FDA Approves Monthly Injectable Olanzapine for Schizophrenia
The FDA has approved Weltruza, the first once-monthly subcutaneous long-acting injectable olanzapine for adults with schizophrenia, available in three strengths without loading doses.
The U.S. Food and Drug Administration has approved Weltruza, a once-monthly subcutaneous long-acting injectable formulation of olanzapine for adults with schizophrenia. Teva Pharmaceuticals announced the approval on October 9, 2026, for this new treatment which requires no oral supplementation or loading doses. The medication will be available in the United States in the coming weeks.
Weltruza is the first and only long-acting injectable version of olanzapine administered monthly via a subcutaneous injection. It is approved in three distinct strengths, each corresponding to a common oral dose.
| Injectable Strength | Equivalent Oral Olanzapine Dose |
|---|---|
| 318 mg | 10 mg |
| 425 mg | 15 mg |
| 531 mg | 20 mg |
Approval was supported by the key Phase III SOLARIS trial. That study demonstrated overall symptom improvement, a significant reduction in illness severity, and better personal and social functioning for participants. All three doses were similarly tolerated.
Clinical evidence and safety profile
The SOLARIS trial found the safety of Weltruza aligned with the well-known profile of oral olanzapine. The most common adverse events included increased weight, somnolence, headache, constipation, and injection site reactions. Discontinuation rates due to these common events were low, at 5% for Weltruza compared to 4% for placebo.
Metabolic changes like high blood sugar, diabetes, dyslipidemia, and weight gain are known risks. Other frequent side effects are sleepiness, drowsiness, fatigue, and difficulty thinking. The drug uses SteadyTeq, a proprietary copolymer technology from Medincell.
Context in schizophrenia treatment
Olanzapine is the most widely prescribed oral antipsychotic for schizophrenia. Long-acting injectable formulations are considered superior for maintenance treatment, yet most patients still receive oral versions. A major barrier has been the historical safety limitation of long-acting olanzapine.
An earlier intramuscular prodrug formulation carried a risk of a severe sedation and delirium syndrome. This effectively excluded olanzapine from the long-acting injectable landscape for practical use. The FDA approval of Weltruza, which does not carry this specific risk, now adds olanzapine to the list of antipsychotics available as a long-acting option.
Expert perspective and broader implications
The approval expands the toolkit for treating schizophrenia, a chronic and severely debilitating disorder affecting an estimated 2.1 million people in the U.S. It also renews a longstanding debate about making long-acting injectables a routine part of maintenance therapy. Dr. Peter J. Weiden, a clinical professor of psychiatry at Stony Brook University, noted the development's significance.
Peter J. Weiden, MD said: "FDA approves monthly subcutaneous olanzapine LAI Weltruza, expanding schizophrenia treatment options and renewing debate on making long-acting injectables routine."
Availability and safety considerations
Weltruza carries serious side effect warnings consistent with the olanzapine class. These include an increased risk of death in elderly people with dementia-related psychosis, neuroleptic malignant syndrome, and drug reaction with eosinophilia and systemic symptoms. Other serious risks include uncontrolled body movements, seizures, difficulty swallowing, and problems controlling body temperature.
Teva has stated that the European Medicines Agency accepted a marketing application for the long-acting injectable, identified as TEV-‘749, in May 2026. That agency has not yet granted approval. Weltruza will be available in the U.S. in the coming weeks.
