Cure My Disease

Don't miss your cure!

 Log in / Sign up

Can a new daily pill offer safer Long-Term schizophrenia control?

NCT ID NCT05443724

Disease control Sponsor: AbbVie Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 21, 2026 · Last updated Aug 21, 2026

Summary

This trial is testing whether emraclidine, an experimental oral medication taken once daily for a year, is safe and tolerable for adults with schizophrenia. Participants who completed earlier studies of emraclidine may join, and researchers will monitor side effects, vital signs, and movement-related symptoms. The goal is to see if this drug can be a long-term treatment option.

What this could mean

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

Active substance
Emraclidine (also known as CVL-231), an oral tablet taken once daily
What this could lead to
If successful, this could support emraclidine as a long-term treatment option for schizophrenia with a favorable safety profile.
What could go wrong
This is a phase 2 open-label trial focused on safety, not efficacy. Side effects or lack of long-term benefit could limit its use.

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

698 people

The number who actually took part.

Started

Sep 2022

Finished

Jun 2025

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: 1. Completed 6 weeks of post-randomization treatment in Trial CVL-231-2001 (NCT05227690) or CVL-231-2002 (NCT05227703) and who, in the opinion of the investigator, could potentially benefit from treatment with emraclidine for schizophrenia. 2. Primary diagnosis of schizophrenia per Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), as confirmed by the Mini International Neuropsychiatric Interview (MINI) for Psychotic Disorders. 3. Participants who have been stable on antipsychotic medication for at least one 3-month in the year prior to screening. 4. Outpatient status at the time of signing the informed consent form informed consent form (ICF). 5. Willing to discontinue all prohibited medications to meet protocol-required washouts prior to and during the trial period. 6. Ability, in the investigator's opinion, to understand the nature of the trial, participate in trial visits, and comply with protocol requirements. Exclusion Criteria: 1. 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. 2. Any of the following: * Schizophrenia is 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. 3. 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. 4. 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 trial that may confound the interpretation of the trial results 5. 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. 6. Risk for suicidal behavior as assessed by the C-SSRS and investigator's clinical assessment. 7. Any condition that could possibly affect drug absorption, including, but not limited to bowel resections, bariatric weight loss surgery, gastric banding, and gastrectomy 8. Use of prohibited medications prior to randomization within the required wash-out period or likely to require prohibited concomitant therapy during the trial. 9. Clinically significant abnormal findings on the physical examination, medical history review, ECG, or clinical laboratory results at screening. 10. Positive pregnancy test result prior to receiving investigational medicinal product (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 the IMP are also excluded.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Schizophrenia are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

