On Oct. 9, 2026, Teva Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has approved WELTRUZA^™ (olanzapine) for extended-release injectable suspension, a new, once-monthly, subcutaneous long-acting injectable (LAI) for the treatment of schizophrenia in adults. WELTRUZA clinical trial results demonstrated improvement in symptoms (PANSS), significant reduction in illness severity (CGI-S), as well as improvement in personal and social functioning (PSP). In the coming weeks, WELTRUZA will be available in three different strengths (318 mg, 425 mg, 531 mg) with no loading doses, no oral supplementation and no post-injection monitoring required.

Olanzapine is the most widely prescribed atypical antipsychotic for schizophrenia as a daily oral treatment. However, it is well documented that daily options may make it difficult to sustain long-term symptom improvement due to challenges with adherence, increasing the risk for instability and relapse. WELTRUZA was developed to address this significant unmet need by offering the established efficacy of olanzapine in a once-monthly subcutaneous injectable formulation.

WELTRUZA will be available in once-monthly subcutaneous injectable doses of 318 mg, 425 mg and 531 mg that correspond to the approved daily dose range of oral olanzapine of 10 mg, 15 mg and 20 mg, respectively.

In the Phase 3 SOLARIS trial, all three doses of WELTRUZA were similarly tolerated, with the most common reported adverse events (AEs) inclusive of increased weight, somnolence, headache, constipation and injection site reactions. Weight gain and metabolic changes were observed and were consistent with the systemic safety profile of oral olanzapine, including clinically significant weight gain. Discontinuations of WELTRUZA due to common AEs were consistent with placebo at 5% and 4% of trial participants, respectively. Please refer to the Important Safety Information below for additional safety information.

An estimated 2.1 million people are currently diagnosed with schizophrenia in the U.S. It is a chronic, progressive and severely debilitating mental disorder that affects how one thinks, feels and behaves. Schizophrenia is a complex medical condition that may require switching from oral options or between long-acting injectable options during the treatment journey.