Is Icatibant legal in the United States?

A synthetic decapeptide that blocks the bradykinin B2 receptor, approved in 2011 for acute attacks of hereditary angioedema. It beat tranexamic acid in one phase 3 trial and did not separate from placebo in the other, and in ACE inhibitor angioedema the larger placebo-controlled trial was null.

Icatibant is a 10 amino acid synthetic peptide built with non-natural amino acids so that proteases cannot break it down, which is what lets a peptide antagonist survive as a subcutaneous injection. It blocks the bradykinin B2 receptor, and since bradykinin is the mediator that produces the swelling in hereditary angioedema, blocking that receptor stops an attack.

Mechanism: In humans, icatibant competitively antagonises the bradykinin B2 receptor. In hereditary angioedema, C1 inhibitor deficiency allows uncontrolled kallikrein activity and excess bradykinin, which increases vascular permeability and produces the characteristic swelling; blocking B2 removes the signal that causes the swelling.

Regulatory history: FDA approved 25 August 2011 (FIRAZYR, NDA 022150) for acute attacks of hereditary angioedema in adults, subcutaneous injection. Listed Prescription on the 11 September 2026 Drugs@FDA query, alongside 6 generic icatibant acetate products approved between 2019 and 2024. It is an acute treatment, not a prophylactic, and it is not approved for ACE inhibitor-induced angioedema.

Approves prescription drugs by indication and polices unapproved products, including peptides sold online. Compounding pharmacies may prepare some compounds under a prescription when the FDA places them on a permitted bulk-substances category.

The classification above is the The Longevity Archive reading of U.S. Food and Drug Administration listings for Icatibant at the reviewed date, not a legal opinion. Rules change, and importing, prescribing and possessing a compound can each be treated differently. Check the regulator directly before acting on anything here.