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icatibant

Trade name: firazyr

Small moleculeapprovedOrphan Drug FDA

Approved

Aug 25, 2011

Icatibant (trade name Firazyr) is a synthetic peptidomimetic drug consisting of ten amino acids, and acts as an effective and specific antagonist of bradykinin B2 receptors. It has been approved in the EU for use in hereditary angioedema, and is under investigation for a number of other conditions in which bradykinin is thought to play a significant role. Icatibant currently has orphan drug status in the United States and FDA approved on August 25, 2011. Icatibant inhibits bradykinin from binding the B2 receptor and thereby treats the clinical symptoms of an acute, episodic attack of HAE. — NCATS

Clinical trial activity

26 trials · 35 clinical orgs · 14 marketing orgs

Phase 1
2
Phase 2
15
Phase 3
11
Phase 4
4

Earliest trial started Aug 1, 2004 (NCT00097695)

Timeline

2000s

  1. Nov 25, 2003

    Orphan Drug Designation

  2. Jan 1, 2004

    Shire — Earliest Phase 3 Sponsor(trial)

  3. Jan 1, 2006

    Earliest Phase 2 Sponsor(trial)

  4. Jan 1, 2007

    Earliest Phase 1 Sponsor(trial)

2010s

  1. Aug 25, 2011

    Shire — Earliest FDA Approval

  2. Aug 25, 2011

    Takeda — Marketing Organization

  3. Aug 25, 2011

    Shire — NDA Organization

  4. Aug 25, 2011

    Takeda — NDA Secondary Org

  5. Jul 15, 2019

    Teva — Marketing Organization

2020s

  1. Mar 9, 2020

    Jiangsu Hansoh Pharmaceutical Co., Ltd. — Marketing Organization

  2. Jun 18, 2020

    Fresenius — Marketing Organization

  3. Jul 13, 2020

    Cipla — Marketing Organization

  4. Sep 2, 2020

    Wilshire Pharmaceuticals — Marketing Organization

  5. Sep 2, 2020

    Slayback Pharma Llc — Marketing Organization

  6. Oct 5, 2020

    Caplin Point Laboratories — Marketing Organization

  7. Oct 6, 2020

    Dr. Reddy's Laboratories — Marketing Organization

  8. Dec 16, 2020

    Nang Kuang Pharmaceutical Co., Ltd. — Marketing Organization

  9. May 21, 2021

    Glenmark Pharmaceuticals — Marketing Organization

  10. Aug 14, 2023

    Eugia Pharma — Marketing Organization

  11. Jun 14, 2024

    Alembic — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedPriority reviewAug 25, 2011

Chemistry & pharmacology

Loading structure…

SMILES

N=C(N)NCCC[C@@H](N)C(=O)N[C@@H](CCCNC(=N)N)C(=O)N1CCC[C@H]1C(=O)N1C[C@H](O)C[C@H]1C(=O)NCC(=O)N[C@@H](Cc1cccs1)C(=O)N[C@@H](CO)C(=O)N1Cc2ccccc2C[C@@H]1C(=O)N1[C@H](C(=O)N[C@@H](CCCNC(=N)N)C(=O)O)C[C@@H]2CCCC[C@@H]21
Mol. weight
1304.55 g/mol
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Parenteral
Availability
Prescription Only

Oral

No

Parenteral

Yes

Topical

No

First in class

Sources

Also known as

  • d-arg(hyp(3)-thi(5)-d-tic(7)-oic(8))bk
  • firazyr
  • firazyr
  • firazyr
  • hoe140
  • hoe140
  • hoe 140
  • hoe 140
  • hoe 140
  • hoe-140
  • hoe-140
  • hoe-140
  • hoe-140
  • hoechst 140
  • hoechst-140
  • icatibant
  • icatibant
  • icatibant
  • icatibant
  • icatibant
  • icatibant
  • icatibant
  • icatibant
  • icatibant
  • icatibant
  • icatibant acetate
  • icatibant acetate
  • icatibant acetate
  • icatibant acetate
  • icatibant acetate
  • je 049
  • je-049
  • win 65365
  • win 65365
  • win-65365
  • win-65365
  • win-65365
  • win-65365
  • win-65365
  • win-65365

