Teva wins U.S. approval for monthly schizophrenia shot Weltruza

Teva said Friday the Food and Drug Administration approved Weltruza, a once-monthly under-the-skin injection of olanzapine for adults with schizophrenia, adding a long-acting option the company says needs no loading doses, oral top-up, or post-injection monitoring.

What the agency cleared

Teva Pharmaceuticals, the U.S. affiliate of Teva Pharmaceutical Industries, said the Food and Drug Administration approved Weltruza (olanzapine) for extended-release injectable suspension as a once-monthly subcutaneous long-acting treatment for schizophrenia in adults. In its release, Teva calls Weltruza the first and only once-monthly subcutaneous long-acting injectable formulation of olanzapine for that use.

The product will ship in three strengths — 318 mg, 425 mg, and 531 mg — that the company maps to daily oral olanzapine doses of 10 mg, 15 mg, and 20 mg. Teva said Weltruza will be available in the United States in the coming weeks and that patients do not need loading doses, oral supplementation, or monitoring after each injection. The company also pointed readers to the full Prescribing Information, including the Medication Guide and boxed warning.

How the trial was framed

Approval rests on the Phase 3 Solaris study. Teva said the trial showed improvement in symptoms, a reduction in illness severity, and better personal and social functioning, with a systemic safety profile consistent with oral olanzapine. In the first eight weeks, 675 adults ages 18 to 64 were randomized equally to a low, medium, or high once-monthly dose or to placebo. Patients who finished that period then entered a 48-week extension on active drug.

The most common adverse events Teva listed were increased weight, somnolence, headache, constipation, and injection-site reactions. Weight gain and metabolic changes tracked the oral olanzapine profile, including clinically significant weight gain. Discontinuations tied to those common events were 5% on Weltruza and 4% on placebo, the company said.

The Medincell link and Europe

Weltruza uses SteadyTeq, a copolymer technology Teva attributes to Medincell for controlled, sustained release of olanzapine. A cnbc.com report said Weltruza is the second U.S.-approved product from Teva's partnership with Medincell after Uzedy, a long-acting risperidone injection cleared in 2023, and that Medincell may be eligible for up to $112 million in additional development and commercial milestone payments plus royalties on sales.

In Europe, Teva said the European Medicines Agency accepted a marketing application in May 2026 for the same long-acting olanzapine program under the code TEV-'749. That application is not approved yet.

How the shares are trading

Teva shares were recently $41.25, up $2.00, or about 5%, on cnbc.com quotes around 3:36 p.m. Eastern, with volume near 10.5 million shares. An investor call was set for 8 a.m. Eastern on Friday.

Olanzapine is already widely used as a daily oral antipsychotic. A monthly shot only helps if clinics stock it, payers cover it, and patients stay on schedule — none of which the approval release settles. U.S. list price, formulary timing, and any change to Teva's financial outlook were not in Friday's announcement.