Pfizer Advances Obesity Drug Development With New Once-Daily Danuglipron Formulation

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Selection of Preferred Formulation

Pfizer made a significant stride in its obesity drug development by announcing the selection of its preferred once-daily modified-release formulation of danuglipron. This decision marks a crucial milestone for the company as it continues to advance its efforts in creating effective obesity treatments. Danuglipron is an oral glucagon-like peptide-1 (GLP-1) receptor agonist designed to assist in weight management. Pfizer’s announcement highlights the company’s commitment to tackling obesity through innovative medical solutions.

Dr. Mikael Dolsten, Chief Scientific Officer and President of Pfizer Research and Development, emphasized the importance of this development. He stated, “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.”

Upcoming Dose Optimization Studies

As part of Pfizer’s advances obesity drug development plans to conduct dose optimization studies in the latter half of 2024. These studies will evaluate multiple doses of the newly formulated danuglipron to determine the most effective regimen. The goal is to gather data that will guide the design of registration-enabling studies, which are crucial for obtaining regulatory approval.

Dr. Dolsten elaborated on the importance of these studies, stating, “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 GL-1 molecule into registration-enabling studies, with the goal of addressing the present and persistent medical needs of people living with obesity.”

Study Results and Future Prospects for Pfizer Advances Obesity Drug Development

The ongoing studies have included over 1,400 healthy adult participants aged 18 and older. Preliminary results indicate that the once-daily dosing profile is consistent with earlier studies on danuglipron, with no liver enzyme elevations observed among participants. This favorable safety profile is encouraging as Pfizer advances obesity drug development and continues to refine the formulation and prepare for larger-scale clinical trials.

Despite the progress, danuglipron remains an investigational medicine and is not yet approved for use by health authorities. The path to regulatory approval will require extensive large-scale clinical trials to demonstrate the drug’s safety, efficacy, and tolerability. Currently, popular FDA-approved weight loss medications like Wegovy and Zepbound are administered as weekly injections, highlighting the potential convenience and appeal of a once-daily oral alternative.

Pfizer advances obesity drug development commitment to addressing obesity through innovative treatments continues to drive its research and development efforts. As the company moves forward with danuglipron’s development, it aims to meet the substantial medical needs of individuals living with obesity, offering hope for more effective and convenient treatment options in the future.