NDASUBCUTANEOUSINJECTABLEPriority Review
Approved
Aug 2011
Lifecycle
Peak
Competitive Pressure
30/100
Clinical Trials
4
Data completeness
4/8 — Partial
Priority Review
Drug data last refreshed 20h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
FIRAZYR (icatibant acetate) is a small-molecule bradykinin B2-receptor antagonist administered via subcutaneous injection. It is indicated for the treatment of acute attacks of hereditary angioedema (HAE), a rare genetic disorder characterized by recurrent episodes of severe swelling. The drug works by blocking bradykinin signaling, a key mediator of angioedema in HAE patients. FIRAZYR represents a breakthrough therapy for acute HAE management, offering rapid symptom relief in patients who previously had limited acute treatment options.
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Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (4)
A Study of Lanadelumab (Takhzyro) and Icatibant (Firazyr®) in Persons With HAE in China
Started Jul 2024
115 enrolled
Hereditary Angioedema (HAE)
FIRAZYR General Drug Use-Results Survey (Japan)
Started Nov 2018
179 enrolled
Hereditary Angioedema (HAE)
Open-label, Single-arm Study to Assess the Pharmacokinetics, Safety, and Tolerability of a Single Subcutaneous Dose of Icatibant in Healthy Japanese Volunteers
Started Feb 2014
12 enrolled
Hereditary Angioedema (HAE)
Firazyr® Patient Registry (Icatibant Outcome Survey - IOS)
Started Jul 2009
1,761 enrolled
Hereditary Angioedema (HAE)
Career Relevance
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.