Pfizer to develop daily oral GLP-1 receptor agonist danuglipron

Pfizer has announced plans to further develop a once-daily formulation of its oral glucagon-like peptide-1 (GLP-1) receptor agonist, danuglipron. This comes after promising results from an ongoing pharmacokinetic study, which showed favorable data supporting the once-daily dosing schedule. The drug is designed to help regulate blood sugar levels by increasing insulin secretion. Another potential benefit includes slowing the digestion of food and enhancing the feeling of fullness post-meal, which could contribute to weight loss.

The current open-label study examines the pharmacokinetics and safety of both immediate and modified-release versions of danuglipron in healthy individuals aged 18 and older. Pfizer reported that the results align with previous studies, showing a pharmacokinetic profile conducive to once-daily dosing and a consistent safety profile.

Mikael Dolsten, Pfizer's chief scientific officer and president of Research and Development, highlighted that the twice-daily version of danuglipron had already shown significant efficacy. He expressed confidence that the once-daily formulation could be highly competitive in the oral GLP-1 market. According to Dolsten, a detailed analysis of prior phase 2b data and trial design has led to the belief that optimizing the modified release formulation and future trial designs could enable the advancement of a competitive oral GLP-1 molecule into registration-enabling studies. The ultimate goal is to address the ongoing medical needs of individuals living with obesity.

In December 2023, Pfizer decided not to proceed with late-stage studies for the twice-daily version of danuglipron. Although the formulation showed statistically significant reductions in body weight across all doses, the phase 2b trial experienced high discontinuation rates of over 50% for all doses, compared to around 40% with placebo.

The announcement of advancing the once-daily formulation came shortly after a study by researchers at Case Western Reserve University School of Medicine in the U.S. found that patients with type 2 diabetes treated with GLP-1 receptor agonists were less likely to develop ten out of thirteen types of obesity-related cancers.

This insight adds another layer of potential benefit to the development of GLP-1 receptor agonists like danuglipron, underscoring the significance of Pfizer's ongoing research and development efforts in this area.