Pfizer Aims to Tackle Obesity with New Daily Danuglipron Medication

Pfizer announced early Thursday morning that it has chosen its preferred once-daily modified release formulation of danuglipron, marking a significant milestone in the development of its obesity drug.

Danuglipron, an oral glucagon-like peptide-1 (GLP-1) receptor agonist, will undergo dose optimisation studies in the latter half of 2024. Pfizer aims to evaluate multiple doses of this formulation, which they hope will inform the registration-enabling studies.

“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,” said Mikael Dolsten, MD., PhD., chief scientific officer & president, Pfizer Research and Development. “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.”

Participants in the study thus far have included healthy adults aged 18 years or older, with results indicating a profile that supports once-daily dosing, consistent with previous danuglipron studies. Notably, there have been no liver enzyme elevations observed among the more than 1,400 study participants.

Danuglipron is an investigational medicine taken as an oral tablet and is currently not approved for use by health authorities.

Currently popular FDA-approved weight loss medications, such as Wegovy and Zepbound, are administered as weekly injections.

Pfizer will still need to conduct large-scale clinical trials to produce the necessary data to demonstrate danuglipron’s safety, efficacy, and tolerability, and then submit this information to the FDA. This process is likely still quite far off.