Teva Pharmaceuticals has announced that the US Food and Drug Administration (FDA) has approved WELTRUZA (olanzapine) for Extended-Release (ER) injectable suspension, a new, once-monthly, subcutaneous Long-Acting Injectable (LAI) for the treatment of schizophrenia in adults.

WELTRUZA clinical trial results demonstrated improvement in symptoms (PANSS), significant reduction in illness severity (CGI-S), as well as improvement in Personal and Social Functioning (PSP).

In the coming weeks, WELTRUZA will be available in 3 different strengths (318 mg, 425 mg, 531 mg) with no loading doses, no oral supplementation and no post-injection monitoring required.

Chris Fox, Executive Vice President, US Commercial and Head—Innovative Franchise, Teva Pharmaceuticals, said, “WELTRUZA offers the proven efficacy of olanzapine in an innovative long-acting subcutaneous injectable, helping to fill a major, long-standing gap in the schizophrenia treatment landscape. WELTRUZA was developed with the patient in mind from day 1 and it is a powerful demonstration of what is possible when the needs of the patient guide the development of a truly innovative medicine. This important milestone also helps further Teva’s Pivot to Growth strategy.”

Olanzapine is the most widely prescribed atypical antipsychotic for schizophrenia as a daily oral treatment. However, it is well documented that daily options may make it difficult to sustain long-term symptom improvement due to challenges with adherence, increasing the risk for instability and relapse. WELTRUZA was developed to address this significant unmet need by offering the established efficacy of olanzapine in a once-monthly subcutaneous injectable formulation.

Eric Hughes, MD, PhD, Executive Vice President, Global R&D and Chief Medical Officer, Teva Pharmaceuticals, said, “This approval reflects the strength of patient-centric innovation at Teva and what our R&D organisation can deliver. 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.”

WELTRUZA will be available in once-monthly subcutaneous injectable doses of 318 mg, 425 mg and 531 mg that correspond to the approved daily dose range of oral olanzapine of 10 mg, 15 mg and 20 mg, respectively.

Christoph Correll, MD, Clinical Professor of Psychiatry, Zucker School of Medicine, Hofstra/Northwell, Hempstead, NY, 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. By offering a subcutaneous Long-Acting Injectable formulation with achievement of therapeutic blood levels without oral cotreatment, loading doses or booster injections, this new treatment option 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.”

In the phase 3 SOLARIS trial, all 3 doses of WELTRUZA were similarly tolerated, with the most common reported Adverse Events (AEs) inclusive of increased weight, somnolence, headache, constipation and injection site reactions.

Weight gain and metabolic changes were observed and were consistent with the systemic safety profile of oral olanzapine, including clinically significant weight gain. Discontinuations of WELTRUZA due to common AEs were consistent with placebo at 5 percent and 4 percent of trial participants, respectively.

WELTRUZA utilises SteadyTeq, a copolymer technology proprietary to Medincell that provides a controlled steady, sustained release of olanzapine.

WELTRUZA will be available in the US in the coming weeks.

The European Medicines Agency (EMA) accepted the Marketing Authorisation Application (MAA) for olanzapine LAI (TEV-‘749) for the treatment of schizophrenia in adults in May 2026.

The EMA submission is supported by an extensive clinical development program, including the phase 3 SOLARIS study.

TEV-‘749 is not approved by the EMA at this time.