FDA Approves Medincell’s Weltruza for Adults with Schizophrenia

Editor’s Take: With no loading doses, oral supplementation, or post-injection monitoring, this FDA approval addresses a gap in schizophrenia care.

Medincell and its partner, Teva Pharmaceuticals, announced the U.S. FDA approved Weltruza (olanzapine) for extended-release injectable suspension. The drug becomes the first once-monthly, subcutaneous, long-acting injectable (LAI) olanzapine formulation for adults with schizophrenia.

How Medincell Explains Drug Benefit

According to Medincell, this indication can help support stabilization for people living with schizophrenia. It is the second FDA-approved medicine using the company’s LAI technology, following Uzedy (risperdone) in 2023.

Uzedy was first approved for treatment of schizophrenia, with that indication expanded to include bipolar I disorder in October 2025.

Advantages of Weltruza

Medincell says Weltruza does not require loading doses or oral supplementation upon initiation of treatment. Also, it eliminates the need for post-injection monitoring.

Taken together, the company says these elements address a long-standing gap in schizophrenia care.

“Beyond its clinical significance, the FDA approval of Weltruza represents a major milestone,” Medincell CEO Christopher Douat said. “This approval provides further validation of our technology. [It] demonstrates our ability to transform innovation into differentiated medicines that create long-term value for patients, partners, and shareholders.”

After FDA Approval

Teva Pharmaceuticals plans to make Weltruza available in the United States in the coming weeks. Medincell, meanwhile, is entitled to mid- to high-single digit royalties on worldwide net sales.

Additionally, Medincell may receive up to $112 million in development and commercial milestones—including $4 million for U.S. approval. The company is also eligible for up to $105 million in sales-based commercial milestones for achieving specific sales thresholds.

A European Marketing Authorization Application for olanzapine LAI was accepted by the European Medicines Agency in May 2026.