Pfizer scraps each day weight reduction pill danuglipron after a liver injury

Pfizer on Monday said it will end development of its experimental each day weight reduction pill after a patient experienced a liver injury that was potentially brought on by the drug in a trial. 

The patient didn’t experience any liver-related symptoms or negative effects, a Pfizer spokesperson said in an announcement. They added that the patient’s liver enzymes “recovered rapidly” after they stopped taking the pill, which is an oral GLP-1 drug called danuglipron. The statement suggests that the patient’s liver enzymes were elevated, which frequently indicates damage to cells within the organ and is a problem that has been linked to another obesity drugs.

The case occurred in a trial that quickly increased the dose of the pill over a brief time period, the spokesperson said. Pfizer’s decision to halt development of the drug got here after “a review of the totality of data, including all clinical data generated thus far for danuglipron and up to date input from regulators,” in keeping with a release.

“While we’re disenchanted to discontinue the event of danuglipron, we remain committed to evaluating and advancing promising programs in an effort to bring revolutionary latest medicines to patients,” Dr. Chris Boshoff, Pfizer’s chief scientific officer, said in the discharge. He added that the corporate continues to be developing other weight reduction drugs.

The announcement adds to a string of setbacks in the corporate’s bid to win a slice of the booming marketplace for GLP-1s, which mimic certain gut hormones to tamp down appetite and regulate blood sugar. Pfizer is amongst several drugmakers racing to bring a more convenient weight reduction medicine to an area dominated by weekly injections, nevertheless it is years behind competitors comparable to Eli Lilly and Novo Nordisk.

Some Wall Street analysts expect the GLP-1 industry to be value greater than $150 billion by the early 2030s. Oral GLP-1s could grow to be value $50 billion of that total, while injections would account for the remaining, in keeping with some analyst estimates.

This isn’t Pfizer’s first set back with danuglipron, specifically, either. The corporate discontinued a twice-daily version of the pill in December 2023 after patients had trouble tolerating the drug in a mid-stage study.

But Pfizer gave the impression to be confident within the once-daily type of danuglipron back in July, when it said it will start conducting studies within the second half of the 12 months to guage multiple doses of the pill.

Despite its decision to scrap the drug, Pfizer on Monday said those studies met key goals and confirmed a certain form and dose of the pill with the potential to deliver “competitive efficacy and tolerability” in late-stage trials.

The corporate also noted that the speed of elevated liver enzymes in individuals who have taken danuglipron is in keeping with approved GLP-1 drugs, which is predicated on a security database of greater than 1,400 patients who’ve taken Pfizer’s pill.

Pfizer scrapped a unique once-daily obesity pill back in June 2023 after patients who took that drug had higher liver enzyme levels in a mid-stage trial. Investors have been pessimistic concerning the company’s potential within the GLP-1 space ever since.

Still, Pfizer has other experimental obesity drugs in its pipeline within the early stages of development that appear to work in a different way from its now-discontinued treatments. That features an oral drug that blocks one other gut hormone called GIPR, which entered phase two trials last 12 months, and a further once-daily oral GLP-1 in phase one trials.

Pfizer believes a drug targeting GIPR may very well be simpler and easier for patients to tolerate, former Chief Scientific Officer Mikael Dolsten, who has since left the corporate, told investors in October. He added that “there are such a lot of applications for GLP-1s.”

Pfizer’s danuglipron promotes weight reduction by targeting GLP-1, which can be how Novo Nordisk’s weight reduction injection Wegovy and diabetes treatment Ozempic work. Eli Lilly’s weight reduction injection Zepbound and diabetes shot Mounjaro goal GLP-1 but in addition activate one other gut hormone called GIP.

The one oral GLP-1 approved by the Food and Drug Administration up to now is Novo Nordisk’s Rybelsus, which treats Type 2 diabetes and raked in about $3.38 billion in sales in 2024.

Pfizer’s announcement Monday comes as the corporate regains its footing and recovers its share price after the rapid decline of its Covid business. Pfizer is betting on its pipeline of cancer drugs to deliver long-term growth, but has emphasized that obesity is a key focus.