DATABASE · 2,000+ PEER-REVIEWED CITATIONS INDEXEDCOMPOUND LIBRARY · 100+ EVIDENCE-GRADED RECORDSGRADE A EVIDENCE · 45 COMPOUNDS WITH MULTIPLE HUMAN RCTSHUMAN EVIDENCE · 97 COMPOUNDS WITH HUMAN STUDY DATAVENDOR DIRECTORY · 11 RESEARCH VENDORS TRACKEDCLINIC DIRECTORY · 10 TELEHEALTH PROVIDERS VETTEDCOA RECORDS · 7 BATCH CERTIFICATES ON FILELIVE DATABASE · UPDATED 2D AGODATABASE · 2,000+ PEER-REVIEWED CITATIONS INDEXEDCOMPOUND LIBRARY · 100+ EVIDENCE-GRADED RECORDSGRADE A EVIDENCE · 45 COMPOUNDS WITH MULTIPLE HUMAN RCTSHUMAN EVIDENCE · 97 COMPOUNDS WITH HUMAN STUDY DATAVENDOR DIRECTORY · 11 RESEARCH VENDORS TRACKEDCLINIC DIRECTORY · 10 TELEHEALTH PROVIDERS VETTEDCOA RECORDS · 7 BATCH CERTIFICATES ON FILELIVE DATABASE · UPDATED 2D AGO
Home/Compounds/Icatibant
OtherFDA approvedRx required

Icatibant

Also known as: Firazyr
Brands: Firazyr

Synthetic decapeptide bradykinin B2 receptor antagonist approved for hereditary angioedema attacks.

A
Grade A
Multiple human RCTs
Human studies29
PubMed citations29
Routesubcutaneous
Regulatory (US)FDA approved · Rx
Last verified2 days ago

Mechanism of action

Selective competitive antagonist of the bradykinin B2 receptor. Blocks the vasoactive effects of bradykinin driving HAE attacks.

Evidence summary

29
Human studies
29
PubMed citations
25
Clinical trials
A
Evidence grade

Evidence summary in progress. See the citations section below for the underlying research papers.

Dosing protocols

Educational information only. Consult a licensed provider before using any peptide.
Administration routes
subcutaneous

Side effects & safety

From the FDA label
Source
dizzinessheadacheinjection site erythemainjection site paininjection site pruritusinjection site reactionnauseapruritusrashurticaria

Terms pulled directly from the referenced source. We don't fabricate frequencies — when a label doesn't publish a percentage, we don't either.

Interactions

No documented drug interactions on file.

Regulatory status

United States
FDA approved

FDA approved for acute attacks of hereditary angioedema in adults (Firazyr)

Compounding
Not permitted

Not available via 503A/503B compounding pharmacies.

Regulatory data last verified 4/19/2026

Clinical trials

NCT05834777Prevention of Intradialytic Hypotension by Inhibiting Bradykinin B2 Receptor A Randomized, Double-blind, Placebo-controlled, Cross Over Explorative StudyRecruiting · Phase 3 · Intradialytic Hypotension · n=26NCT04488081I-SPY COVID TRIAL: An Adaptive Platform Trial to Reduce Mortality and Ventilator Requirements for Critically Ill PatientsActive Not Recruiting · Phase 2 · COVID-19 · n=1500NCT06346899The Real-World Effectiveness and Safety of Lanadelumab (Takhzyro) and Icatibant (Firazyr®) for Hereditary Angioedema: An Observational Study in ChinaCompleted · Hereditary Angioedema (HAE) · n=115NCT07009262A Prospective, Non-interventional Study in Patients With Type I or II Hereditary Angioedema Using Icatibant for On-demand Treatment of AttacksCompleted · Hereditary Angioedema · n=88NCT07290855A Phase IV Clinical Study of Evaluating the Safety and Efficacy of Icatibant Injection (Icanticure) in the Treatment of Patients With Bradykinin Induced AngioedemaCompleted · Phase 4 · Bradykinin-mediated Angioedema · n=5NCT05509569Specified Drug Use Surveillance of FIRAZYR Subcutaneous Injection 30mg Syringe for Pediatric Subjects With Hereditary Angioedema (All-Case Investigation)Completed · Hereditary Angioedema (HAE) · n=32NCT04113109Mechanisms Underlying Hypotensive Response to ARB/NEP Inhibition - Aim 2Completed · Phase 4 · Heart Failure · n=46NCT04057131FIRAZYR General Drug Use-Results Survey (Japan)Completed · Hereditary Angioedema (HAE) · n=179NCT06587464Exploring Symptom Profile and Treatment Patterns in Korean HAE Patients Using Digital Patient Diary: A Retrospective Descriptive Study (SPEAKUP Study)Completed · Hereditary Angioedema (HAE) · n=19NCT01034969Icatibant Outcome Survey (IOS) RegistryCompleted · Hereditary Angioedema (HAE) · n=1761NCT05489640A Real-World Study to Determine Patient Characteristics, Treatment Patterns, Clinical and Patient-Reported Outcomes of Patients With Hereditary Angioedema That Self-Administered Icatibant Using Homecare Services in the UKCompleted · Hereditary Angioedema (HAE) · n=85NCT05407597Prospective, Randomised, Double-blind Trial of Icatibant Compared to Placebo in Patients With Early Severe Acute Respiratory Syndrome Coronavirus 2 (SARS CoV-2) InfectionCompleted · Phase 2 · SARS CoV 2 Infection · n=32

