As of September 2026, icatibant is an approved medicine in the US and the EU for sudden attacks of hereditary angioedema, a genetic swelling condition. In the FAST trials behind that approval, attack symptoms eased faster than in the comparison groups. A vial that came to you outside a pharmacy was not in those trials, and looking at it will not tell you what it holds.
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What is icatibant?
Icatibant is a lab-made, peptide-like compound that blocks B2 receptors for bradykinin, a natural hormone that widens blood vessels. Hoechst, later Sanofi, first developed it under the name HOE 140. It was approved in the EU in 2008 and by the FDA in 2011, to treat sudden attacks of hereditary angioedema in adults.
Does icatibant work?
For sudden attacks of hereditary angioedema, the FDA and the EMA reviewed the trials and approved it. In that condition a genetic deficiency lets bradykinin build up unchecked, which causes sudden swelling attacks.
What we found. 4+ completed randomized trials counted on the record. 2 study rows listed below. One names three trials and the other is a patient registry, so the number shows with a plus sign until every trial is listed.
| Study | Tested in | Status | What it shows |
|---|---|---|---|
| FAST-1, FAST-2 and FAST-3, the main trials for the EU and FDA approvals | People | Completed. Approval followed | Attack symptoms eased faster than in the comparison groups |
| Icatibant Outcome Survey, a registry kept after approval | People | Ongoing. The record gives two start years, 2008 and 2011 | Long-term registry data show a consistent safety profile across thousands of treated attacks |
Is icatibant safe?
The record describes a well-established human safety record. Its registry reports a consistent safety profile across thousands of treated attacks. The key concerns are reactions where the medicine is given, and a warning that it can mask signs of a throat (laryngeal) attack, which calls for monitoring. Long-term data in children and during pregnancy remain more limited than in adults. Every line here concerns Firazyr. A vial from elsewhere is taken up in the vial section.
Is icatibant legal?
- United States
- Approved by the FDA in August 2011 as Firazyr, for sudden attacks of hereditary angioedema in adults.
- European Union
- Approved in July 2008 for the same use.
- Sport
- Not named on WADA's list. That is not clearance.
Not medical advice. Approval and sport status as of . Medical disclaimer
What is in a vial sold as icatibant?
The FAST trials tested icatibant on the way to its approval as Firazyr. Nothing on this record points to icatibant being sold outside pharmacies. A vial that reached you another way was not in those trials, and the checklist lists what to ask whoever sold it.
What don't we know?
- What long-term data in children will show. They remain more limited than in adults.
- What long-term data in pregnancy will show. The record says the same of them.
- Whether trials in children or in preventing attacks will widen its approved group.
- What a vial holds if it did not come from a pharmacy.
The other side
Icatibant comes with a prescription and the care of doctors who treat hereditary angioedema. Its registry covers thousands of treated attacks, and the record calls its human safety record well established. Where the record runs thin is long-term data in children and in pregnancy.
What would change this record?
- More trial data in children. The record says it could broaden the group the medicine is approved for.
- Trial data on using it to prevent attacks, which could do the same.
Three questions to ask next
- What does 'research use only' actually mean?
- How can you tell if a peptide vendor is legitimate?
- How do you read a certificate of analysis?
Ask better questions.
More questions about icatibant
What is icatibant used for?
- To treat sudden attacks of hereditary angioedema in adults. That is its approved use in the US and the EU.
Is icatibant the same as Firazyr?
- Firazyr is the brand name for icatibant. The record also gives an early development name, HOE 140.
What is hereditary angioedema?
- A genetic condition, HAE for short. The record says a genetic deficiency lets bradykinin build up unchecked, which causes sudden swelling attacks.
Is icatibant approved for children?
- Not on this record. It gives the approved use as attacks in adults, and says more trial data in children could broaden that group.
Is icatibant banned in sport?
- It is not named on WADA's list. The record gives no sport source for that. If you compete, check the current List.
Record checked on . Each source shows the date it was checked.
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