Icatibant

Generic Name: Icatibant

Brand Names: Firazyr, Sajazir, Icatibant Accord

Drug Type: Small Molecule

Chemical Formula: C_₅₉H_₈₉N_₁₉O_₁₃S

CAS Number: 130308-48-4

Unique Ingredient Identifier: 7PG89G35Q7

Background: 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 cur...

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

Associated Therapies: -

Clinical Trials

Prevention of Intradialytic Hypotension by Inhibiting Bradykinin B2 Receptor

Phase 3

Recruiting

Conditions: Intradialytic Hypotension

Interventions: Drug: Placebo
Drug: Icatibant

First Posted Date: 2023-04-28

Last Posted Date: 2023-12-18

Lead Sponsor: Vanderbilt University Medical Center

Target Recruit Count: 26

Registration Number: NCT05834777

Locations: 🇺🇸
Vanderbilt Fresenius, Nashville, Tennessee, United States

A Survey of Icatibant in Pediatric Participants with Hereditary Angioedema

Recruiting

Conditions: Hereditary Angioedema (HAE)

Interventions: Drug: Icatibant

First Posted Date: 2022-08-22

Last Posted Date: 2024-10-02

Lead Sponsor: Takeda

Target Recruit Count: 10

Registration Number: NCT05509569

Locations: 🇯🇵
Takeda selected site, Tokyo, Japan

Inhibition of Bradykinin in COVID-19 Infection With Icatibant

Phase 2

Completed

Conditions: SARS CoV 2 Infection

Interventions: Drug: 0.9% Sodium Chloride Injection
Drug: Icatibant

First Posted Date: 2022-06-07

Last Posted Date: 2023-09-07

Lead Sponsor: Belfast Health and Social Care Trust

Target Recruit Count: 32

Registration Number: NCT05407597

Locations: 🇬🇧
Mater Infirmorum Hospital, Belfast, Antrim, United Kingdom

I-SPY COVID-19 TRIAL: An Adaptive Platform Trial for Critically Ill Patients

Phase 2

Recruiting

Conditions: COVID-19

Interventions: Drug: Remdesivir
Drug: Imatinib Mesylate
Drug: Dexamethasone
Biological: dornase alfa
Drug: Celecoxib
Biological: IC14
Biological: narsoplimab
Drug: Cenicriviroc
Drug: Apremilast
Drug: Icatibant
Drug: Aviptadil
Drug: Cyproheptadine
Drug: Cyclosporine
Drug: Famotidine

First Posted Date: 2020-07-27

Last Posted Date: 2024-03-19

Lead Sponsor: QuantumLeap Healthcare Collaborative

Target Recruit Count: 1500

Registration Number: NCT04488081

Locations: 🇺🇸
Columbia University Medical Center, New York, New York, United States
🇺🇸
Sanford Health, Sioux Falls, South Dakota, United States
🇺🇸
University of Rochester Medical Center, Rochester, New York, United States

and more 33 locations

Mechanisms Underlying Hypotensive Response to ARB/NEP Inhibition - Aim 2

Phase 4

Recruiting

Conditions: Heart Failure

Interventions: Drug: LCZ 696
Drug: Icatibant
Drug: placebo
Drug: Para-aminohippurate
Drug: Iohexol

First Posted Date: 2019-10-02

Last Posted Date: 2024-03-05

Lead Sponsor: Vanderbilt University Medical Center

Target Recruit Count: 80

Registration Number: NCT04113109

Locations: 🇺🇸
Vanderbilt University Medical Center, Nashville, Tennessee, United States

A Study of Icatibant for Acute Attacks of Hereditary Angioedema in Japanese Participants

Phase 3

Completed

Conditions: Hereditary Angioedema (HAE)

Interventions: Drug: Icatibant

First Posted Date: 2019-03-25

Last Posted Date: 2021-06-03

Lead Sponsor: Shire

Target Recruit Count: 8

Registration Number: NCT03888755

Locations: 🇯🇵
Niigata City General Hospital, Niigata, Japan
🇯🇵
Nihon University Itabashi Hospital, Tokyo, Japan
🇯🇵
Kobe University Hospital, Kobe, Japan

and more 5 locations

Mitochondria and Chronic Kidney Disease

Phase 2

Completed

Conditions: Hemodialysis-Induced Symptom
Mitochondrial Diseases

Interventions: Drug: Icatibant
Drug: Placebo

First Posted Date: 2017-06-06

Last Posted Date: 2019-10-29

Lead Sponsor: Vanderbilt University Medical Center

Target Recruit Count: 11

Registration Number: NCT03177798

Locations: 🇺🇸
Vanderbilt University Medical Center, Nashville, Tennessee, United States

Mechanism(s) Underlying Cardiovascular Effects of ARB/NEP Inhibition - Aim 2

Phase 2

Withdrawn

Conditions: Heart Failure NYHA Class III
Heart Failure NYHA Class II
Heart Failure NYHA Class I

Interventions: Drug: Valsartan 80 mg bid
Drug: Enalapril 10 mg bid
Drug: Sacubitril-Valsartan 200 mg bid
Drug: Icatibant
Drug: Placebo

First Posted Date: 2016-12-29

Last Posted Date: 2018-01-11

Lead Sponsor: Vanderbilt University Medical Center

Registration Number: NCT03005184

Locations: 🇺🇸
Vanderbilt University Medical Center, Nashville, Tennessee, United States

Blinded Safety & Efficacy Placebo Controlled Study of Icatibant for Angiotensin Converting Enzyme Inhibitor Induced Angioedema

Phase 3

Completed

Conditions: Angiotensin Converting Enzyme Inhibitor Induced Angioedema

Interventions: Drug: Placebo
Drug: Icatibant

First Posted Date: 2013-08-09

Last Posted Date: 2021-06-08

Lead Sponsor: Shire

Target Recruit Count: 118

Registration Number: NCT01919801

Locations: 🇺🇸
Federal Health Care Center, Chicago, Illinois, United States
🇺🇸
Cook County Hospital, Chicago, Illinois, United States
🇺🇸
University of Maryland School of Medicine, Baltimore, Maryland, United States

and more 51 locations

Effect of Bradykinin Receptor Antagonism on ACE Inhibitor-associated Angioedema

Phase 4

Terminated

Conditions: ACE Inhibitor-associated Angioedema

Interventions: Other: Placebo
Drug: icatibant

First Posted Date: 2012-04-10

Last Posted Date: 2017-02-17

Lead Sponsor: Vanderbilt University Medical Center

Target Recruit Count: 33

Registration Number: NCT01574248

Locations: 🇺🇸
University of California, San Diego, San Diego, California, United States
🇺🇸
Vanderbilt University Medical Center, Nashville, Tennessee, United States

Drug Development Updates

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