The FDA has approved WELTRUZA (olanzapine) for extended-release injectable suspension, a once-monthly subcutaneous long-acting injectable for adults with schizophrenia, Teva announced October 9. It is the first and only once-monthly subcutaneous formulation of olanzapine, and it requires no loading doses, no oral supplementation at treatment initiation and no post-injection monitoring. The product will be available in the US in the coming weeks in three strengths, 318 mg, 425 mg and 531 mg, corresponding to the approved daily oral olanzapine doses of 10 mg, 15 mg and 20 mg.
The approval is based on the pivotal phase 3 SOLARIS trial, which showed symptom improvement on the PANSS scale, significant reduction in illness severity and improvement in personal and social functioning, with a systemic safety profile consistent with oral olanzapine. Teva filed the new drug application in December 2025. The formulation uses SteadyTeq, a copolymer technology from Medincell designed for steady, sustained drug release; it is the second FDA-approved medicine built on Medincell’s long-acting injectable platform after UZEDY (risperidone) in 2023. Medincell is entitled to mid- to high-single-digit royalties on worldwide net sales plus up to $112 million in development and commercial milestones, including a $4 million payment on US approval. The European Medicines Agency accepted a marketing authorization application in May 2026; the drug is not yet approved in Europe.
The convenience gains do not erase olanzapine’s known risks. Across 3,971 injections in SOLARIS, no cases of post-injection delirium/sedation syndrome were observed or confirmed, but the label retains a PDSS warning because the syndrome has occurred with the intramuscular extended-release olanzapine and its occurrence with subcutaneous dosing is unknown. The label also carries a boxed warning for increased mortality in elderly patients with dementia-related psychosis, and weight gain and metabolic changes were consistent with the systemic profile of oral olanzapine.
For Teva, the approval is a tangible win for its Pivot to Growth strategy and its neuroscience franchise: olanzapine is the most widely prescribed atypical antipsychotic in its class as a daily oral therapy, but daily dosing creates the adherence gaps that drive instability and relapse. A monthly subcutaneous option that reaches therapeutic blood levels without oral cotreatment gives Teva a differentiated long-acting injectable positioned directly against that adherence problem.