US approves schizophrenia drug that needs to be administered once a month
The US has approved a schizophrenia drug that allows daily pill intake to be replaced by a single monthly injection. The U.S. Food and Drug Administration (FDA) has authorized the use of WELTRUZA — the country's first subcutaneous, extended-release form of olanzapine. This was reported by pharmaceutical company Teva.
The drug is intended for the treatment of schizophrenia in adults. Unlike olanzapine tablets, which must be taken daily, WELTRUZA is administered subcutaneously once a month. Patients do not require additional initial doses, simultaneous pill intake, or mandatory medical observation after the injection. The drug will be available in three dosages: 318, 425, and 531 mg.
The FDA's decision is based on the results of the phase 3 SOLARIS clinical trial, which involved 675 patients aged 18 to 64 years. According to Teva, the use of the drug contributed to a reduction in schizophrenia symptoms, a decrease in disease severity, and an improvement in patients' personal and social functioning.
The most common side effects were weight gain, drowsiness, headache, constipation, and reactions at the injection site. The company noted that the overall safety profile of the new formulation is consistent with the known characteristics of oral olanzapine. Treatment was discontinued due to common undesirable effects in 5% of participants receiving the drug and 4% of those receiving placebo.
Teva explained that the new drug formulation should help address the problem of treatment adherence. The need to take pills daily can complicate long-term therapy and increase the risk of relapses. According to company estimates, approximately 2.1 million people in the US are diagnosed with schizophrenia.
WELTRUZA is expected to appear on the American market in the coming weeks. In May 2026, the European Medicines Agency (EMA) also accepted an application for the drug's registration for consideration, but has not yet approved its use.
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