Is Tirzepatide legal in the US?
Yes, FDA approved for type 2 diabetes, weight loss and sleep apnea.
Tirzepatide is approved by the FDA as Mounjaro (2022) for type 2 diabetes in adults, extended to children 10 and older and to cardiovascular risk reduction in adults with type 2 diabetes and established cardiovascular disease, and as Zepbound (2023) for chronic weight management and for moderate to severe obstructive sleep apnea in adults with obesity. 1341011
As Mounjaro: type 2 diabetes in adults and children 10 and older. It is also approved to lower cardiovascular risk in adults with type 2 diabetes and heart disease. As Zepbound: chronic weight management in adults with obesity or overweight plus a weight-related condition. It is also approved for moderate to severe obstructive sleep apnea in adults with obesity. 1341011
Read the full Tirzepatide page
More on Tirzepatide
Citations
- FDA 2025: Mounjaro (tirzepatide) prescribing information accessdata.fda.gov
- Jastreboff 2022, NEJM: Tirzepatide once weekly for the treatment of obesity (SURMOUNT-1) doi.org
- FDA 2025: Zepbound (tirzepatide) prescribing information accessdata.fda.gov
- FDA 2024: FDA approves first medication for obstructive sleep apnea fda.gov
- 2022, Int J Mol Sci: Tirzepatide, a dual GIP/GLP-1 receptor agonist, mechanism and metabolic effects doi.org
- 2024, Diabetologia: network meta-analysis of tirzepatide versus semaglutide in type 2 diabetes (28 RCTs) doi.org
- Aronne 2024, JAMA: Continued treatment with tirzepatide for maintenance of weight reduction (SURMOUNT-4) doi.org
- Garvey 2023, Lancet: Tirzepatide once weekly in adults with obesity and type 2 diabetes (SURMOUNT-2) doi.org
- FDA Drugs@FDA: Mounjaro NDA 215866 accessdata.fda.gov
- FDA 2026: Mounjaro label, pediatric type 2 diabetes accessdata.fda.gov
- FDA 2026: Mounjaro label, cardiovascular risk reduction accessdata.fda.gov
- FDA Drugs@FDA: Zepbound NDA 217806 accessdata.fda.gov
- FDA: Concerns with unapproved GLP-1 drugs used for weight loss fda.gov
- Malhotra 2024, NEJM: Tirzepatide for obstructive sleep apnea and obesity (SURMOUNT-OSA) doi.org
- Jastreboff 2024, NEJM: Tirzepatide for obesity treatment and diabetes prevention, three-year SURMOUNT-1 doi.org
- 2025, Cureus: tirzepatide versus semaglutide for weight loss, meta-analysis of seven direct comparative studies doi.org
- Rescalli 2026, Hum Psychopharmacol: tirzepatide initiation in lithium-treated bipolar disorder, renal and lithium safety over 12 months pubmed.ncbi.nlm.nih.gov
Reference information only, not medical advice. Drawn from the Tirzepatide article, fact-checked against the cited sources. No dosing anywhere on this site.