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New hope for Treatment-Resistant schizophrenia? phase 3 trial launches

NCT ID NCT07184619

Symptom relief Sponsor: Newron Pharmaceuticals SPA 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Sep 11, 2026 · Updated 4 times

Summary

This study tests an experimental drug called evenamide for people with schizophrenia that hasn't improved with standard antipsychotics. About 400 adults will receive either evenamide or a placebo added to their current medication for 12 weeks. The goal is to see if evenamide reduces symptoms like hallucinations and delusions better than placebo, and to check its safety.

Why investors are watching

Newron Pharmaceuticals, a micro-cap company, runs this phase III trial of evenamide as an add-on for treatment-resistant schizophrenia. The trial tests whether evenamide helps patients whose current antipsychotic does not control their symptoms, and the result matters because a company this small depends on a single late-stage readout.

If it works: A positive result could support a path toward regulatory approval and give the company a treatment for a hard-to-treat patient group.

If it fails: A failure or delay could set the program back, and late-stage trials in schizophrenia often fail to show a benefit over placebo.

AI-written from the trial record. Speculative, and not investment advice.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 400 people

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

Started

Jan 2026

Expected to finish

Mar 2027

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 years and older

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: * Age - 18 years, or older. * If female, the subject has a negative pregnancy test at the screening visit and at baseline, is not lactating, and agrees to use adequate contraception, unless not of childbearing potential. * Meets current DSM-5-TR criteria for schizophrenia. * Has shown treatment-resistance to antipsychotics as per TRRIP working group definition (Howes et al., 2017). * Currently receiving "standard of care" therapy of a minimal recommended therapeutic dose of one or more antipsychotic(s). * Has a Clinical Global Impression - Severity of disease (CGI-S) rating of "mildly ill" to "among the most extremly ill" at baseline. * Has a BPRS total score ≥ 45 at screening and baseline. * Has a PANSS total score ≥ 70 at baseline. * Has a Global Assessment of Functioning (GAF) scale total score ≤ 50. * Adherence to prescribed antipsychotic treatment. * Patient has provided written informed consent prior to participating in the study. Key Exclusion Criteria: * Current DSM-5-TR diagnosis of schizophreniform disorder, schizoaffective disorder, or other primary psychiatric diagnosis, such as bipolar disorder or major depressive disorder * History (within three months of study entry) or current diagnosis of "Substance Use Disorder" as defined by the DSM-5-TR criteria. * Severity of current episode of psychosis requires that the patient be hospitalized to stabilize the severity of his/her psychotic symptoms. However, these patients may qualify for the study provided their antipsychotic dose has been stable for 6 weeks prior to screening. * History or current diagnosis of other psychiatric or behavioral disorders. * Known suicidal risk, or a suicide attempt within the past 2 years. * History of neuroleptic malignant syndrome or priapism. * Disease/medical condition of any type that may impact the patient's safety or interfere with any of the study evaluations. * History or current diagnosis of epilepsy or seizure disorder, or occurrence of a seizure within the past year, or repeated drug-induced seizures.

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Conditions

The condition(s) this trial relates to.

Schizophrenia Schizophrenia, Treatment-Resistant treatment-refractory schizophrenia

As listed by the trial registrant

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

Treatment resistant schizophrenia

How to take part

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

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    18 sites in 3 countries. The list below names each one and where it is.

  3. 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 ↗

  4. 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

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Ahana Hospitals LLP

    RECRUITING

    Madurai, Tamil Nadu, 625020, India

  • All India Institute Of Medical Sciences

    NOT_YET_RECRUITING

    Nagpur, Maharashtra, 441108, India

  • All India Institute of Medical Sciences

    NOT_YET_RECRUITING

    Bībīnagar, Telangana, 508126, India

  • Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine

    SUSPENDED

    Baltimore, Maryland, 21224, United States

  • Fundación para el Estudio y Tratamiento de las Enfermedades Mentales

    ACTIVE_NOT_RECRUITING

    Buenos Aires, Buenos Aires F.D., 1133, Argentina

  • Gauhati Medical College and Hospital

    RECRUITING

    Guwahati, Assam, 781032, India

  • Grady Behavioral Health Center, -Department of Psychiatry and Behavioral Sciences, Emory University School of Medicine

    SUSPENDED

    Atlanta, Georgia, 30322, United States

  • Help Hospital

    RECRUITING

    Vijayawada, Andhra Pradesh, 520002, India

  • Hospital Tuanku Fauziah

    RECRUITING

    Kangar, 01000, Malaysia

  • Kuala Lumpur Hospital

    RECRUITING

    Kuala Lumpur, Kuala Lumpur, 50586, Malaysia

  • Manhattan Psychiatric Center, The Nathan Kline Institute for Psychiatric Research

    SUSPENDED

    New York, New York, 10035, United States

  • Masina Hospital Trust

    RECRUITING

    Mumbai, Maharashtra, 400027, India

  • New Manak Healthcare Hospital

    RECRUITING

    Navi Mumbai, Maharashtra, 400706, India

  • Sentosa Hospital

    RECRUITING

    Kuching, 93250, Malaysia

  • Seth Sukhlal Karnani Memorial Hospital

    NOT_YET_RECRUITING

    Kolkata, West Bengal, 700025, India

  • Sultan Abdul Halim Hospital

    RECRUITING

    Sungai Petani, 08000, Malaysia

  • UCLA DGSOM, UCLA Health, UCLA Semel Institute

    SUSPENDED

    Los Angeles, California, 90095, United States

  • Udyan Health Care

    RECRUITING

    Lucknow, Uttar Pradesh, 226012, India

  • University of Miami, Miller School of Medicine; Jackson Behavioral Health Hospital

    SUSPENDED

    Miami, Florida, 33136, United States

More trials for these conditions

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