The U.S. Food and Drug Administration (FDA) has officially accepted a New Drug Application (NDA) from Teva Pharmaceuticals for a promising new treatment option in schizophrenia care, marking a significant regulatory milestone that could change how millions of adults manage this chronic psychiatric condition.
Teva’s application, accepted on February 20, 2026, seeks approval for an extended-release, once-monthly injectable suspension of olanzapine (TEV-’749) designed specifically for adults living with schizophrenia. If approved, this novel therapy would offer an alternative to daily oral medications — a development that could improve treatment adherence and stability for patients who struggle with the demands of everyday therapy regimens.
Olanzapine is one of the most widely prescribed antipsychotics globally, but until now, there has been no long-acting injectable formulation of the drug that doesn’t require extensive post-injection monitoring under a Risk Evaluation and Mitigation Strategy (REMS). This requirement, unique to current olanzapine injectables, has limited broader use due to the need for certified clinics and 3-hour patient observation after each dose.
The FDA’s acceptance means the agency will now begin a formal review process, evaluating the safety, efficacy and manufacturing quality of TEV-’749 before deciding whether the treatment can be made available to patients. This acceptance usually occurs about two months after the NDA submission and typically leads into several months of detailed regulatory review.
At the heart of Teva’s submission are the Phase 3 SOLARIS trial results, which showed that TEV-’749 demonstrated a safety and efficacy profile consistent with currently available olanzapine treatments. Crucially, the study found no evidence suggesting the need for extensive post-injection monitoring, a major potential benefit that could simplify and broaden access to this form of therapy.
More than 675 adult participants aged 18 to 64 were enrolled in the SOLARIS trial, which measured outcomes such as symptom management, tolerability and overall patient response across a 56-week treatment period. The positive data from this large-scale, multinational study provided the foundation for Teva’s NDA acceptance by the FDA.
Experts and advocates underscored the potential impact of an extended-release injectable option that simplifies treatment schedules for people living with schizophrenia. Treatment adherence is a well-documented challenge in psychiatric care, with missed doses often contributing to symptom relapse and hospitalizations. A once-monthly formulation could reduce this burden and support better long-term outcomes.
In statements accompanying the FDA acceptance, Teva leadership emphasized their commitment to closing gaps in current schizophrenia treatment options. By offering a familiar, once-monthly format built on a well-established antipsychotic — olanzapine — the company aims to combine proven therapy with modern delivery mechanisms to better align with patient needs.
The next steps involve the FDA’s detailed review, which could take several months as regulators assess the full dataset, including safety monitoring plans and manufacturing controls. Should the agency grant approval, TEV-’749 could emerge as one of the first olanzapine long-acting injectables without strict REMS-related monitoring, significantly broadening how and where treatment can be administered.
Mental health advocates and clinicians are watching closely, noting that innovations like this could help shift the treatment paradigm toward more patient-friendly approaches that reduce service barriers while maintaining therapeutic effectiveness. As schizophrenia affects roughly 1% of the global population and often requires lifelong management, new therapeutic formats have the potential to meaningfully improve quality of life for many individuals.
With regulatory review now underway, the medical community — patients, caregivers, clinicians and researchers alike — will be looking for further updates from the FDA on this important step forward in psychiatric treatment innovation.
