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

Teva Pharmaceuticals today announced that the US Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for olanzapine extended-release injectable suspension (TEV-'749) for the treatment of adults with schizophrenia. The NDA was submitted to the FDA in December 2025.²

TEV-'749 is an investigational once-monthly subcutaneous long-acting injectable (LAI) of the second-generation atypical antipsychotic olanzapine. The NDA for TEV-'749 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 living with schizophrenia. The results demonstrated an efficacy and safety profile consistent with currently available olanzapine formulations.

“This is a big step forward for helping many patients on their recovery journey for schizophrenia,” Peter J. Weiden, MD, a clinical professor of psychiatry at SUNY Stony Brook School of Medicine, told Psychiatric Times in an exclusive interview. “For years it has been widely accepted that the active moiety olanzapine can be a more effective treatment than other first line options, but for practical purposes offering a long-acting option is not feasible given specific safety concerns associated with IM olanzapine pamoate, which is the only approved formulation available today.”

There is currently no long-acting olanzapine formulation without an FDA-required Risk Evaluation and Mitigation Strategy (REMS). The REMS mandates administration in a certified health care facility and requires the patient be monitored for 3 hours postinjection. TEV-‘749, on the other hand, is designed to improve treatment adherence and help patients maintain long-term stability. In the phase 3 SOLARIS trial, TEV-'749 was administered by investigators as a once-monthly subcutaneous injection, and it demonstrated an efficacy and safety profile consistent with currently available olanzapine formulations but showed no evidence for the need for postinjection monitoring.

“Treatment adherence remains a major challenge and unmet need for people living with schizophrenia, including many who rely on oral forms of olanzapine. TEV-'749, our investigational subcutaneously delivered olanzapine LAI, has the potential to help provide stability by offering the proven efficacy and safety of olanzapine as a once-monthly treatment,” said Eric Hughes, MD, PhD, the executive vice president of global R&D and chief medical officer at Teva. “For too long, the lack of a viable long-acting olanzapine formulation has limited the options available to these individuals, and we look forward to working with the FDA on the review of this NDA for TEV-'749 to help address this gap in care.”

TEV-'749 uses SteadyTeq technology, a copolymer technology proprietary to Medincell that provides a controlled steady, sustained release of olanzapine.

“Daily olanzapine is one of the most widely prescribed antipsychotics for people living with schizophrenia, and this long‑acting formulation may better fit into their lives,” said Christophe Douat, the chief executive officer of Medincell. “As experience with long‑acting injectables continues to grow, they are increasingly recognized as an important treatment option in serious psychiatric conditions. The potential reach of a practical long‑acting option is significant.”

“The Teva formulation is very different in that it is given as subcutaneous rather than IM, and the clinical development program leading up to this NDA has shown it to be a safe and effective treatment,” added Weiden, who is the Schizophrenia and Psychosis Section Editor for Psychiatric Times. “Hopefully the NDA will be successful. If so, it will be a major step forward in tailoring the right long-acting antipsychotic to the needs of the individual patient.”

References

1. U.S. Food and Drug Administration (FDA) accepts Teva’s New Drug Application (NDA) for olanzapine extended-release injectable suspension (TEV-'749) for the once-monthly treatment of schizophrenia in adults. News release. February 20, 2026. Accessed February 20, 2026. https://www.tevapharm.com/news-and-media/latest-news/u.s.-food-and-drug-administration-fda-accepts-tevas-new-drug-application-nda-for-olanzapine-extended

2. Kuntz L. NDA submission: olanzapine extended-release injectable suspension for treatment of schizophrenia. Psychiatric Times. December 9, 2025. https://www.psychiatrictimes.com/view/nda-submission-olanzapine-extended-release-injectable-suspension-for-treatment-of-schizophrenia