FDA Approves Lumateperone For Prevention of Relapse in Schizophrenia

The U.S. Food and Drug Administration approved an expanded use of lumateperone (Caplyta) to help prevent relapse in adults with Schizophrenia, not just treat active symptoms.

The decision was based on Phase 3 trial data showing the drug reduced relapse risk by about 63%, with most patients remaining stable over six months.

Overall, the approval adds an important long-term treatment option aimed at maintaining stability and reducing repeated episodes and hospitalizations in schizophrenia care.