Pfizer Pushes Boundaries With Advanced Once-Daily Oral GLP-1 Agonist Danuglipron

Pfizer Inc. (NYSE: PFE) announced today that it has chosen its preferred once-daily modified release formulation for danuglipron, an oral GLP-1 receptor agonist, based on results from the ongoing pharmacokinetic study (NCT06153758). In the second half of 2024, Pfizer will conduct dose optimization studies, evaluating multiple doses of this preferred formulation to guide future registration-enabling studies.

Mikael Dolsten, MD., PhD., Chief Scientific Officer & President, Pfizer Research and Development, “Obesity is a key therapeutic area for Pfizer, and the company has a robust pipeline of three clinical and several pre-clinical candidates. The most advanced of them, danuglipron, has demonstrated good efficacy in a twice-daily formulation, and we believe a once-daily formulation has the potential to have a competitive profile in the oral GLP-1 space. Following a thorough analysis of our previous Phase 2b data and trial design, we believe that with the preferred modified release formulation and future trial design optimization, we can advance a competitive oral GLP-1 molecule into registration enabling studies, with the goal of addressing the present and persistent medical needs of people living with obesity.”

An ongoing open-label, randomized study is currently assessing the pharmacokinetics and safety of both immediate- and modified-release formulations of danuglipron when taken orally by healthy adults aged 18 years and older. Thus far, the study findings indicate a pharmacokinetic profile that supports once-daily dosing, alongside a safety record consistent with previous danuglipron studies. Notably, no instances of liver enzyme elevations have been observed among over 1,400 participants involved in the study.