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New monthly shot could simplify schizophrenia treatment

NCT ID NCT05693935

Disease control Sponsor: Teva Branded Pharmaceutical Products R&D LLC 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a monthly injection of olanzapine (TV-44749) in 675 adults with schizophrenia to see if it controls symptoms better than a placebo. Participants received up to 14 injections over about a year. The goal is to offer a long-acting option that may improve treatment adherence and symptom management.

What this could mean

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

Active substance
olanzapine (extended-release injectable suspension)
What this could lead to
If successful, this monthly injection could provide a new, convenient way to manage schizophrenia symptoms and reduce the need for daily pills.
What could go wrong
This is a completed phase 3 trial, but results are not yet published. The injection may not work better than placebo, and side effects like weight gain or drowsiness are possible.

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

675 people

The number who actually took part.

Started

Jan 2023

Finished

Jan 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 64 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: * The participant has a current confirmed diagnosis of schizophrenia according to the DSM-5, for \>1 year * The participant has exacerbation of schizophrenia that started ≤8 weeks prior to screening and would benefit from psychiatric hospitalization or continued hospitalization for symptoms of schizophrenia. * Participants who have received an antipsychotic treatment (other than clozapine) in the past year must have been responsive based on the investigator's judgment (and based on discussions with family members, caregivers, or healthcare professionals, as applicable). * Body mass index between 18.0 and 40.0 kg/m2, inclusive, at the time of screening * Women may be included only if they have a negative beta-human chorionic gonadotropin (β-HCG) test at screening and baseline * Women of childbearing potential must agree not to try to become pregnant, and, unless they have exclusively same-sex partners, must agree to use a highly effective method of contraception prior to the first administration of IMP, and agree to continue the use of this method for the duration of the study, and for 70 days after the last dose of IMP * The participant is in adequate health as determined by medical and psychiatric history, medical examination, electrocardiogram (ECG), serum chemistry, hematology, coagulation urinalysis, and serology. * NOTE- Additional criteria apply, please contact the investigator for more information Exclusion Criteria: * The participant has a current clinically significant DSM-5 diagnosis other than schizophrenia (has a primary current diagnosis other than schizophrenia or a comorbid diagnosis that is primarily responsible for the current symptoms and functional impairment). * The participant has a known history of the following: (a) borderline personality disorder, antisocial personality disorder, or bipolar disorder; (b) traumatic brain injury causing ongoing cognitive difficulties, Alzheimer's disease, or another form of dementia, or any chronic organic disease of the central nervous system; and (c) intellectual disability of a severity that would impact ability to participate in the study. * The participant was hospitalized for \>14 days (with the exception of social or administrative hospitalization) in the current exacerbation episode prior to screening. * The participant has a significant risk of violent behavior based on the participant's medical history or investigator's judgment. * The participant has a significant risk of committing suicide based on the participant's medical history or C-SSRS, and the investigator's judgment. * The participant is currently using an LAI antipsychotic or is still under the coverage period of the specific LAI at time of screening. * The participant has taken clozapine or has received electroconvulsive therapy within the last 12 months prior to screening. * The participant is currently receiving daily oral olanzapine at a dose \>20 mg/day. * The participant has current or a history of known hypersensitivity to olanzapine or any of the excipients of TV-44749 or the oral formulation of olanzapine. * The participant has had a significant sedation or delirium after antipsychotic treatment according to medical and psychiatric history and as judged by the investigator or suffered from delirium due to a medical condition. * The participant has a non-fasting glucose level of ≥200 mg/dL at screening * The participant meets criteria for moderate to severe substance use disorder (based on DSM-5 criteria) within the past 6 months (excluding those related to caffeine or nicotine) * NOTE- Additional criteria apply, please contact the investigator for more information

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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

