Is Icatibant legal in the United States?

Icatibant is a lab-made peptide that blocks bradykinin. It was approved in 2011 as a shot for sudden attacks of hereditary angioedema, an inherited swelling disorder. In one large final-stage study it worked much faster than tranexamic acid tablets. In the other, it did not clearly beat a dummy shot. For swelling caused by blood pressure pills, the larger study against a dummy shot found no benefit.

Icatibant is a lab-made peptide, 10 building blocks long. It uses unnatural building blocks so the body's enzymes cannot chew it up.

How it works: In people, icatibant blocks the bradykinin B2 receptor. In hereditary angioedema, people are short of a protein called C1 inhibitor.

Approval history: FDA approved 25 August 2011 (FIRAZYR, NDA 022150) for sudden attacks of hereditary angioedema in adults, an inherited condition that causes bouts of severe swelling. Given as a shot under the skin. Listed as Prescription when we checked the FDA drug database (Drugs@FDA) on 11 September 2026, along with 6 generic icatibant acetate products approved between 2019 and 2024. It treats an attack once it starts. It does not prevent attacks, and it is not approved for swelling caused by ACE inhibitors, a type of blood pressure drug.

Approves prescription drugs, each for a named use. It also acts against unapproved products, including peptides sold online. Compounding pharmacies, which mix drugs to order, may make some compounds with a prescription. That only applies when the FDA puts the compound in a category of bulk ingredients it allows.

The legal category above is how The Longevity Archive reads U.S. Food and Drug Administration listings for Icatibant on the reviewed date. It is not a legal opinion. Rules change. Bringing a compound into the country, prescribing it and owning it can each be treated differently. Check with the agency before you act on anything here.

Check FDA directly

Whether Icatibant is banned in sport is set by the World Anti-Doping Code and by military rules, not by its legal status in the United States. Before you compete or get tested, look up Icatibant by name on the Prohibited List, or look up a named product in Global DRO. Under the World Anti-Doping Code, category S0 bans, at all times, any drug-like substance that meets two tests. No other section of the List covers it. And no government health regulator anywhere has a current approval for it as a treatment in people. Many substances that are approved somewhere are banned by name in another section. So approval does not mean a substance is allowed in sport.

• WADA Prohibited List
• Global DRO (check a named product)
• USADA (US athletes)
• Operation Supplement Safety (US service members)

The rules you compete or serve under decide this, not this page.