Pfizer Ends Development of Danuglipron Following Safety Concerns

Pfizer has officially halted the development of its oral obesity drug candidate, danuglipron, after a clinical trial participant experienced a potential drug-induced liver injury. The asymptomatic case was resolved after discontinuation, but Pfizer decided to end the program based on the incident, cumulative trial data, and regulatory feedback. Danuglipron, a GLP-1 receptor agonist, had previously completed multiple Phase I and II studies involving around 1,400 patients. Despite positive pharmacokinetic results, safety concerns have led to its discontinuation.

This marks Pfizer’s second danuglipron setback, following the December 2023 termination of its twice-daily version due to gastrointestinal side effects. The company also dropped lotiglipron in mid-2023 over elevated liver enzymes.

Pfizer is still active in the obesity drug space, currently developing PF-07976016, a GIP receptor antagonist in Phase IIa trials. However, it faces intense competition from established players like Novo Nordisk and Eli Lilly, as well as rising biotech contenders like Viking Therapeutics.

24-04-2025