Pfizer Advances Development of Once-Daily Formulation of Oral GLP-1 Receptor Agonist Danuglipron
- Clinical evaluation of several modified release once-daily formulations of danuglipron resulted in encouraging pharmacokinetic data for several candidates with one showing the most favorable profile
- The company plans to conduct dose optimization studies with a focus on the preferred formulation to inform the registration enabling studies
“Obesity is a key therapeutic area for
The ongoing open-label, randomized study is evaluating the pharmacokinetics and safety of immediate- and modified release formulations of danuglipron administered orally in healthy adults 18 years or older. To date, study results have demonstrated a pharmacokinetic profile supportive of once-daily dosing. with a safety profile consistent with prior danuglipron studies including no liver enzyme elevations observed in more than 1,400 study participants.
About Danuglipron
Danuglipron (PF-06882961) is an investigational medicine that is taken as a tablet by mouth and is not approved for use by health authorities at this time. Danuglipron, which was discovered and developed in-house at
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Disclosure Notice
The information contained in this release is as of
This release contains forward-looking information about Pfizer’s potential future development of once-daily formulation of danuglipron, an investigational oral GLP-1 receptor agonist, including its potential benefits and a planned dose optimization study of the preferred formulation to inform the registration enabling studies, as well as Pfizer’s pipeline of clinical and pre-clinical candidates in the obesity space, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials (including the planned dose optimization study), regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; uncertainties regarding the future development of danuglipron, including whether or when danuglipron will advance to future studies or phases of development (including the registration enabling studies); the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from the clinical studies; whether and when drug applications for any potential indications for danuglipron may be filed in any jurisdictions; whether and when regulatory authorities in any jurisdictions may approve any such applications, which will depend on a myriad of factors, including making a determination as to whether the product’s benefits outweigh its known risks and determination of the product’s efficacy and, if approved, whether danuglipron will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety, and/or other matters that could affect the availability or commercial potential of danuglipron; uncertainties regarding the impact of COVID-19 on Pfizer’s business, operations and financial results; and competitive developments.
A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended
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