Drugs / Icatibant
Icatibant
also known as
HOE140 · Firazyr · Icanticure · Icatibant accord · ICATIBANT ACETATE · Icatibanto · TAK-667
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | FIRAZYR | — | 2011-08-25 | fda.gov ↗ |
| Approved | EU (EMA) | Firazyr | — | 2008-07-11 | europa.eu ↗ |
Trials 23 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT02045264 | Feb 2014 | hereditary angioedema | Shire | Completed | No outcome recorded |
| Phase 1 | NCT00517582 | Sep 2007 → Sep 2011 | angioedema | Vanderbilt University | Terminated | No outcome recorded |
| Phase 27 trials | ||||||
| Phase 2 | NCT04978051 | Apr → Nov 2021 | pneumonia | Sebastian Videla | Completed | No outcome recorded |
| Phase 2 | NCT05010876 | Feb → Jun 2021 | COVID-19 | Ramsay Santé | Completed | No outcome recorded |
| Phase 2 | NCT04488081 | Jul 2020 → Jul 2028 expected | COVID-19 | QuantumLeap Healthcare Collaborative | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03005184 | Sep 2017 → Jan 2020 | mild heart failure, moderate heart failure | Vanderbilt University Medical Center | Withdrawn | No outcome recorded |
| Phase 2 | NCT03177798 | Aug 2017 → Jun 2018 | dialysis disequilibrium syndrome, mitochondrial disease | Vanderbilt University Medical Center | Completed | No outcome recorded |
| Phase 2 | NCT00303056 | Feb 2006 → Jul 2007 | arthritic joint disease | Sanofi | Completed | No outcome recorded |
| Phase 2 | NCT01154361 | — | angioedema | Technical University of Munich | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT00223704 | May 2006 → Jun 2012 | — | Vanderbilt University | Completed | No outcome recorded |
| Phase 39 trials | ||||||
| Phase 3 | NCT05834777 | Dec 2023 → Jul 2026 overdue | — | Vanderbilt University Medical Center | Recruiting | No outcome recorded |
| Phase 3 | NCT04654351 | Jan → Jul 2021 | hereditary angioedema | Takeda | Completed | No outcome recorded |
| Phase 3 | NCT03888755 | Mar 2015 → Feb 2016 | hereditary angioedema | Shire | Completed | No outcome recorded |
| Phase 3 | NCT01919801 | Dec 2013 → Aug 2015 | renin-angiotensin-aldosterone system-blocker-induced angioedema | Shire | Completed | No outcome recorded |
| Phase 3 | NCT01386658 | Jan 2012 → Mar 2018 | hereditary angioedema | Shire | Completed | No outcome recorded |
| Phase 3 | NCT00997204 | Sep 2009 → Jun 2011 | hereditary angioedema | Shire | Completed | No outcome recorded |
| Phase 3 | NCT00912093 | Jul 2009 → Oct 2010 | hereditary angioedema | Shire | Completed | No outcome recorded |
| Phase 3 | NCT00500656 | Mar 2005 → Jul 2006 | hereditary angioedema | Shire | Completed | No outcome recorded |
| Phase 3 | NCT00097695 | Dec 2004 → Jul 2006 | angioedema | Shire | Completed | No outcome recorded |
| Phase 44 trials | ||||||
| Phase 4 | NCT07290855 | Sep 2024 → May 2025 | hereditary angioedema, non-histaminic angioedema | Nang Kuang Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 4 | NCT04113109 | Nov 2019 → Apr 2025 | heart failure | Vanderbilt University Medical Center | Completed | No outcome recorded |
| Phase 4 | NCT01457430 | Dec 2011 → Apr 2014 | hereditary angioedema | Massachusetts General Hospital | Completed | No outcome recorded |
| Phase 4 | NCT01574248 | Aug 2011 → Sep 2015 | renin-angiotensin-aldosterone system-blocker-induced angioedema | Vanderbilt University Medical Center | Terminated | No outcome recorded |
Also used as a comparator or background therapy in 3 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT05407597 Comparator | May 2022 → Jun 2023 | COVID-19 | Belfast Health and Social Care Trust | Completed | No outcome recorded |
| Phase not applicable2 trials | ||||||
| — | NCT00965393 Comparator | Aug 2009 → Oct 2010 | myocardial ischemia | University of Edinburgh | Completed | No outcome recorded |
| — | NCT00965120 Comparator | Aug 2009 → Oct 2010 | ischemic disease | University of Edinburgh | Completed | No outcome recorded |
Press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2018-09-21 | Takeda | Shire Receives Approval of FIRAZYR(R) (icatibant injection) for the Treatment of Hereditary Angioedema (HAE) Attacks in Japan takeda.com ↗ |
| 2017-10-26 | Takeda | Shire Receives European Approval for Label Extension of FIRAZYR® (icatibant injection) for the Symptomatic Treatment of Acute Hereditary Angioedema (HAE) Attacks in Paediatric Patients takeda.com ↗ |
Evidence & citations 12 cited values
Every value below carries the sentence it was read from. 28 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Icatibant | “Icatibant 10 MG/ML Prefilled Syringe” NCT04978051 ↗ |
| Known as | Firazyr | ChEMBL registry synonym — accepted as the source's own label CHEMBL2028850 ↗ |
| Known as | HOE140 | “HOE140 Icatibant” NCT00303056 ↗ |
| Known as | Icanticure | “Icatibant Injection (Icanticure®)” NCT07290855 ↗ |
| Known as | Icatibant accord | ChEMBL registry synonym — accepted as the source's own label CHEMBL2028850 ↗ |
| Known as | ICATIBANT ACETATE | ChEMBL registry synonym — accepted as the source's own label CHEMBL2028850 ↗ |
| Known as | Icatibanto | ChEMBL registry synonym — accepted as the source's own label CHEMBL2028850 ↗ |
| Known as | TAK-667 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04654351 ↗ |
| Action | Inhibit | “Icatibant is a selective bradykinin B2 receptor antagonist.” PMID 20818888 ↗ Aug 20101“Bradykinin B2 receptor antagonist” CHEMBL2028850 ↗ |
| Modality | Peptide | “Icatibant: a stable, synthetic decapeptide” NCT00500656 ↗ |
| Route | Subcutaneous | “Icatibant was given once, subcutaneously, at a dose of 30 mg.” PMID 20818888 ↗ Aug 2010 |
| Target | BDKRB2 | “Bradykinin B2 receptor antagonist” CHEMBL2028850 ↗ |