FDA-Approved Dual GLP-1/GIP Receptor Agonists
Currently, only one dual GLP-1 and GIP receptor agonist is FDA-approved: tirzepatide (Mounjaro for type 2 diabetes, Zepbound for obesity). 1, 2
Approval Timeline and Indications
- Tirzepatide received FDA approval in May 2022 for the treatment of type 2 diabetes 3
- The medication subsequently received FDA approval in November 2023 for obesity treatment 2
- Tirzepatide is administered as a once-weekly subcutaneous injection, with maximum approved daily dose of 15 mg weekly 1
Mechanism Distinguishing It From Single-Receptor Agonists
- Tirzepatide is classified as a "Dual GIP and GLP-1 RA" in the American Diabetes Association's 2025 pharmacologic treatment guidelines, representing a distinct drug class from traditional GLP-1 receptor agonists 1
- The dual-hormone mechanism acts on both GLP-1 receptors and glucose-dependent insulinotropic polypeptide (GIP) receptors, providing superior weight loss (20.9%) compared to semaglutide (14.9%), a pure GLP-1 receptor agonist 2
- Tirzepatide's dual-receptor action provides enhanced metabolic benefits, including delayed gastric emptying, suppressed appetite, and improved insulin secretion, compared to semaglutide's single-receptor action 2
Clinical Superiority Evidence
- Tirzepatide demonstrates superior efficacy with dose-dependent effects (5,10, and 15 mg), showing greater reduction in HbA1c and body weight compared to placebo, basal insulin, and two GLP-1 analogues (dulaglutide and semaglutide) in the SURPASS clinical program 4
- The medication achieves mean weight loss of 20.9% at 72 weeks, representing a 6% absolute advantage over semaglutide 2.4 mg weekly 2
Pricing Considerations
- The median average wholesale price (AWP) for tirzepatide 15 mg pen is $1,283 per 30-day supply, with median NADAC (National Average Drug Acquisition Cost) of $1,030 1