Is Icatibant legal in Australia?

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.

Registers or lists therapeutic goods on the ARTG and schedules substances in the Poisons Standard. Many peptides are Schedule 4 (prescription only), so possession without a prescription and personal importation are restricted even when no product is registered.

The classification above is the The Longevity Archive reading of Therapeutic Goods 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.