Xanomeline

BMS's Cobenfy, a new drug class for schizophrenia, received FDA approval. Its distinct mechanism of action offers potential for patients unresponsive to atypical antipsychotics. However, market penetration may be challenging due to existing generic options. Cobenfy's cost and dosing regimen could hinder adoption, though it shows promise as an adjunctive therapy. Competitors are also exploring muscarinic pathway treatments.

Schizophrenia symptoms are linked to dopamine dysregulation, with current antipsychotics targeting D2 receptors. Clozapine, binding to different receptors, showed promise but faced side effects. Research on muscarinic receptors (M1 and M4) revealed their importance in cognitive functions and perception. Xanomeline, initially for Alzheimer’s, was tested for schizophrenia but caused unacceptable side effects. Karuna Therapeutics combined xanomeline with trospium, creating Cobenfy, which addresses positive, negative symptoms, and cognitive issues without severe side effects. Cobenfy’s approval highlights the value of basic research despite long timelines.

Bristol Myers Squibb's acquisition of Karuna Therapeutics paid off with the FDA approval of KarXT, a first-in-class muscarinic agonist for schizophrenia. KarXT combines xanomeline and trospium to target schizophrenia symptoms while reducing side effects, showing efficacy in phase 3 trials. This approval offers a new treatment approach for schizophrenia, addressing both positive and negative symptoms, and avoiding some side effects of older drugs.

The FDA approved Cobenfy, a new schizophrenia treatment combining xanomeline and trospium, representing a 30-year collaborative effort involving Monash University researchers. This marks the first major advancement in schizophrenia treatment in decades, offering a more targeted approach than traditional dopamine-focused drugs.

The FDA approved Bristol Myers Squibb's Cobenfy, a new oral medication for schizophrenia in adults, targeting specific brain receptors without affecting dopamine pathways. This marks the first new class of medicine in decades for schizophrenia, potentially changing the treatment paradigm. Cobenfy showed significant symptom reduction in Phase 3 trials and offers a novel approach by targeting M1 and M4 receptors, unlike traditional antipsychotic drugs.

The FNIH applauds the FDA's approval of Cobenfy, a novel oral medication for schizophrenia, targeting a different brain area than traditional antipsychotics to reduce side effects. The FNIH-managed AMP® Program Schizophrenia aims to develop tools for early risk stage identification and psychosis prevention.

PureTech Health's KarXT, now marketed as Cobenfy, receives FDA approval for treating schizophrenia in adults, triggering $29m in payments from Royalty Pharma and Karuna Therapeutics. Cobenfy, developed by combining xanomeline with trospium chloride, aims to address tolerability issues in neuropsychiatric treatments. PureTech anticipates 2% royalties on net annual sales exceeding $2bn, with Cobenfy's success generating $1.1bn for the company, enabling self-funding of its pipeline, including LYT-100 for idiopathic pulmonary fibrosis.

Cobenfy, a new class of medication for schizophrenia, has been approved by the FDA. Developed by Monash University scientists, it combines xanomeline and trospium to improve symptoms and reduce side effects.