Danuglipron – BiotechReality – Information Intelligence System for Biopharma

Pfizer (PFE) announced the discontinuation of the development of danuglipron, an oral glucagon-like peptide-1 (GLP-1) receptor agonist, which was under investigation for chronic weight management. Pfizer's dose-optimization studies of once-daily danuglipron formulations (NCT06567327 and NCT06568731) met key pharmacokinetic objectives and confirmed a formulation and dose with the potential to deliver a competitive efficacy and tolerability profile in Phase 3 testing, based on previous studies of twice-daily danuglipron. While the overall frequency of liver enzyme elevations in the danuglipron safety database of over 1,400 participants is consistent with approved agents in the class, a single asymptomatic participant in one of the dose-optimization studies experienced potential drug-induced liver injury, which resolved after danuglipron was discontinued. Pfizer has chosen to cease development of danuglipron following an assessment of all available information, including all clinical data obtained to date and current regulatory input. Also Read: Sanofi’s Investigational New Drug Tolebrutinib for Multiple Sclerosis Shows Positive Results in Phase 3 Trials Cardiovascular and metabolic diseases including obesity remain important areas of unmet medical need, and we plan to continue applying our global capabilities to advance a pipeline of investigational treatments that have the potential to fill critical gaps in patient care, including continued development of our oral GIPR antagonist candidate and other earlier obesity programs, While we are disappointed to discontinue the development of danuglipron, we remain committed to evaluating and advancing promising programs in an effort to bring innovative new medicines to patients. Chris Boshoff Data from the danuglipron clinical development program will be presented at a scientific meeting or published in a peer-reviewed journal in the future. Source: Pfizer Last Modified:

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Pfizer Announces Development Discontinuation of Danuglipron an Oral GLP-1 Receptor Agonist

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