WELTRUZA (Olanzapine LAI (44749)) - (SOLARIS)

October 9, 2026: Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) announced FDA approval of WELTRUZA (olanzapine) extended-release injectable suspension for schizophrenia in adults. The product is described as the first once-monthly subcutaneous long-acting injectable olanzapine, with no loading doses, no oral supplementation, and no post-injection monitoring required. Teva said U.S. launch is expected in the coming weeks in 318 mg, 425 mg, and 531 mg strengths.

Approval was based on the Phase 3 SOLARIS trial, an 8-week randomized, double-blind, placebo-controlled study in 675 adults with schizophrenia, followed by a 48-week second period. Teva said WELTRUZA improved symptoms on PANSS, reduced illness severity on CGI-S, and improved personal and social functioning on PSP. Across all three doses, common adverse events included increased weight, somnolence, headache, constipation, and injection-site reactions; weight gain and metabolic changes were consistent with oral olanzapine. Discontinuations due to common adverse events were 5% for WELTRUZA and 4% for placebo.

Teva also said the EMA accepted the MAA for olanzapine LAI (TEV-’749) in May 2026; it is not yet approved in Europe.