NEW YORK: Pfizer Inc. (PFE.N) has announced plans to re-enter clinical trials later this year for a modified, once-daily version of its weight-loss medication danuglipron, after discontinuing a twice-daily formulation late last year due to adverse effects.
The decision marks Pfizer’s renewed effort to capture a share in the lucrative weight-loss medication market, which is currently dominated by Eli Lilly’s Zepbound and Novo Nordisk’s Wegovy. Pfizer’s new medication is part of the second generation of weight-loss pills.
According to industry analysts, the weight-loss medication market is anticipated to grow substantially, potentially reaching annual sales of nearly $150 billion by the early 2030s.
Pfizer did not provide a specific timeline for the development of the once-daily danuglipron but indicated plans to evaluate the reformulated medication at various doses in the second half of this year before advancing to clinical trials.
The pharmaceutical giant had halted the development of the twice-daily danuglipron due to a high incidence of adverse effects such as nausea and vomiting. Meanwhile, another weight-loss medication, lotiglipron, was discontinued over safety concerns related to elevated liver enzyme levels in some patients.
JP Morgan analyst Chris Schott expressed caution regarding Pfizer’s new formulation, noting concerns over its tolerability profile. He suggested that the drug may have a limited role in the market until more clarity on its safety and efficacy is established.
Pfizer’s stock rose by 2.8% to $29.14 in premarket trading following the announcement. The company’s shares have faced challenges recently, partly due to concerns over its pipeline and a decline in sales of COVID-19 medicines, with shares having declined more than 50% from their peak in December 2021.
Pfizer highlighted preliminary trial results from over 1,400 healthy adult volunteers, indicating no significant issues with elevated liver enzymes with the once-daily dose of danuglipron. The medication belongs to the class of GLP-1s, which mimic the GLP-1 hormone to regulate blood sugar, slow digestion, and reduce appetite. Initially developed for type 2 diabetes treatment, GLP-1s have found application in weight-loss therapies.
