FDA Accepts Teva's Application for Monthly Schizophrenia Treatment TEV-'749
The FDA has accepted Teva and Medincell's New Drug Application for olanzapine extended-release injectable suspension (TEV-'749), a once-monthly subcutaneous treatment for schizophrenia in adults that showed no evidence for post-injection monitoring requirements.
The U.S. Food and Drug Administration has accepted a New Drug Application for olanzapine extended-release injectable suspension (TEV-'749) for the treatment of schizophrenia in adults. Teva Pharmaceutical Industries Ltd. and Medincell announced the acceptance on February 20, 2026. The drug is designed as a once-monthly subcutaneous injection to improve real-world treatment adherence and help patients maintain long-term stability.
Currently, there is no long-acting olanzapine formulation without an FDA-required Risk Evaluation and Mitigation Strategy (REMS), which mandates administration in a certified healthcare facility and requires a 3-hour post-injection monitoring period. In the Phase 3 SOLARIS trial, TEV-'749 demonstrated an efficacy and safety profile consistent with currently available olanzapine formulations and showed no evidence for the need for post-injection monitoring.
The NDA is based on results from the Phase 3 SOLARIS trial, which studied the drug's efficacy, safety and tolerability in participants aged 18 to 64 living with schizophrenia through Week 56. The multinational study randomized 675 patients to receive subcutaneous injections of once-monthly olanzapine LAI at different doses or placebo over an initial 8-week period, followed by a 48-week treatment period.
"Treatment adherence remains a major challenge and unmet need for people living with schizophrenia, including many who rely on oral forms of olanzapine," said the Executive Vice President, Global R&D and Chief Medical Officer at Teva. The company stated that TEV-'749 has the potential to help address a significant unmet need in available schizophrenia treatment options by addressing the lack of viable long-acting olanzapine formulations.
Daily olanzapine is one of the most widely prescribed antipsychotics for people living with schizophrenia. TEV-'749 utilizes SteadyTeq, a copolymer technology proprietary to Medincell that provides controlled sustained release of olanzapine.
TEV-'749 is not approved by any regulatory authority for any use at this time.