Teva Pharmaceuticals Submits NDA on TEV-‘749 for Schizophrenia to the FDA

Teva Pharmaceuticals announced on December 9, 2025, that the company submitted a New Drug Application (NDA) to the US Food & Drug Administration (FDA) for olanzapine extended-release injectable suspension (TEV-‘749) for the treatment of schizophrenia in adults.1

“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, executive vice president, global R&D and chief medical officer at Teva, in a statement.1

The NDA submission includes results from the phase 3, multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled 56-week SOLARIS trial assessing the efficacy, safety, and tolerability of TEV-749, a second-generation antipsychotic olanzapine, in patients aged 18 – 64 years with schizophrenia. TEV- ‘749 uses SteadyTeq™, a copolymer technology proprietary to Medincell that delivers a controlled steady, sustained release of olanzapine.1

In the first 8 weeks, 675 patients were randomized 1:1:1 to receive once-monthly TEV-‘749 at a low, medium, or high dose, or placebo. For the next 48 weeks, patients who completed the first period were randomized and equally allocated to 1 of the 3 olanzapine arms. The end-of-treatment visit took place 4 weeks after the administration of the last treatment dose, followed by a follow-up visit 4 weeks after.1

The trial demonstrated a consistent efficacy and safety profile compared to currently available oral olanzapine formulations. In April, Teva shared that 92% of 70 patients, 87% of 24 nurses, and 73% of 11 physicians reported high satisfaction with TEV-‘749. Unlike other long-acting injectables, which consist of 2 basic molecules—risperidone and aripiprazole—TEV’749 offers a new molecule.2

“Not every patient responds well or tolerates all medicines,” SOLARIS investigator Andrew J. Cutler, MD, clinical associate professor of psychiatry at SUNY Upstate Medical University, told HCPLive earlier this year.2 “It's nice to have another option that some people may do especially well with.”

Approximately 1% of the world’s population and 3.5 million individuals in the US will develop schizophrenia in their lifetime, with approximately 80% of patients experiencing multiple relapses over the first 5 years of treatment.1 Each relapse raises the risk of loss of function, treatment refractoriness, and changes in brain morphology. TEV- ‘749 may have the potential to support real-world adherence and improve stability, addressing the treatment gap for people living with schizophrenia.

“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,” Hughes continued.1

References

1. Teva Pharmaceuticals Submits New Drug Application to FDA for Olanzapine Extended-Release Injectable Suspension. Tevapharm.com. Published 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. Cutler A. TEV- ‘749 Once-Monthly LAI Yields High Satisfaction in Phase 3 Trial, with Andrew J. Cutler, MD. HCPLive. April 21, 2025. https://www.hcplive.com/view/tev--749-once-monthly-lai-yields-high-satisfaction-in-phase-3-trial-with-andrew-j-cutler-md. Accessed December 9, 2025.