美国FDA批准Cobenfy(KarXT)用于成人精神分裂症治疗

On November 14, 2024, the U.S. Food and Drug Administration approved Cobenfy (KarXT), a first-in-class muscarinic agonist for the treatment of schizophrenia in adults.

This oral drug represents the first new drug class in decades that selectively targets M1 and M4 receptors in the brain without blocking D2 receptors.

Cobenfy (KarXT) related clinical trials

This approval is based on the EMERGENT clinical trial project.

In the Phase 3 EMERGENT-2 and EMERGENT-3 trials, Cobenfy (KarXT) met its primary endpoint, demonstrating statistically significant reductions in schizophrenia symptoms compared to placebo in the change from baseline to week 5 in the Positive and Negative Symptom Scale total scores (9.6-point and 8.4-point reductions in EMERGENT-2 and EMERGENT-3, respectively).

Cobenfy (KarXT) Adverse Reactions

In both trials, the most common adverse reactions (incidence ≥5% and at least twice the rate in the placebo group) included nausea, dyspepsia, constipation, vomiting, hypertension, abdominal pain, diarrhea, tachycardia, dizziness, and gastroesophageal reflux disease.

"Due to the heterogeneous nature of schizophrenia, it is not a 'one size fits all' disease and patients are often stuck in a cycle of discontinuing and switching medications," said Rishi Kakar, MD, Ph.D., a researcher on the EMERGENT project. "By leveraging a novel pathway of action, pyridoxine provides new options for managing this challenging disease."