PARSIPPANY, N.J., and TEL AVIV, Israel — October 9, 2026
Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd., announced that the U.S. Food and Drug Administration (FDA) has approved WELTRUZA™ (olanzapine) extended-release injectable suspension for adults with schizophrenia. The medicine is the first and only once-monthly subcutaneous long-acting injectable formulation of olanzapine, according to the company. WELTRUZA is designed to provide sustained treatment without loading doses, oral supplementation or routine post-injection monitoring, addressing practical challenges associated with daily oral medication adherence.
Phase 3 SOLARIS Trial Demonstrated Clinical Improvement
The approval is supported by results from the pivotal Phase 3 SOLARIS trial, which evaluated WELTRUZA in adults with schizophrenia. The study demonstrated improvement in symptoms measured by the Positive and Negative Syndrome Scale (PANSS), reduced illness severity assessed using the Clinical Global Impression–Severity scale (CGI-S), and improved personal and social functioning measured by the Personal and Social Performance scale (PSP). The trial included 675 patients randomized to receive one of three WELTRUZA dose levels or placebo during the initial eight-week period. These findings support the medicine’s efficacy for the approved indication.
Monthly Dosing Offers an Alternative to Daily Medication
WELTRUZA will be available in three strengths: 318 mg, 425 mg and 531 mg, corresponding to oral olanzapine daily doses of 10 mg, 15 mg and 20 mg, respectively. The medicine uses SteadyTeq™, a proprietary copolymer technology developed by Medincell, to provide controlled, sustained release of olanzapine following subcutaneous administration. Teva expects U.S. availability in the coming weeks. The company is also pursuing regulatory review in Europe, where the European Medicines Agency accepted the marketing authorization application for the long-acting injectable formulation in May 2026; European approval has not yet been granted.
Advertisement
Safety Profile and Regulatory Outlook
In the SOLARIS trial, WELTRUZA was generally tolerated across the three dose groups. Common adverse events included weight gain, somnolence, headache, constipation and injection-site reactions. Weight gain and metabolic changes were consistent with the known systemic safety profile of oral olanzapine. The prescribing information includes important warnings concerning metabolic changes, neuroleptic malignant syndrome, tardive dyskinesia and other serious reactions. Post-injection delirium/sedation syndrome has been reported with another extended-release intramuscular olanzapine product; whether it can occur with subcutaneous WELTRUZA is unknown. Teva said the approval advances its neuroscience portfolio and supports its broader Pivot to Growth strategy.
Source::Teva Pharmaceuticals press release
