At a glance
FDA approval FDA-approved 11 applications
Randomized controlled trials 33 of 1,816 publications on PubMed
Registered clinical trials 33 2 active
Adverse event reports 8,933 6,175 classified as serious
- Icatibant is an FDA-approved drug, marketed as Firazyr, Icatibant (first approval: August 25, 2011).
- PubMed lists 1,816 publications mentioning it, including 33 randomized controlled trials and 1,040 animal-only studies.
- ClinicalTrials.gov lists 33 registered studies testing it (2 active).
- FDA's adverse event system (FAERS) holds 8,933 reports mentioning it; 6,175 classified as serious. Reports do not prove causation.
Research topics
Most frequent MeSH subject headings in the latest PubMed records (English, as indexed).
Regulatory status
Drugs@FDA applications
| Application | Product | Status | First approval | Sponsor |
| NDA022150 | FIRAZYR | Approved, marketed | August 25, 2011 | TAKEDA PHARMS USA |
| ANDA210118 | ICATIBANT ACETATE | Approved, marketed | July 15, 2019 | TEVA PHARMS USA |
| ANDA211021 | ICATIBANT ACETATE | Approved, marketed | March 9, 2020 | JIANGSU HANSOH PHARM |
| ANDA208317 | ICATIBANT ACETATE | Approved, marketed | June 18, 2020 | FRESENIUS KABI USA |
| ANDA212446 | ICATIBANT ACETATE | Approved, marketed | July 13, 2020 | CIPLA |
| ANDA211501 | ICATIBANT ACETATE | Approved, marketed | September 2, 2020 | WILSHIRE PHARMS INC |
| ANDA213054 | ICATIBANT ACETATE | Approved, discontinued | October 5, 2020 | CAPLIN |
| ANDA212081 | ICATIBANT ACETATE | Approved, marketed | December 16, 2020 | NANG KUANG PHARM CO |
| ANDA213222 | ICATIBANT ACETATE | Approved, discontinued | May 21, 2021 | GLENMARK PHARMS LTD |
| ANDA213521 | ICATIBANT ACETATE | Approved, marketed | August 14, 2023 | EUGIA PHARMA |
| ANDA213773 | ICATIBANT ACETATE | Approved, marketed | June 14, 2024 | ALEMBIC |
Source: Drugs@FDA (openFDA) · verified October 30, 2026 · API query
FDA compounding safety list
Not on FDA's list of bulk drug substances that may present significant safety risks in compounding.
Source: FDA.gov — Category 2 bulk drug substances · verified October 30, 2026
Removal of a substance from a regulatory list does not mean it has been approved. A "research use only" label does not make a product safe or legal for human use.
Scientific publications
- All publications 1,816
- Human (MeSH) 636
- Animal only 1,040
- Clinical trials 47
- Randomized controlled trials 33
- Systematic reviews & meta-analyses 8
- Case reports 87
- Retracted 0
Counts are PubMed records that mention the peptide in the title or abstract. Categories overlap, and a mention is not the same as testing the peptide as a treatment. Each number opens the exact PubMed search. Effects seen in laboratory or animal studies may not occur in humans. A registered clinical trial does not show that a substance is effective or safe.
