Olanzapine long-acting injectable (LAI) suspension (TEV-'749) has the potential to offer the efficacy of olanzapine in a once-monthly, subcutaneous formulation1

If approved, TEV-'749 could help address a significant unmet need in available schizophrenia treatment options by addressing the lack of viable long-acting olanzapine formulations1

Teva is committed to advancing this innovative treatment option and further building on its differentiated LAI franchise and scientific leadership in complex neurological conditions as it drives forward its Pivot to Growth strategy

PARSIPPANY, N.J. and TEL AVIV, Israel and PARIS, Feb. 20, 2026 (GLOBE NEWSWIRE) -- Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), and Medincell (Euronext: MEDCL), announced today that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for olanzapine extended-release injectable suspension (TEV-'749) for the treatment of schizophrenia in adults. TEV-'749 is designed to improve real-world treatment adherence and help patients maintain long-term stability, with the goal of addressing a critical treatment gap for people living with schizophrenia.

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 administered as a once-monthly subcutaneous injection demonstrated an efficacy and safety profile consistent with currently available olanzapine formulations and showed no evidence for the need for post-injection 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, Executive Vice President, 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.”

“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, CEO 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 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.1 The results demonstrated an efficacy and safety profile consistent with currently available olanzapine formulations.1

TEV-'749 is an investigational once-monthly subcutaneous LAI of the second-generation atypical antipsychotic olanzapine. It is not approved by any regulatory authority for any use at this time.

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

About Subcutaneous OLAnzapine Extended-Release Injection Study (SOLARIS)

SOLARIS is a multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy, safety and tolerability of olanzapine extended-release injectable suspension for subcutaneous use as a treatment in patients (ages 18-64 years) with schizophrenia.1 For period one of the study (first 8 weeks), 675 patients were randomized to receive a subcutaneous injection of once-monthly olanzapine LAI (TEV-'749) (low, medium or high dose) or placebo in a 1:1:1:1 ratio.1 For period two (next 48 weeks), patients who completed period one were randomized and equally allocated to one of the three olanzapine LAI (TEV-'749) treatment groups.1 The end-of-treatment and follow-up visits were 4 and 8 weeks after administration of the last treatment dose, respectively.1 The primary objective of the Phase 3 SOLARIS study was to evaluate the efficacy of olanzapine LAI (TEV-'749) in adult patients with schizophrenia.1 A key secondary objective was to further evaluate the efficacy of olanzapine LAI (TEV-'749) based on additional parameters in adult patients with schizophrenia.1 A secondary objective of period two of the study was to evaluate the safety and tolerability of olanzapine LAI (TEV-'749) in adult patients with schizophrenia.1

Data on file. Parsippany, NJ: Teva Neuroscience, Inc.

Substance Abuse and Mental Health Services Administration. Schizophrenia. https://www.samhsa.gov/mental-health/schizophrenia. Accessed February 2026.

Velligan DI, Rao S. The Epidemiology and Global Burden of Schizophrenia. J Clin Psychiatry. 2023;84(1):MS21078COM5. https://doi.org/10.4088/JCP.MS21078COM5.

Wander C. (2020). Schizophrenia: Opportunities to Improve Outcomes and Reduce Economic Burden Through Managed Care. The Am J Manag Care. 26(3 Suppl), S62–S68. https://doi.org/10.37765/ajmc.2020.43013.

Emsley, R., & Kilian, S. (2018). Efficacy and safety profile of paliperidone palmitate injections in the management of patients with schizophrenia: an evidence-based review. Neuropsychiatric Dis. Treat., 14, 205-223.

Emsley, R., Chiliza, B., Asmal, L. et al. (2013) The nature of relapse in schizophrenia. BMC Psychiatry 13, 50.

Andreasen, N. C., et al. (2013). Relapse duration, treatment intensity, and brain tissue loss in schizophrenia: a prospective longitudinal MRI study. The Am J Psychiatry, 170(6), 609-615.

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Source: Teva Pharmaceutical Industries Ltd