bradykinin B2 antagonist

Icatibant

US: FDA-approvedEU: AuthorisedUK: AuthorisedCA: AuthorisedAU: RegisteredCH: AuthorisedBR: RegistadoRS: AuthorisedSG: RegisteredTR: Ruhsatli

Answer

Icatibant is authorised or registered in the US, the EU, the UK, Canada, Australia, Switzerland, Brazil, Serbia, Singapore and Turkey: 10 of the 10 registers read. Highest trial phase: Phase 3 (3 phase 3 trials, 0 with posted results). It has 37 registered trials, 2 of them running. Brand names on the FDA label register: Sajazir, Icatibant and Firazyr.

RegulatorTrial register10 regulators' registers, read 2026-09-03 to 2026-10-03 · ClinicalTrials.gov and EU CTIS, read 2026-10-03

Not medical, legal or regulatory advice.

Registered trials37Trial register ClinicalTrials.gov and EU CTIS
Running now2Trial register recruiting, active or enrolling
Results posted13Trial register with results on the register
Stopped early8.1%Trial register all peptides: 10%

37 trials by status

Trial register
Running 2Completed 28Stopped early 3Other or not stated 4

ClinicalTrials.gov and EU CTIS · read 2026-10-03 · 13 trials have posted results

Trials first submitted per year

Trial register

ClinicalTrials.gov first-submitted date, last 10 years · read 2026-10-03. 19 trials carry no first-submitted date (EU CTIS publishes none, or the year is outside this range).

Status by jurisdiction

World map
Authorised or registeredNot on the register, or withdrawnNot read yet, or status unknown
WhereStatusRegisterRead
United StatesFDA-approvedFDA, openfda2026-10-03
European UnionAuthorisedEMA, ema2026-10-03
United KingdomAuthorisedMHRA, uk-mhra2026-10-03
CanadaAuthorisedHealth Canada, ca-dpd2026-10-03
AustraliaRegisteredTGA, au-artg2026-10-03
SwitzerlandAuthorisedSwissmedic, ch-swissmedic2026-10-03
BrazilRegistadoANVISA, br-anvisa2026-10-03
SerbiaAuthorisedALIMS, rs-alims2026-09-03
SingaporeRegisteredHSA, sg-hsa2026-09-03
TurkeyRuhsatliTITCK, tr-titck2026-09-03

An EU decision applies in the 30 territories the EU register covers: its member states, and Iceland, Liechtenstein and Norway. A dashed tile has no register read for this peptide.

Side effects

Trial register
4 placebo-controlled trials · 330 people on Icatibant · grey is placebo
Hereditary angioedema18.1% 18.7%
Headache10.1% 6.7%
ClinicalTrials.gov posted results · read 2026-10-03All side effects

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REGISTERED TRIALS

Newest 10 of 37 trials

All 37 trials
NCT04113109
Mechanisms Underlying Hypotensive Response to ARB/NEP Inhibition - Aim 2
completed · register updated 2026-08-11
NCT05509569
A Survey of Icatibant in Pediatric Participants With Hereditary Angioedema
completed · register updated 2026-08-07
2024-516247-62-00
A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Orally Administered Deucricti
no status recorded · register updated 2026-07-17
2023-505766-28-00
A Phase II/III, Extension Study of Orally Administered PHA-022121 for Acute Treatment of Angioedema Attacks in Patients with Hered
no status recorded · register updated 2026-06-01
NCT05834777
Prevention of Intradialytic Hypotension by Inhibiting Bradykinin B2 Receptor
currently recruiting participants · register updated 2026-04-15
NCT04488081
I-SPY COVID-19 TRIAL: An Adaptive Platform Trial for Critically Ill Patients
running, but no longer enrolling · register updated 2026-03-16
NCT06346899
A Study of Lanadelumab (Takhzyro) and Icatibant (Firazyr®) in Persons With HAE in China
completed · register updated 2026-01-21
NCT07009262
A Study Observing US Patients With HAE Type I or II Who Take Icatibant to Treat HAE Attacks
completed · register updated 2026-01-13
NCT07290855
A Study to Evaluate the Safety and Efficacy of Icatibant in Patients With Bradykinin Induced Angioedema
completed · register updated 2025-12-18
2023-507268-37-00
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Crossover Study of Oral Deucrictibant Soft Capsule for On-Demand Treatmen
no status recorded · register updated 2025-09-16

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