Pfizer streamlines GLP-1 drug development, advancing danuglipron
Pfizer Inc. will continue late-stage clinical development for its oral GLP-1 receptor agonist candidate, danuglipron, for obesity and Type 2 diabetes. The company will discontinue development of lotiglipron.
New York – Pfizer Inc. announced on Monday its decision to advance its oral glucagon-like peptide-1 receptor agonist (GLP-1-RA) candidate, danuglipron, into late-stage clinical development for adults with obesity and Type 2 diabetes mellitus (T2DM). The company will discontinue the clinical development of its other GLP-1-RA candidate, lotiglipron.
The continuation of danuglipron development is subject to results from an ongoing Phase 2 trial, Pfizer stated. The company plans to finalize its late-stage program plans for danuglipron by the end of 2023 and is also developing a once-daily modified-release version. The Phase 2b study for danuglipron in obesity is fully enrolled.
Previous Phase 2 study data for danuglipron in T2DM, published in JAMA Network Open, showed dose-dependent reductions in HbA1c, fasting plasma glucose, and body weight over 16 weeks. Common adverse events included nausea, vomiting, and diarrhea. The safety profile to date, including transaminase changes, appears similar to the peptidic GLP-1-RA class.
Pfizer cited pharmacokinetic data from Phase 1 drug-drug interaction studies and elevated transaminase laboratory measurements as reasons for discontinuing lotiglipron. While no liver-related symptoms or failure were reported, Pfizer opted to halt further development. No similar transaminase elevations have been observed in the danuglipron program involving over 1,400 participants.