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The U.S. Food and Drug Administration has approved the expanded use of Johnson & Johnson’s Caplyta to help stop relapse in patients with schizophrenia.

Regulators signed off April 24 on the New Brunswick-based pharma giant’s supplemental new drug application to add relapse prevention to Caplyta‘s label.

The FDA previously approved the oral therapy for adults to treat schizophrenia, bipolar depression and major depressive disorder, either alone or in combination with other medications like antidepressants, lithium or valproate.

J&J gained access to the treatment in April 2025. The treatment came on board with its $14.6 billion acquisition of Bedminster-headquartered neurological drugmaker Intra-Cellular Therapies.

The company anticipates Caplyta will eventually bring in $5 billion in annual sales as its uses expand.

Clinical trial results

The latest approval comes after a 26-week clinical trial. Results showed that Caplyta reduced relapse risk by 63% and kept 84% of patients relapse-free over six months, J&J said.

Caplyta also kept patients on treatment longer overall, with fewer people discontinuing the medication for any reason, including relapses or side effects, during the study period, the company said.

According to J&J, the most common treatment-related adverse effect was headaches. About 5% of trial participants reported having them, the company said.

Schizophrenia is a chronic condition that affects roughly 3 million U.S. adults. Studies show patients may experience multiple relapses as they try to manage the disease. Those episodes can often lead to worsening symptoms and repeated hospitalizations.

Additionally, the annual economic burden of schizophrenia in the U.S. is estimated at about $366.8 million due to healthcare costs, lost productivity and caregiving needs, JAMA Psychiatry reported.

J&J Vice President of Global Medical Affairs Celine Goldberger said, “People living with schizophrenia deserve treatment options that help support stability over time, not just symptom control in the short term.

“This label update — backed by long-term Phase 3 data demonstrating a significant delay in time to relapse—reinforces our commitment to advancing evidence-based therapies to support each patient’s individual needs including a proven therapy that supports stability over time,” she added.