epocrates

Pfizer halts development of oral GLP-1 drug due to liver injury

April 15, 2025

Pfizer announced that it would be discontinuating the development of danuglipron, an oral GLP-1 receptor agonist being investigated for chronic weight management, following a review of clinical data and regulatory input.

According to the company’s press release, the decision to discontinue danuglipron was based on a comprehensive review of evidence from studies, including a phase 2 trial in adults with obesity, which showed significant weight reduction but increased GI side effects and higher discontinuation rates with twice-daily dosing. Pfizer then investigated a once-daily formulation through two dose optimization studies, which met key pharmacokinetic objectives and identified a suitable formulation for phase 3 trials. While the overall frequency of liver enzyme elevations with danuglipron was 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, the company decided to discontinue development of the molecule.

Sources:

(2025, April 14). Pfizer. Pfizer Provides Update on Oral GLP-1 Receptor Agonist Danuglipron. [Press release]. https://www.pfizer.com/news/press-release/press-release-detail/pfizer-provides-update-oral-glp-1-receptor-agonist

Myshko, D. (2025, April 14). Managed Healthcare Executive. Liver Injury Ends Development of Pfizer’s Oral GLP-1 for Obesity. https://www.managedhealthcareexecutive.com/view/liver-injury-ends-development-of-pfizer-s-oral-glp-1-for-obesity