FDA Approves Weltruza, Monthly Subcutaneous Olanzapine for Schizophrenia

Teva announced that the FDA has approved olanzapine for extended-release injectable suspension (Weltruza, Teva), a once-monthly subcutaneous long-acting injectable (LAI) formulation of the atypical antipsychotic, for the treatment of schizophrenia in adults. The company described Weltruza as the first once-monthly subcutaneous LAI formulation of olanzapine.

Weltruza will be offered in 318mg, 425mg, and 531mg doses that correspond to daily oral olanzapine doses of 10mg, 15mg, and 20mg, respectively. According to Teva, treatment requires no loading doses, oral supplementation, or post-injection monitoring. The formulation uses Medincell’s SteadyTeq copolymer technology for controlled, sustained release. Teva said the drug will be available in the US in the coming weeks.

The approval was based on the phase 3 SOLARIS trial, in which 675 patients aged 18 to 64 years with schizophrenia were randomized 1:1:1:1 to low-, medium-, or high-dose subcutaneous olanzapine or placebo during an 8-week, double-blind first period, followed by a 48-week second period. Efficacy was assessed by PANSS (primary objective) and by CGI-S and PSP (key secondary objective). According to Teva, results showed improved symptoms, a significant reduction in illness severity, and improved personal and social functioning; the release cited company data on file and did not include numerical efficacy results.

In SOLARIS, the most common adverse events (AEs) included increased weight, somnolence, headache, constipation, and injection site reactions. Teva said weight gain, including clinically significant weight gain, and metabolic changes were consistent with the systemic safety profile of oral olanzapine. Discontinuations due to common AEs occurred in 5% of Weltruza-treated participants and 4% of placebo recipients.

Weltruza’s prescribing information includes a boxed warning, and the safety information accompanying the release notes an increased risk of death in elderly patients with dementia-related psychosis, which the drug is not intended to treat. Post-injection delirium/sedation syndrome has occurred with another extended-release olanzapine product given intramuscularly; the safety information states that whether the syndrome can occur with subcutaneous Weltruza is unknown.

Source: Teva Pharmaceuticals. Teva announces U.S. Food and Drug Administration (FDA) approval of Weltruza (olanzapine) for extended-release injectable suspension, as the first and only once-monthly subcutaneous injectable olanzapine for adults with schizophrenia. Press release. Teva Pharmaceuticals; October 9, 2026. Accessed October 11, 2026.