Is Icatibant legal?
Written by Aaron CuhaReviewed Sep 2026
- US: FDA-approved, prescription only
- UK: Prescription only; check current MHRA status
- AU: Prescription only; check current TGA status
- CA: Prescription only; check current Health Canada status
The US comes first because most people ask about it. Each country has its own page. It names the agency, the law or rule, and what the legal category means in real life.
All four countries, side by side
| What we list | United States · FDA | United Kingdom · MHRA | Australia · TGA | Canada · Health Canada |
|---|---|---|---|---|
| Status | Approved | Prescription route | Prescription route | Prescription route |
| Legal category | FDA-approved, prescription only | Prescription only; check current MHRA status | Prescription only; check current TGA status | Prescription only; check current Health Canada status |
| Note | FIRAZYR, NDA 022150, approved 25 August 2011, listed Prescription on 11 September 2026, with 6 generic icatibant acetate injections also listed Prescription. | None recorded | None recorded | None recorded |
| Agency | Check FDA directly | Check MHRA directly | Check TGA directly | Check Health Canada directly |
US FDA status: 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.. Reviewed Sep 2026.
Country by country
Is Icatibant legal in the United States?
Yes. Icatibant is an approved medicine in the United States. Its legal category is "FDA-approved, prescription only". The approval covers the use on its label. It is given out on prescription, not sold over the counter. Products labeled "research use only" are not covered by that approval, and that label does not make them legal to use in people. On the evidence, 5 completed human trials are cited on its profile.
The full United States answerIs Icatibant legal in the United Kingdom?
Icatibant is available in the United Kingdom only through a prescriber. Its legal category is "Prescription only; check current MHRA status". It is not sold over the counter. Using it rests on the prescriber's judgment, not on an approval to sell it. Vials sold "for research use only" fall outside that route, and the label does not make them legal to use in people. On the evidence, 5 completed human trials are cited on its profile.
The full United Kingdom answerIs Icatibant legal in Australia?
Icatibant is available in Australia only through a prescriber. Its legal category is "Prescription only; check current TGA status". It is not sold over the counter. Using it rests on the prescriber's judgment, not on an approval to sell it. Vials sold "for research use only" fall outside that route, and the label does not make them legal to use in people. On the evidence, 5 completed human trials are cited on its profile.
The full Australia answerIs Icatibant legal in Canada?
Icatibant is available in Canada only through a prescriber. Its legal category is "Prescription only; check current Health Canada status". It is not sold over the counter. Using it rests on the prescriber's judgment, not on an approval to sell it. Vials sold "for research use only" fall outside that route, and the label does not make them legal to use in people. On the evidence, 5 completed human trials are cited on its profile.
The full Canada answerIcatibant in sport and the military
Whether Icatibant is banned in sport is set by the World Anti-Doping Code and by military rules, not by its legal status. 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.
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General information, current as of Sep 2026. Not legal advice. Legal status changes. For your own situation, check with the agency or a lawyer. Educational use only. This database summarizes published research and is not medical advice. Where a dose appears it is a record of what a trial or clinic ran, or what people describe doing, with its source attached. Nothing here is a recommendation for personal use. Sellers named on the price pages are ranked by certificate tier, then price, and any affiliate income is disclosed there. Naming a seller is not a recommendation to buy or use anything.