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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.

Disclaimer Read more

This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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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

  • Research Site

    Anaheim, California, 92805, United States

  • Research Site

    Bellflower, California, 90706, United States

  • Research Site

    Culver City, California, 90230, United States

  • Research Site

    Long Beach, California, 90806, United States

  • Research Site

    San Diego, California, 92102, United States

  • Research Site

    Sherman Oaks, California, 91403, United States

  • Research Site

    Hollywood, Florida, 33021, United States

  • Research Site

    Miami Springs, Florida, 33166, United States

  • Research Site

    Atlanta, Georgia, 30331, United States

  • Research Site

    Decatur, Georgia, 30030, United States

  • Research Site

    Chicago, Illinois, 60641, United States

  • Research Site

    Lake Charles, Louisiana, 70629, United States

  • Research Site

    Gaithersburg, Maryland, 20877, United States

  • Research Site

    St Louis, Missouri, 63125, United States

  • Research Site

    Marlton, New Jersey, 08053, United States

  • Research Site

    New York, New York, 10032, United States

  • Research Site

    Richardson, Texas, 75080, United States

  • Research Site

    Burgas, 8000, Bulgaria

  • Research Site

    Kardzhali, 6600, Bulgaria

  • Research Site

    Novi Iskar, 1282, Bulgaria

  • Research Site

    Plovdiv, 4000, Bulgaria

  • Research Site

    Sofia, 1202, Bulgaria

  • Research Site

    Sofia, 1431, Bulgaria

  • Research Site

    Zagreb, 10090, Croatia

  • Research Site

    Daugavpils, LV-5417, Latvia

  • Research Site

    Riga, LV-1005, Latvia

  • Research Site

    Strenči, LV-4730, Latvia

  • Research Site

    Arkhangelsk, 163530, Russia

  • Research Site

    Engel's, 413124, Russia

  • Research Site

    Moscow, 117152, Russia

  • Research Site

    Moscow, 141371, Russia

  • Research Site

    Saint Petersburg, 188820, Russia

  • Research Site

    Saint Petersburg, 190005, Russia

  • Research Site

    Saint Petersburg, 192019, Russia

  • Research Site

    Saint Petersburg, 197341, Russia

  • Research Site

    Saratov, 410028, Russia

  • Research Site

    Saratov, 410060, Russia

  • Research Site

    Stavropol, 357034, Russia

  • Research Site

    Tomsk, 634014, Russia

  • Research Site

    Belgrade, 11000, Serbia

  • Research Site

    Kovin, 26220, Serbia

  • Research Site

    Kragujevac, 34000, Serbia

  • Research Site

    Niš, 18000, Serbia

  • Research Site

    Novi Kneževac, 23330, Serbia

  • Research Site

    Vršac, 26300, Serbia

  • Research Site

    Kharkiv, 61068, Ukraine

  • Research Site

    Kherson, 73488, Ukraine

  • Research Site

    Kyiv, 01030, Ukraine

  • Research Site

    Kyiv, 01133, Ukraine

  • Research Site

    Kyiv, 08631, Ukraine

  • Research Site

    Lviv, 79021, Ukraine

  • Research Site

    Vinnytsia, 21005, Ukraine