Pfizer Inc. (NSE: PFIZER), a leading pharmaceutical company in the U.S., has announced that a once-daily oral formulation of danuglipron, its investigational GLP-1 agonist for the treatment of type 2 diabetes and obesity, has been selected for full clinical development. This decision is based on positive findings from an ongoing pharmacokinetic study (NCT06153758), which is evaluating several candidates in 1,400 healthy adults to identify the formulation with the most favorable profile. The selected candidate will now proceed to dose optimization studies in preparation for registration-enabling studies.
Danuglipron, which has already shown good efficacy in a twice-daily formulation, is being optimized by Pfizer to ensure competitiveness in the oral GLP-1 agonist field. Mikael Dolsten, Pfizer’s outgoing Chief Scientific Officer, stated, “After a meticulous review of our previous Phase IIb data and trial design, we are confident that with the preferred modified release formulation and future enhancements in trial design, we can progress a competitive oral GLP-1 molecule towards registration-enabling studies.” Pfizer intends to initiate dose-optimization studies in the second half of 2024.- Flcube.com
