FDA Approves Revolutionary Schizophrenia Drug

In a breakthrough for people living with schizophrenia, the FDA has approved a new oral medication for adults. Unlike traditional antipsychotic drugs, the medication, which will be marketed under the name Cobenfy, targets a different pathway in the brain, offering new hope for treatment.

The first schizophrenia medication in decades with a new mechanism of action won US regulatory approval today. The approval offers the hope of an antipsychotic that would be more effective and better tolerated than current therapies.

The drug, known as KarXT, targets proteins in the brain known as muscarinic receptors, which relay neurotransmitter signals between neurons and other cells. Activating these receptors dampens the release of the chemical dopamine, a nervous-system messenger that is central to the hallmark symptoms of schizophrenia, such as hallucinations and delusions.

Schizophrenia is a serious mental disorder that affects about 1% of people in the U.S. and around 24 million worldwide. It causes people to struggle with distinguishing reality from imagination, and symptoms typically appear in the late teens or early adulthood. The condition affects how people think, feel, and behave, impacting work, education, relationships, and overall functioning. People with schizophrenia are 2 to 3 times more likely to die younger, with about 5% dying by suicide.

“This is the first new approach to schizophrenia treatment in decades, offering an alternative to the standard medications that many patients have used,” said Tiffany Farchione, MD, director of the Division of Psychiatry at the FDA’s Center for Drug Evaluation and Research.