Pfizer's Competitive Aspirations for Daily Oral GLP-1

Pfizer announced on Thursday that it will proceed with the development of a once-daily oral formulation of danuglipron, a GLP-1 receptor agonist, after deciding to discontinue the twice-daily version due to a high drop-out rate in a Phase IIb study. The twice-daily formulation was associated with frequent gastrointestinal side effects, including nausea, vomiting, and diarrhea, leading to more than half of the participants discontinuing the treatment.

Chief scientific officer Mikael Dolsten emphasized the company’s focus on optimizing the trial design and improving the drug's formulation to advance it into registration-enabling studies. Dolsten expressed confidence that the preferred modified-release formulation would be competitive in the market.

Pfizer stated that it has tested various once-daily formulations of danuglipron and found some with promising pharmacokinetic profiles. The company plans to begin dose-optimization studies for the most favorable formulation in the second half of the year, with results anticipated in the first quarter of 2025. These results will guide the registration-enabling program for danuglipron, also known by its code name PF-06882961.

This announcement follows Pfizer's recent disclosure that Mikael Dolsten will step down after over 15 years with the company. An external search for his successor is already in progress. Dolsten’s departure comes at a time when competition in key growth areas such as obesity is intensifying, with comparisons being drawn to rivals like Eli Lilly.

Overall, Pfizer remains committed to advancing its oral GLP-1 receptor agonist, danuglipron, despite previous setbacks, and is focusing on optimizing the drug to make it a viable option for patients.