Trospium

• Over 120 Alzheimer's Disease treatment therapies are under development by 110+ companies globally, ranging from preclinical to marketed phases. • Emerging therapies like NRDN-201, ST-501, and KarXT are in various clinical trial phases, showing potential for significant market impact. • MapLight Therapeutics initiated a Phase 1 trial for ML-007/PAC, targeting schizophrenia and Alzheimer's disease psychosis, with Phase 2 trials planned. • The FDA granted conventional approval to Leqembi (lecanemab-irmb), marking the first amyloid beta-directed antibody to transition from accelerated approval.

• The FDA approved Rezdiffra (resmetirom) as the first specific treatment for nonalcoholic steatohepatitis (NASH), addressing a critical unmet need for patients with liver damage. • Duvyzat (givinostat) gained approval as the first nonsteroidal treatment for all genetic variants of Duchenne muscular dystrophy (DMD), offering a new option for patients aged 6 and older. • Cobenfy (xanomeline and trospium) was approved for schizophrenia, representing the first new class of antipsychotic medication in 35 years, with a novel mechanism of action. • Itovebi (inavolisib) received approval in combination with palbociclib and fulvestrant for certain types of breast cancer, demonstrating a 57% reduction in disease progression or death.

The FDA has approved a novel treatment for schizophrenia, marking the first in decades to target cholinergic receptors instead of dopamine receptors.

• The FDA approved Bristol Myers Squibb's Cobenfy (xanomeline and trospium chloride) as the first schizophrenia treatment to target cholinergic receptors, offering a new mechanism of action. • Cobenfy's approval marks a significant breakthrough, potentially improving both psychotic and cognitive symptoms by targeting muscarinic M1 and M4 receptors in the brain. • Experts suggest Cobenfy's approval may encourage further research and development in mental health, particularly for treatments combining old and new medicines to alleviate side effects. • While offering a novel approach, some experts emphasize the need for real-world clinical trials comparing Cobenfy with existing antipsychotics to fully understand its benefits.

• AbbVie's emraclidine failed to demonstrate statistically significant improvement in schizophrenia symptoms in Phase II trials, a setback for the muscarinic pathway approach. • Bristol Myers Squibb's Cobenfy (KarXT), a muscarinic agonist, now stands as the frontrunner in schizophrenia treatment after AbbVie's trial failures. • Neurocrine Biosciences is advancing NBI-1117568, an oral muscarinic M4 selective agonist, with Phase III trials planned for early 2025, showing a potential path forward. • Other companies like Neumora Therapeutics and Reviva Pharmaceuticals are also exploring novel mechanisms for schizophrenia treatment, indicating a dynamic therapeutic landscape.