trial

A Trial of the Efficacy and Safety of SEP-363856 in Acutely Psychotic Participants With Schizophrenia

NCTId NCT06894212
as of 2026-07-01
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at a glance
Phase 3 · Recruiting
Enrollment 522 (estimated)
Sponsored by Otsuka Pharmaceutical Development & Commercialization, Inc.
Primary completion 2026-10-20
Synthesized from structured facts only — each point cited above.

Design & status

Phase
Phase 3
Status
Recruiting
Enrollment
522 (estimated)
Study type
Interventional
Allocation
Randomized
Model
Parallel
Masking
Single
Start
2025-02-28
Primary completion
2026-10-20
Eligibility
ALL · 18 Years · 65 Years

Interventions & indications

Drugs
Ulotaront

Sponsors

Otsuka Pharmaceutical Development & Commercialization, Inc.Lead Sponsor

Sites

73 total
Bentonville, United StatesLittle Rock, United StatesLittle Rock, United StatesRogers, United StatesBellflower, United StatesCulver City, United StatesGarden Grove, United StatesLemon Grove, United StatesMontclair, United StatesRiverside, United StatesRiverside, United StatesSan Diego, United States

Linked catalysts

1
A Trial of the Efficacy and Safety of SEP-363856 in Acutely Psychotic Participan — primary completion2026-10-20

Facts & assertions

4 sourced
Enrollment
522
Phase
PHASE3
Primary Completion Date
2026-10-20
Status
RECRUITING
relationships
The graph out of here
drug
Ulotaront
drug
lead_sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
company
indication
Schizophrenia
indication
Schizophrenia
indication