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, 30318-3102, United States

  • Atlanta, Georgia

    Atlanta, Georgia, 30328-4018, United States

  • Atlanta, Georgia

    Atlanta, Georgia, 30331, United States

  • Austin, Texas

    Austin, Texas, 78754-5122, United States

  • Bellflower, California

    Bellflower, California, 90706-7079, United States

  • Berlin, New Jersey

    Berlin, New Jersey, 08009, United States

  • Berwyn, Illinois

    Berwyn, Illinois, 60402-2248, United States

  • Bonita Springs,Florida

    Bonita Springs, Florida, 34134-4154, United States

  • Bryant, Arkansas

    Bryant, Arkansas, 72022-9252, United States

  • Cedarhurst, New York

    Cedarhurst, New York, 11516-1905, United States

  • Charlotte, North Carolina

    Charlotte, North Carolina, 28211-4849, United States

  • Chicago, Illinois

    Chicago, Illinois, 60611-3478, United States

  • Chicago, Illinois

    Chicago, Illinois, 60622-1702, United States

  • Chicago, Illinois

    Chicago, Illinois, 60623, United States

  • Chicago, Illinois

    Chicago, Illinois, 60640-5017, United States

  • Chicago, Illinois

    Chicago, Illinois, 60641-4023, United States

  • Culver City, California

    Culver City, California, 90230-6632, United States

  • DeSoto, Texas

    DeSoto, Texas, 75115-2066, United States

  • Decatur, Georgia

    Decatur, Georgia, 30030-3438, United States

  • Flowood, Mississippi

    Flowood, Mississippi, 39232-8016, United States

  • Fort Myers, Florida

    Fort Myers, Florida, 33901-3711, United States

  • Franklin,Tennessee

    Franklin, Tennessee, 37067-5967, United States

  • Gaithersburg, Maryland

    Gaithersburg, Maryland, 20877-1409, United States

  • Garden Grove, California

    Garden Grove, California, 92845-2506, United States

  • Gyor, Gyor-Moson-Sopron

    Győr, Győr-Moson-Sopron, 9024, Hungary

  • Hialeah, Florida

    Hialeah, Florida, 33012-4648, United States

  • Hialeah, Florida

    Hialeah, Florida, 33016-1814, United States

  • Houston, Texas

    Houston, Texas, 77043, United States

  • Houston, Texas

    Houston, Texas, 77074, United States

  • Ivano Frankivsk, Ivano Frankivsk

    Ivano-Frankivsk, Ivano-Frankivsk Oblast, 76011, Ukraine

  • Kalocsa, Bács-Kiskun

    Kalocsa, Bács-Kiskun county, 6300, Hungary

  • Kropyvnytskyi, Kropyvnytskyi

    Kropyvnytskyi, 25491, Ukraine

  • Kyiv, Kyïv

    Kyiv, 04080, Ukraine

  • La Habra, California

    La Habra, California, 90631-3842, United States

  • Las Vegas, Nevada

    Las Vegas, Nevada, 89102-1972, United States

  • Lemon Grove, California

    Lemon Grove, California, 91945-2956, United States

  • Little Rock, Arkansas

    Little Rock, Arkansas, 72211-3702, United States

  • Lviv, L'vivs'ka Oblast

    Lviv, Lviv Oblast, 79021, Ukraine

  • Marrero, Louisiana

    Marrero, Louisiana, 70072-3083, United States

  • Miami Lakes, Florida

    Miami Lakes, Florida, 33016-1553, United States

  • Miami Lakes, Florida

    Miami Lakes, Florida, 33016, United States

  • Miami Springs, Florida

    Miami Springs, Florida, 33166-7225, United States

  • Miami, Florida

    Miami, Florida, 33122-1335, United States

  • Miami, Florida

    Miami, Florida, 33125-5114, United States

  • Miami, Florida

    Miami, Florida, 33155, United States

  • Montclair, California

    Montclair, California, 91763-2231, United States

  • New Haven, Connecticut

    New Haven, Connecticut, 06519-1109, United States

  • New York, New York

    New York, New York, 10036-4811, United States

  • North Canton, Ohio

    North Canton, Ohio, 44718-2567, United States

  • Oakland Park, Florida

    Oakland Park, Florida, 33334-4135, United States

  • Oklahoma City, Oklahoma

    Oklahoma City, Oklahoma, 73102-1018, United States

  • Orange,California

    Orange, California, 92868-4447, United States

  • Pazardzhik, Pazardzhik

    Pazardzhik, 4400, Bulgaria

  • Phoenix, Arizona

    Phoenix, Arizona, 85012-2707, United States

  • Pico Rivera, California

    Pico Rivera, California, 90660-4920, United States

  • Plano, Texas

    Plano, Texas, 75093-0010, United States

  • Pleven, Pleven

    Pleven, 5800, Bulgaria

  • Richardson, Texas

    Richardson, Texas, 75080-3764, United States

  • Riverside, California

    Riverside, California, 92506-3237, United States

  • San Diego, California

    San Diego, California, 92103-2209, United States

  • San Diego, California

    San Diego, California, 92121, United States

  • San Diego, California

    San Diego, California, 92123, United States

  • San Juan, Puerto Rico

    San Juan, 918, Puerto Rico

  • San Juan, Puerto Rico

    San Juan, 926, Puerto Rico

  • Savannah,Georgia

    Savannah, Georgia, 31405-5702, United States

  • Sherman Oaks, California

    Sherman Oaks, California, 91403-1747, United States

  • Shreveport, Louisiana

    Shreveport, Louisiana, 71101-4603, United States

  • Sliven, Sliven

    Sliven, 8800, Bulgaria

  • Smila, Smila

    Smila, 20708, Ukraine

  • Sofia, Sofia-Grad

    Sofia, Sofia-Grad, 1202, Bulgaria

  • Sofia, Sofia-Grad

    Sofia, Sofia-Grad, 1407, Bulgaria

  • Sofia, Sofia-Grad

    Sofia, Sofia-Grad, 1431, Bulgaria

  • Sofia, Sofia-Grad

    Sofia, Sofia-Grad, 1510, Bulgaria

  • Sofia, Sofia-Grad

    Sofia, Sofia-Grad, 1606, Bulgaria

  • Sofia, Sofia-Grad

    Sofia, Sofia-Grad, 1680, Bulgaria

  • Stara Zagora, Stara Zagora

    Stara Zagora, 6003, Bulgaria

  • Staten Island, New York

    Staten Island, New York, 10314-1607, United States

  • Torrance, California

    Torrance, California, 90502-4432, United States

  • Varna, Varna

    Varna, 9000, Bulgaria

  • Veliko Tarnovo, Veliko Tarnovo

    Veliko Tarnovo, 5000, Bulgaria

  • Vinnytsia, Vinnytsia

    Vinnytsia, 21018, Ukraine

  • Vratsa, Vratsa

    Vratsa, 3000, Bulgaria

  • Walnut Creek, California

    Walnut Creek, California, 94549, United States

  • West Palm Beach, Florida

    West Palm Beach, Florida, 33407-2015, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.