Pfizer's once-daily oral GLP-1 drug passes first clinical tests

Pfizer is making a move on its obesity pipeline after multiple quarters of questions from investors and analysts.

The New York pharma giant said Thursday it will move a once-daily, modified release formulation of danuglipron into dose optimization studies by the end of this year to “inform the registration enabling studies.” Data from the dose optimization Phase 1b are expected in the first quarter of 2025, according to a Pfizer spokesperson.

Last December, Pfizer abandoned a twice-daily version of the oral GLP-1 due to high rates of gastrointestinal side effects. It was in Phase 2b testing at the time, meaning Pfizer could’ve entered late-stage testing and gotten closer to mounting a challenge against market leaders Novo Nordisk and Eli Lilly.

Pfizer’s shares $PFE were up about 1.3% after the opening bell.

Mikael Dolsten

Getting an obesity drug into late-stage testing could be one of the last major moves under Pfizer chief scientific officer Mikael Dolsten, who will be leaving around early 2025, once the company has found his successor, Pfizer announced earlier this week. In Thursday’s announcement, Dolsten described obesity as a “key therapeutic area” for the company, noting they have three clinical-stage candidates and more in preclinical R&D.

“Following a thorough analysis of our previous Phase 2b data and trial design, we believe that with the preferred modified release formulation and future trial design optimization, we can advance a competitive oral GLP-1 molecule into registration enabling studies, with the goal of addressing the present and persistent medical needs of people living with obesity,” Dolsten said in the press release.

Analysts have pinned high hopes on a simpler obesity drug in the form of a pill. Novo’s Wegovy and Lilly’s Zepbound require injections, which involve more complex manufacturing and have led the pharma companies to go on multibillion-dollar investment sprees to shore up their ability to meet demand.

Editor’s note: This story was updated with a comment from a Pfizer spokesperson and stock reaction. Max Bayer contributed reporting.