Pfizer Advances Development of Once-Daily Oral GLP-1 Receptor Agonist Danuglipron for Obesity Treatment

1. Preferred Formulation Selected: Pfizer has identified its preferred once-daily modified release formulation of danuglipron, an oral glucagon-like peptide-1 (GLP-1) receptor agonist, for obesity treatment.
2. Dose Optimization Studies: The company plans to conduct dose optimization studies in the second half of 2024 to evaluate multiple doses of the preferred formulation and inform registration-enabling studies.
3. Pharmacokinetic Profile: The ongoing study has demonstrated a pharmacokinetic profile supportive of once-daily dosing, with a safety profile consistent with prior danuglipron studies, including no liver enzyme elevations observed in over 1,400 study participants.
4. Competitive Profile: Pfizer believes the once-daily formulation has the potential to have a competitive profile in the oral GLP-1 space, particularly compared to current FDA-approved weight loss medications Wegovy and Zepbound, which are weekly injections.
5. Future Development: Pfizer will need to conduct large-scale clinical trials to produce the necessary data to show danuglipron is safe, effective, and tolerable before submitting it to the FDA for approval.