FDA approves Teva's Weltruza as first once-monthly subcutaneous olanzapine injection for schizophrenia
Teva has secured FDA approval for Weltruza, the first once-monthly subcutaneous extended-release olanzapine injection for adults with schizophrenia.
The approval is supported by the Phase III SOLARIS trial, which demonstrated improvements in schizophrenia symptoms, overall illness severity and personal and social functioning.
Weltruza requires no loading doses, oral supplementation or post-injection monitoring, offering a differentiated long-acting treatment option for adults living with schizophrenia.
Field | Content |
Article Type | Approvals |
Drug Name | Weltruza |
Generic Name | Olanzapine |
Company | Teva Pharmaceuticals |
Regulatory Authority | U.S. Food and Drug Administration |
Approval Type | New long-acting injectable formulation approval |
Indication | Schizophrenia |
Patient Population | Adults with schizophrenia |
Therapy Area | Psychiatry; mental health |
Technology/Modality | Once-monthly subcutaneous extended-release injectable antipsychotic |
Administration | Subcutaneous injection once monthly |
Clinical Study | Phase III SOLARIS |
Key Clinical Findings | Improvements in schizophrenia symptoms, illness severity and personal and social functioning |
Treatment Requirements | No loading doses, oral supplementation or post-injection monitoring required |
Geography | United States |
What Happened | The FDA approved Weltruza as the first once-monthly subcutaneous extended-release olanzapine injection for adults with schizophrenia. |
Why It Matters | The approval introduces a differentiated long-acting olanzapine formulation that may simplify treatment administration and reduce monitoring burdens compared with other injectable olanzapine approaches. |
Supporting Context | The Phase III SOLARIS trial demonstrated improvements across schizophrenia symptom severity and functional outcomes. |
Potential Impact | A once-monthly treatment without oral supplementation or post-injection monitoring requirements could offer greater flexibility for eligible patients and healthcare providers. |
Key Takeaway | Teva has received FDA approval for the first once-monthly subcutaneous olanzapine injection for adults with schizophrenia. |
What to Watch | US commercial launch, prescribing uptake, payer coverage, clinical adoption and real-world treatment persistence. |
Primary Source | Teva Pharmaceuticals |
Relevant Date | 9 October 2026 |
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