Breaking· Health· Updated
FDA Approves Teva's Monthly Schizophrenia Injection Weltrusa
On Friday, 9 October 2026, Teva Pharmaceutical Industries announced that the U.S. Food and Drug Administration (FDA) approved WELTRUZA, its new monthly subcutaneous injection for adults with schizophrenia. The approval supports Teva's strategic shift toward developing innovative, proprietary branded drugs. Following the announcement, Teva's stock rose 3% in pre-market trading and surged approximately 4.5% in early Wall Street trading, bringing the company's market valuation to $47.8 billion.
8 newsrooms · 1 language · since
What happened
- 01The U.S. FDA approved Teva's WELTRUZA, the first monthly subcutaneous injection for adults with schizophrenia, on Friday, 9 October 2026.
- 02Teva's stock rose approximately 4.5% in early Wall Street trading following the announcement, reaching a market valuation of $47.8 billion.
- 03WELTRUZA utilizes SteadyTeq polymer technology, developed with Medincell, to eliminate the need for post-injection medical monitoring.
- 04Clinical trials, including the SOLARIS study with 675 patients, showed significant improvement in schizophrenia symptoms and patient functioning.
- 05Teva projects annual sales of 1.5 to 2 billion shekels for the drug, while Israel Hayom reports potential sales of up to $1 billion annually.
- 06The drug targets approximately 2.1 million adult schizophrenia patients in the United States and will launch there in the coming weeks.
- 07Teva is currently seeking marketing approval for the monthly schizophrenia injection in Europe.
WELTRUZA, which contains the active ingredient olanzapine, is administered as a single monthly injection. It utilizes SteadyTeq polymer technology, developed in collaboration with French biotech firm Medincell, to ensure a controlled, sustained release of the drug. This formulation eliminates the need for post-injection medical monitoring, loading doses, or concurrent oral medication in the initial weeks, addressing a major barrier in schizophrenia treatment.
Clinical trials, including the SOLARIS study involving 675 patients, demonstrated that WELTRUZA effectively improved schizophrenia symptoms, reduced disease severity, and enhanced patients' social and functional abilities. The drug targets an estimated 2.1 million adult schizophrenia patients in the United States. Teva plans to launch the drug in the U.S. in the coming weeks and is currently seeking marketing approval in Europe.
Financially, Teva presented a forecast to investors projecting that the treatment could generate annual sales of 1.5 to 2 billion shekels. According to Israel Hayom, investors and analysts anticipate even higher sales potential, with projections ranging from hundreds of millions to potentially $1 billion annually.
Summarized by baba from the reports of 7 newsrooms. Updated
Latest report: Ynet. Read Ynet’s original
The coverage
8 newsrooms on this story
Who covered it
- LeftNone
- Centre1
- Right2
- HarediNone
- ArabNone
- Other5
