Pfizer targets obesity with new once-daily drug Danuglipron

Pfizer announced early Thursday morning that it had selected its preferred once-daily modified-release formulation of danugliprone, a move it said was a significant milestone in the development of the obesity drug.

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 that it hopes will inform the potential trials.

“Obesity is an important therapeutic area for Pfizer, and the company has a robust pipeline of three clinical and several preclinical candidates. The most advanced of these, danugliprone, has shown good efficacy in a twice-daily formulation, and we believe that a formulation a once daily has the potential to have a competitive profile in the oral GLP-1 space,” says Mikael Dolsten, MD, PhD., chief scientific officer & President, Pfizer Research and Development.

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“After 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 taking address the current and ongoing medical needs of people living with obesity.”

Study participants to date have included healthy adults aged 18 years or older and results to date have shown a profile that supports once-daily dosing, which is consistent with previous danuglipron studies. Notably, no liver enzyme elevations were observed among the more than 1,400 study participants.

Danuglipron is an investigational drug that is taken as a tablet by mouth and is not currently approved for use by health authorities.

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Current popular FDA approved weight loss medications Wegovy and Zepbound are weekly injections.

Pfizer will still need to do large-scale clinical trials to generate the data necessary to show it’s safe, effective and tolerable, and then submit to the FDA — a process that’s likely still much further down the line.

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