April 14 (UPI) — Pfizer on Monday announced it is halting development of a daily weight loss pill after one patient experienced a liver injury and previous problems with other pill versions.
The pharmaceutical company based in New York City had been studying danuglipron since 2022.
Pfizer said a Phase 2 study met key pharmacokinetic objectives, and a competitive efficacy and tolerability in Phase 3 testing. More than 1,400 people who took the experimental drug had raised liver enzymes about the same as for other approved drugs.
But one person had problems.
“A single asymptomatic participant in one of the dose-optimization studies experienced potential drug-induced liver injury which resolved after discontinuation of danuglipron,” the company said in a news release. “After a review of the totality of information, including all clinical data generated to date for danuglipron and recent input from regulators, Pfizer has decided to discontinue development of the molecule.”
The company plans to present data from the danuglipron clinical development program at a scientific forum or submitted for publication in a peer-reviewed journal.
And the company is working to develop other weight-loss drugs, Dr. Chris Boshoff, MD, Ph.D., chief scientific officer and president and Research and Development at Pfizer, said.
“Cardiovascular and metabolic diseases including obesity remain important areas of unmet medical need, and we plan to continue applying our global capabilities to advance a pipeline of investigational treatments that have the potential to fill critical gaps in patient care, including continued development of our oral GIPR antagonist candidate and other earlier obesity programs,” Boshoff said in a statement. “While we are disappointed to discontinue the development of danuglipron, we remain committed to evaluating and advancing promising programs in an effort to bring innovative new medicines to patients.”
In June 2023, Pfizer scrapped once-daily weight-loss pill back after patients had higher liver enzyme levels in a mid-stage trial.
In December 2023, Pfizer discontinued development of a twice-daily version after patients had trouble tolerating it in a mid-stage study.
In July 2024, the company conducted studies to evaluate multiple doses.
Pfizer is among several drugmakers seeking to develop a pill form for weight loss rather than weekly injections, including by competitors Eli Lilly with Zepbound and Novo Nordisk with Wegovy. The companies also make Type 2 diabetes drugs that can bring about weight loss.
GLP-1s mimics certain gut hormones to reduce appetite and regulate blood sugar.
The Food & Drug Administration has approved the only oral GLP-1 pill form: Novo Nordisk’s Rybelsus, which treats Type 2 diabetes. In 2024, it brought in $3.38 billion in sales.
CNBC reported Wall Street analysts expect the GLP-1 industry to be worth more than $150 billion by the early 2030s and oral ones could be worth $50 billion of that total.
The company for 175 years “had worked to make a difference for all who rely on us,” according to the news release.” Its revenue was $63.6 billion in 20234 with net income of $8.02 billion.
At 1:30 p.m., Pfizer’s stock was down 2 cents to $21.89.
Pfizer worked with BioNTech, based in Germany, to develop a vaccine to prevent Covid-19. It became available in the United States in December 2020 with the U.S. government paying $3.2 billion for the first 105 million doses. The company had revenue of $11 billion in 2023 from sales of Comirnaty, the mRNA Covid-19 vaccine.
