FDA greenlights Weltruza, first monthly subcutaneous olanzapine

On October 9, 2026, FDA approved Weltruza (olanzapine) extended-release injectable suspension for the treatment of adults with schizophrenia. The approval introduces the first once-monthly subcutaneous long-acting injectable (LAI) formulation of olanzapine and offers a new option for patients who may have difficulty maintaining daily oral therapy.

“Olanzapine has been a trusted and foundational treatment option for people living with schizophrenia for more than 30 years, but adherence continues to be a major barrier to stability, particularly for those who rely on daily oral medications,” said Christoph Correll, MD, clinical professor of psychiatry at the Zucker School of Medicine at Hofstra/Northwell.

Weltruza is available in once-monthly doses of 318 mg, 425 mg, and 531 mg, corresponding to oral olanzapine doses of 10 mg, 15 mg, and 20 mg daily. It requires no oral supplementation, loading doses, or booster injections.

Weltruza also requires no post-injection monitoring. In contrast, intramuscular long-acting olanzapine requires at least three hours of observation after each injection because of the risk of post-injection delirium/sedation syndrome (PDSS).

The approval was supported by results from the phase 3 SOLARIS trial, which evaluated once-monthly subcutaneous olanzapine in adults with schizophrenia. Treatment improved schizophrenia symptoms, reduced overall illness severity, and enhanced personal and social functioning compared with placebo. At week 8, Weltruza reduced Positive and Negative Syndrome Scale (PANSS) total scores by approximately 10 to 11 points more than placebo across the evaluated dose range.

The safety profile was generally consistent with that of oral olanzapine. The most common adverse reactions included weight gain, somnolence, headache, constipation, and injection-site reactions. Clinically significant weight gain and metabolic effects, including hyperglycemia and dyslipidemia, were also observed, while rates of treatment discontinuation due to adverse events were similar to those seen with placebo.

Labeling includes a boxed warning regarding increased mortality in older adults with dementia-related psychosis, as well as warnings for metabolic abnormalities, orthostatic hypotension, falls, neuroleptic malignant syndrome, tardive dyskinesia, drug reaction with eosinophilia and systemic symptoms (DRESS), seizures, leukopenia, and potential PDSS.

“By offering a subcutaneous long-acting injectable formulation with achievement of therapeutic blood levels without oral cotreatment, loading doses or booster injections, this new treatment option can help empower patients, support their care partners and provide clinicians with an important new tool to assist in managing this complex condition more effectively,” Dr. Correll said.

Source: Teva Pharmaceuticals. (2026 Oct 09). Teva Announces U.S. Food and Drug Administration (FDA) Approval of WELTRUZA™ (Olanzapine) For Extended-Release Injectable Suspension, as the First and Only Once-Monthly Subcutaneous Injectable Olanzapine for Adults with Schizophrenia