Source: PubMed (NCBI) · verified October 30, 2026
Clinical trials
- Registered
- 33
- Active
- 2
- With posted results
- 15
| Study | Status | Phase | Start |
| Prevention of Intradialytic Hypotension by Inhibiting Bradykinin B2 Receptor NCT05834777 Vanderbilt University Medical Center | Active, not recruiting | Phase 3 | December 11, 2023 |
| I-SPY COVID-19 TRIAL: An Adaptive Platform Trial for Critically Ill Patients NCT04488081 QuantumLeap Healthcare Collaborative | Active, not recruiting | Phase 2 | July 31, 2020 |
| A Study Observing US Patients With HAE Type I or II Who Take Icatibant to Treat HAE Attacks NCT07009262 KalVista Pharmaceuticals, Ltd. | Completed | — | April 21, 2025 |
| A Study to Explore Hereditary Angioedema (HAE) Symptoms and Treatment Patterns in Korean People NCT06587464 Takeda | Completed | — | October 16, 2024 |
| A Study to Evaluate the Safety and Efficacy of Icatibant in Patients With Bradykinin Induced Angioedema NCT07290855 Nang Kuang Pharmaceutical Co., Ltd. | Completed | Phase 4 | September 27, 2024 |
| A Study of Lanadelumab (Takhzyro) and Icatibant (Firazyr®) in Persons With HAE in China NCT06346899 Takeda | Completed | — | July 20, 2024 |
| A Study in Adults With Hereditary Angioedema (HAE) Who Currently Receive Icatibant at Home NCT05489640 Takeda | Completed | — | November 18, 2022 |
| A Survey of Icatibant in Pediatric Participants With Hereditary Angioedema NCT05509569 Takeda | Completed | — | August 24, 2022 |
| Inhibition of Bradykinin in COVID-19 Infection With Icatibant NCT05407597 Belfast Health and Social Care Trust | Completed | Phase 2, Phase 3 | May 16, 2022 |
| Investigating the Efficacy and Safety ICATIBANT For The Treatment of Patients With SARS-CoV-2 (COVID-19) Infection NCT04978051 Sebastian Videla | Completed | Phase 2 | April 12, 2021 |
Show 23 more studies
| Study | Status | Phase | Start |
| Evaluation of the Effects of Bradykinin Antagonists on Pulmonary Manifestations of COVID-19 Infections (AntagoBrad-Cov Study). NCT05010876 GCS Ramsay Santé pour l'Enseignement et la Recherche | Completed | Phase 2 | February 4, 2021 |
| A Study of Icatibant (TAK-667) in Japanese Children and Teenagers With Acute Attacks of Hereditary Angioedema NCT04654351 Takeda Results posted | Completed | Phase 3 | January 15, 2021 |
| Mechanisms Underlying Hypotensive Response to ARB/NEP Inhibition - Aim 2 NCT04113109 Vanderbilt University Medical Center Results posted | Completed | Phase 4 | November 1, 2019 |
| FIRAZYR General Drug Use-Results Survey (Japan) NCT04057131 Shire Results posted | Completed | — | November 20, 2018 |
| Mechanism(s) Underlying Cardiovascular Effects of ARB/NEP Inhibition - Aim 2 NCT03005184 Vanderbilt University Medical Center | Withdrawn | Phase 2 | Sep 2017 |
| Mitochondria and Chronic Kidney Disease NCT03177798 Vanderbilt University Medical Center Results posted | Completed | Phase 2 | August 1, 2017 |
| A Study of Icatibant for Acute Attacks of Hereditary Angioedema in Japanese Participants NCT03888755 Shire Results posted | Completed | Phase 3 | March 18, 2015 |
| Open-label, Single-arm Study to Assess the Pharmacokinetics, Safety, and Tolerability of a Single Subcutaneous Dose of Icatibant in Healthy Japanese Volunteers NCT02045264 Shire Results posted | Completed | Phase 1 | February 21, 2014 |
| Blinded Safety & Efficacy Placebo Controlled Study of Icatibant for Angiotensin Converting Enzyme Inhibitor Induced Angioedema NCT01919801 Shire Results posted | Completed | Phase 3 | December 2, 2013 |
| A Pharmacokinetic, Tolerability and Safety Study of Icatibant in Children and Adolescents With Hereditary Angioedema NCT01386658 Shire Results posted | Completed | Phase 3 | January 27, 2012 |
