New schizophrenia drug shows promise in large trial

NCT ID NCT04092686

Completed Disease control Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This Phase 3 trial tested an investigational drug called SEP-363856 in 464 people with schizophrenia who were experiencing acute psychosis. Participants received either the drug or a placebo daily for up to 9 weeks. The study measured changes in symptoms like hallucinations and delusions using standard psychiatric scales. The goal was to see if the drug could safely reduce symptom severity compared to placebo.

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 (an investigational drug for schizophrenia)
What this could lead to: If successful, this drug could offer a new treatment option to reduce psychotic symptoms like hallucinations and delusions in people with schizophrenia.
What could go wrong: This is a Phase 3 trial, but results are not yet published. The drug may not work better than placebo, and side effects are possible. It is not a cure.

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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

Locations

Research Site

Rogers, Arkansas, 72758, United States
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Anaheim, California, 92805, United States
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Bellflower, California, 90706, United States
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Culver City, California, 90230, United States
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Long Beach, California, 90806, United States
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San Diego, California, 92102, United States
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Sherman Oaks, California, 91403, United States
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Hollywood, Florida, 33021, United States
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Miami Springs, Florida, 33166, United States
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Atlanta, Georgia, 30331, United States
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Decatur, Georgia, 30030, United States
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Chicago, Illinois, 60641, United States
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Lake Charles, Louisiana, 70629, United States
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Gaithersburg, Maryland, 20877, United States
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St Louis, Missouri, 63125, United States
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Marlton, New Jersey, 08053, United States
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New York, New York, 10032, United States
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Richardson, Texas, 75080, United States
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Burgas, 8000, Bulgaria
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Kardzhali, 6600, Bulgaria
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Novi Iskar, 1282, Bulgaria
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Plovdiv, 4000, Bulgaria
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Sofia, 1202, Bulgaria
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Sofia, 1431, Bulgaria
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Zagreb, 10090, Croatia
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Daugavpils, LV-5417, Latvia
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Riga, LV-1005, Latvia
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Strenči, LV-4730, Latvia
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Arkhangelsk, 163530, Russia
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Engel's, 413124, Russia
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Moscow, 117152, Russia
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Moscow, 141371, Russia
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Saint Petersburg, 188820, Russia
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Saint Petersburg, 190005, Russia
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Saint Petersburg, 192019, Russia
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Saint Petersburg, 197341, Russia
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Saratov, 410028, Russia
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Saratov, 410060, Russia
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Stavropol, 357034, Russia
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Tomsk, 634014, Russia
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Belgrade, 11000, Serbia
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Kovin, 26220, Serbia
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Kragujevac, 34000, Serbia
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Niš, 18000, Serbia
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Novi Kneževac, 23330, Serbia
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Vršac, 26300, Serbia
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Kharkiv, 61068, Ukraine
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Kherson, 73488, Ukraine
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Kyiv, 01030, Ukraine
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Kyiv, 01133, Ukraine
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Kyiv, 08631, Ukraine
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Lviv, 79021, Ukraine
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Vinnytsia, 21005, Ukraine

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