Showing 12 of 25 indexed studies. View all on ClinicalTrials.gov →

Citations

PMID 40400016Betschel SD, Peter J et al. · Factors contributing to non-compliance with on-demand treatment guidelines in hereditary angioedema.Allergy, asthma, and clinical immunology : official journal of the Canadian Society of Allergy and Clinical Immunology (2025)HumanPMID 40089800Li HH, Aygören-Pürsün E et al. · Indirect treatment comparison of oral sebetralstat and intravenous recombinant human C1 esterase inhibitor for on-demand treatment of hereditary angioedema attacks.Allergy, asthma, and clinical immunology : official journal of the Canadian Society of Allergy and Clinical Immunology (2025)HumanPMID 39724968Cohn DM, Soteres DF et al. · Interplay between on-demand treatment trials for hereditary angioedema and treatment guidelines.The Journal of allergy and clinical immunology (2025)HumanPMID 34195359Rosi-Schumacher M, Shah SJ et al. · Clinical manifestations of hereditary angioedema and a systematic review of treatment options.Laryngoscope investigative otolaryngology (2024)HumanPMID 37170244Gamboa JL, Mambungu CA et al. · Bradykinin B2 receptor blockade and intradialytic hypotension.BMC nephrology (2023)HumanPMID 36610464Malchair P, Giol J et al. · Three-Day Icatibant on Top of Standard Care in Patients With Coronavirus Disease 2019 Pneumonia: A Randomized, Open-Label, Phase 2, Proof-of-Concept Trial.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America (2023)HumanPMID 36535404Brusco I, Fialho MFP et al. · Kinins and their B1 and B2 receptors as potential therapeutic targets for pain relief.Life sciences (2023)HumanPMID 36462104Liu X, Shi J et al. · Therapeutic Polypeptides and Peptidomimetics: Powerful Tools for COVID-19 Treatment.Clinical drug investigation (2023)HumanPMID 35861129Maurer M, Aberer W et al. · The Icatibant Outcome Survey: 10 years of experience with icatibant for patients with hereditary angioedema.Clinical and experimental allergy : journal of the British Society for Allergy and Clinical Immunology (2022)HumanPMID 36044174Šimac DV, Štimac T et al. · Is Icatibant Safe for the Treatment of Hereditary Angioedema During Pregnancy?Current allergy and asthma reports (2022)HumanPMID 35145604Jones DH, Bansal P et al. · Clinical profile and treatment outcomes in patients with hereditary angioedema with normal C1 esterase inhibitor.The World Allergy Organization journal (2022)HumanPMID 36172291Valerieva A, Longhurst HJ · Treatment of hereditary angioedema-single or multiple pathways to the rescue.Frontiers in allergy (2022)HumanPMID 32919903Hide M, Horiuchi T et al. · Management of hereditary angioedema in Japan: Focus on icatibant for the treatment of acute attacks.Allergology international : official journal of the Japanese Society of Allergology (2021)HumanPMID 31835086Montinaro V, Cicardi M · ACE inhibitor-mediated angioedema.International immunopharmacology (2020)HumanPMID 31283393Longhurst HJ, Bork K · Hereditary angioedema: an update on causes, manifestations and treatment.British journal of hospital medicine (London, England : 2005) (2020)HumanPMID 30220453Depetri F, Tedeschi A et al. · Angioedema and emergency medicine: From pathophysiology to diagnosis and treatment.European journal of internal medicine (2019)HumanPMID 29696352Herr AC, Biedermann T et al. · [Allergic emergencies].Der Hautarzt; Zeitschrift fur Dermatologie, Venerologie, und verwandte Gebiete (2019)HumanPMID 27672078van den Elzen M, Go MFCL et al. · Efficacy of Treatment of Non-hereditary Angioedema.Clinical reviews in allergy & immunology (2018)HumanPMID 27128215Leach JK, Spencer K et al. · Pharmacokinetics of single and repeat doses of icatibant.Clinical pharmacology in drug development (2018)HumanPMID 27123689Farkas H · Icatibant as acute treatment for hereditary angioedema in adults.Expert review of clinical pharmacology (2017)Human

Showing 20 of 29 papers. View all on PubMed →