| Efficacy, Safety and Tolerability of Icatibant for the Treatment of HAE NCT01457430 Massachusetts General Hospital Results posted | Completed | Phase 4 | Dec 2011 |
| Effect of Bradykinin Receptor Antagonism on ACE Inhibitor-associated Angioedema NCT01574248 Vanderbilt University Medical Center Results posted | Terminated | Phase 4 | Aug 2011 |
| EASSI - Evaluation of the Safety of Self-Administration With Icatibant NCT00997204 Shire Results posted | Completed | Phase 3 | September 25, 2009 |
| The Effect of Ischaemic-Reperfusion in Man - A Bradykinin Dependent Pathway NCT00965120 University of Edinburgh | Completed | N/A | Aug 2009 |
| The Effect of Ischaemic-Reperfusion and Remote Ischaemic Preconditioning in Man - A Bradykinin Dependent Pathway NCT00965393 University of Edinburgh | Completed | N/A | Aug 2009 |
| A Study of Icatibant in Patients With Acute Attacks of Hereditary Angioedema (FAST-3) NCT00912093 Shire Results posted | Completed | Phase 3 | July 16, 2009 |
| Firazyr® Patient Registry (Icatibant Outcome Survey - IOS) NCT01034969 Shire | Completed | — | July 10, 2009 |
| Bradykinin Receptor Blocker in ACE Inhibitor-associated Angioedema NCT00517582 Vanderbilt University | Terminated | Phase 1 | Sep 2007 |
| Bradykinin Receptor Antagonism During Cardiopulmonary Bypass NCT00223704 Vanderbilt University Results posted | Completed | Phase 2, Phase 3 | May 2006 |
| Efficacy and Safety Study of Intra-articular Multiple Doses of Icatibant in Patients With Painful Knee Osteoarthritis NCT00303056 Sanofi | Completed | Phase 2 | Feb 2006 |
| Subcutaneous Treatment With Icatibant for Acute Attacks of Hereditary Angioedema (HAE) NCT00500656 Shire Results posted | Completed | Phase 3 | March 1, 2005 |
| Subcutaneous Treatment With Icatibant for Acute Attacks of Hereditary Angioedema NCT00097695 Shire Results posted | Completed | Phase 3 | December 28, 2004 |
| AMelioration of Angiotensin Converting Enzyme Inhibitor Induced Angioedema Study NCT01154361 Technical University of Munich | Completed | Phase 2 | — |
All 33 studies on ClinicalTrials.gov ↗
Source: ClinicalTrials.gov · verified October 30, 2026
Adverse event reports
- Reports
- 8,933
- Serious
- 6,175
- With death outcome
- 287
Most reported reactions
- Hereditary angioedema 3,597
- Drug ineffective 823
- Product dose omission issue 681
- Weight decreased 641
- Weight increased 616
- Product use issue 501
- Injection site pain 493
- Off label use 444
- Headache 432
- Inappropriate schedule of product administration 415
- Malaise 390
- Stress 374
Adverse event reports do not prove that the substance caused these effects. Side effects not listed here may still occur. Reaction terms are MedDRA terms as reported to FAERS.
Source: FDA FAERS (FAERS data as of July 30, 2026) · verified October 30, 2026 · API query
FDA prescribing information
Official US prescribing information. Dosing sections are intentionally not shown.
- Firazyr HUMAN PRESCRIPTION DRUG Takeda Pharmaceuticals America, Inc. July 7, 2025
- Icatibant HUMAN PRESCRIPTION DRUG Alembic Pharmaceuticals Inc. July 1, 2025
- Icatibant HUMAN PRESCRIPTION DRUG Alembic Pharmaceuticals Limited June 27, 2025
- Icatibant HUMAN PRESCRIPTION DRUG Hikma Pharmaceuticals USA Inc. April 25, 2024
- Icatibant HUMAN PRESCRIPTION DRUG Eugia US LLC April 2, 2024
- SAJAZIR HUMAN PRESCRIPTION DRUG Cycle Pharmaceuticals Ltd-Uk February 16, 2024
- ICATIBANT HUMAN PRESCRIPTION DRUG Cipla USA Inc. February 16, 2024
- Icatibant HUMAN PRESCRIPTION DRUG Teva Pharmaceuticals USA, Inc. February 15, 2024
- Icatibant HUMAN PRESCRIPTION DRUG Fresenius Kabi USA, LLC November 8, 2023
Source: DailyMed / openFDA
Change history
No changes since monitoring began on October 30, 2026.