FDA Approves Teva's Weltruza: First Once-Monthly Subcutaneous Olanzapine Long-Acting Injectable for Schizophrenia
October 9, 2026. The FDA approved WELTRUZA (olanzapine) extended-release injectable suspension, Teva's once-monthly subcutaneous long-acting injectable (LAI) for schizophrenia in adults — the first and only subcutaneous olanzapine LAI. The formulation's distinguishing feature, per Teva's announcement: "WELTRUZA will be available in three different strengths (318 mg, 425 mg, 531 mg) with no loading doses, no oral supplementation and no post-injection monitoring required12."
Why that matters. Olanzapine is, per Teva, "the most widely prescribed atypical antipsychotic for schizophrenia as a daily oral treatment," but adherence is the chronic failure mode — relapse, rehospitalization, and, per the company, "changes in brain morphology" over repeated relapses. A monthly injection that requires no oral coverage, no initiation loading regimen, and no clinic observation after each shot removes the practical barriers that have kept LAI uptake low. An estimated 2.1 million Americans are diagnosed with schizophrenia.
The evidence base. Approval rests on the Phase 3 SOLARIS trial (8-week placebo-controlled period, 675 patients randomized 1:1:1:1 to three WELTRUZA doses or placebo; 48-week extension): improvement on PANSS, CGI-S illness severity, and PSP personal/social functioning. Safety tracked oral olanzapine as expected — "Weight gain and metabolic changes were observed and were consistent with the systemic safety profile of oral olanzapine, including clinically significant weight gain" — while discontinuations for common adverse events were 5% on drug vs 4% on placebo.
Provenance and next steps. The drug uses SteadyTeq, a copolymer release technology proprietary to France's Medincell; Reuters notes it is "the second US-approved product from Israel-based Teva's partnership with French biotech company Medincell after Uzedy, a long-acting injectable form of antipsychotic drug risperidone, which the FDA approved in 2023." Teva says WELTRUZA will be available in the US "in the coming weeks," and the EMA accepted the EU marketing application (TEV-'749) in May 2026 — not yet approved there.
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An instance of Chronic disease markets belong to therapies that convert daily maintenance into highly convenient, discrete interventions. — The most widely prescribed daily antipsychotic is converted into a monthly injection stripped of every practical adherence barrier that kept long-acting forms underused. ↩︎
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An instance of Chronic disease markets belong to therapies that convert daily maintenance into highly convenient, discrete interventions. — Stripping the practical burdens that kept long-acting antipsychotics underused converts a daily oral regimen with clinic observation into a single monthly shot — convenience as the product. ↩︎