Pfizer this week (April 14) revealed that it has decided to “discontinue development” of danuglipron – an oral glucagon-like peptide-1 receptor agonist (GLP-1RA) – which was being investigated “for chronic weight management”.
The pharmaceutical company had been studying a “once-daily” formulation of danuglipron after previously calling off a “twice-daily” version of the same drug in December 2023.
But it decided to discontinue this latest study after “a single asymptomatic participant in one of the dose-optimisation studies experienced potential drug-induced liver injury”.
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According to Pfizer, the once-daily dose of danuglipron had “met key...objectives” and had the potential “to deliver a competitive efficacy and tolerability profile” in the next phase of testing.
It said that the “overall frequency of liver enzyme elevations across the over 1,400 participant safety database...[was] in line with approved agents in the class”.
But after a review of “the totality of information...Pfizer has decided to discontinue development of the molecule”, it added.
“Unmet medical need”
Pfizer chief scientific officer Chris Boshoff said that while the company is “disappointed to discontinue the development of danuglipron, [it remains] committed to evaluating and advancing promising programs in an effort to bring innovative new medicines to patients”.
“Cardiovascular and metabolic diseases including obesity remain important areas of unmet medical need, and we plan to continue applying our global capabilities to advance a pipeline of investigational treatments that have the potential to fill critical gaps in patient care,” he added.
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It comes after the company decided at the end of 2023 that the “twice-daily danuglipron formulation [would] not advance into phase three studies” due to “high discontinuation rates” of the drug that were “greater than 50%” and “high rates” of nausea and vomiting.
Then-chief scientific officer Mikael Dolsten said at the time that Pfizer believed “an improved once-daily formulation of danuglipron could play an important role in the obesity treatment paradigm”.
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Meanwhile, the British Medical Journal (BMJ) published a study in February that revealed GLP-1RAs “are not associated with an increased risk of suicidal ideation, self-harm and suicide...among patients with type 2 diabetes”.
And another study published in January found that GLP-1RAs were associated with a “reduced risk of substance use” and “neurocognitive disorders” including Alzheimer’s and dementia.
