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

What is semaglutide?

Semaglutide is a synthetic peptide medicine developed by Novo Nordisk. It acts on the GLP-1 receptor. GLP-1 (glucagon-like peptide-1) is a hormone the gut releases after eating, and it is involved in blood sugar control and appetite signals. Semaglutide was designed to last much longer in the body than natural GLP-1.

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 semaglutide 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

  • Ozempic: approved for certain adults with type 2 diabetes.
  • Rybelsus: a tablet approved for certain adults with type 2 diabetes.
  • Wegovy: approved for chronic weight management in certain adults and adolescents, with additional approved uses listed on its label.

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

How is it accessed?

Semaglutide is available only by prescription from a licensed healthcare provider and is dispensed by a licensed pharmacy. The FDA has warned consumers about counterfeit and unapproved products sold as semaglutide, including products sold online. Those products are not covered by the FDA approval of the brand-name medicines.

Why Peptide Labs does not sell semaglutide

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.

For personal medical questions, including questions about semaglutide, the right person to ask is a licensed healthcare provider.

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.