Rhythm Pharmaceuticals announced expanded Phase 3 TRANSCEND trial data showing an 18.8% placebo-adjusted BMI reduction at 52 weeks for setmelanotide in acquired hypothalamic obesity, with FDA PDUFA goal date set for March 20, 2026.
Three GLP-1 weight-loss drugs—semaglutide, tirzepatide and retatrutide—reduced weight and improved metabolic health in mice lacking the MC4R gene, offering potential treatment for rare genetic obesity.
Amgen, Celltrion, and Palatin Technologies are advancing obesity drug candidates through clinical development, with trials planned for 2026-2028 targeting liver fat reduction, multiple biological pathways, and rare genetic obesity conditions.
Triple-agonist drug retatrutide has demonstrated weight loss outcomes similar to bariatric surgery in Phase 3 trials. Research shows GLP-1 drugs work through brain-mediated appetite suppression and are effective even in genetic obesity.
The FDA is set to announce decisions in March 2026 on several drug applications, including label expansions for approved therapies and new drug candidates, with some making repeat approval attempts.