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07290855Phase 4Sep 27, 2024Nang Kuang Pharmaceutical Co., Ltd.
NCT05834777Phase 3Dec 11, 2023Pharvaris Netherlands B.V., Renal Research Institute, Vanderbilt University
NCT05407597Phase 2/Phase 3 (Phase 3)May 12, 2022Queen's University, Belfast
NCT04978051Phase 2Apr 12, 2021Hospital Universitari de Bellvitge, University of Barcelona
NCT05010876Phase 2Feb 4, 2021GCS Ramsay Santé pour l’Enseignement et la Recherche, University of Montpellier
NCT04654351Phase 3Jan 15, 2021Takeda
NCT04488081Phase 2Jul 31, 2020Columbia University, Emory University, QuantumLeap Healthcare Collaborative, Sanford Health, University of Alabama, Birmingham, University of California, San Diego, University of California, San Francisco, University of Colorado, Denver, University of Minnesota, University of Pennsylvania, University of Southern California, Wake Forest University, Yale University, Yeshiva University
NCT04113109Phase 4Oct 31, 2019Vanderbilt University
NCT03177798Phase 2Jul 15, 2017Vanderbilt University
NCT03005184N/AJan 1, 2017Vanderbilt University
NCT03888755Phase 3Mar 18, 2015Shire
NCT02045264Phase 1Feb 1, 2014Shire
NCT01919801Phase 3Dec 1, 2013PPD, Shire
NCT01457430Phase 4Dec 1, 2011Harvard University, Shire
NCT01386658Phase 3Nov 1, 2011Shire
NCT01574248Phase 4Aug 1, 2011Shire, Vanderbilt University
NCT01154361Phase 2Jun 29, 2010Technical University of Munich
NCT00997204Phase 3Sep 1, 2009Jerini, Shire
NCT00965120N/AAug 1, 2009Aarhus University, University of Edinburgh, University of Oxford
NCT00965393N/AAug 1, 2009Aarhus University, University of Edinburgh, University of Oxford
Showing 20 of 26 trials
Page 1 / 2

Organizations

Research & Development (35)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
ShireFor profit10832004
Vanderbilt UniversityAcademic/Hospital7752006
Aarhus UniversityAcademic/Hospital2012009
University of EdinburghAcademic/Hospital2212009
University of OxfordAcademic/Hospital2012009
University of Southern CaliforniaAcademic/Hospital2022004
Columbia UniversityAcademic/Hospital1012020
Emory UniversityAcademic/Hospital1012020
GCS Ramsay Santé pour l’Enseignement et la RechercheAcademic/Hospital1112021
Harvard UniversityAcademic/Hospital1112011
Hospital Universitari de BellvitgeAcademic/Hospital1112021
JeriniFor profit1012009
Nang Kuang Pharmaceutical Co., Ltd.For profit1112024
National Heart, Lung, and Blood Institute (NHLBI)Government1012007
Pharvaris Netherlands B.V.For profit1012023
PPDFor profit1012013
QuantumLeap Healthcare CollaborativeAcademic/Hospital1112020
Queen's University, BelfastAcademic/Hospital1112022
Renal Research InstituteAcademic/Hospital1012023
Sanford HealthAcademic/Hospital1012020
35 organizations
Page 1 / 2

Marketing (15)

OrganizationOrg typeRelationshipDate
AlembicFor profitMKTGJun 14, 2024
Caplin Point LaboratoriesFor profitMKTGOct 5, 2020
CiplaFor profitMKTGJul 13, 2020
Dr. Reddy's LaboratoriesFor profitMKTGOct 6, 2020
Eugia PharmaFor profitMKTGAug 14, 2023
FreseniusFor profitMKTGJun 18, 2020
Glenmark PharmaceuticalsFor profitMKTGMay 21, 2021
Jiangsu Hansoh Pharmaceutical Co., Ltd.For profitMKTGMar 9, 2020
Nang Kuang Pharmaceutical Co., Ltd.For profitMKTGDec 16, 2020
ShireFor profitNDAAug 25, 2011
Slayback Pharma LlcFor profitMKTGSep 2, 2020
TakedaFor profitMKTGAug 25, 2011
TakedaFor profitNDA2Aug 25, 2011
TevaFor profitMKTGJul 15, 2019
Wilshire PharmaceuticalsFor profitMKTGSep 2, 2020