Novo Nordisk Financial Report Reveals Monlunabant Failure But Several Bright Spots for Kidney Disease

In its financial report for 2024, Danish drug maker Novo Nordisk announced that a phase II trial of the small molecule oral cannabinoid receptor 1 inverse agonist monlunabant failed to meet its primary endpoint.

The trial examined the efficacy and safety of a once-daily 10-mg and 25-mg dose of monlunabant versus placebo at improving urine albumin-creatinine ratio after 16 weeks in 254 individuals with diabetic kidney disease. The most common adverse events were gastrointestinal, but neuropsychiatric side effects were also reported and were more frequent with monlunabant than placebo. Currently, the drug is being evaluated for further clinical development for kidney disease.

The disappointing news was tempered by the label expansion for Ozempic in the United States and European Union, extending the drug’s use to kidney indications based on positive results from the FLOW trial. In addition, Novo Nordisk reported that it recently submitted applications to the FDA and the European Medicines Agency for Rybelsus for the indication of reducing the risk of major adverse cardiovascular events in individuals with type 2 diabetes and established cardiovascular disease and/or chronic kidney disease (CKD) based on data from the SOUL trial.

Finally, the report noted that a phase II trial is in progress to investigate the safety and efficacy of different doses of a subcutaneous once-weekly gastric inhibitory polypeptide and glucagon‐like peptide‐1 dual agonist in approximately 450 individuals with CKD, with or without type 2 diabetes and with overweight or obesity.

Source: Press release