European regulators accept Teva and Medincell’s application for long-acting Schizophrenia injection

Teva Pharmaceutical Industries (NYSE:TEVA) and Medincell announced Thursday that the European Medicines Agency has accepted their Marketing Authorization Application for TEV-749, an investigational long-acting injectable formulation designed to treat adults living with schizophrenia.

The regulatory milestone advances a potential therapeutic alternative aimed at mitigating the steep rates of medication nonadherence that historically complicate the clinical management of serious psychiatric conditions.

Administered subcutaneously once every four weeks, TEV-749 utilizes a proprietary copolymer technology called SteadyTeq to provide a controlled, prolonged release of olanzapine—one of Europe’s most frequently prescribed daily oral antipsychotics.

Schizophrenia affects between 0.3% and 1.5% of the population across Europe, often bringing severe disruptions to employment, social integration, and physical longevity.

Clinical data submitted to the European Medicines Agency, including findings from the pivotal Phase 3 SOLARIS study, indicated that the long-acting injection matched the efficacy, systemic safety parameters, and overall drug exposure levels established by oral olanzapine formulations.

While long-acting injectable options are well established in European psychiatric care, the market has lacked a viable, subcutaneous long-acting formulation for olanzapine.

The drug remains unapproved by global health authorities, though it is currently tracking through parallel regulatory timelines.

The regulatory filing in Europe follows an implicit push into the U.S. commercial market, where the Food and Drug Administration accepted Teva’s New Drug Application for the same compound in February 2026.