Pfizer has picked a preferred once-daily modified release formulation for its oral glucagon-like peptide-1 (GLP-1) receptor agonist, danuglipron, based on results from an ongoing pharmacokinetic study.
Danuglipron, the most advanced drug in Pfizer's pipeline of three clinical and several preclinical candidates, showed strong efficacy when taken twice-daily in a phase 2b trial of adults with obesity. But the dosing also produced high rates of adverse events, with more than half of trial participants discontinuing the drug. This led Pfizer to make the call last December to pursue the once-daily dosing.
Now, Pfizer plans to conduct dose optimization studies in the second half of 2024 evaluating multiple doses of the preferred modified release formulation to inform the registration enabling studies.
Pfizer, like many other drugmakers, is vying for a piece of the weight loss market projected to hit $100 billion in sales by 2030.