Pfizer Selects Once-Daily Formulation for Oral GLP-1 Drug Danuglipron
Pfizer has selected a preferred once-daily modified-release formulation for its oral GLP-1 receptor agonist, danuglipron. The company plans dose optimization studies in the second half of 2024.
New York – Pharmaceutical giant Pfizer has chosen a preferred modified-release formulation of its oral glucagon-like peptide-1 (GLP-1) receptor agonist, danuglipron, intended for once-daily dosing. The company announced on Thursday that it plans to conduct dose optimization studies in the second half of 2024 to gather data that will inform registration-enabling studies.
The selection follows encouraging pharmacokinetic data from ongoing studies of several modified-release, once-daily formulations. Pfizer aims for the new formulation to offer a competitive profile in the growing market for oral GLP-1 treatments, particularly for obesity management. The twice-daily version of danuglipron has previously demonstrated efficacy.
Pharmacokinetic data from the current studies support the once-daily dosing regimen. The safety profile observed has been consistent with previous danuglipron studies, with no liver enzyme elevations reported in over 1,400 participants. These findings are critical as Pfizer advances its pipeline in obesity, a key therapeutic area for the company.
Danuglipron is an investigational medicine, not yet approved by health authorities. As a GLP-1 receptor agonist, it is designed to help control blood sugar levels and potentially aid in weight loss by increasing satiety. Pfizer is actively developing other treatments for obesity, with three clinical and several pre-clinical candidates in its pipeline.