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Home » US FDA clears Cobenfy, first new schizophrenia drug in decades
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US FDA clears Cobenfy, first new schizophrenia drug in decades

Sep. 27, 2024
By Nuala Moran
The FDA has approved Cobenfy, a dual M1/M4 muscarinic agonist that offers a fundamentally different approach to treating schizophrenia. The fixed dose combination of xanomeline-trospium is the first to act via a novel mechanism for the serious psychiatric disorder in over 50 years, finally expanding the treatment options beyond dopamine-targeted therapies. Bristol Myers Squibb Co., which acquired Cobenfy developer Karuna Therapeutics Inc. for $14 billion in a deal that closed in March 2024, said the drug will be available in the U.S. from late October.
BioWorld Regulatory Neurology/psychiatric Small molecule U.S. FDA

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