In This Article:
Pfizer PFE announced that it is discontinuing the development of danuglipron, its investigational oral GLP-1 receptor agonist (GLP-1 RA), which is being developed to treat obesity.
The decision follows a safety signal observed during two dose-optimization studies, in which one study participant experienced a case of potential drug-induced liver injury. Although the individual was asymptomatic and fully recovered after stopping the treatment, Pfizer stated that its decision was based on a comprehensive review of all clinical data generated to date, along with recent regulatory feedback.
While the two dose-optimization studies had met key pharmacokinetic goals and identified a dose with the potential for competitive efficacy and tolerability, the safety concerns ultimately led Pfizer to stop further development of danuglipron.
Obesity Drug Troubles Continue for Pfizer
This is the second time that Pfizer has faced setbacks in connection with the pipeline development of danuglipron. In December 2023, the company announced that it would not move forward with phase III studies on the twice-daily formulation of danuglipron. Though the drug was effective in reducing weight in a phase IIb study, it caused several gastrointestinal side effects like nausea, vomiting and diarrhea. Back then, the company said that the pharmacokinetic study of the once-daily formulation of danuglipron continues, and it will focus on its development.
This also marks the second time in two years that Pfizer has given up on an obesity drug. Back in 2023, Pfizer had dropped the development of another GLP-1-RA candidate, lotiglipron, due to elevated levels of a type of liver enzymes seen in a study.
Following these setbacks, Pfizer has decided to focus on developing its other obesity candidates, which are either in early-stage or mid-stage development. One such candidate is PF-07976016, an investigational GIP receptor being evaluated in a mid-stage study for obesity.
PFE Stock Performance
Year to date, shares of Pfizer have lost nearly 17% compared with the industry’s 7% decline.
Image Source: Zacks Investment Research
LLY, NVO and VKTX Stocks Rise on PFE’s Setback
Post Pfizer’s announcement, shares of Eli Lilly LLY and Novo Nordisk NVO rose 3% and 2%, respectively, on Monday. Both companies dominate the diabetes and obesity market on the back of the tremendous success of their GLP-1 products. Lilly markets its dual GIP and GLP-1 RA, tirzepatide, as Mounjaro for type II diabetes and as Zepbound for obesity. Novo markets its semaglutide drugs as Ozempic pre-filled pen and Rybelsus oral tablet for type II diabetes and as Wegovy injection for weight management.