New pill aims to quiet schizophrenia psychosis in weeks

NCT ID NCT05227690

Symptom relief Sponsor: AbbVie Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This Phase 2 trial tested two doses of emraclidine (10 mg and 30 mg daily) against a placebo in 385 people with schizophrenia who were having a sudden worsening of psychotic symptoms. The study lasted 6 weeks and measured symptom changes using a standard rating scale. The goal was to see if emraclidine can safely and effectively reduce symptoms like hallucinations and delusions.

What this could mean

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

Active substance: Emraclidine (CVL-231)
What this could lead to: If successful, emraclidine could offer a new option to quickly reduce severe psychotic symptoms in people with schizophrenia.
What could go wrong: This is an early Phase 2 trial with a small number of participants and a short 6-week duration. The drug may not work better than placebo, and side effects are still being studied.

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

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

385 people

The number who actually took part.

Started

Jun 2022

Finished

Aug 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Primary diagnosis of schizophrenia per DSM-5, as confirmed by the MINI for Psychotic Disorders. * CGI-S ≥4 (moderately to severely ill) at the time of signing the ICF and Baseline. * PANSS Total Score between 85 and 120, inclusive, at the time of signing the ICF and at Baseline. * Experiencing an acute exacerbation or relapse of psychotic symptoms, with onset less than 60 days prior to signing the ICF. * Willing to discontinue all prohibited medications to meet protocol-required washouts prior to and during the trial period. * Body mass index of 18.0 to 40.0 kg/m2 and a total body weight ≥50 kg (110 lbs). * Ability, in the opinion of the investigator, to understand the nature of the trial, participate in trial visits, and comply with protocol requirements. Exclusion Criteria: * Current DSM-5 diagnosis other than schizophrenia (note: anxiety symptoms secondary to schizophrenia are allowed); Acute depressive symptoms within 30 days prior to signing the ICF that require treatment with an antidepressant are exclusory. Acute manic symptoms within 30 days prior to signing the ICF that require treatment with a mood stabilizer are exclusory. * Any of the following: * Schizophrenia considered resistant/refractory to antipsychotic treatment by history (failure to respond to 2 or more courses of adequate pharmacological treatment defined as an adequate dose per label and a treatment duration of at least 4 weeks) * History of response to clozapine treatment only or failure to respond to clozapine treatment * Any of the following regarding history of schizophrenia: * Time from initial onset of schizophrenia \<2 years based on prior records or participant self-report * Presenting with an initial diagnosis of schizophrenia * Presenting for the first time with an acute psychotic episode requiring treatment * Reduction (improvement) in PANSS total score of ≥20% between Screening and Baseline. * Current or past history of significant cardiovascular, pulmonary, gastrointestinal, renal, hepatic, metabolic, genitourinary, endocrine (including diabetes mellitus), malignancy (except for basal cell carcinoma of the skin and cervical carcinoma in situ, at the discretion of the investigator), hematological, immunological, neurological, or psychiatric disease that, in the opinion of the investigator or medical monitor, could compromise either participant safety or the results of the trial. * Active central nervous system infection, demyelinating disease, degenerative neurological disease, brain tumor, prior hospitalization for severe head trauma, seizures (excluding febrile seizures in childhood), or any central nervous system disease deemed to be progressive during the course of the trial that may confound the interpretation of the trial results * Diagnosis of moderate to severe substance or alcohol-use disorder (excluding nicotine or caffeine) as per DSM-5 criteria within 12 months prior to signing the ICF. * Risk for suicidal behavior as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) and investigator's clinical assessment. * Any condition that could possibly affect drug absorption. * Use of prohibited medications prior to randomization within the required wash-out period or likely to require prohibited concomitant therapy during the trial. * Clinically significant abnormal findings on the physical examination, medical history review, ECG, or clinical laboratory results at screening. * Positive pregnancy test result prior to receiving IMP. Note: female participants who are pregnant, breastfeeding, or planning to become pregnant during IMP treatment or within 7 days after the last dose of IMP are also excluded.

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Conditions

The condition(s) this trial relates to.

psychiatric disorder schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders

As listed by the trial registrant

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

Schizophrenia

Contacts and locations

Locations

Anaheim, California

Anaheim, California, 92805-5854, United States
Atlanta, Georgia

Atlanta, Georgia, 30328-4018, United States
DeSoto, Texas

DeSoto, Texas, 75115-2092, United States
Decatur, Georgia

Decatur, Georgia, 30030-3438, United States
Flowood, Mississippi

Flowood, Mississippi, 39232-8016, United States
Gaithersburg, Maryland

Gaithersburg, Maryland, 20877-1409, United States
Garden Grove, California

Garden Grove, California, 92845-2506, United States
Hialeah, Florida

Hialeah, Florida, 33012-4648, United States
Hollywood, Florida

Hollywood, Florida, 33021-5414, United States
Houston, Texas

Houston, Texas, 77043-2735, United States
Irving, Texas

Irving, Texas, 75062-2323, United States
Lemon Grove, California

Lemon Grove, California, 91945-2956, United States
Little Rock, Arkansas

Little Rock, Arkansas, 72211-3702, United States
Mangonia Park, Florida

Mangonia Park, Florida, 33407-2413, United States
Montclair, California

Montclair, California, 91763-2231, United States
North Canton, Ohio

North Canton, Ohio, 44720, United States
Oakland Park, Florida

Oakland Park, Florida, 33334-4135, United States
Richardson, Texas

Richardson, Texas, 75080, United States
Riverside, California

Riverside, California, 92506-3257, United States
San Diego, California

San Diego, California, 92123, United States
Shreveport, Louisiana

Shreveport, Louisiana, 71101-4603, United States
Stara Zagora

Stara Zagora, 6003, Bulgaria
Veliko Tarnovo

Veliko Tarnovo, 5000, Bulgaria
Veliko Tarnovo, Veliko Tarnovo

Veliko Tarnovo, 5047, Bulgaria
Vratsa, Vratsa

Vratsa, 3000, Bulgaria

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