Tirzepatide: What It Is and Its U.S. Regulatory Status

What is tirzepatide?

Tirzepatide is a synthetic peptide medicine developed by Eli Lilly. It acts on two hormone receptors: the GIP receptor and the GLP-1 receptor. GIP and GLP-1 are incretin hormones, which the gut releases after eating. Because it activates both, tirzepatide is described as a dual GIP and GLP-1 receptor agonist.

U.S. regulatory status

Current status: FDA-approved prescription drug (Rx only).

This means the FDA has reviewed and approved at least one product containing tirzepatide for specific uses, and it can only be dispensed with a valid prescription. The approval covers the approved product itself. It does not extend to unapproved products sold under the same name.

Brand names and approved uses

• Mounjaro: approved for use in adults with type 2 diabetes, together with diet and exercise.
• Zepbound: approved for chronic weight management in certain adults with obesity, or with overweight and a weight-related health condition. It is also approved for moderate to severe obstructive sleep apnea in adults with obesity.

Both products carry a boxed warning about the risk of thyroid C-cell tumors. A prescriber reviews personal and family medical history before deciding whether tirzepatide is appropriate.

How is it accessed?

Tirzepatide is available only by prescription from a licensed healthcare provider, and it is dispensed by a licensed pharmacy. The FDA has publicly raised concerns about unapproved GLP-1 products, including some sold as tirzepatide. Those products are not covered by the approval of Mounjaro or Zepbound.

Why Peptide Labs does not sell tirzepatide

Peptide Labs does not sell this compound. This page is general information, not medical advice. We are not a pharmacy, and we do not provide prescription medicines of any kind.

If you have questions about tirzepatide or a related health concern, talk to a licensed healthcare provider who knows your medical history.

Related reading

See the full list of compound profiles in the Peptide Guide. For background on what the label “FDA-approved prescription drug” means, read what "FDA-approved prescription drug" means.