Pfizer is advancing its oral
glucagon-like peptide-1 (GLP-1) receptor agonist,
danuglipron, by selecting a preferred once-daily modified release formulation. This decision is based on results from an ongoing pharmacokinetic study, aimed at improving the drug's efficacy and tolerability.
Danuglipron stands as the most advanced candidate in Pfizer's pipeline, which includes other clinical and preclinical candidates. In a previous phase 2b trial involving adults with
obesity, danuglipron demonstrated significant efficacy when administered twice daily. However, this regimen also led to a high occurrence of adverse events, causing more than half of the participants to discontinue the treatment. This prompted Pfizer to consider a once-daily dosing strategy, a decision made in December.
In the latter half of 2024, Pfizer intends to carry out dose optimization studies for the preferred modified release formulation. These studies will evaluate multiple doses to help determine the most effective and safe dosage for registration-enabling studies.
Pfizer's move is part of a broader effort among pharmaceutical companies to capture a share of the weight loss market, which is anticipated to reach $100 billion in sales by 2030. The company aims to enhance danuglipron's competitive edge by improving its dosing regimen, thereby making it more tolerable for patients while maintaining its efficacy.
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