The FDA has approved Teva’s Weltruza, an extended-release olanzapine injection administered monthly beneath the skin, for adults with schizophrenia. Teva expects the medicine to become available in the United States in the coming weeks.
The treatment does not require loading doses, oral supplementation or post-injection monitoring. According to Teva, it is the first approved once-monthly subcutaneous injectable formulation of olanzapine.
Weltruza will be offered in three strengths: 318 milligrams, 425 milligrams and 531 milligrams. Those doses correspond to daily oral olanzapine doses of 10 milligrams, 15 milligrams and 20 milligrams, respectively.
Approval was based on the Phase 3 SOLARIS trial, which showed improvement in schizophrenia symptoms, reduced illness severity and improved personal and social functioning. These outcomes were assessed using the Positive and Negative Syndrome Scale, Clinical Global Impression-Severity scale and Personal and Social Performance scale.
The systemic safety profile was consistent with oral olanzapine. Common adverse events included weight gain, somnolence, headache, constipation and injection-site reactions. Weight gain and metabolic changes included clinically significant weight gain.
Discontinuations attributed to common adverse events occurred in 5% of Weltruza recipients and 4% of placebo recipients. Teva said all three doses were similarly tolerated.
The formulation uses Medincell’s proprietary SteadyTeq copolymer technology to provide controlled, sustained release of olanzapine.
Teva said adherence challenges with daily oral treatments can increase the risk of instability and relapse.
The European Medicines Agency accepted an application for the injectable formulation, known as TEV-749, in May 2026. The medicine has not received European regulatory approval.
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