Pfizer Progresses Once-Daily Oral GLP-1 Agonist Danuglipron

Pfizer Inc. has announced promising results from a pharmacokinetic study of danuglipron, an oral glucagon-like peptide-1 (GLP-1) receptor agonist. The study (NCT06153758) has led the company to choose a preferred once-daily modified release formulation of danuglipron. A series of dose optimization studies focusing on this formulation is planned for the second half of 2024 to guide subsequent registration-enabling studies.

Danuglipron, the most advanced candidate in Pfizer’s obesity treatment pipeline, has shown good efficacy in its current twice-daily formulation. Mikael Dolsten, MD., PhD., Chief Scientific Officer and President of Pfizer Research and Development, emphasized the potential competitive edge of a once-daily formulation in the oral GLP-1 market. He highlighted the company’s plans to leverage previous Phase 2b data and trial design to enhance the future trials and advance danuglipron into registration-enabling studies. This approach aims to meet the ongoing medical needs of individuals dealing with obesity.

The ongoing open-label, randomized study examines the pharmacokinetics and safety profiles of both immediate and modified release formulations of danuglipron when administered orally to adults aged 18 and older. Results so far indicate a favorable pharmacokinetic profile for once-daily dosing, with safety findings consistent with previous danuglipron studies, notably no liver enzyme elevations among over 1,400 participants.

Danuglipron (PF-06882961) is still under investigation and not yet approved for use by health authorities. Developed by Pfizer, this oral GLP-1 receptor agonist is designed to maintain healthy blood sugar levels by increasing insulin release. Additionally, it may slow food digestion and enhance feelings of fullness post-meal, potentially contributing to weight loss.

Pfizer’s broader mission centers around developing innovative medications that enhance patient lives. The company is committed to high standards of quality, safety, and value in healthcare product development. Pfizer’s work spans developed and emerging markets, focusing on wellness, prevention, treatment, and cures for critical diseases. The company collaborates with healthcare providers, governments, and communities to ensure access to affordable healthcare worldwide. For over 175 years, Pfizer has been dedicated to making a significant impact on global health.

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