New schizophrenia shot could replace daily pills
NCT ID NCT06315283
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a new long-acting olanzapine injection (TV-44749) against the standard oral olanzapine pill in 153 people with schizophrenia. The goal was to see if the shot delivers similar drug levels and is safe. Participants received multiple doses over 21 weeks, with researchers measuring how well the body absorbs the drug and tracking side effects.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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153 people
The number who actually took part.
- Started
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Mar 2024
- Finished
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Sep 2025
- 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 64 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: * Agree to maintain current smoking or nonsmoking status at the time informed consent is obtained and throughout the trial until completion of the EOT or ET visit (ie, nonsmoking participants must agree not to start smoking and participants who smoke will be excluded if they plan to discontinue smoking during the trial period). * Have a current confirmed diagnosis of schizophrenia according to an evaluation by the Investigator, as defined by the DSM-5 (American Psychiatric Association 2013a). * Are clinically stable on oral olanzapine 20 mg daily (ie, dose has not changed in the last 4 weeks) and not currently on other antipsychotic treatments at the time of screening. Participants on alternative olanzapine regimens (eg, 10 mg twice daily) may be considered for inclusion in the trial based upon the Investigator's clinical judgment. * Women may be included only if they have a negative serum beta human chorionic gonadotropin (HCG) test result at screening; they are surgically sterile (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or postmenopausal (postmenopausal status will be confirmed by a follicle-stimulating hormone screen according to the clinical laboratory standard value) for at least 1 year; or they are practicing a highly effective method of birth control and not planning pregnancy for at least 30 days before the trial, for the duration of the trial, and for 70 days after the last dose administration, if they are sexually active and of childbearing potential. * Men must be sterile; or if they are potentially of reproductive competence and have sexual relationship with female partners of childbearing potential, they must use, together with their female partners, highly effective birth control methods for the duration of the trial and for 70 days after the last dose administration. NOTE- Additional criteria apply, please contact the investigator for more information Exclusion Criteria: * History or known risk of narrow-angle glaucoma. * History or a complication of diabetes (hemoglobin A1c 6.5% or above and/or fasting plasma glucose 126 mg/dL or above). * Evidence of significant hepatic disorder. * The participant is a pregnant or lactating woman or plans to become pregnant during the trial or within 70 days after the last dose administration. * Known hypersensitivity or idiosyncratic reaction to olanzapine (or unable to tolerate oral olanzapine dose) or any of the excipients of TV-44749 in any formulation, their related compounds, or to any metabolites, or any compound listed as being present in TV-44749 or oral olanzapine. * Presence of excessive pigment, bruises, scars, or tattoos around the potential injection area. * Personal or family history of arrhythmia, sudden unexplained death at a young age (before 40 years) in a first-degree relative, long QT syndrome, personal history of syncope, or history of uncontrolled high blood pressure. Participants with history of high blood pressure who no longer require treatment or participants who are treated with antihypertensive medications and whose blood pressure is currently well-controlled, may be enrolled. * Substance use disorder criteria for alcohol, drug, or any other substance dependence (with the exception of nicotine or caffeine) have been met within the past 12 months prior to screening as defined by the DSM-5 (American Psychiatric Association 2013b). * A current clinically significant DSM-5 diagnosis other than schizophrenia. NOTE- Additional criteria apply, please contact the investigator for more information
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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.
Contacts and locations
Locations
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Teva Investigational Site 15737
Marlton, New Jersey, 08053, United States
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Teva Investigational Site 15738
Hollywood, Florida, 33024, United States
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Teva Investigational Site 15739
Los Alamitos, California, 90720, United States
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Teva Investigational Site 15740
Torrance, California, 90504, United States
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Teva Investigational Site 15741
Atlanta, Georgia, 30331, United States
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Teva Investigational Site 15742
Decatur, Georgia, 30030, United States
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Teva Investigational Site 31326
Zamora, 49021, Spain
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Teva Investigational Site 34310
Surrey, KT22 7AD, United Kingdom
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Teva Investigational Site 60053
Zagreb, 10090, Croatia
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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