FDA Approves Monthly Olanzapine Shot for Schizophrenia

The once-monthly subcutaneous formulation, sold as Weltruza, is approved for adults with schizophrenia.

Updated on Nov. 3, 2026 in Weight Loss

Bold flat-color vector editorial illustration of an unlabeled glass vial beside a clear syringe, with a single suspended drop above, evoking a long-acting injectable treatment. — The FDA approved once-monthly subcutaneous olanzapine, sold as Weltruza, for adults with schizophrenia on October 9, 2026, based on Phase 3 SOLARIS trial results. AI Illustration. Upload story photo >

The FDA approved once-monthly subcutaneous olanzapine (Weltruza) for adults with schizophrenia on October 9, 2026. Phase 3 SOLARIS trial data showed all three doses improved functional scores more than placebo at week eight.

Why it matters

The long-acting injectable offers a dosing option that may ease adherence problems common in schizophrenia care. Weight gain remains the most frequent side effect, which keeps metabolic monitoring central to treatment decisions.

Mean PSP scores rose 4.6 points during the open-label safety period of up to 48 weeks, while weight gain of 5.6 kg averaged across 137 patients treated 48 weeks or more. Long-term effects beyond that window were not reported in the extraction.

The players

Food and Drug Administration (FDA)

The FDA is the U.S. federal agency responsible for approving prescription drugs for safety and effectiveness before they reach patients.

Christoph Correll, MD

Correll is a clinical professor of psychiatry at the Zucker School of Medicine at Hofstra/Northwell and served as coordinating investigator for the SOLARIS trial.

The details

The formulation reaches blood levels within one to two days without oral cotreatment, a loading dose, a booster injection, or post-injection observation. Christoph Correll, MD, coordinating investigator for SOLARIS, discussed the functional and metabolic outcomes with HCPLive.

September 21, 2025: Teva released long-term SOLARIS safety data.
July 8, 2026: JAMA Psychiatry published a network meta-analysis online.
October 9, 2026: The FDA approved once-monthly subcutaneous olanzapine.
November 3, 2026: HCPLive published the Correll interview.

Roadmap

The approval extends the FDA's existing framework for long-acting injectable antipsychotics by adding a once-monthly subcutaneous olanzapine option. It also places olanzapine alongside newer metabolic-focused treatments now under study for antipsychotic-related weight gain.

Patients and clinicians may weigh the injectable's once-monthly schedule against its weight-gain profile when choosing maintenance therapy. Metabolic monitoring remains part of care for anyone starting the drug.

The takeaway

Once-monthly dosing may help patients stay on treatment, but weight gain needs ongoing attention. Discuss metabolic monitoring with a clinician before starting any long-acting antipsychotic.