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Are there clinical trials for Icatibant?
Icatibant has 33 registered clinical trials, including 21 completed interventional studies and trials reaching Phase 4. Its use in humans is supported by established registered clinical evidence.
Trial breakdown
By phase
| Phase 3 | 11 |
| Phase 2 | 9 |
| Phase 4 | 4 |
| Not applicable | 2 |
| Phase 1 | 2 |
By status
| Completed | 28 |
| Terminated | 2 |
| Withdrawn | 1 |
| Recruiting | 1 |
| Active, not recruiting | 1 |
Active trials
- Prevention of Intradialytic Hypotension by Inhibiting Bradykinin B2 ReceptorPhase 3 · Recruiting · 26 participants · Vanderbilt University Medical Center · started 2023-12-11NCT05834777
- I-SPY COVID-19 TRIAL: An Adaptive Platform Trial for Critically Ill PatientsPhase 2 · Active, not recruiting · 1500 participants · QuantumLeap Healthcare Collaborative · started 2020-07-31NCT04488081
Most recent registered trials
- A Study Observing US Patients With HAE Type I or II Who Take Icatibant to Treat HAE AttacksCompleted · 88 participants · KalVista Pharmaceuticals, Ltd. · started 2025-04-21NCT07009262
- A Study to Explore Hereditary Angioedema (HAE) Symptoms and Treatment Patterns in Korean PeopleCompleted · 19 participants · Takeda · started 2024-10-16NCT06587464
- A Study to Evaluate the Safety and Efficacy of Icatibant in Patients With Bradykinin Induced AngioedemaPhase 4 · Completed · 5 participants · Nang Kuang Pharmaceutical Co., Ltd. · started 2024-09-27NCT07290855
- A Study of Lanadelumab (Takhzyro) and Icatibant (Firazyr®) in Persons With HAE in ChinaCompleted · 115 participants · Takeda · started 2024-07-20NCT06346899
- Prevention of Intradialytic Hypotension by Inhibiting Bradykinin B2 ReceptorPhase 3 · Recruiting · 26 participants · Vanderbilt University Medical Center · started 2023-12-11NCT05834777
- A Study in Adults With Hereditary Angioedema (HAE) Who Currently Receive Icatibant at HomeCompleted · 85 participants · Takeda · started 2022-11-18NCT05489640
- A Survey of Icatibant in Pediatric Participants With Hereditary AngioedemaCompleted · 32 participants · Takeda · started 2022-08-24NCT05509569
- Inhibition of Bradykinin in COVID-19 Infection With IcatibantPhase 2 / Phase 3 · Completed · 32 participants · Belfast Health and Social Care Trust · started 2022-05-16NCT05407597
- Investigating the Efficacy and Safety ICATIBANT For The Treatment of Patients With SARS-CoV-2 (COVID-19) InfectionPhase 2 · Completed · 73 participants · Sebastian Videla · started 2021-04-12NCT04978051
- Evaluation of the Effects of Bradykinin Antagonists on Pulmonary Manifestations of COVID-19 Infections (AntagoBrad-Cov Study).Phase 2 · Completed · 44 participants · GCS Ramsay Santé pour l'Enseignement et la Recherche · started 2021-02-04NCT05010876
- A Study of Icatibant (TAK-667) in Japanese Children and Teenagers With Acute Attacks of Hereditary AngioedemaPhase 3 · Completed · 2 participants · Takeda · started 2021-01-15NCT04654351
- I-SPY COVID-19 TRIAL: An Adaptive Platform Trial for Critically Ill PatientsPhase 2 · Active, not recruiting · 1500 participants · QuantumLeap Healthcare Collaborative · started 2020-07-31NCT04488081
Frequently asked questions
Are there clinical trials for Icatibant?
Icatibant has 33 registered clinical trials, including 21 completed interventional studies and trials reaching Phase 4. Its use in humans is supported by established registered clinical evidence.
Does a registered trial mean the peptide works?
No. Registration means a study was formally listed before or during the research. It says nothing about the result. A completed trial can find no benefit, and many registered studies are never published.
What is the difference between a registered trial and published evidence?
Registration records that a study exists. Publication reports what it found. This page counts registrations, which is the more complete picture of research activity, but it is not a measure of proven effectiveness.
Why do phases matter?
Phase 1 tests safety in a small group. Phase 2 looks for early signs of effect. Phase 3 tests effectiveness against a comparator in a large group, and is what regulators normally require. Phase 4 studies happen after approval. A compound with only Phase 1 trials has not been shown to work.
Source: ClinicalTrials.gov API v2, U.S. National Library of Medicine. Studies where Icatibant is registered as an intervention. Last updated 2026-09-23.