FDA Approves Teva's Weltruza as First Once-Monthly Subcutaneous Olanzapine for Schizophrenia

Teva Pharmaceuticals received U.S. FDA approval on Friday for Weltruza, a once-monthly extended-release injectable suspension of olanzapine, for the treatment of schizophrenia in adults. The drug, developed with partner MedinCell and previously known by its trial designation TEV-'749, is a subcutaneous formulation designed to improve real-world adherence and clinical stability in a patient population historically challenged by daily oral regimens.

The approval was based on results from the Phase 3 SOLARIS trial, which evaluated the drug's efficacy, safety and tolerability in participants aged 18 to 64 with schizophrenia over a 56-week period. Investor's Business Daily described the clearance as first-of-its-kind, noting Weltruza represents a novel subcutaneous delivery of olanzapine with a once-monthly dosing schedule not previously available in this form.

Teva shares climbed in premarket trading following the announcement and extended gains during the regular session. The stock had already risen approximately 26% in 2026 before Friday's move, continuing a multi-year recovery for the Israeli drugmaker. The Weltruza approval adds to Teva's growing schizophrenia portfolio, which already includes UZEDY, its once-monthly risperidone injectable approved in 2023 and subsequently cleared for bipolar disorder maintenance in late 2025.