Icatibant

Overview

Icatibant (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.

Indication

Approved for use in acute attacks of hereditary angioedema (HAE). Investigated for use/treatment in angioedema, liver disease, and burns and burn infections.

Associated Conditions

ACE Inhibitor-associated Angioedema
Hereditary angioedema breakthrough attack

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Prevention of Intradialytic Hypotension by Inhibiting Bradykinin B2 Receptor	2023/04/28	NCT05834777	Phase 3	Recruiting	Vanderbilt University Medical Center
A Survey of Icatibant in Pediatric Participants with Hereditary Angioedema	2022/08/22	NCT05509569	N/A	Active, not recruiting	Takeda
Inhibition of Bradykinin in COVID-19 Infection With Icatibant	2022/06/07	NCT05407597	Phase 2	Completed	Belfast Health and Social Care Trust
Evaluation of the Effects of Bradykinin Antagonists on Pulmonary Manifestations of COVID-19 Infections (AntagoBrad-Cov Study).	2021/08/18	NCT05010876	Phase 2	Completed	GCS Ramsay Santé pour l'Enseignement et la Recherche
Investigating the Efficacy and Safety ICATIBANT For The Treatment of Patients With SARS-CoV-2 (COVID-19) Infection	2021/07/27	NCT04978051	Phase 2	Completed	Sebastian Videla
A Study of Icatibant (TAK-667) in Japanese Children and Teenagers With Acute Attacks of Hereditary Angioedema	2020/12/04	NCT04654351	Phase 3	Completed	Takeda
I-SPY COVID-19 TRIAL: An Adaptive Platform Trial for Critically Ill Patients	2020/07/27	NCT04488081	Phase 2	Recruiting	QuantumLeap Healthcare Collaborative
Mechanisms Underlying Hypotensive Response to ARB/NEP Inhibition - Aim 2	2019/10/02	NCT04113109	Phase 4	Completed	Vanderbilt University Medical Center
FIRAZYR General Drug Use-Results Survey (Japan)	2019/08/15	NCT04057131	N/A	Completed	Shire
A Study of Icatibant for Acute Attacks of Hereditary Angioedema in Japanese Participants	2019/03/25	NCT03888755	Phase 3	Completed	Shire

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Firazyr	Takeda Pharmaceuticals America, Inc.	54092-702	SUBCUTANEOUS	30.0 mg in 3 mL	1/19/2024
SAJAZIR	Cycle Pharmaceuticals Ltd-Uk	70709-013	SUBCUTANEOUS	30 mg in 3 mL	5/31/2023
Icatibant	Fresenius Kabi USA, LLC	63323-574	SUBCUTANEOUS	10 mg in 1 mL	8/28/2019
Icatibant	Teva Pharmaceuticals USA, Inc.	0093-3066	SUBCUTANEOUS	10 mg in 1 mL	10/27/2022
Icatibant	Eugia US LLC	55150-351	SUBCUTANEOUS	30 mg in 3 mL	4/7/2023
Icatibant	Hikma Pharmaceuticals USA Inc.	24201-207	SUBCUTANEOUS	30 mg in 3 mL	11/30/2023
ICATIBANT	Apotex Corp.	60505-6214	SUBCUTANEOUS	30 mg in 3 mL	2/29/2024
Icatibant	Slayback Pharma LLC	71225-114	SUBCUTANEOUS	30 mg in 3 mL	1/28/2021
ICATIBANT	Cipla USA Inc.	69097-664	SUBCUTANEOUS	30 mg in 3 mL	5/31/2023
ICATIBANT	Bryant Ranch Prepack	72162-2106	SUBCUTANEOUS	30 mg in 3 mL	9/19/2023

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
Icatibant Accord	Accord Healthcare S.L.U.,Edificio Este Planta 6a,World Trade Center,Moll De Barcelona S/n,08039 Barcelona,SPAIN	Authorised	7/16/2021
Icatibant Accord	Accord Healthcare S.L.U.,Edificio Este Planta 6a,World Trade Center,Moll De Barcelona S/n,08039 Barcelona,SPAIN	Authorised	7/16/2021
Firazyr	Takeda Pharmaceuticals International AG,50-58 Baggot Street Lower,Block 2 Miesian Plaza,Dublin 2,Co Dublin,D02 HW68,IRELAND	Authorised	7/11/2008

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
ICATIBANT WOCKHARDT icatibant (as acetate) 30 mg/3 mL solution for injection pre-filled syringe (with needle)	353730	Wockhardt Bio Pty Ltd	Medicine	A	7/17/2024
ICATIBANT GH icatibant (as acetate) 30 mg/3 mL solution for injection pre-filled syringe	364112	Generic Health Pty Ltd	Medicine	A	6/22/2022
ICATIBANT WKT icatibant (as acetate) 30 mg/3 mL solution for injection pre-filled syringe (with needle)	353731	Wockhardt Bio Pty Ltd	Medicine	A	7/17/2024
CIPLA ICATIBANT icatibant (as acetate) 30 mg/3 mL solution for injection pre-filled syringe	314007	Cipla Australia Pty Ltd	Medicine	A	5/4/2020
ICATIBANT LUPIN icatibant (as acetate) 30 mg/3 mL solution for injection pre-filled syringe	364111	Generic Health Pty Ltd	Medicine	A	6/22/2022
FIRAZYR icatibant (as acetate) 30 mg/3 mL injection pre-filled syringe	160313	Takeda Pharmaceuticals Australia Pty Ltd	Medicine	A	9/3/2010
ICATICIP icatibant (as acetate) 30 mg/3 mL solution for injection pre-filled syringe	314006	Cipla Australia Pty Ltd	Medicine	A	5/4/2020
ICATIBANT MYLAN icatibant (as acetate) 30 mg/3 mL solution for injection pre-filled syringe	313640	Alphapharm Pty Ltd	Medicine	A	3/12/2021
ICAZYR icatibant (as acetate) 30 mg/3 mL solution for injection pre-filled syringe	314004	Cipla Australia Pty Ltd	Medicine	A	5/4/2020
FYZANT Icatibant (as acetate) 30mg/3mL solution for injection pre-filled syringe	355650	Juno Pharmaceuticals Pty Ltd	Medicine	A	3/18/2022

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
No Health Canada approvals found for this drug.

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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