Xanomeline

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A study on Medicaid acceptance among allergists in the US highlights barriers to care, affecting children's health outcomes. NYU Langone Health newsletters reference AJMC.com interviews on cancer care and overcoming medical mistrust. An AJMC.com article suggests reducing avoidable ED visits for mental health could save $8.3 billion annually. The FDA approved the first cholinergic receptor-targeting treatment for schizophrenia. A bill reintroduced by Sen Mike Lee aims to simplify biosimilar interchangeability requirements.

KarXT, a new schizophrenia drug targeting muscarinic receptors, has sparked excitement in psychiatric medicine, with several similar drugs in development. However, the failure of a highly anticipated muscarinic drug, emraclidine, in a trial raises questions about the future of this approach. KarXT's success has revived interest in muscarinic drugs, but the development process remains challenging and uncertain.

AI has contributed to drug development, including the creation of a new schizophrenia medication, Cobenfy, through AI-powered predictive algorithms. This innovation highlights the potential for greater AI healthcare advancements in the coming decade.

The FDA approved Bristol Myers Squibb’s Cobenfy, the first schizophrenia treatment targeting cholinergic receptors, offering a new alternative to traditional antipsychotics. Cobenfy, unlike previous treatments, does not target dopamine receptors, potentially reducing adverse effects like movement disorders and metabolic dysfunction. Despite skepticism, the approval opens doors for further innovations in mental health treatment.

AbbVie Inc's emraclidine failed two Phase 2 trials for schizophrenia, impacting Bristol Myers Squibb's Cobenfy competition. Despite this, analysts remain positive on AbbVie's immunology franchise, though BMO Capital Markets lowered their price target to $208.

FDA approves Cobenfy, a schizophrenia treatment targeting muscarinic cholinergic receptors, marking the first novel mechanism in over 70 years. Developed by Karuna Therapeutics (now Bristol Myers Squibb), Cobenfy combines xanomeline and trospium to address positive, negative, and cognitive symptoms. Two Phase 3 trials, EMERGENT-2 and EMERGENT-3, showed significant improvements in PANSS scores, though results for negative symptoms were mixed. Long-term data is needed to assess functional recovery potential.

KarXT (Cobenfy) was approved by the FDA for treating schizophrenia, marking the first new mechanism of action since 1954. Developed by Karuna Therapeutics, KarXT combines xanomeline and trospium to modulate brain circuits via a nondopaminergic mechanism. Clinical trials demonstrated significant improvements in symptoms, with KarXT not classified as an antipsychotic, differing from traditional D2R antagonists. Adverse events are mitigated by trospium's anticholinergic properties, and the drug has no boxed warnings. This approval introduces a novel neurotransmitter target for schizophrenia treatment.

Small molecule therapies remain crucial; FDA approves BMS's Cobenfy for schizophrenia, Gilead licenses lenacapavir for HIV, ARS's neffy for anaphylaxis, AstraZeneca's Tagrisso for lung cancer, Bayer's darolutamide for prostate cancer, Novartis' Kisqali for breast cancer, and Pfizer withdraws voxelotor for sickle cell disease due to safety concerns.