(NEW YORK) — Pfizer announced early Thursday morning that it has selected its preferred once-daily modified release formulation of danuglipron, a move that it said was a significant milestone in the obesity drug’s development.
Danuglipron, an oral glucagon-like peptide-1 (GLP-1) receptor agonist, will undergo dose optimization studies in the second half of 2024 as Pfizer seeks to evaluate multiple doses of the 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 so far have included healthy adults aged 18 years or older and the results thus far have shown a profile that supports once-daily dosing, which is 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 that is taken as a tablet by mouth and is currently not approved for use by health authorities.
Current popular FDA approved weight loss medications Wegovy and Zepbound are weekly injections.
Pfizer will still need to do large scale clinical trials to produce the data necessary to show it’s safe, effective and tolerable and then submit to FDA — a process which is still likely much further down the line.
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