FDA Approves Monthly Olanzapine LAI for Adults With Schizophrenia
Key Clinical Summary
- The US Food and Drug Administration (FDA) approved olanzapine (Weltruza), a once-monthly long-acting subcutaneous olanzapine injection, for adults with schizophrenia.
- The approval follows the phase 3 SOLARIS trial, in which treatment with subcutaneous olanzapine improved schizophrenia symptoms, illness severity, and personal and social functioning.
- Weltruza requires no loading dose, oral supplementation, or post-injection monitoring, although weight gain and metabolic changes remain clinical considerations.
Teva Pharmaceuticals announced the FDA approval of subcutaneous olanzapine (Weltruza) for extended-release injectable suspension on October 9, 2026. According to the company, it is the first once-monthly subcutaneous olanzapine injection for adults with schizophrenia.
Weltruza will be offered in monthly doses of 318, 425, and 531 milligrams, corresponding to approved daily oral olanzapine doses of 10, 15, and 20 milligrams, respectively.
Additionally, Weltruza’s “novel formulation innovation [eliminates] the need for monitoring after each injection, addressing a significant barrier to treatment and advancing care for people living with schizophrenia,” said Eric Hughes, MD, PhD, Chief Medical Officer, Teva, in the company’s news release.
Study Findings and Approval Details
Approval was based on SOLARIS, a phase 3, 8-week, multicenter, randomized, double-blind, placebo-controlled trial involving 675 adults aged 18 to 64 years with schizophrenia. Participants were assigned equally to 1 of 3 monthly olanzapine doses (low, medium, or high) or placebo. A subsequent 48-week period evaluated continued treatment, including safety and tolerability.
According to Teva, trial results showed improvement in schizophrenia symptoms, reduced illness severity, and improved personal and social functioning, as measured by the Positive and Negative Syndrome Scale (PANSS), Clinical Global Impression - Severity (CGI-S), and Personal and Social Performance Scale (PSP).
Common adverse events in SOLARIS included increased weight, somnolence, headache, constipation, and injection-site reactions. Discontinuation due to common adverse events was reported in 5% of Weltruza recipients and 4% of placebo recipients.
Clinical Implications
The monthly formulation offers another option when taking daily oral medication presents an adherence challenge. Clinicians must still consider olanzapine’s metabolic risks: Teva reported weight gain and metabolic changes consistent with oral olanzapine. Although post-injection monitoring is not required, the release states that it is unknown whether post-injection delirium and sedation syndrome can occur with the formulation.
Expert Commentary
“Adherence continues to be a major barrier to stability,” said Psych Congress faculty member Christoph Correll, MD, regarding schizophrenia patients currently relying on daily oral medication. The ability to achieve therapeutic blood levels without oral cotreatment or loading doses, therefore, may potentially benefit patients, care partners, and clinicians.
Teva expects to make the treatment available in the United States in the coming weeks.
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