FDA Approves First Once-Monthly Subcutaneous Olanzapine LAI for Adults With Schizophrenia

The FDA approved Weltruza, the first once-monthly subcutaneous long-acting injectable formulation of olanzapine for adults with schizophrenia, offering a new treatment option without the need for loading doses, oral supplementation, or postinjection monitoring. The approval followed positive phase 3 trial results showing efficacy and a favourable safety profile with no reported postinjection delirium/sedation syndrome events.

This Wire brief sits within Fusion42's coverage of Medtech, and 20 sources have reported it between 9 Oct 2026 and 13 Oct 2026.