Pfizer Announced The Decision To Discontinue The Development Of Danuglipron (PF-06882961), An Oral Glucagon-like Peptide-1 Receptor Agonist Being Investigated For Chronic Weight Management

Pfizer's dose-optimization studies of once-daily formulations of danuglipron (NCT06567327 and NCT06568731) met key pharmacokinetic objectives and confirmed a formulation and dose with the potential to deliver a competitive efficacy and tolerability profile in Phase 3 testing, based on earlier studies of twice-daily danuglipron. While the overall frequency of liver enzyme elevations across the over 1,400 participant safety database of danuglipron is in-line with approved agents in the class, a single asymptomatic participant in one of the dose-optimization studies experienced potential drug-induced liver injury which resolved after discontinuation of danuglipron. After a review of the totality of information, including all clinical data generated to date for danuglipron and recent input from regulators, Pfizer has decided to discontinue development of the molecule.