Pfizer Advances Development of Once-Daily Formulation of Oral GLP-1 Receptor Agonist Danuglipron
Pfizer announced progress in developing a once-daily formulation of the oral GLP-1 receptor agonist danuglipron, showing promising pharmacokinetic data for several candidates. Based on the ongoing pharmacokinetic study NCT06153758, Pfizer selected its preferred formulation and will conduct dose optimization studies in the second half of 2024. Danuglipron, which has shown good efficacy in its twice-daily form, is pivotal in Pfizer's obesity treatment pipeline. The ongoing study has confirmed a supportive pharmacokinetic profile for once-daily dosing and a consistent safety profile with no liver enzyme elevations in over 1,400 participants. The company aims to advance danuglipron into registration-enabling studies to address the medical needs of people living with obesity.
- Pfizer has chosen a promising once-daily formulation for danuglipron after favorable pharmacokinetic data.
- Dose optimization studies for the chosen formulation are scheduled for the second half of 2024.
- Ongoing study results showed a pharmacokinetic profile supportive of once-daily dosing.
- Safety profile consistent with prior danuglipron studies, with no liver enzyme elevations in over 1,400 participants.
- None.
Insights
Pfizer's announcement about the development of a once-daily formulation for danuglipron, an oral GLP-1 receptor agonist, is a significant milestone in the treatment of obesity. The pharmacokinetic data suggest promising improvements in medication adherence and patient convenience, which are critical for chronic conditions like obesity. The once-daily dosing regimen can potentially reduce the pill burden and improve compliance, making it easier for patients to maintain their treatment plans.
It's important for investors to note that the ongoing clinical trials have shown a consistent safety profile with no liver enzyme elevations in over 1,400 participants. This indicates that the new formulation maintains the safety standards of the existing twice-daily formulation. Additionally, the next phase involving dose optimization studies will further refine the efficacy and safety, positioning the drug for future registration-enabling studies.
From a long-term perspective, this development can strengthen Pfizer's pipeline in the competitive oral GLP-1 space. If successful, it can capture a significant market share given the rising prevalence of obesity globally.
The pivot to a once-daily formulation of danuglipron underscores Pfizer's strategic focus on addressing the unmet needs in the obesity therapeutic market. As of now, the twice-daily formulation has demonstrated good efficacy, but the convenience of once-daily dosing could make it more attractive to both patients and healthcare providers.
This move can potentially differentiate Pfizer's product in the highly competitive GLP-1 receptor agonist market, which includes established players like Novo Nordisk's oral semaglutide. With the global obesity drug market expected to grow substantially in the coming years, a successful once-daily formulation could drive significant revenue growth for Pfizer.
Moreover, the absence of adverse liver enzyme effects in a large cohort is a critical differentiator, enhancing the drug's safety profile. This not only boosts confidence among investors but also positions Pfizer well against competitors with less favorable safety profiles.
In the short term, the news could drive positive sentiment around Pfizer's stock, but the real financial impact will be seen post-approval and market adoption.
The announcement of an advanced stage in the development of a once-daily formulation for danuglipron reflects positively on Pfizer's R&D capabilities and its commitment to expanding its product portfolio in the lucrative obesity treatment market. The ongoing pharmacokinetic studies showing favorable results are a positive indicator for future success, potentially leading to significant market penetration upon approval.
Financially, this development could have substantial implications. If the once-daily formulation proves to be effective and safe, it could streamline production and distribution processes, reducing costs associated with the twice-daily dosage. Furthermore, the market's reaction to the announcement could provide a short-term boost to Pfizer's stock price due to heightened investor confidence in the company's growth prospects.
In the long term, successful commercialization of this formulation could lead to a new revenue stream, strengthening Pfizer's position in the obesity treatment market and increasing its competitive edge. However, investors should remain cautious and monitor the progress of the ongoing and upcoming trials.
- 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 Pfizer, and the company has a robust pipeline of three clinical and several pre-clinical candidates. The most advanced of them, danuglipron, has demonstrated good efficacy in a twice-daily formulation, and we believe a once-daily formulation has the potential to have a competitive profile in the oral GLP-1 space,” said Mikael Dolsten, MD., PhD., Chief Scientific Officer & President, Pfizer Research and Development. “Following a thorough analysis of our previous Phase 2b data and trial design, we believe that with the preferred modified release formulation and future trial design optimization, we can advance a competitive oral GLP-1 molecule into registration enabling studies, with the goal of addressing the present and persistent medical needs of people living with obesity.”
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 Pfizer, is a type of investigational medicine known as a GLP-1 receptor agonist. This investigational medicine is intended to keep blood sugar at healthy levels and work by increasing the amount of insulin released. Other potential effects include slowing down the digestion of food and increasing the feeling of fullness after eating, which may be associated with weight loss.
About Pfizer: Breakthroughs That Change Patients’ Lives
At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development, and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments, and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world’s premier innovative biopharmaceutical companies, we collaborate with health care providers, governments, and local communities to support and expand access to reliable, affordable health care around the world. For more than 175 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.Pfizer.com. In addition, to learn more, please visit us on www.Pfizer.com and follow us on X at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.
Disclosure Notice
The information contained in this release is as of July 11, 2024. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.
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 December 31, 2023 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned “Risk Factors” and “Forward-Looking Information and Factors That May Affect Future Results”, as well as in its subsequent reports on Form 8-K, all of which are filed with the
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