Medincell: FDA green light for Weltruza, up to $112M in milestone payments
American partner Teva Pharmaceuticals has received approval from the U.S. Food and Drug Administration for a monthly injectable formulation of olanzapine, developed using Medincell's technology. In a statement published on October 9, 2026, the Montpellier-based company detailed the royalties and milestone payments to which this approval entitles it.
A monthly injectable olanzapine with no loading dose
Weltruza (olanzapine) is a long-acting injectable suspension intended for adults with schizophrenia. According to the statement, it is the first and only long-acting injectable formulation of olanzapine administered subcutaneously once monthly. The treatment requires neither a loading dose nor oral supplementation at initiation, and does not require monitoring after injection.
This is the second FDA-approved medication based on Medincell's long-acting injectable technology, following Uzedy (risperidone). The latter was approved for schizophrenia in April 2023, then for bipolar I disorder in October 2025, and is commercialized in the United States by Teva.
Teva Pharmaceuticals plans to make Weltruza available in the United States in the coming weeks, with the launch scheduled for the fourth quarter of 2026. In Europe, a marketing authorization application for long-acting olanzapine was accepted by the EMA in May 2026.
Up to $112 million in conditional milestone payments
Medincell is entitled to royalties on Weltruza's net worldwide sales, at a rate in the mid to high end of the single-digit range. The company is also eligible for development and commercial milestone payments of up to $112 million.
This amount includes a $4 million payment related to U.S. approval, as well as up to $105 million in commercial milestone payments, contingent on the achievement of specified sales thresholds.
For Christophe Douat, Chief Executive Officer of Medincell, "beyond its clinical significance, Weltruza's FDA approval represents a major milestone in the execution of Medincell's Shift to Growth strategy, with the emergence of a second significant growth driver." The company announced an online investor conference for October 9, 2026 at 4:00 p.m. (Paris time), with the recording to be made available on its website following the event.
