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Pfizer advances daily oral GLP-1 research
The company plans to launch dose optimization studies for a once-daily modified-release formulation for danuglipron.
On July 11, 2024, Pfizer Inc. announced that its pharmacokinetic study on once-daily modified release formulation for danuglipron, an oral glucagon-like peptide-1 (GLP-1) receptor agonist, supported advancements in dose optimization studies, which are expected to launch in the second half of 2024.
According to the press release, danuglipron is a once-daily oral GLP-1 medication discovered and developed by Pfizer researchers. Like other GLP-1 medications, it can manage blood sugar levels and treat obesity by promoting satiety.
Pfizer previously attempted a similar once-daily version of an oral GLP-1 drug; however, initial studies were discontinued in June 2023 due to elevated liver enzymes. At the time, the company chose to continue with danuglipron, which was initially a twice-daily medication. Trials were discontinued in December 2023 when the drug showed inferior weight loss and an elevated probability of side effects such as nausea.
However, researchers have worked on modifying danuglipron to act as a once-daily modified-release tablet, hoping for better outcomes and reduced side effects. According to the press release, the data from early clinical evaluations of the drug suggest a favorable profile that supports continued research.
“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, in the press release.
“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.”
As GLP-1 drugs continue to rise in popularity, understanding different delivery methods or formulations may offer a broader range of medications to accommodate the needs of various patients.
