Teva wins FDA approval for WELTRUZA once-monthly olanzapine

Teva Pharmaceuticals has received FDA approval for WELTRUZA (olanzapine) for extended-release injectable suspension, a once-monthly subcutaneous long-acting injectable (LAI) for adults with schizophrenia. The company says it is the first subcutaneous LAI formulation of olanzapine available in the US, and that it will be on the market in the coming weeks in three dose strengths: 318 mg, 425 mg and 531 mg.

The approval is based on the Phase 3 SOLARIS trial, an eight-week, randomised, double-blind, placebo-controlled study enrolling 675 patients aged 18 to 64 years. All three doses met the primary endpoint, measured by the Positive and Negative Syndrome Scale (PANSS), and showed significant improvement on the Clinical Global Impressions-Severity scale (CGI-S) and the Personal and Social Performance scale (PSP). Safety was broadly consistent with oral olanzapine, with the most commonly reported adverse events including weight gain, somnolence, headache, constipation and injection site reactions. Discontinuations due to adverse events were 5% on WELTRUZA versus 4% on placebo.

What sets WELTRUZA apart

The distinguishing feature of WELTRUZA is its administration profile. Existing intramuscular LAI olanzapine formulations, notably the long-established Zyprexa Relprevv, carry a post-injection delirium/sedation syndrome (PDSS) risk that has historically required patients to be observed for at least three hours after each injection. Teva says the subcutaneous delivery via its partner Medincell's SteadyTeq copolymer technology avoids the requirement for post-injection monitoring, removing a significant logistical barrier for clinics and patients alike. It is not yet known whether PDSS can occur with subcutaneous delivery, and the prescribing information includes appropriate warnings.

Christoph Correll, Clinical Professor of Psychiatry at the Zucker School of Medicine at Hofstra/Northwell, said the formulation "can help empower patients, support their care partners and provide clinicians with an important new tool to assist in managing this complex condition more effectively."

Market context and regulatory outlook

Olanzapine is, according to Teva's own data, the most widely prescribed atypical antipsychotic for schizophrenia in the US. An estimated 2.1 million Americans are currently diagnosed with the condition. The long-acting injectable market for schizophrenia is well established, with Janssen's paliperidone palmitate franchise (Invega Sustenna, Invega Trinza) and Otsuka's aripiprazole monohydrate (Abilify Maintena) among the major incumbents. Teva's entry differentiates primarily on the olanzapine molecule's familiarity to prescribers and on the removal of the monitoring requirement that constrained the intramuscular predecessor.

Regulatory progress outside the US is at an earlier stage. The European Medicines Agency accepted Teva's marketing authorisation application for the same compound, designated TEV-749, in May 2026; approval there has not yet been granted. The EMA review, supported by the SOLARIS dataset, will be a key watch point for investors assessing the commercial ceiling of the franchise.

Teva framed the approval as a milestone in its broader Pivot to Growth strategy, which centres on building a differentiated innovative portfolio alongside its generics business. WELTRUZA joins fremanezumab (Ajovy) and anti-CD38 programmes in the company's neuroscience and immunology pipeline as a revenue-generating approved asset.