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ICATIBANT ACETATE
ICATIBANT ACETATE is a drug. It is currently FDA-approved (first approved 2008) for Acute HAE Attacks.
Icatibant blocks bradykinin from binding to the B2 receptor, reducing HAE symptoms.
Icatibant acetate is a marketed drug used for the treatment of acute hereditary angioedema (HAE) attacks, leveraging its mechanism of blocking bradykinin from binding to the B2 receptor. Its key strength lies in its direct action on the B2 receptor, effectively reducing HAE symptoms. The primary risk is the key composition patent expiry in 2028, which could lead to increased competition from generics.
At a glance
| Generic name | ICATIBANT ACETATE |
|---|---|
| Target | bradykinin B2 receptor |
| Modality | Recombinant protein |
| Phase | FDA-approved |
| First approval | 2008 |
Mechanism of action
Icatibant works by blocking the bradykinin B2 receptor, preventing bradykinin from causing vasodilation and the associated symptoms of hereditary angioedema (HAE). This helps manage acute HAE attacks.
Approved indications
- Acute HAE Attacks
Common side effects
- Injection site reaction
- Pyrexia
- Transaminase increased
- Dizziness
Drug interactions
- ACE inhibitors
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:
- ICATIBANT ACETATE CI brief — competitive landscape report
- ICATIBANT ACETATE updates RSS · CI watch RSS
Frequently asked questions about ICATIBANT ACETATE
What is ICATIBANT ACETATE?
How does ICATIBANT ACETATE work?
What is ICATIBANT ACETATE used for?
When was ICATIBANT ACETATE approved?
What development phase is ICATIBANT ACETATE in?
What are the side effects of ICATIBANT ACETATE?
What does ICATIBANT ACETATE target?
Related
- Target: All drugs targeting bradykinin B2 receptor
- Indication: Drugs for Acute HAE Attacks
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing