New schizophrenia pill shows promise in Long-Term safety trial

NCT ID NCT07225712

Recruiting now Disease control Sponsor: Otsuka Pharmaceutical Co., Ltd. Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 3 trial is testing the long-term safety of a daily pill called SEP-363856 for adults with schizophrenia. Researchers will monitor 100 Japanese participants for side effects over 52 weeks. The goal is to see if this drug can be a safe option for ongoing disease control.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: SEP-363856 (a daily pill)
What this could lead to: If successful, this could provide a new long-term treatment option for schizophrenia with a manageable safety profile.
What could go wrong: This is an open-label, uncontrolled trial with no placebo group, so results may be biased. It only includes stable Japanese patients, so findings may not apply to others.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

schizophrenia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

SCHIZOPHRENIA

Contacts and locations

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Study contacts

Contact

Phone: •••-•••-••••

Locations

Jimbo Kokorono Clinic
RECRUITING

Fukuoka, Japan

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