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Pfizer Halts Development of Oral Obesity Drug Danuglipron After Safety Review

Weight-Loss Pill Stopped After Trial Setback

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Pfizer Inc. announced today that it will discontinue the development of danuglipron (PF-06882961), an oral GLP-1 receptor agonist under investigation for chronic weight management. The decision follows a comprehensive review of clinical trial data, including a case of potential drug-induced liver injury. Image; Pfizer image source: János Korom Dr. >17 Million views from Wien, Austria, CC BY-SA 2.0 https://creativecommons.org/licenses/by-sa/2.0, via Wikimedia Commons. medication for illustration purposes
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Mega Doctor News

NEW YORK — Pfizer Inc. announced today that it will discontinue the development of danuglipron (PF-06882961), an oral GLP-1 receptor agonist under investigation for chronic weight management. The decision follows a comprehensive review of clinical trial data, including a case of potential drug-induced liver injury.

The company’s dose-optimization studies (NCT06567327 and NCT06568731) had achieved key pharmacokinetic goals and identified a once-daily formulation with the potential for competitive efficacy and tolerability in Phase 3 trials. However, among more than 1,400 participants, one individual experienced asymptomatic liver enzyme elevations consistent with potential liver injury, which resolved after discontinuation of the drug.

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Dr. Chris Boshoff. Image: LinkedIN

While the overall safety profile was in line with other approved drugs in the GLP-1 class, Pfizer opted to stop development after evaluating the totality of data and receiving input from regulatory authorities.

“Cardiovascular and metabolic diseases, including obesity, remain important areas of unmet medical need,” said Dr. Chris Boshoff, Chief Scientific Officer and President of Research and Development at Pfizer. “We plan to continue advancing a pipeline of investigational treatments, including our oral GIPR antagonist candidate and other earlier-stage obesity programs.”

Pfizer intends to present findings from the Danuglipron clinical program at a scientific forum or submit them for publication in a peer-reviewed journal. The move reflects Pfizer’s continued commitment to innovation in the obesity and metabolic health space despite challenges in drug development. Source: Pfizer.com

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