Pfizer said Thursday it is pushing ahead with a once-daily, modified-release formulation of its oral GLP-1 obesity therapy danuglipron, with dose optimization studies in the second half of 2024.
Pfizer on Thursday announced that it will move forward with its oral GLP-1 analog danuglipron, which the pharma hopes will help it carve out a niche in the lucrative obesity market.
According to its announcement, Pfizer has settled on a once-daily, modified-release formulation of danuglipron. The company aims to initiate dose optimization studies for danuglipron in the second half of 2024 to inform future registrational trials.
“Obesity is a key therapeutic area for Pfizer,” CSO Mikael Dolsten said in a statement, adding that its once-daily formulation “has the potential to have a competitive profile in the oral GLP-1 space.” The pharma is currently advancing a “robust pipeline” of obesity therapies, including three clinical candidates and several pre-clinical molecules. Danuglipron is the most mature of these assets.
Pfizer is currently running an open-label and randomized trial of the GLP-1 receptor agonist, assessing the safety and pharmacokinetic profile of immediate- and modified-release formulations in healthy adults. Pharmacokinetic data so far have demonstrated the potential of once-daily, danuglipron dosing, with safety findings showing no new signals of concern.
“Following a thorough analysis of our previous Phase IIb 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,” Dolsten said.
Investors appear to be pleased with Pfizer’s decision to finally advance an obesity candidate. The pharma was trading 4% higher in premarket trading on Thursday, according to SeekingAlpha.
Danuglipron is part of an increasingly popular class of drugs called GLP-1 receptor agonists. The treatments work by mimicking the GLP-1 hormone and activating its corresponding receptor.GLP-1 analogs promote the secretion of insulin from the pancreas in response to blood sugar levels,slowing gastric emptying while reducing hunger and helping suppress appetite.
Pfizer was previously working on a twice-daily formulation of danuglipron, but announced in December 2023 that it was scrapping those plans in favor of a once-daily mix. Phase IIb data showed that the twice-daily regimen carried a high rate of adverse events without offering weight-loss advantages over competitors.
Despite current macro headwinds—such as supply issues, high costs and spotty insurance coverage—analysts expect the obesity market to soar to over $100 billion in value by the early 2030s. The current landscape is dominated by Eli Lilly and Novo Nordisk, which market Zepbound (tirzepatide) and Ozempic (semaglutide), respectively.
Currently available therapies come in the form of injectables, and many anticipate that oral drugs could take the space to even greater heights. Lilly leads the pack in this regard, with its GLP-1 pill orfoglipron eliciting weightloss between 9.4% and 14.7% at 36 weeks. Joining Pfizer and Lilly in the oral obesity race are Novo, Viking Therapeutics and Structure Therapeutics.
