Cobenfy FDA Approval History
Last updated by Judith Stewart, BPharm on Oct 1, 2024.
FDA Approved: Yes (First approved September 26, 2024)
Brand name: Cobenfy
Generic name: xanomeline and trospium chloride
Dosage form: Capsules
Company: Bristol-Myers Squibb Company
Treatment for: Schizophrenia
Cobenfy (xanomeline and trospium chloride) is a muscarinic agonist and muscarinic antagonist combination indicated for the treatment of schizophrenia in adults.
- Schizophrenia is a persistent and often disabling mental illness affecting how a person thinks, feels, and behaves.
- Cobenfy contains xanomeline and trospium chloride. Xanomeline is a muscarinic agonist that acts primarily at the M1 and M4 muscarinic receptors to improve the positive, negative, and cognitive symptoms associated with schizophrenia. Stimulation of the muscarinic receptors can however cause severe and undesirable cholinergic adverse effects, and these are thought to be reduced by the addition of the antimuscarinic agent trospium chloride.
- The FDA approval of Cobenfy was supported by data from the Phase 3 EMERGENT-2 and EMERGENT-3 trials. In both trials, Cobenfy met its primary endpoint, demonstrating statistically significant reductions of schizophrenia symptoms.
- Cobenfy capsules are administered orally, twice daily, at least 1 hour before a meal or at least 2 hours after a meal.
- Cobenfy does not have atypical antipsychotic class warnings and precautions and does not have a boxed warning.
- Warnings and precautions associated with Cobenfy include the risk of urinary retention, decreased gastrointestinal motility, risk of angioedema, increased heart rate, and central nervous system effects.
- Common adverse reactions inlclude nausea, dyspepsia, constipation, vomiting, hypertension, abdominal pain, diarrhea, tachycardia, dizziness, and gastrointestinal reflux disease.
Development timeline for Cobenfy
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.