Schizophrenia: US approves olanzapine as a once-monthly injection under the skin

The US Food and Drug Administration (FDA) has approved Weltruza, an extended-release olanzapine formulation for adults with schizophrenia, specialist outlets such as Psychiatric Times reported on 9 October 2026. The drug is injected once a month under the skin (subcutaneously); it was developed by Teva together with the French company Medincell. According to Teva, it is the first and only long-acting olanzapine injection of its kind, requiring no loading doses, no additional tablets and no post-injection monitoring.

For context: in the US, the existing intramuscular long-acting olanzapine may only be given at certified facilities, followed by three hours of monitoring because of a rare post-injection delirium/sedation syndrome (PDSS). In the phase 3 SOLARIS trial with 675 participants aged 18 to 64, no PDSS cases were observed across 3,971 injections in the programme, according to Psychiatric Times. The approved doses of 318, 425 and 531 milligrams correspond to 10, 15 and 20 milligrams of oral olanzapine a day.

The label nevertheless carries a PDSS warning, as the risk with subcutaneous dosing is not fully known. Teva expects US availability “in the coming weeks”, according to the report. The drug is not yet approved in the EU; the European Medicines Agency (EMA) accepted the marketing application in May 2026. Long-acting injections are meant to help when taking tablets every day is difficult. The right therapy is a decision for patients together with their doctors.