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Pfizer decides to continue development of GLP agonist Danuglipron | iPharmaCenter

Pfizer Progresses with Once-Daily Oral GLP-1 Receptor Agonist Danuglipron


Pfizer has reported positive pharmacokinetic results from clinical trials of several once-daily modified release formulations of danuglipron, an oral GLP-1 receptor agonist. One formulation, in particular, showed the most promising profile. The company will focus on this preferred formulation for upcoming dose optimization studies, which will guide further registration-enabling studies.


The chosen formulation emerged from an ongoing pharmacokinetic study (NCT06153758). Pfizer plans to begin dose optimization studies in the latter half of 2024, assessing various doses of the preferred formulation to support the registration process.


The current open-label, randomized study involves healthy adults aged 18 and older and examines the pharmacokinetics and safety of both immediate- and modified-release formulations of danuglipron. Results thus far indicate a pharmacokinetic profile that supports once-daily dosing, with a safety profile consistent with earlier studies. No liver enzyme elevations have been observed among more than 1,400 participants.


About Danuglipron

Danuglipron (PF-06882961) is an investigational oral medication not yet approved by health authorities. Developed by Pfizer, danuglipron is a GLP-1 receptor agonist designed to help maintain healthy blood sugar levels by increasing insulin secretion. It may also slow digestion and enhance feelings of fullness after meals, potentially aiding in weight loss.

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