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WELTRUZA™ (olanzapine) for extended-release injectable suspension is the first and only once-monthly subcutaneous long-acting injectable (LAI) formulation of olanzapine for the treatment of schizophrenia in adults with no loading doses, no oral supplementation and no post-injection monitoring required
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The approval is based on results from the pivotal Phase 3 SOLARIS trial, which demonstrated overall symptom improvement, significant reduction in illness severity and improvement in personal and social functioning, with a systemic safety profile consistent with oral olanzapine1
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As Teva drives forward its Pivot to Growth strategy, the company continues to deliver on its commitment to patient-centered innovation in neuroscience, including a differentiated long-acting injectable franchise
PARSIPPANY, N.J. and TEL AVIV, Israel, Oct. 09, 2026 (GLOBE NEWSWIRE) -- Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced that the U.S. Food and Drug Administration (FDA) has approved WELTRUZA™ (olanzapine) for extended-release injectable suspension, a new, once-monthly, subcutaneous long-acting injectable (LAI) for the treatment of schizophrenia in adults. WELTRUZA clinical trial results demonstrated improvement in symptoms (PANSS), significant reduction in illness severity (CGI-S), as well as improvement in personal and social functioning (PSP).1 In the coming weeks, WELTRUZA will be available in three different strengths (318 mg, 425 mg, 531 mg) with no loading doses, no oral supplementation and no post-injection monitoring required.1
“WELTRUZA offers the proven efficacy of olanzapine in an innovative long-acting subcutaneous injectable, helping to fill a major, long-standing gap in the schizophrenia treatment landscape,” said Chris Fox, Executive Vice President, U.S. Commercial and Head of Innovative Franchise at Teva. “WELTRUZA was developed with the patient in mind from day one and it is a powerful demonstration of what is possible when the needs of the patient guide the development of a truly innovative medicine. This important milestone also helps further Teva’s Pivot to Growth strategy.”
Olanzapine is the most widely prescribed atypical antipsychotic for schizophrenia as a daily oral treatment.2 However, it is well documented that daily options may make it difficult to sustain long-term symptom improvement due to challenges with adherence, increasing the risk for instability and relapse.1 WELTRUZA was developed to address this significant unmet need by offering the established efficacy of olanzapine in a once-monthly subcutaneous injectable formulation.1
“This approval reflects the strength of patient-centric innovation at Teva and what our R&D organization can deliver,” said Eric Hughes, MD, PhD, Executive Vice President, Global R&D and Chief Medical Officer at Teva. “WELTRUZA combines proven science and novel formulation innovation to eliminate the need for monitoring after each injection, addressing a significant barrier to treatment and advancing care for people living with schizophrenia.”
WELTRUZA will be available in once-monthly subcutaneous injectable doses of 318 mg, 425 mg and 531 mg that correspond to the approved daily dose range of oral olanzapine of 10 mg, 15 mg and 20 mg, respectively.1
“Olanzapine has been a trusted and foundational treatment option for people living with schizophrenia for more than 30 years, but adherence continues to be a major barrier to stability, particularly for those who rely on daily oral medications,” said Christoph Correll, MD, Clinical Professor of Psychiatry at the Zucker School of Medicine at Hofstra/Northwell, Hempstead, NY. “By offering a subcutaneous long-acting injectable formulation with achievement of therapeutic blood levels without oral cotreatment, loading doses or booster injections, this new treatment option can help empower patients, support their care partners and provide clinicians with an important new tool to assist in managing this complex condition more effectively.”
In the Phase 3 SOLARIS trial, all three doses of WELTRUZA were similarly tolerated, with the most common reported adverse events (AEs) inclusive of increased weight, somnolence, headache, constipation and injection site reactions.1 Weight gain and metabolic changes were observed and were consistent with the systemic safety profile of oral olanzapine, including clinically significant weight gain.1 Discontinuations of WELTRUZA due to common AEs were consistent with placebo at 5% and 4% of trial participants, respectively.1 Please refer to the Important Safety Information below for additional safety information.
An estimated 2.1 million people are currently diagnosed with schizophrenia in the U.S. It is a chronic, progressive and severely debilitating mental disorder that affects how one thinks, feels and behaves.3 Schizophrenia is a complex medical condition that may require switching from oral options or between long-acting injectable options during the treatment journey.
WELTRUZA utilizes SteadyTeq™, a copolymer technology proprietary to Medincell that provides a controlled steady, sustained release of olanzapine.
WELTRUZA will be available in the U.S. in the coming weeks.
The European Medicines Agency (EMA) accepted the Marketing Authorization Application (MAA) for olanzapine long-acting injectable (TEV-‘749) for the treatment of schizophrenia in adults in May 2026. The EMA submission is supported by an extensive clinical development program, including the Phase 3 SOLARIS study. TEV-‘749 is not approved by the EMA at this time.
