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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