NDA Submission: Olanzapine Extended-Release Injectable Suspension for Treatment of Schizophrenia

Teva Pharmaceuticals has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for olanzapine extended-release injectable suspension (TEV-'749) for the treatment of adults with schizophrenia.¹ The NDA for olanzapine long-acting injectable (LAI) is based on results from the phase 3 SOLARIS trial, including week 56 results studying its efficacy, safety, and tolerability in participants aged 18 to 64 with schizophrenia.² These results demonstrate that olanzapine LAI meets efficacy and safety endpoints in a broad adult population of individuals living with schizophrenia.

“The innovation of olanzapine LAI comes from its delivery of olanzapine, a foundational treatment for schizophrenia, as a once-monthly subcutaneous formulation,” said Eric Hughes, MD, PhD, the executive vice president of Global R&D and chief medical officer at Teva. “Teva is committed to working closely with the FDA on the review of this olanzapine LAI application as we seek to help address the critical unmet needs of people living with schizophrenia.”

Olanzapine LAI is an investigational once-monthly subcutaneous LAI of the second-generation antipsychotic olanzapine. In the SOLARIS trial, it demonstrated an efficacy and safety profile consistent with currently available oral olanzapine formulations. It is not currently approved by any regulatory authority for any use.

The SOLARIS study is a multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled trial to evaluate the efficacy, safety, and tolerability of olanzapine LAI for subcutaneous use as a treatment in participants aged 18 to 64 years with schizophrenia. For period 1 of the study (first 8 weeks), 675 participants were randomly assigned to receive a subcutaneous injection of once-monthly olanzapine LAI (low, medium, or high dose) or placebo in a 1:1:1:1 ratio. For period 2 (next 48 weeks), participants who completed period 1 were randomly assigned and equally allocated to 1 of the 3 olanzapine LAI treatment groups. The end-of-treatment and follow-up visits were 4 and 8 weeks after administration of the last treatment dose, respectively. The primary endpoint was to evaluate the efficacy of olanzapine LAI. A secondary objective of period 2 of the study was to evaluate the safety and tolerability of olanzapine LAI in adult patients with schizophrenia.

Olanzapine LAI utilizes SteadyTeq™ copolymer technology, proprietary to Medincell, that provides a controlled steady, sustained release of olanzapine.

“Olanzapine is a long-established treatment option for schizophrenia with a well-known safety and efficacy profile, and olanzapine LAI (TEV-'749) is building on that legacy with an innovative long-acting formulation that may help fill a significant gap in the current treatment landscape,” said Christoph Correll, MD, the professor of psychiatry at the Zucker School of Medicine, Hempstead, NY and SOLARIS study coordinating investigator.² “As a clinician, this is a critical development for people living with schizophrenia who may not prefer, or have difficulties adhering to daily oral treatment options.”

References

1. Teva Pharmaceuticals submits New Drug Application to FDA for olanzapine extended-release injectable suspension (TEV-'749) for the once-monthly treatment of schizophrenia in adults. News release. December 9, 2025. Accessed December 9, 2025. https://www.tevapharm.com/news-and-media/latest-news/teva-pharmaceuticals-submits-new-drug-application-to-fda-for-olanzapine-extended-release-injectable-suspe/

2. New long-term safety data from the completed phase 3 SOLARIS trial support the potential of olanzapine LAI (TEV-'749) as the first long-acting olanzapine treatment option for schizophrenia with no PDSS observed. News release. September 20, 2025. Accessed December 9, 2025. https://ir.tevapharm.com/news-and-events/press-releases/press-release-details/2025/New-Long-term-Safety-Data-from-the-Completed-Phase-3-SOLARIS-Trial-Support-the-Potential-of-Olanzapine-LAI-TEV-749-as-the-First-Long-Acting-Olanzapine-Treatment-Option-for-Schizophrenia-with-No-PDSS-Observed/default.aspx