About Subcutaneous Olanzapine Extended-Release Injection Study (SOLARIS)
SOLARIS was an 8 week, multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy, safety and tolerability of olanzapine extended-release injectable suspension for subcutaneous use as a treatment in patients (ages 18-64 years) with schizophrenia.1 For period one of the study (first 8 weeks), 675 patients were randomized to receive a subcutaneous injection of once-monthly olanzapine LAI (WELTRUZA) (low, medium or high dose) or placebo in a 1:1:1:1 ratio.1 For period two (next 48 weeks), patients who completed period one on placebo were re-randomized and equally allocated to one of the three olanzapine LAI (WELTRUZA) treatment groups, while patients who completed period one on active olanzapine LAI (WELTRUZA) remained on their established dose strength.1 The end-of-treatment and follow-up visits were 4 and 8 weeks after administration of the last treatment dose, respectively.1 The primary objective of the Phase 3 SOLARIS study was to evaluate the efficacy of olanzapine LAI (WELTRUZA) in adult patients with schizophrenia, as measured by PANSS.1 A key secondary objective was to further evaluate the efficacy of olanzapine LAI (WELTRUZA) based on additional parameters in adult patients with schizophrenia, as measured by CGI-S and PSP.1 A secondary objective of period two of the study was to evaluate the safety and tolerability of olanzapine LAI (WELTRUZA) in adult patients with schizophrenia.1
About Schizophrenia
Schizophrenia is a chronic, progressive and severely debilitating mental disorder that affects how one thinks, feels and acts.4 Patients experience an array of symptoms, which may include delusions, hallucinations, disorganized speech or behavior and impaired cognitive ability.4,5,6 Approximately 1% of the world’s population will develop schizophrenia in their lifetime, and 2.1 million people in the U.S. are currently diagnosed with the condition.3,4,5 Although schizophrenia can occur at any age, the average age of onset tends to be in the late teens to the early 20s for men and the late 20s to early 30s for women.4 The long-term course of schizophrenia is marked by episodes of partial or full remission broken by relapses that often occur in the context of psychiatric emergency and require hospitalization.6 Approximately 80% of patients experience multiple relapses over the first five years of treatment, and each relapse carries a biological risk of loss of function, treatment refractoriness and changes in brain morphology.7,8,9 Patients are often unaware of their illness and its consequences, contributing to treatment nonadherence, high discontinuation rates and, ultimately, significant direct and indirect healthcare costs from subsequent relapses and hospitalizations.4,5,6,7,8,9
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is transforming into a leading innovative biopharmaceutical company, enabled by a world-class generics business. For over 120 years, Teva’s commitment to bettering health has never wavered. From innovating in the fields of neuroscience and immunology to providing complex generic medicines, biosimilars and pharmacy brands worldwide, Teva is dedicated to addressing patients’ needs, now and in the future. At Teva, We Are All In For Better Health.
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Data on file. [CSR/SOLARIS]. West Chester, PA: Teva Neuroscience, Inc.
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Data on file. [TRx data sourced from IQVIA NPA Full Year 2025; orals factored for SCZ using Analytics Link 2022.] Parsippany, NJ: Teva Neuroscience, Inc.
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Data on file. [DRG/Clarivate (Nov 2025 Market Forecast Assumptions-Schizophrenia)]. Parsippany, NJ: Teva Neuroscience, Inc.
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Substance Abuse and Mental Health Services Administration. Schizophrenia. https://www.samhsa.gov/mental-health/schizophrenia. Accessed February 2026.
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Velligan DI, Rao S. The Epidemiology and Global Burden of Schizophrenia. J Clin Psychiatry. 2023;84(1):MS21078COM5. https://doi.org/10.4088/JCP.MS21078COM5.
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Wander C. (2020). Schizophrenia: Opportunities to Improve Outcomes and Reduce Economic Burden Through Managed Care. The Am J Manag Care. 26(3 Suppl), S62–S68. https://doi.org/10.37765/ajmc.2020.43013.
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Emsley, R., & Kilian, S. (2018). Efficacy and safety profile of paliperidone palmitate injections in the management of patients with schizophrenia: an evidence-based review. Neuropsychiatric Dis. Treat., 14, 205–223.
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Emsley, R., Chiliza, B., Asmal, L. et al. (2013) The nature of relapse in schizophrenia. BMC Psychiatry 13, 50.
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Andreasen, N. C., et al. (2013). Relapse duration, treatment intensity, and brain tissue loss in schizophrenia: a prospective longitudinal MRI study. The Am J Psychiatry, 170(6), 609–615.