Pfizer announced early Thursday that it has chosen its preferred once-daily modified release formulation of danuglipron, marking a significant step forward in the development of this obesity treatment.
Danuglipron, an oral glucagon-like peptide-1 (GLP-1) receptor agonist, is set to enter dose optimization studies in the latter half of 2024. These studies aim to evaluate multiple doses of the formulation, which will help inform the registration-enabling studies.
“Obesity is a key therapeutic area for Pfizer, and we have a strong pipeline, including three clinical and several pre-clinical candidates,” said Mikael Dolsten, MD, PhD, chief scientific officer and president of Pfizer Research and Development. “Our analysis of Phase 2b data indicates that while the twice-daily formulation has shown good efficacy, a once-daily version could offer a competitive edge in the oral GLP-1 market. With the preferred modified release formulation and optimized trial design, we believe we can advance a promising oral GLP-1 candidate into registration studies to meet the ongoing medical needs of individuals living with obesity.”
So far, participants in the study have included healthy adults aged 18 and older, and results indicate that once-daily dosing is viable, aligning with findings from previous danuglipron studies. Importantly, no liver enzyme elevations have been reported among the over 1,400 study participants.
As an investigational medication, danuglipron is taken orally and is not yet approved by health authorities. In contrast, currently popular FDA-approved weight loss medications, such as Wegovy and Zepbound, require weekly injections.
Pfizer will need to conduct large-scale clinical trials to gather the necessary data on the drug’s safety, efficacy, and tolerability before submitting it for FDA approval—a process that remains some time away.
