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10 Oct 2025, 13:13
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To inform the registration-enabling studies, the drugmaker intends to conduct dosage optimisation studies on several doses of their preferred modified release formulation in the second half of 2024.
Mikael Dolsten, Chief Scientific Officer & President at Pfizer Research and Development, stated that the business has a strong pipeline of three clinical and several pre-clinical prospects. "Obesity is a key therapeutic area for Pfizer."
"In a twice-daily formulation, the most developed one, danuglipron, has shown good performance, and we think a once-daily formulation has the potential to have a competitive profile in the oral GLP-1 area," he continued.
"With the chosen modified release formulation and further trial design optimisation, we believe we can advance a competitive oral GLP-1 molecule into registration enabling studies, with the goal of addressing the current and ongoing medical needs of people living with obesity," the statement reads. "After a thorough analysis of our previous Phase 2b data and trial design."
According to Pfizer, a current open-label, randomised trial is evaluating the safety and pharmacokinetics of danuglipron immediate- and modified-release formulations in people in good health.
Thus far, the data point to a pharmacokinetic profile appropriate for once-daily dosage and a safety profile in line with earlier research, demonstrating no increases in liver enzymes in more than 1,400 subjects.
(Sources: investing.com, reuters.com)