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FDA Medication Tracker

← All approvals · Other · 2024

Cobenfy (xanomeline and trospium chloride)

The FDA approved Cobenfy (xanomeline and trospium chloride) on September 26, 2024 to treat schizophrenia.
Brand name
Cobenfy
Generic name
xanomeline and trospium chloride
FDA approval date
September 26, 2024
Approved use (FDA wording)
To treat schizophrenia
Company
Bristol-Myers
Application
NDA216158
Dosage form / route
CAPSULE · ORAL
Drug class (EPC)
Cholinergic Muscarinic Agonist [EPC]
Boxed warning on label
Not listed
Category on this site
Other

Indications and usage, from the FDA label

COBENFY is indicated for the treatment of schizophrenia in adults. COBENFY is a combination of xanomeline, a muscarinic agonist, and trospium chloride, a muscarinic antagonist, indicated for the treatment of schizophrenia in adults. ( 1 )

Official sources

Facts only. This site lists what the FDA has approved and what the FDA says each drug is approved for, quoted or closely paraphrased from FDA and openFDA records. It gives no medical advice, no dosing, and no comparisons, and it says nothing about whether a drug is right for anyone. Talk to a licensed clinician about any medication. Records can lag or contain errors; the FDA's own pages are authoritative.