
Study type
Interventional
Allocation
Na
Model
Single Group
Masking
None
Start
2022-12-19
Primary completion
2024-04-01
Eligibility
ALL · 18 Years · 65 Years

Interventions & indications

Drugs
Ulotaront

Sponsors

Otsuka Pharmaceutical Development & Commercialization, Inc.Lead Sponsor

Sites

25 total
Anaheim, United StatesBellflower, United StatesCulver City, United StatesGarden Grove, United StatesLemon Grove, United StatesRiverside, United StatesSan Diego, United StatesSantee, United StatesTorrance, United StatesHollywood, United StatesMiami, United StatesMiami, United States

Linked catalysts

1
A Clinical Study That Will Evaluate How Well SEP-363856 Works and How Safe it is — primary completion2024-04-01

Facts & assertions

4 sourced
Enrollment
101
Phase
PHASE3
Primary Completion Date
2024-04-01
Status
COMPLETED
relationships
The graph out of here
drug
Ulotaront
drug
lead_sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
company
indication
Schizophrenia
indication
Schizophrenia
indication