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New schizophrenia shot could offer cheaper alternative to Brand-Name drug

NCT ID NCT07493551

Disease control Sponsor: CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd. 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study tests whether a new generic version of a 3-month schizophrenia injection works the same as the brand-name drug Invega Trinza. About 260 Chinese adults with stable schizophrenia will receive multiple doses of either the test or reference drug. The goal is to see if the two formulations reach similar drug levels in the blood and have similar safety profiles.

What this could mean

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

Active substance
paliperidone palmitate injection (3-month formulation)
What this could lead to
If successful, this could provide a more affordable, equally effective long-acting treatment option for schizophrenia patients in China.
What could go wrong
This is a bioequivalence study, not a test of new efficacy or safety. It only compares two formulations in a specific population, so results may not apply broadly.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 260 people

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

Started

Oct 2024

Expected to finish

Dec 2026

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.

Inclusion Criteria: * 18 to 65 years old (including 18 and 65 years old). * Patients diagnosed with schizophrenia (by ICD-10 criteria) before screening. * Weight: male patients with weight ≥50.0 kg, female patients with weight ≥45.0 kg, with the body mass index of 19.0\~35.0 kg/m\^2 (including 19.0 and 35.0). * Positive and Negative Syndrome Scale (PANSS) total score lower than 70 at screening and baseline. * Clinical Global Impression-Severity (CGI-S) lower than 4 at screening and baseline. * Patients and their guardians voluntarily sign the ICF and are able to comply with the requirements of the study. Exclusion Criteria: * Be allergic, or have a clear history of allergies to trial drugs and components. * Patients with cardiovascular, liver, kidney, gastrointestinal, psychiatric, or neurological diseases that may affect participation in the trial, as determined by the investigator. * History of tardive dyskinesia.

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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

How to take part

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

  1. The places running it

    1 site. 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

  • Beijing Anding Hospital Capital Medical University

    RECRUITING

    Beijing, Beijing Municipality, 100120, China

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