Pfizer Halts Oral GLP-1 Drug Danuglipron Development Amid Liver Safety Concerns

New York, Pfizer Inc. (NYSE: PFE) announced yesterday it discontinued development of danuglipron (PF-06882961), an investigational oral GLP-1 receptor agonist intended for chronic weight management. The decision follows a comprehensive review of clinical data and recent regulatory feedback.

Pfizer Ends Oral GLP-1 Drug Danuglipron Development Due to Liver Safety

Although Pfizer’s dose-optimization studies for once-daily danuglipron (NCT06567327 and NCT06568731) successfully met pharmacokinetic objectives and identified a formulation with promising efficacy and tolerability for Phase 3 trials. A potential safety concern led to the program’s termination. Specifically, one participant experienced possible drug-induced liver injury, which resolved after stopping the medication. While the overall incidence of liver enzyme elevations across the 1,400+ participant safety database aligned with existing approved treatments, the isolated event prompted heightened scrutiny.

“Obesity and related metabolic disorders continue to represent significant unmet medical needs,” said Dr. Chris Boshoff, Chief Scientific Officer and President of Research and Development at Pfizer. “While it’s disappointing to end development of danuglipron, we remain committed to advancing innovative therapies, including our oral GIPR antagonist candidate and other early-stage obesity programs.”

Pfizer plans to present data from the danuglipron clinical program at a scientific conference or submit it for publication in a peer-reviewed journal. The move marks a strategic shift in Pfizer’s metabolic disease pipeline. The company redirects its focus to alternative approaches in the competitive obesity treatment landscape.

Rising Demand for GLP-1 Receptor Agonists in Obesity and Diabetes Care

GLP-1 receptor agonists have become a cornerstone in the treatment of obesity and type 2 diabetes, driven by their ability to promote weight loss, improve glycemic control, and reduce cardiovascular risk. These drugs mimic the action of the natural hormone GLP-1, which helps regulate blood sugar and appetite. With the global obesity epidemic showing no signs of slowing down, demand for effective and sustainable treatment options has surged. It created a multibillion-dollar market opportunity for pharmaceutical companies.

Novo Nordisk Leverages Semaglutide to Lead the Market

Danish pharmaceutical giant Novo Nordisk has led the way in this space with semaglutide, a once-weekly injectable GLP-1 receptor agonist. It is marketed under the brand names Ozempic for type 2 diabetes and Wegovy for chronic weight management. Clinical trials have demonstrated significant weight reduction of up to 15% or more in some patients, along with notable improvements in blood glucose control. These results have helped propel semaglutide into widespread clinical use. This made Wegovy the first GLP-1 therapy specifically approved for weight loss in non-diabetic individuals.

Eli Lilly’s Tirzepatide Raises the Bar

Eli Lilly has further intensified the competition with tirzepatide, a dual GLP-1/GIP receptor agonist that has shown superior efficacy compared to semaglutide in head-to-head trials. Marketed as Mounjaro for diabetes and Zepbound for obesity, tirzepatide has demonstrated weight loss exceeding 20% in some clinical studies. It redefines expectations for pharmacologic obesity treatment. Its strong clinical profile and rapid uptake have positioned Lilly as a major contender in the obesity therapeutics market.

Pfizer’s Exit Reflects a Highly Competitive and Evolving Landscape

In this increasingly crowded and high-performing therapeutic class, the bar for safety and efficacy continues to rise. Pfizer’s decision to discontinue development of its oral GLP-1 receptor agonist danuglipron. The decision underscores the challenges of differentiating new entrants amid already strong clinical benchmarks. Despite promising pharmacokinetic data and competitive efficacy potential, the program was halted due to safety considerations and strategic portfolio prioritization. As the obesity treatment market continues to evolve, companies must balance innovation with regulatory rigor and commercial viability.

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Author

Steven Chung

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