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Firazyr (ICATIBANT)
Firazyr works by blocking the action of bradykinin, a protein that causes blood vessels to swell and leads to symptoms of HAE.
Firazyr (ICATIBANT) is a small molecule bradykinin B2 receptor antagonist developed by Shire Orphan Therapies and currently owned by Takeda Pharmaceuticals USA. It targets the B2 bradykinin receptor to treat Hereditary Angioneurotic Edema (HAE), a rare genetic disorder characterized by recurrent episodes of severe swelling. Firazyr was FDA-approved in 2011 and is now available as a generic medication. As an off-patent medication, it is no longer protected by active patents, allowing multiple generic manufacturers to produce the drug. Key safety considerations include the potential for anaphylaxis and the need for proper dosing and administration.
At a glance
| Generic name | ICATIBANT |
|---|---|
| Sponsor | Takeda |
| Drug class | Bradykinin B2 Receptor Antagonist |
| Target | B2 bradykinin receptor |
| Modality | Recombinant protein |
| Therapeutic area | Neuroscience |
| Phase | FDA-approved |
| First approval | 2011 |
Mechanism of action
Icatibant is competitive antagonist selective for the bradykinin B2 receptor, with an affinity similar to bradykinin. Hereditary angioedema is caused by an absence or dysfunction of C1-esterase-inhibitor, key regulator of the Factor XII/kallikrein proteolytic cascade that leads to bradykinin production. Bradykinin is vasodilator which is thought to be responsible for the characteristic HAE symptoms of localized swelling, inflammation, and pain. Icatibant inhibits bradykinin from binding the B2 receptor and thereby treats the clinical symptoms of an acute, episodic attack of HAE.
Approved indications
- Hereditary angioneurotic edema
Common side effects
- Injection site reaction
- Pyrexia
- Dizziness
- Transaminase increased
- Urticaria
Key clinical trials
- I-SPY COVID-19 TRIAL: An Adaptive Platform Trial for Critically Ill Patients (PHASE2)
- A Study of Lanadelumab (Takhzyro) and Icatibant (Firazyr®) in Persons With HAE in China
- A Study Observing US Patients With HAE Type I or II Who Take Icatibant to Treat HAE Attacks
- A Study to Evaluate the Safety and Efficacy of Icatibant in Patients With Bradykinin Induced Angioedema (PHASE4)
- A Survey of Icatibant in Pediatric Participants With Hereditary Angioedema
- Mechanisms Underlying Hypotensive Response to ARB/NEP Inhibition - Aim 2 (PHASE4)
- FIRAZYR General Drug Use-Results Survey (Japan)
- A Study to Explore Hereditary Angioedema (HAE) Symptoms and Treatment Patterns in Korean People
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Firazyr CI brief — competitive landscape report
- Firazyr updates RSS · CI watch RSS
- Takeda portfolio CI