WELTRUZA™ (olanzapine) extended-release suspension for injection is the first and currently the only approved long-acting olanzapine injection (LAI) for the treatment of schizophrenia in adults, administered subcutaneously once a month; treatment requires no loading dose, no oral medication supplementation, and no post-injection monitoring.
This approval is based on the results of the pivotal Phase III SOLARIS study. The study showed that WELTRUZA improved overall symptoms, significantly reduced disease severity, and improved individual and social functioning; its systemic safety profile was consistent with that of oral olanzapine.¹
As Teva continues to advance its global “Pivot to Growth” strategy, it will further fulfill its commitment to innovation in the field of patient-centered neuroscience and continue to build a differentiated portfolio of long-acting injectable products.
On October 9, Teva Pharmaceutical Industries (NYSE and Tel Aviv Stock Exchange: TEVA) announced that WELTRUZA™ (olanzapine) extended-release suspension for injection has been approved by the U.S. Food and Drug Administration (FDA). This drug is a novel long-acting injectable (LAI) administered once monthly via subcutaneous injection for the treatment of schizophrenia in adults.
Clinical trial results show that WELTRUZA can improve patient symptoms (PANSS), significantly reduce disease severity (CGI-S), and improve personal and social functioning (PSP).¹ WELTRUZA is available in three dosage strengths: 318 mg, 425 mg, and 531 mg; treatment requires no loading dose, no oral medication supplementation, and no post-injection monitoring.¹
Olanzapine is a widely used atypical antipsychotic in routine oral prescriptions for schizophrenia.² However, ample literature demonstrates that daily oral administration may struggle to maintain symptom improvement long-term due to treatment adherence challenges, thereby increasing the risk of instability and relapse.¹ To address this significant unmet need, WELTRUZA offers a new treatment option for patients, administered once monthly via subcutaneous injection, building upon the established efficacy of olanzapine.¹
Dr. Eric Hughes
Teva Global R&D Executive Vice President and Chief Medical Officer
"This approval fully demonstrates Teva's patient-centered innovation philosophy and R&D capabilities. WELTRUZA combines a mature scientific foundation with innovative formulation technology, eliminating the need for monitoring after each injection. This is expected to reduce a significant obstacle in the treatment process and bring new treatment options to patients with schizophrenia."
Christoph Correll, MD
Hofstra University Zucker School of Medicine
Professor of Psychiatry
"For more than 30 years, olanzapine has been a trusted and important foundational treatment option for schizophrenia. However, treatment adherence remains a major challenge in maintaining disease stability, especially for patients who require daily oral medication. This new subcutaneous long-acting injectable formulation achieves the required blood concentrations without the need for combination with oral medication or loading doses, which helps improve patient autonomy, supports caregivers, and provides clinicians with an important new treatment option for more effectively managing this complex disease."
In the Phase III SOLARIS study, the tolerability of the three doses of WELTRUZA was similar, with the most frequently reported adverse events (AEs) including weight gain, somnolence, headache, constipation, and injection site reactions.¹ The weight gain and metabolic changes observed in the study were consistent with the systemic safety profile of oral olanzapine, including clinically significant weight gain.¹ The proportion of subjects who discontinued WELTRUZA due to common adverse events was similar to that in the placebo group, at 5% and 4%, respectively.¹
Schizophrenia is a chronic, progressive mental disorder that can lead to severe functional impairment, affecting a patient's thinking, feelings, and behavior.³ Due to the complexity of the disease, patients may need to switch from oral therapy to long-acting injectable therapy, or switch between different long-acting injectable therapy regimens during treatment.
WELTRUZA utilizes SteadyTeq™ technology. This proprietary copolymer technology from Medincell enables controlled, stable, and sustained release of olanzapine.

Source: https://mp.weixin.qq.com/s?__biz=MzkxNjUzNTM3MQ==&mid=2247489069&idx=1&sn=fe81365f60031df8c91070870587812c&chksm=c0844de27fa899150181e8332957920b25767