Peptides / Tirzepatide / United States

Tirzepatide in the United States

Legal status, what it is, and the listed suppliers in the United States that list it.

Legal status in the United States

Approved medicine. The FDA label for Mounjaro states it is indicated alongside diet and exercise to improve glycaemic control in adults and children aged 10 and over with type 2 diabetes. A separate label, Zepbound, covers reducing and maintaining weight reduction in adults with obesity, or overweight with a weight-related condition, and treating moderate to severe obstructive sleep apnoea in adults with obesity.

As understood at 2026-09-26. Verify with the FDA.

What Tirzepatide is

Tirzepatide is a synthetic peptide that activates two hormone receptors at once: GIP and GLP-1, both involved in insulin release and appetite. It is a licensed medicine in the UK, the US and Australia, which makes it the most heavily regulated substance covered on this site, and it has the largest trial programme of anything here.

Full Tirzepatide page: targets and research →

Clinical Research

Tirzepatide Once Weekly for the Treatment of Obesity
Jastreboff AM, Aronne LJ, Ahmad NN, et al. (2022). New England Journal of Medicine. human 2,539 adults with obesity, or overweight with a weight-related complication, excluding diabetes; phase 3, double-blind, placebo-controlled, 72 weeks
Tirzepatide for Obesity Treatment and Diabetes Prevention
Jastreboff AM, le Roux CW, Stefanski A, et al. (2025). New England Journal of Medicine. human 1,032 SURMOUNT-1 participants who had both obesity and prediabetes, followed to 176 weeks plus a 17-week period off treatment
Tirzepatide for the Treatment of Obstructive Sleep Apnea and Obesity
Malhotra A, Grunstein RR, Fietze I, et al. (2024). New England Journal of Medicine. human adults with moderate-to-severe obstructive sleep apnoea and obesity across two phase 3 trials, one in people not using positive airway pressure and one in people already using it; 52 weeks
Tirzepatide for Heart Failure with Preserved Ejection Fraction and Obesity
Packer M, Zile MR, Kramer CM, et al. (2025). New England Journal of Medicine. human 731 patients with heart failure, an ejection fraction of at least 50 percent and obesity; international, double-blind, placebo-controlled, at least 52 weeks
Tirzepatide versus GLP-1 receptor agonists and stroke in patients with atrial fibrillation and type 2 diabetes
Lin CL, Lin KC, Yu JM, et al. (2026). Nature Communications. human humans, 14,118 matched pairs, retrospective cohort from an international federated electronic health-record network, adults with atrial fibrillation and type 2 diabetes