FDA Approves WELTRUZA, a Monthly Subcutaneous Olanzapine Injection
Published in Brain/Neurology, Diseases!, Drugs development & discovery.
October 9, 2026
Teva announced that the U.S. Food and Drug Administration approved WELTRUZA, an extended-release olanzapine injection for adults with schizophrenia. The formulation is administered under the skin once monthly and uses Medincell’s SteadyTeq copolymer technology to sustain drug release.
According to Teva, treatment does not require loading doses, supplementary oral olanzapine or mandatory post-injection observation. The company expects U.S. availability in the coming weeks. Approval was supported by the Phase 3 SOLARIS study, which reported improvements in psychiatric symptoms, illness severity and personal and social functioning.
The delivery change does not remove olanzapine’s systemic risks. Reported adverse effects included weight gain, sleepiness, headache, constipation and injection-site reactions. The safety information also describes metabolic changes and warns of increased mortality in elderly patients with dementia-related psychosis; WELTRUZA is not approved for that condition.
This is a U.S. regulatory milestone for a new formulation of an established medicine. The announcement does not establish a cure for schizophrenia or prove superiority over every other long-acting antipsychotic.