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

Teva Pharmaceuticals received FDA approval for a new injection form of olanzapine, an antipsychotic drug for schizophrenia. The company claims this could improve patient adherence compared to daily oral treatment, potentially reducing relapse risks. Olanzapine is the most widely prescribed atypical antipsychotic.

Teva, in partnership with Medincell, received USFDA approval for Weltruza, a once-monthly schizophrenia injection. Teva expects to launch the drug in the US soon. Medincell's technology enables extended-release medication. Analysts note potential for improved treatment adherence. Medincell may receive up to $112 million in milestone payments and royalties. Teva's shares rose 2% in Tel Aviv; Medincell's shares gained 16.9% in Paris.

The FDA approved Teva Pharmaceuticals' once-monthly olanzapine injection (Weltruza) for adults with schizophrenia. The subcutaneous injection uses novel technology for steady release, eliminating post-injection monitoring. The approval was based on the Phase 3 SOLARIS trial, showing significant symptom reduction and a safety profile consistent with oral olanzapine.

Teva Pharmaceutical Industries received FDA approval for Weltruza, a once-monthly injection for schizophrenia. Shares rose 4.7% on Oct. 9. The drug will launch in the U.S. soon, offering an alternative to daily oral treatments. Teva's Uzedy, another schizophrenia treatment, saw sales surge 51% YoY to $140M in H1 2026. Teva also progresses with its branded pipeline, including duvakitug for inflammatory bowel diseases.

Teva Pharmaceuticals received FDA approval for WELTRUZA, a once-monthly olanzapine injection for schizophrenia. Developed with Medincell's SteadyTeq technology, it requires no loading doses or post-injection monitoring. Teva plans a US launch in three strengths. The approval follows positive Phase III trial results, showing symptom improvements and a safety profile consistent with oral olanzapine. Medincell may earn royalties and milestone payments.

FDA approved Teva's Weltruza, a once-monthly olanzapine injection for schizophrenia, based on phase 3 trial results. Motivista's CT-155, a digital therapeutic, received clearance for negative schizophrenia symptoms. Neurosterix's NTX-253 completed phase 1 and will enter phase 2. Newron's evenamide faces a US trial hold due to 4 deaths in studies.