Teva Seeks EU Nod for Monthly Schizophrenia Drug to Tackle Adherence

PARIS, France – May 21, 2026 – Teva Pharmaceuticals and its partner Medincell have taken a significant step toward addressing a long-standing challenge in schizophrenia treatment, announcing that the European Medicines Agency (EMA) has accepted its Marketing Authorization Application (MAA) for TEV-‘749. The investigational drug is a once-every-four-weeks subcutaneous injection of olanzapine, one of the most widely prescribed antipsychotics for schizophrenia.

If approved, this long-acting injectable (LAI) could represent a pivotal advancement for the millions of Europeans living with schizophrenia, a chronic condition where medication adherence is a persistent and critical hurdle. The submission, supported by data from the comprehensive Phase 3 SOLARIS study, marks a key milestone in Teva’s ‘Pivot to Growth’ strategy, reinforcing its focus on innovative treatments for complex neurological disorders.

A New Hope for a Critical Unmet Need

Schizophrenia affects up to 1.5% of the population in Europe, a condition characterized by psychosis, cognitive impairment, and social withdrawal. While oral antipsychotic medications are the foundation of treatment, ensuring patients take them consistently is one of the biggest obstacles to long-term stability. Research indicates that up to 53% of patients with schizophrenia in Europe are partially or non-adherent to their prescribed daily medication. This non-adherence is a primary driver of relapse, which can lead to hospitalization, a decline in function, and changes in brain morphology.

Olanzapine is a highly effective and commonly used oral antipsychotic, but a viable long-acting injectable version has remained an elusive goal for the industry. This gap leaves a significant unmet need for patients who could benefit from the drug's efficacy without the burden of daily pills.

“Treatment adherence remains a challenge for people living with schizophrenia including those who rely on oral forms of Olanzapine,” said Eric Hughes, MD, PhD, Executive Vice President and Chief Medical Officer at Teva. “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-every four weeks treatment.”

By providing a steady dose of medication over a month from a single subcutaneous injection, TEV-‘749 is designed to help smooth the peaks and troughs of drug levels in the body, maintain therapeutic efficacy, and significantly reduce the risk of missed doses. This could free patients and their caregivers from the daily stress of medication management and allow for a greater focus on psychosocial recovery.

Reshaping a Competitive Market

The European market for LAI antipsychotics is a dynamic and growing space, projected to expand from approximately $1.6 billion in 2025 to over $2.9 billion by 2035. The field includes established treatments like long-acting formulations of aripiprazole and paliperidone, which offer monthly and even multi-month dosing schedules. However, Teva’s TEV-‘749 would enter the market not just as another LAI, but as the first major contender to offer olanzapine in a convenient, modern subcutaneous formulation.

“Daily oral olanzapine is one of the most commonly prescribed antipsychotics in Europe for people living with schizophrenia, and long-acting injectables are already well established in managing serious psychiatric conditions across the region,” noted Christophe Douat, CEO of Medincell. “We believe a practical long-acting olanzapine option that fits more naturally into patients’ lives can help address a real and persistent need in schizophrenia.”

The subcutaneous administration of TEV-‘749 is another key differentiator, as it can be perceived as less invasive and painful than the deep intramuscular injections required for many existing LAIs.

The Technology Powering the Innovation

At the heart of TEV-‘749 is the innovative SteadyTeq™ copolymer technology, a proprietary drug delivery platform developed by the French biopharmaceutical company Medincell. This technology, which Medincell calls BEPO®, allows a drug to be mixed with biocompatible polymers to form a small depot under the skin after injection. This depot slowly and predictably biodegrades, releasing the medication at a controlled and steady rate over an extended period.

The viability of this platform is not merely theoretical. It is the same technology behind UZEDY® (risperidone), another schizophrenia treatment developed in partnership by Teva and Medincell, which gained FDA approval in the U.S. in 2023. The success of UZEDY®, which offers one- and two-month subcutaneous dosing, has already validated the SteadyTeq™ platform's ability to create effective and commercially successful long-acting therapies. The application for TEV-‘749 builds on this proven track record, showcasing the power of strategic partnerships to drive pharmaceutical innovation.

Fueling Teva's Strategic Pivot

The advancement of TEV-‘749 is a cornerstone of Teva’s ‘Pivot to Growth’ strategy, a corporate initiative launched in 2023 to shift the company’s focus from its historical strength in generics toward a more balanced portfolio with a strong emphasis on innovative specialty medicines. Neuroscience is a primary pillar of this strategy, and the potential approval of a second major LAI for a severe mental health condition would solidify Teva's position as a leader in the field.

With this innovative pipeline, Teva aims to generate over $5 billion in revenue from its innovative medicines by 2030. The success of products like TEV-‘749 is crucial to achieving this goal and securing the company's long-term growth. By leveraging cutting-edge technology from partners like Medincell to solve persistent clinical problems, Teva is executing a clear plan to bring meaningful new options to patients while simultaneously building sustainable value for the company. The EMA's review of the application will now be a closely watched process by patients, clinicians, and investors alike.