Contacts and locations

Locations

  • Teva Investigational Site 15441

    Charlotte, North Carolina, 28211, United States

  • Teva Investigational Site 15442

    Gaithersburg, Maryland, 20877, United States

  • Teva Investigational Site 15443

    Richardson, Texas, 75080, United States

  • Teva Investigational Site 15444

    San Diego, California, 92123, United States

  • Teva Investigational Site 15446

    Miami, Florida, 33155, United States

  • Teva Investigational Site 15447

    Shreveport, Louisiana, 71101, United States

  • Teva Investigational Site 15448

    Austin, Texas, 78754, United States

  • Teva Investigational Site 15449

    Santee, California, 92071, United States

  • Teva Investigational Site 15450

    Orange, California, 92868, United States

  • Teva Investigational Site 15451

    Marlton, New Jersey, 08053, United States

  • Teva Investigational Site 15452

    Miami, Florida, 33122, United States

  • Teva Investigational Site 15453

    Rogers, Arkansas, 72758, United States

  • Teva Investigational Site 15454

    Dayton, Ohio, 45417, United States

  • Teva Investigational Site 15455

    Pico Rivera, California, 90660, United States

  • Teva Investigational Site 15456

    Miami, Florida, 33155, United States

  • Teva Investigational Site 15457

    Hialeah, Florida, 33016, United States

  • Teva Investigational Site 15458

    Hollywood, Florida, 33024, United States

  • Teva Investigational Site 15459

    Bellflower, California, 90706, United States

  • Teva Investigational Site 15460

    Bentonville, Arkansas, 72712, United States

  • Teva Investigational Site 15461

    Sherman Oaks, California, 91403, United States

  • Teva Investigational Site 15462

    Miami, Florida, 33173, United States

  • Teva Investigational Site 15464

    Irving, Texas, 75062, United States

  • Teva Investigational Site 15465

    Little Rock, Arkansas, 72211, United States

  • Teva Investigational Site 15466

    Flowood, Mississippi, 39232, United States

  • Teva Investigational Site 15467

    Miami Lakes, Florida, 33016, United States

  • Teva Investigational Site 15468

    Atlanta, Georgia, 30331, United States

  • Teva Investigational Site 15469

    Decatur, Georgia, 30030, United States

  • Teva Investigational Site 15470

    Anaheim, California, 92805, United States

  • Teva Investigational Site 15471

    Riverside, California, 92506, United States

  • Teva Investigational Site 15472

    North Canton, Ohio, 44720, United States

  • Teva Investigational Site 15473

    Miami Lakes, Florida, 33016, United States

  • Teva Investigational Site 15474

    La Habra, California, 90631, United States

  • Teva Investigational Site 15477

    West Palm Beach, Florida, 33407, United States

  • Teva Investigational Site 15478

    Oklahoma City, Oklahoma, 73112, United States

  • Teva Investigational Site 15479

    Miami, Florida, 33155, United States

  • Teva Investigational Site 15480

    Chicago, Illinois, 60641, United States

  • Teva Investigational Site 15481

    Lemon Grove, California, 91945, United States

  • Teva Investigational Site 15482

    Los Angeles, California, 91436, United States

  • Teva Investigational Site 15483

    Torrance, California, 90504, United States

  • Teva Investigational Site 15484

    Miami Springs, Florida, 33166, United States

  • Teva Investigational Site 15485

    Chicago, Illinois, 60640, United States

  • Teva Investigational Site 15486

    DeSoto, Texas, 75115, United States

  • Teva Investigational Site 15487

    St Louis, Missouri, 63141, United States

  • Teva Investigational Site 15488

    Hollywood, Florida, 33021, United States

  • Teva Investigational Site 15489

    Homestead, Florida, 33030, United States

  • Teva Investigational Site 15490

    Garden Grove, California, 92845, United States

  • Teva Investigational Site 15491

    Long Beach, California, 90807, United States

  • Teva Investigational Site 15494

    Miami Lakes, Florida, 33014, United States

  • Teva Investigational Site 15495

    Miami, Florida, 33122, United States

  • Teva Investigational Site 15496

    Miami, Florida, 33176-2302, United States

  • Teva Investigational Site 15497

    Los Angeles, California, 90015, United States

  • Teva Investigational Site 15498

    Hollywood, Florida, 33021, United States

  • Teva Investigational Site 15500

    Peachtree Corners, Georgia, 30071, United States

  • Teva Investigational Site 52123

    Iași, 700282, Romania

  • Teva Investigational Site 52124

    Bucharest, 041914, Romania

  • Teva Investigational Site 52126

    Iași, 700282, Romania

  • Teva Investigational Site 52127

    Bucharest, 10825, Romania

  • Teva Investigational Site 59202

    Rousse, 7003, Bulgaria

  • Teva Investigational Site 59203

    Kazanlak, 6100, Bulgaria

  • Teva Investigational Site 59205

    Sofia, 1202, Bulgaria

  • Teva Investigational Site 59206

    Vratsa, 3000, Bulgaria

  • Teva Investigational Site 59207

    Plovdiv, 4000, Bulgaria

  • Teva Investigational Site 59208

    Lovech, 5500, Bulgaria

  • Teva Investigational Site 59209

    Veliko Tarnovo, 5000, Bulgaria

  • Teva Investigational Site 59210

    Burgas, 8000, Bulgaria

  • Teva Investigational Site 59211

    Sliven, 8800, Bulgaria

  • Teva Investigational Site 59212

    Sofia, 1377, Bulgaria

  • Teva Investigational Site 59214

    Pleven, 5800, Bulgaria

  • Teva Investigational Site 59215

    Razgrad, 7200, Bulgaria

  • Teva Investigational Site 82057

    Bursa, 16059, Turkey (Türkiye)

  • Teva Investigational Site 82058

    Adapazarı, 54290, Turkey (Türkiye)

  • Teva Investigational Site 82059

    Ankara, 6010, Turkey (Türkiye)

  • Teva Investigational Site 88044

    Hangzhou, 310012, China

  • Teva Investigational Site 88052

    Beijing, 100088, China

  • Teva Investigational Site 88053

    Shanghai, 200030, China

  • Teva Investigational Site 88054

    Tianjin, 300222, China

  • Teva Investigational Site 88055

    Jining Shi, 272051, China

  • Teva Investigational Site 88060

    Hefei, 230022, China

  • Teva Investigational Site 88064

    Zhumadian, 463002, China

  • Teva Investigational Site 88068

    Nanchang, 330046, China

  • Teva Investigational Site 88071

    Wuhan, 430030, China

  • Teva Investigational Site 88072

    Xinxiang, 453003, China

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