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New schizophrenia drug shows promise in Long-Term safety trial

NCT ID NCT07459647

Disease control Sponsor: MapLight Therapeutics Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Sep 02, 2026 · Updated 5 times

Summary

This study is testing a new drug called ML-007C-MA for adults with schizophrenia. The goal is to see if it is safe and works well over a full year. About 500 people who have recently been in a related study or are new to the trial will take the drug twice daily. Researchers will track side effects and how well the drug controls symptoms.

What this could mean

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

Active substance
ML-007C-MA (a combination drug taken twice daily)
What this could lead to
If successful, this could provide a new long-term treatment option for schizophrenia that is safe and effective for daily use.
What could go wrong
This is an early phase 2 open-label study, so results are not definitive. Side effects or lack of effectiveness may still emerge, and the drug may not work for everyone.

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

About 500 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2026

Expected to finish

Feb 2030

An estimate. End dates often move.

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.

Key Inclusion Criteria: 1. Must be able and willing to provide informed consent for all required study procedures. 2. Has a primary diagnosis of schizophrenia based on the DSM-5 criteria that is confirmed by semi-structured clinical interview (Mini International Neuropsychiatric Interview for DSM-5). 3. May benefit from long-term pharmacotherapy for schizophrenia, based on assessment of the investigator. 4. Is appropriate for an outpatient level of care and resides in a stable living situation, based on assessment of the investigator. 5. Has an identified reliable informant(s) available to participate in relevant assessments. Site staff may serve as the informant if the site has had regular contact with the participant for \>1 year. Key Exclusion Criteria: 1. Has any DSM-5 disorder, other than schizophrenia, within the 12 months before Screening that is primarily responsible for the current symptoms or functional impairment. 2. Is discontinuing effective and well-tolerated antipsychotic therapy for the purpose of enrolling in this study. 3. Has received any prohibited therapy within the Screening Period unless discontinued before Baseline. 4. Has current evidence of a clinically significant and/or unstable medical comorbidity at Screening or Baseline. 5. Has clinically significant abnormal physical examination, ECG, or clinical safety laboratory result at Screening or Baseline. 6. Has an elevated risk of suicidal behavior. 7. Has a known allergy to ML-007C-MA, its active ingredients or their excipients. 8. Has a DSM-5 diagnosis of moderate to severe substance use disorder (except tobacco or caffeine use disorder) within the 12 months before Screening (confirmed using MINI version 7.0.2 at Screening). 9. Has an elevated risk of violent or destructive behavior, based on participant history and investigator judgment.

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Conditions

The condition(s) this trial relates to.

brain disorder central nervous system disorder nervous system disorder psychiatric disorder Psychotic Disorders schizophrenia

As listed by the trial registrant

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

Schizophrenia

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    42 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Clinical Site

    RECRUITING

    Little Rock, Arkansas, 72204, United States

  • Clinical Site

    RECRUITING

    Little Rock, Arkansas, 72211, United States

  • Clinical Site

    RECRUITING

    Rogers, Arkansas, 72758, United States

  • Clinical Site

    RECRUITING

    Bellflower, California, 90706, United States

  • Clinical Site

    RECRUITING

    Cerritos, California, 90703, United States

  • Clinical Site

    RECRUITING

    Culver City, California, 90230, United States

  • Clinical Site

    RECRUITING

    Garden Grove, California, 92845, United States

  • Clinical Site

    RECRUITING

    Lemon Grove, California, 91945, United States

  • Clinical Site

    RECRUITING

    Long Beach, California, 90807, United States

  • Clinical Site

    RECRUITING

    Los Angeles, California, 90015, United States

  • Clinical Site

    RECRUITING

    Montclair, California, 91763, United States

  • Clinical Site

    RECRUITING

    Oceanside, California, 92056, United States

  • Clinical Site

    RECRUITING

    Orange, California, 92868, United States

  • Clinical Site

    RECRUITING

    Pico Rivera, California, 94596, United States

  • Clinical Site

    RECRUITING

    Riverside, California, 92506, United States

  • Clinical Site

    RECRUITING

    San Diego, California, 92123, United States

  • Clinical Site

    RECRUITING

    Sherman Oaks, California, 91403, United States

  • Clinical Site

    RECRUITING

    Torrance, California, 90504, United States

  • Clinical Site

    RECRUITING

    Hollywood, Florida, 33021, United States

  • Clinical Site

    RECRUITING

    Hollywood, Florida, 33024, United States

  • Clinical Site

    RECRUITING

    Miami, Florida, 33166, United States

  • Clinical Site

    RECRUITING

    Miami Lakes, Florida, 33016, United States

  • Clinical Site

    RECRUITING

    West Palm Beach, Florida, 33407, United States

  • Clinical Site

    RECRUITING

    Atlanta, Georgia, 30331, United States

  • Clinical Site

    RECRUITING

    Decatur, Georgia, 30030, United States

  • Clinical Site

    RECRUITING

    Chicago, Illinois, 60640, United States

  • Clinical Site

    RECRUITING

    Gaithersburg, Maryland, 20877, United States

  • Clinical Site

    RECRUITING

    Boston, Massachusetts, 02116, United States

  • Clinical Site

    RECRUITING

    Watertown, Massachusetts, 02472, United States

  • Clinical Site

    RECRUITING

    Ann Arbor, Michigan, 48105, United States

  • Clinical Site

    RECRUITING

    Las Vegas, Nevada, 89102, United States

  • Clinical Site

    RECRUITING

    Las Vegas, Nevada, 89119, United States

  • Clinical Site

    RECRUITING

    Marlton, New Jersey, 08053, United States

  • Clinical Site

    RECRUITING

    New York, New York, 10029, United States

  • Clinical Site

    RECRUITING

    Staten Island, New York, 10314, United States

  • Clinical Site

    RECRUITING

    The Bronx, New York, 10641, United States

  • Clinical Site

    RECRUITING

    North Canton, Ohio, 44720, United States

  • Clinical Site

    RECRUITING

    West Chester, Ohio, 45069, United States

  • Clinical Site

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • Clinical Site

    RECRUITING

    Austin, Texas, 78754, United States

  • Clinical Site

    RECRUITING

    DeSoto, Texas, 75115, United States

  • Clinical Site

    RECRUITING

    Richardson, Texas, 75080, United States

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