Danuglipron FDA Approval Status
Last updated by Judith Stewart, BPharm on July 11, 2024.
FDA Approved: No
Generic name: danuglipron
Company: Pfizer Inc.
Treatment for: Weight Loss (Obesity/Overweight)
Danuglipron is an oral, glucagon-like peptide-1 (GLP-1) receptor agonist in development for the treatment of obesity.
- Obesity is a complex disease that occurs when an individual’s weight is higher than what is considered healthy for his/her height. According to the CDC, people with a body mass index (BMI) of 30 or higher are considered obese.
- Danuglipron is a GLP-1 receptor agonist that works by stimulating insulin secretion and inhibiting glucagon secretion to lower blood sugar levels, and to delay gastric emptying, which positively regulates appetite and food intake, eventually leading to weight loss.
- The ongoing open-label, randomized study (NCT06153758) of danuglipron is evaluating the pharmacokinetics and safety of immediate- and modified release formulations of danuglipron administered orally in healthy adults 18 years or older. While danuglipron has demonstrated good efficacy in a twice-daily oral formulation, Pfizer plans to conduct dose optimization studies and continue development in a modified release once-daily formulation.
- Danuglipron is also being studied for the treatment of type 2 diabetes mellitus.
Development timeline for danuglipron
Further information
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