Pfizer announced early Thursday morning that it has selected its preferred once-daily modified release formulation of danuglipron, a move that it said was a significant milestone in the obesity drug’s development.
Danuglipron, an oral glucagon-like peptide-1 (GLP-1) receptor agonist, will undergo dose optimization studies in the second half of 2024 as Pfizer seeks to evaluate multiple doses of the formulation which they hope will 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.”
In this file photo, a person walks past the Pfizer Headquarters building in the Manhattan borough of New York City, Dec. 7, 2020.
Carlo Allegri/Reuters
Participants in the study so far have included healthy adults aged 18 years or older and the results thus far have shown a profile that supports once-daily dosing, which is consistent with previous danuglipron studies. Notably, there have been no liver enzyme elevations observed among the more than 1,400 study participants.
Danuglipron is an investigational medicine that is taken as a tablet by mouth and is currently not approved for use by health authorities.
Current popular FDA approved weight loss medications Wegovy and Zepbound are weekly injections.
Pfizer will still need to do large scale clinical trials to produce the data necessary to show it’s safe, effective and tolerable and then submit to FDA — a process which is still likely much further down the line.
Pfizer, one of the leading pharmaceutical companies in the world, has recently introduced a new once-daily drug called danuglipron for the treatment of obesity. This groundbreaking medication offers hope to the millions of people struggling with weight management and related health issues.
Obesity is a major public health concern, with rates on the rise globally. It is associated with a range of serious health conditions, including heart disease, diabetes, and certain types of cancer. Despite the availability of various weight loss treatments, many individuals find it difficult to achieve and maintain a healthy weight.
Danuglipron works by targeting the body’s metabolism, helping to regulate appetite and promote fat burning. This unique mechanism of action sets it apart from other weight loss medications currently on the market. Clinical trials have shown promising results, with participants experiencing significant reductions in body weight and improvements in metabolic markers.
One of the key advantages of danuglipron is its once-daily dosing, making it convenient and easy to incorporate into daily routines. This can help improve adherence to treatment, which is crucial for long-term success in managing obesity.
It is important to note that danuglipron is not a magic pill and should be used in conjunction with a healthy diet and regular exercise. Lifestyle modifications are essential for achieving sustainable weight loss and overall well-being.
As with any medication, danuglipron may have side effects and interactions with other drugs. It is important to consult with a healthcare provider before starting treatment to ensure that it is safe and appropriate for individual needs.
In conclusion, Pfizer’s introduction of danuglipron represents a significant advancement in the field of obesity treatment. This innovative drug offers new hope for individuals struggling with weight management and provides a valuable tool in the fight against this growing epidemic. With proper guidance and support, danuglipron has the potential to help many people achieve their weight loss goals and improve their overall health.
