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New schizophrenia shot could offer cheaper alternative to abilify maintena
NCT ID NCT07547384
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study compares a new injectable form of aripiprazole (SYH9096) to the approved drug Abilify Maintena® in 116 adults with stable schizophrenia. Participants receive five injections of each version, one month apart, to see if the new version reaches similar drug levels in the blood. The goal is to show the two are bioequivalent, meaning they work the same way in the body.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- aripiprazole injection (a long-acting antipsychotic medication)
- What this could lead to
- If successful, this could provide a more affordable or accessible version of a monthly injection that helps control schizophrenia symptoms.
- What could go wrong
- This is an early-stage bioequivalence study, not a test of effectiveness. The new injection may not be absorbed the same way in all patients, and side effects could differ.
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
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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
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About 116 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Apr 2026
An estimate. Start dates often move.
- Expected to finish
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Nov 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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\. Aged 18 to 65 years (inclusive), male or female. * 2\. Patients diagnosed with schizophrenia according to ICD-10 criteria, with a Positive and Negative Syndrome Scale (PANSS) total score ≤ 70, judged as clinically stable for at least 28 days prior to screening (no medication changes or hospitalization due to condition changes). * 3\. Receiving treatment with ≤ 2 other oral antipsychotic medications, which must have been at a stable dose for ≥ 14 days before the first study injection (excluding prohibited medications). * 4\. Body weight ≥ 45 kg for females and ≥ 50 kg for males; Body Mass Index (BMI) between 18.5 and 35.0 kg/m² (inclusive). * 5\. Subject or partner has no pregnancy plan and agrees to use effective non-drug contraception during the study and for six months after the last dose. * 6\. Subjects and their legal guardians voluntarily sign the Informed Consent Form (ICF) and are able to comply with all study requirements. Exclusion Criteria: * 1.Diagnosis of any psychiatric disorder other than schizophrenia according to ICD-10 criteria. * 2.History or presence of clinically significant cardiovascular, hepatic, renal, gastrointestinal, psychiatric, or neurological diseases that, in the investigator's judgment, would affect participation in the study. * 3.Patients with Parkinson's disease, Lewy body dementia, or dementia-related psychosis. * 4.History or presence of Neuroleptic Malignant Syndrome (NMS). * 5.History or presence of epilepsy or convulsive disorders (except childhood febrile seizures), or a history of stroke or transient ischemic attack (TIA) within one year before signing the Informed Consent Form (ICF). * 6.Concurrent tardive dyskinesia (or history) or severe akathisia. * 7.Esophageal motility dysfunction or dysphagia with a potential risk of aspiration pneumonia. * 8.Cardiovascular Risks: Congenital long QT syndrome; presence of uncontrolled or significant cardiovascular disease, including NYHA Class II or higher heart failure, unstable angina, myocardial infarction, or significant arrhythmia/frequent ventricular premature beats within 6 months before the first dose; QTcF \> 450 ms in males or \> 470 ms in females; presence of risk factors for Torsades de Pointes or sudden death (such as bradycardia, clinically significant hypokalemia, or current use of QTc-prolonging medications; excluding bradycardia judged by the investigator to be risk-controllable and stable after treatment, corrected hypokalemia, or instances where QTc-prolonging medications are discontinued or evaluated as acceptable for stable use) or other clinically significant ECG abnormalities judged by the investigator as potentially affecting subject safety or interfering with study participation. * 9.Blood Pressure Abnormalities: Poorly controlled hypertension (SBP \> 160 mmHg and/or DBP \> 100 mmHg after stable antihypertensive treatment); symptomatic hypotension; or orthostatic hypotension (SBP drop ≥ 20 mmHg or DBP drop ≥ 10 mmHg within 3 minutes of standing during screening or baseline). * 10.Glycosylated hemoglobin (HbA1c) level ≥ 7% at screening or baseline. * 11.Laboratory Abnormalities: 1) TBiL \> 1.5 × ULN, or AST/ALT \> 2 × ULN; 2) CLcr \< 90 mL/min; 3) WBC \< 3 × 10⁹/L, Neutrophils \< 1.5 × 10⁹/L, Platelets \< 75 × 10⁹/L, RBC \< 3.0 × 10¹²/L, or Hemoglobin \< 100 g/L. * 12.Positive results for HBsAg, HCV-Ab, HIV-Ab, or Syphilis-Ab that, in the investigator's judgment, affect study participation. * 13.Severe Suicide Risk: 1) Positive response to item 4 or 5 of "suicidal ideation" on C-SSRS within the past 6 months; 2) History of suicidal behavior within the past 6 months; or 3) Judged by the investigator to have a severe suicide risk. * 14.Received electroconvulsive therapy (ECT) or invasive psychiatric treatment within 28 days before signing the ICF. * 15.History of Blood Loss: Blood loss ≥ 400 mL within 3 months or ≥ 200 mL within 1 month before signing the ICF. * 16.Major surgery within 3 months before signing the ICF, or planned surgery during the study or within one month after study completion. * 17.Other Clinical Studies: Participation in any other drug clinical study within one month before the first dose (except for aripiprazole BE studies). * 18.Long-acting Injectable (LAI) History: Prior treatment with non-aripiprazole LAIs where the interval since the last dose is shorter than the labeled dosing interval of that LAI; or a requirement for other LAIs during the study. * 19.Medication Contraindications: Use of Chlorpromazine or Thioridazine within 28 days before the first dose; or use of strong/moderate CYP3A4 or CYP2D6 inhibitors or inducers within 14 days or five half-lives (whichever is longer). * 20.Consumption of foods or beverages rich in xanthines, grapefruit, or caffeine within 48 hours before the first dose, or other special diets that could affect drug pharmacokinetics. * 21.History of drug abuse, drug usage, or positive drug screening within one year before signing the ICF. * 22.Chronic Alcohol Consumption: Males \> 14 units/week, females \> 7 units/week (1 unit ≈ 10g pure alcohol). * 23.History of needle phobia or blood phobia judged by the investigator to be clinically significant. * 24.Known or suspected hypersensitivity to the study drug or any of its components. * 25.Female Status: Women who are pregnant, breastfeeding, or planning to become pregnant (excludes those postmenopausal for ≥ 1 year or surgically sterilized). * 26.Other conditions that the investigator deems unsuitable for participation in the study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
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