FDA Approves Weltruza: Teva and Medincell Plan to Launch Schizophrenia Injection

Teva Pharmaceutical Industries secured U.S. Food and Drug Administration approval for Weltruza, a once-monthly subcutaneous injectable suspension of olanzapine designed to treat schizophrenia in adults, Reuters reported on October 9, 2026. The drug utilizes polymer technology developed by French biotech firm Medincell and marks the second psychiatric medication from the partnership to clear U.S. regulators following the 2023 approval of Uzedy.

Teva Plans US Launch of Long-Acting Injectable

Teva leads development and commercialization for the new long-acting injectable and plans to launch the product in the United States within the coming weeks. Under the existing partnership agreement, Medincell is eligible to receive mid- to high-single-digit royalties on worldwide net sales, alongside up to $112 million in development and commercial milestone payments. Market reaction was immediate on European exchanges, with Teva shares closing 2 percent higher in Tel Aviv and Medincell shares climbing 16.9 percent in Paris.

Beyond the U.S. market, commercialization efforts are expanding. The European Medicines Agency accepted a marketing authorization application for the olanzapine formulation in May 2026, though authorization across European territories remains pending, Psychiatric Times noted.

SOLARIS Trial Shows Improvements in Patient Functioning

The regulatory filing relied on data from the SOLARIS trial, which evaluated the therapy across doses of 318 mg, 425 mg, and 531 mg, corresponding to oral olanzapine doses of 10 mg, 15 mg, and 20 mg respectively. Psychiatric Times reported that Teva observed improvements in Positive and Negative Syndrome Scale total scores, significant reductions in Clinical Global Impression-Severity illness severity, and enhanced Personal and Social Performance functioning. Post hoc analyses of the open-label period indicated that more than half of participants achieved clinical stabilization, with over 20 percent of those treated for six months or longer meeting remission criteria.

Safety evaluations showed that discontinuation rates due to adverse events reached 5 percent for the treatment group compared to 4 percent for the placebo cohort. Common adverse events mirrored the known systemic safety profile of oral olanzapine, encompassing weight gain, somnolence, headache, constipation, and injection site reactions. Across 3,971 injections administered during the trial, no cases of post-injection delirium/sedation syndrome were observed or confirmed, though product labeling retains a warning regarding the syndrome alongside a boxed warning for increased mortality in elderly patients with dementia-related psychosis.

Addressing Treatment Adherence in Psychiatric Care

The formulation utilizes Medincell’s copolymer technology, named SteadyTeq in regulatory disclosures, which engineers a steady, sustained release of the active pharmaceutical ingredient over extended periods. Industry analysts point out that long-acting injectables address persistent treatment-adherence challenges associated with chronic psychiatric conditions like schizophrenia by eliminating the need for daily oral supplementation. TipRanks noted that Weltruza functions without requiring loading doses or oral supplementation at treatment initiation, while also removing requirements for post-injection monitoring that typically complicate long-acting therapy administration.