Clinical Trials

Numerous clinical trials evaluate Icatibant Acetate across Phase 1 through Phase 4 development stages for conditions such as hereditary angioedema, ACE inhibitor-induced angioedema, joint disease, mitochondrial dysfunction, and SARS-CoV-2 infection. Sponsored by pharmaceutical companies like Shire, Sanofi, and Takeda, alongside academic institutions including Massachusetts General Hospital and Vanderbilt University Medical Center, these studies span completed, active, recruiting, terminated, and withdrawn recruitment statuses.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT04488081 ACTIVE_NOT_RECRUITING
COVID-19
QuantumLeap Healthcare Collaborative
 2020-07-31 PHASE2
NCT05834777 RECRUITING
Intradialytic Hypotension
Vanderbilt University Medical Center
 2023-12-11 PHASE3
NCT07290855 COMPLETED
Bradykinin-mediated Angioedema; Hereditary Angioedema (HAE)
Nang Kuang Pharmaceutical Co., Ltd.
 2024-09-27 PHASE4
NCT04113109 COMPLETED
Heart Failure
Vanderbilt University Medical Center
 2019-11-01 PHASE4
NCT05407597 COMPLETED
SARS CoV 2 Infection
Belfast Health and Social Care Trust
 2022-05-16 PHASE2; PHASE3
NCT04978051 COMPLETED
COVID-19 Pneumonia
Sebastian Videla
 2021-04-12 PHASE2
NCT04654351 COMPLETED
Hereditary Angioedema
Takeda
 2021-01-15 PHASE3
NCT05010876 COMPLETED
Covid19
GCS Ramsay Santé pour l'Enseignement et la Recherche
 2021-02-04 PHASE2
NCT03005184 WITHDRAWN
Heart Failure NYHA Class I; Heart Failure NYHA Class II; Heart Failure NYHA Class III
Vanderbilt University Medical Center
 2017-09 PHASE2
NCT03177798 COMPLETED
Hemodialysis-Induced Symptom; Mitochondrial Diseases
Vanderbilt University Medical Center
 2017-08-01 PHASE2
NCT01386658 COMPLETED
Hereditary Angioedema (HAE)
Shire
 2012-01-27 PHASE3
NCT03888755 COMPLETED
Hereditary Angioedema (HAE)
Shire
 2015-03-18 PHASE3
NCT01574248 TERMINATED
ACE Inhibitor-associated Angioedema
Vanderbilt University Medical Center
 2011-08 PHASE4
NCT01919801 COMPLETED
Angiotensin Converting Enzyme Inhibitor Induced Angioedema
Shire
 2013-12-02 PHASE3
NCT01457430 COMPLETED
Hereditary Angioedema
Massachusetts General Hospital
 2011-12 PHASE4
NCT02045264 COMPLETED
Hereditary Angioedema (HAE)
Shire
 2014-02-21 PHASE1
NCT00997204 COMPLETED
Hereditary Angioedema
Shire
 2009-09-25 PHASE3
NCT00912093 COMPLETED
Hereditary Angioedema
Shire
 2009-07-16 PHASE3
NCT00303056 COMPLETED
Joint Disease
Sanofi
 2006-02 PHASE2
NCT00500656 COMPLETED
Hereditary Angioedema
Shire
 2005-03-01 PHASE3
NCT00097695 COMPLETED
Angioedema
Shire
 2004-12-28 PHASE3
NCT01154361 COMPLETED
Angioedema
Technical University of Munich
 PHASE2

(data from https://clinicaltrials.gov, updated on 2026-03-16)

Check the Icatibant Acetate product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Icatibant Acetate selectively binds to and antagonizes the bradykinin B2 receptor, inhibiting bradykinin-mediated signaling pathways that induce intracellular calcium mobilization, endothelial nitric oxide release, and increased vascular permeability. By blocking B2 receptor activation and preventing microvascular leakage and fluid extravasation, this compound suppresses acute localized tissue swelling, providing direct clinical utility in bradykinin-mediated disorders such as hereditary angioedema.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

Jump to

Note: Technical data last updated: Sep 1, 2026.