Pfizer Discontinues Clinical Development of Oral GLP-1 Receptor Agonist Danuglipron Due to Safety Concerns

On April 14, in New York, Pfizer announced the decision to halt the development of oral glucagon-like peptide-1 (GLP-1) receptor agonists.Dosedanuglipron (PF-06882961), which is under research for chronic weight management. In 2023, Pfizer terminated another small-molecule GLP-1 Receptor AgonistClinical Development of Lotiglipron.

PfizerdanuglipronDose Optimization Studies for Once-Daily Formulations (NCT06567327 and NCT06568731) Achieved Key Pharmacokinetic Objectives and Were Based on EarlydanuglipronThe twice-daily regimen demonstrated in the study confirms that a formulation and dosage could offer competitive efficacy and tolerability in Phase 3 clinical trials. Although the overall frequency of elevated liver enzymes in the safety database of more than 1,400 participants using danuglipron was consistent with approved drugs in this class, one asymptomatic participant experienced potential drug-induced liver injury in a dose-optimization study after discontinuation.Danuglipron was alleviated. After reviewing all the information, including so farAfter reviewing all clinical data generated by danuglipron and the latest communications with regulatory agencies, Pfizer has decided to halt the development of this molecule.

Pfizer Chief Scientific Officer and President of R&D, Dr. Chris Boshoff, said:"Cardiovascular and metabolic diseases, including obesity, remain significant areas of unmet medical need. We plan to continue leveraging our global capabilities to advance a range of investigational therapies that have the potential to fill critical gaps in patient care, including the continued development of our oral GIPR antagonist candidate and other early-stage obesity programs. Although we have decided to stop"We are disappointed in the development of danuglipron, but we remain committed to evaluating and advancing promising projects, striving to bring innovative new drugs to patients."

Data from the danuglipron clinical development program will be presented at scientific forums or submitted for publication in peer-reviewed journals in the future.