HQ Team
October 10, 2026: Israel’s Teva Pharmaceutical Industries Ltd’s, Weltruza, a once-monthly injection for treatment of schizophrenia in adults, has been approved by the US Food and Drug Administration.
The USFDA’s green light for olanzapine, or branded as Weltruza, follows results from end-stage clinical trials that demonstrated improvement in symptoms, significant reduction in illness severity, and improvement in personal and social functioning, according to the Tel Aviv-based company.
“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,” said Chris Fox, Executive Vice President, US Commercial and Head of Innovative Franchise at Teva.
It “was developed with the patient in mind from day one 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,” she said.
Psychosis
Weltruza will be available in once-monthly subcutaneous injectable doses of 318 mg, 425 mg and 531 mg.
Schizophrenia causes psychosis and is associated with considerable disability and major disruptions to everyday life, including personal, family, social, educational and occupational functioning.
Globally, 1 in 300 (or 27 million) people live with schizophrenia, according to the World Health Organization. More than two out of three people with psychosis do not receive specialist mental health care.
Stigma, discrimination and violation of human rights of people with schizophrenia are common. A range of effective care options for people with schizophrenia exists and at least one in three people with schizophrenia will be able to fully recover.
Sedation syndrome
An estimated 2.1 million people are currently diagnosed with schizophrenia in the US. The chronic, progressive and severely debilitating mental disorder affects how one thinks, feels and behaves.
“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,” said Eric Hughes, MD, PhD, Executive Vice President, Global R&D and Chief Medical Officer at Teva.
The medicine may cause serious side effets including post-injection delirium or sedation syndrome which can happen when too much olanzapine enters the bloodstream too quickly. It may also lead to strokes in elderly people that can result in death.
The most common side effects of olanzapine in patients with schizophrenia include weight gain, sleepiness, headache, and constipation. Injection site reactions, including hardness, pain, redness, itching, and swelling, were reported with Weltruza, according to the company statement.
