- Pfizer (PFE, Financial) discontinues development of its oral GLP-1 receptor agonist, danuglipron, for chronic weight management.
- The decision followed a potential drug-induced liver injury in a study participant, despite pharmacokinetic goals being met.
- Pfizer remains committed to developing obesity treatments, focusing on their oral GIPR antagonist candidate.
Pfizer Inc. (PFE) has announced the discontinuation of danuglipron, an oral GLP-1 receptor agonist under development for chronic weight management. The decision follows a dose-optimization study participant experiencing potential drug-induced liver injury, which resolved after treatment cessation. Although the liver enzyme elevations were generally consistent with approved agents in the same class, this safety concern led to the termination of danuglipron's development.
The studies involved over 1,400 participants, and the dose-optimization studies of danuglipron met key pharmacokinetic objectives. Despite this setback, Pfizer intends to continue advancing its pipeline for cardiovascular and metabolic diseases, including obesity, by pursuing development of its oral GIPR antagonist candidate and other early-stage obesity programs.
Data from the danuglipron clinical development program will be presented at a scientific forum or submitted for publication in a peer-reviewed journal in the future. Pfizer emphasizes their commitment to researching innovative treatments to address unmet medical needs in obesity and related conditions, even after the discontinuation of danuglipron.
