Immune · FDA Approved
Icatibant (Firazyr)
FDA-approved
01 · Overview
A synthetic decapeptide bradykinin B2 receptor antagonist containing five non-natural amino acids for enhanced stability and receptor selectivity. Icatibant competitively blocks bradykinin, the primary mediator of swelling in hereditary angioedema (HAE) caused by C1 esterase inhibitor deficiency.
By preventing bradykinin-induced vasodilation and increased vascular permeability, it is used to treat acute attacks of mucosal and subcutaneous edema.
02 · Research summary & key findings
FDA-approved in August 2011 (Firazyr) for acute attacks of hereditary angioedema in adults; generic versions are now available. In the phase 3 FAST-3 trial, icatibant shortened median time to at least 50 percent reduction in symptom severity (2.0 vs. 19.8 hours with placebo) and time to almost complete symptom relief (8.0 vs. 36.0 hours) for cutaneous or abdominal attacks (Lumry et al., Ann Allergy Asthma Immunol, 2011) (PMID 22123383). All icatibant-treated subjects had injection site reactions, but no serious adverse events were reported (PMID 22123383). It is given as a subcutaneous injection that patients can self-administer.
03 · Regulatory status
Icatibant (Firazyr) has received FDA approval and is available for clinical use under appropriate medical supervision. Consult a qualified healthcare provider for prescribing information.
Icatibant (Firazyr) is an FDA-approved medicine prescribed for the conditions on its label. It is not part of our intake, so we do not propose protocols for it. If you think it may be relevant to you, talk to your own doctor. How to ask your doctor.
04 · Administration routes
- Subcutaneous injection
References
- [1]Randomized placebo-controlled trial of the bradykinin B₂ receptor antagonist icatibant for the treatment of acute attacks of hereditary angioedema: the FAST-3 trial Ann Allergy Asthma Immunol, 2011. PMID 22123383
Primary literature
- PubMed: "Icatibant"
Peer-reviewed literature indexed by the National Library of Medicine.
- ClinicalTrials.gov: "Icatibant"
Registered interventional and observational studies, including status and phase.
- PubChem: "Icatibant"
Chemical structure, molecular properties, and bioactivity data.
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