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Drug

Icatibant

Approved · EMA
Emerging researchLate-stage development

Also known as Firazyr, Sajazir.

RxNorm1148138ChEMBLCHEMBL2028850UNII7PG89G35Q7
2
Research papers
2
Active clinical trials
1
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Prevention of Intradialytic Hypotension by Inhibiting Bradykinin B2 Receptor A Randomized, Double-blind, Placebo-controlled, Cross Over Explorative Study

Clinical trial2026-07-01Primary completion · ClinicalTrials.gov

I-SPY COVID TRIAL: An Adaptive Platform Trial to Reduce Mortality and Ventilator Requirements for Critically Ill Patients

Clinical trial2026-03-16Results expected Q3 2028 · ClinicalTrials.gov

A Phase IV Clinical Study of Evaluating the Safety and Efficacy of Icatibant Injection (Icanticure) in the Treatment of Patients With Bradykinin Induced Angioedema

Clinical trial2025-09-26Completed · ClinicalTrials.gov

Mechanisms Underlying Hypotensive Response to ARB/NEP Inhibition - Aim 2

Clinical trial2025-07-30Completed · ClinicalTrials.gov

Prospective, Randomised, Double-blind Trial of Icatibant Compared to Placebo in Patients With Early Severe Acute Respiratory Syndrome Coronavirus 2 (SARS CoV-2) Infection

Clinical trial2023-07-07Completed · ClinicalTrials.gov

Evaluation of the Effects of Bradykinin Antagonists on Pulmonary Manifestations of COVID-19 Infections (AntagoBrad-Cov Study).

Clinical trial2021-06-21Completed · ClinicalTrials.gov

A Phase III Randomized, Double-Blind,Placebo-Controlled, Multicenter Study of Icatibant for Subcutaneous Injection in Patients With Acute Attacks of Hereditary Angioedema (HAE)

Clinical trial2021-06-11Results posted · ClinicalTrials.gov

Open Label, Multicenter Study to Evaluate Safety, Local Tolerability, Convenience, and Efficacy of a Self-Administered Subcutaneous Formulation of Icatibant for the Treatment of Acute Attacks of Hereditary Angioedema

Clinical trial2021-06-11Results posted · ClinicalTrials.gov

Randomised Double Blind, Controlled, Parallel Group, Multicentre Study of a Subcutaneous Formulation of Icatibant Versus Oral Tranexamic Acid for the Treatment of Hereditary Angioedema (HAE)

Clinical trial2021-06-09Results posted · ClinicalTrials.gov

Randomized Trial of Icatibant for Angiotensin-Converting Enzyme Inhibitor-Induced Upper Airway Angioedema.

Research2017-05-25The journal of allergy and clinical immunology. In practice

Approval: Firazyr (EMA)

Regulatory2008-07-11EMA

Novel pharmacotherapy of acute hereditary angioedema with bradykinin B2-receptor antagonist icatibant.

Research2006-12-01Allergy

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Icatibant
Aliases & brands
FirazyrSajazir
RxNorm CUI
1148138
ChEMBL ID
CHEMBL2028850
UNII
7PG89G35Q7
Regulatory jurisdictions
ema

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2008-07-11
Latest approval
2008-07-11
Authorities
EMA
Total events
1
emaEuropean Medicines Agency· 1 event
2008-07-11Approval
Approval: Firazyr (EMA)

Indication: Firazyr is indicated for symptomatic treatment of acute attacks of hereditary angioedema (HAE) in adults (with C1-esterase-inhibitor deficiency).

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

18 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
18
registered trials across all phases
LATEST COMPLETION 2025
2
Active studies
1
Recruiting
13
Late-stage (III+)
14
Completed
2
Discontinued
PHASE DISTRIBUTIONn = 18
Phase 11Phase 24Phase 2 / 31Phase 38Phase 44

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

A Phase IV Clinical Study of Evaluating the Safety and Efficacy of Icatibant Injection (Icanticure) in the Treatment of Patients With Bradykinin Induced Angioedema

CompletedPH IVNang Kuang Pharmaceutical Co., Ltd.n=52025

Mechanisms Underlying Hypotensive Response to ARB/NEP Inhibition - Aim 2

CompletedPH IVVanderbilt University Medical Centern=462025

Effect of Bradykinin Receptor Antagonism on ACE Inhibitor-associated Angioedema - a Mulitcenter Trial

TerminatedPH IVVanderbilt University Medical Centern=332016

Open Label, Multicenter Study to Evaluate Efficacy, Safety and Tolerability of a Self-Administered Subcutaneous Formulation of Icatibant for the Treatment of Acute Attacks of Hereditary Angioedema (IHA)

CompletedPH IVMassachusetts General Hospitaln=192014

Prevention of Intradialytic Hypotension by Inhibiting Bradykinin B2 Receptor A Randomized, Double-blind, Placebo-controlled, Cross Over Explorative Study

RecruitingPH IIIVanderbilt University Medical Centern=262026

Recent completions

Trials that read out recently, adding to the completed evidence base.

A Phase IV Clinical Study of Evaluating the Safety and Efficacy of Icatibant Injection (Icanticure) in the Treatment of Patients With Bradykinin Induced Angioedema

CompletedPH IVNang Kuang Pharmaceutical Co., Ltd.n=52025

Mechanisms Underlying Hypotensive Response to ARB/NEP Inhibition - Aim 2

CompletedPH IVVanderbilt University Medical Centern=462025

Prospective, Randomised, Double-blind Trial of Icatibant Compared to Placebo in Patients With Early Severe Acute Respiratory Syndrome Coronavirus 2 (SARS CoV-2) Infection

CompletedPH II/IIIBelfast Health and Social Care Trustn=322023

Evaluation of the Effects of Bradykinin Antagonists on Pulmonary Manifestations of COVID-19 Infections (AntagoBrad-Cov Study).

CompletedPH IIGCS Ramsay Santé pour l'Enseignement et la Recherchen=442021

Mitochondrial Dysfunction in Chronic Kidney Disease

CompletedPH IIVanderbilt University Medical Centern=112018

A Multicenter, Open-Label, Non-Randomized Study to Assess the Pharmacokinetics, Tolerability, and Safety of a Single Subcutaneous Administration of Icatibant in Children and Adolescents With Hereditary Angioedema

CompletedPH IIIShiren=322018

Research activity

2 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time
20062017
Major research themes1
Bradykinin B2 Receptor Antagonists1
Journals, researchers & institutions
Top journals
  • Allergy1
  • The journal of allergy and clinical immunology. In practice1
Leading researchers
  • Baptista J1
  • Bas M1
  • Bernstein JA1
  • Bier H1
  • Body R1
  • Greve J1
  • Hoffmann TK1
  • Kimura A1
Leading institutions
free-text, unnormalised
  • Clinical Development1
  • Department of Emergency Medicine and Cardiovascular Research Institute1
  • Manchester Royal Infirmary1
  • Queen's University1
  • SUNY Downstate Medical Center/Kings County Hospital Medical Center1
  • Universitätsklinikum Düsseldorf1
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.