The most widely used atypical antipsychotic is now available as a once-monthly injection for schizophrenia patients after a US Food and Drug Administration (FDA) approval.
Teva’s olanzapine, which has been used to treat the mental disorder for decades, will now be available as an extended-release injectable suspension. The once-monthly subcutaneous long-acting injectable will be known under the brand name Weltruza.
Weltruza utilises copolymer technology developed by Medincell that provides a controlled steady, sustained release of olanzapine. Teva said the drug will be available in the US in the coming weeks.
The oral version of olanzapine, which was approved in 1996 for schizophrenia, has become a central pillar of atypical antipsychotic options for the disorder. Atypical antipsychotics, also known as second-generation psychotics, offer fewer side effects than first-generation treatments. Olanzapine is the most widely prescribed atypical antipsychotic for schizophrenia and until now has been used a daily oral treatment.
Teva said it developed Weltruza to facilitate long-term symptom improvement by improving adherence. The company said it is “well documented” that patients find it difficult to follow daily administration, which makes it difficult to sustain long-term symptom improvement.
Christoph Correll, clinical professor of psychiatry and frequent research collaborator with Teva, said: “Olanzapine has been a trusted and foundational treatment option for people living with schizophrenia for more than 30 years, but adherence continues to be a major barrier to stability, particularly for those who rely on daily oral medications.”
Teva will offer Weltruza in once monthly 318mg, 425mg and 531mg doses. These correspond to the approved daily dose range of oral olanzapine of 10mg, 15mg and 20mg, respectively. The new therapy does not need loading doses, oral supplementation or post-injection monitoring.
Approval was based on the Phase III SOLARIS trial (NCT05693935), which showed that the drug improved schizophrenia symptoms, reduced illness severity, and helped personal and social functioning. All three doses of the injectable formulation were similarly tolerated. Discontinuations of Weltruza due to common adverse events (AEs) were consistent with placebo.
Teva’s chief medical officer Eric Hughes said: “Weltruza combines proven science and novel formulation innovation to eliminate the need for monitoring after each injection, addressing a significant barrier to treatment and advancing care for people living with schizophrenia.”
Bringing Weltruza to market is part of the company’s ‘Pivot to Growth Strategy’. Launched in May 2023, CEO Richard Francis is aiming to transition the company from a traditional generics manufacturer into a global biopharmaceutical leader. An update in February of this year demonstrated that the company has achieved 11 consecutive quarters of growth. Schizophrenia remains one of the company’s core growth engines.
In a research note, Leerink Partners called Weltruza’s approval an “important milestone for Teva and an important contributor to sales growth going forward”. The firm estimates $1.3bn in sales in 2026, with a significant number of patients switching from the oral product.
In interviews with Pharmaceutical Technology’s sister publication Clinical Trials Arena, experts noted the complexities of designing schizophrenia trials, including strong placebo responses, may be thwarting drug development, with calls for a wider reform of the neuropsychiatric trial ecosystem that can also tackle fraudulent behaviour.
