Overview
Indocyanine Green is a water soluble, tricarbocyanine dye with a peak spectral absorption at 800 nm. The chemical name for Indocyanine Green is 1 H-Benz[e]indolium, 2-[7-[1,3-dihydro-1,1-dimethyl-3-(4-sulfobutyl)-2H-benz[e] indol-2-ylidene]-1,3,5-heptatrienyl]-1,1-dimethyl-3-(4-sulfobutyl)-,hydroxide, inner salt, sodium salt. Indocyanine Green for Injection USP has a pH of approximately 6.5 when reconstituted. Each vial of Indocyanine Green for Injection USP contains 25 mg of Indocyanine Green as a sterile lyophilized powder with no more than 5% sodium iodide.
Indication
For Determining Cardiac Output, Hepatic Function and Liver Blood Flow For ophthalmic angiography
Associated Conditions
No associated conditions information available.
Research Report
Comprehensive Monograph on Indocyanine Green (DB09374)
Executive Summary
Indocyanine Green (ICG) is a tricarbocyanine dye with a remarkable history, evolving from a mid-20th-century diagnostic tool into a cornerstone of modern near-infrared (NIR) fluorescence-guided surgery. First approved by the U.S. Food and Drug Administration (FDA) in 1959, its initial applications were centered on measuring cardiac output and hepatic function, leveraging its unique pharmacokinetic profile. This profile is characterized by rapid and strong binding to plasma proteins, which confines the molecule to the intravascular space, and an exclusive, rapid elimination pathway through the liver into the bile without undergoing metabolic alteration.
The advent of sophisticated NIR imaging technologies has catalyzed a renaissance for ICG, transforming it into a versatile intraoperative navigation aid. Its spectral properties, with absorption and emission peaks in the NIR window, allow for deep tissue penetration with a high signal-to-noise ratio, enabling real-time visualization of anatomical structures and physiological processes. Key contemporary applications include ophthalmic angiography for diagnosing choroidal diseases, intraoperative cholangiography to prevent bile duct injury during cholecystectomy, comprehensive perfusion assessment to reduce anastomotic leaks in colorectal surgery and flap necrosis in reconstructive surgery, and high-precision sentinel lymph node mapping in oncologic surgery.
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2025/05/29 | Phase 1 | Recruiting | Eva Sevick | ||
2025/04/23 | Phase 1 | Recruiting | OPTOSURGICAL, LLC | ||
2025/03/12 | Phase 4 | Not yet recruiting | |||
2025/03/10 | Phase 1 | Not yet recruiting | VPIX Medical | ||
2024/11/04 | Not Applicable | Not yet recruiting | City of Hope Medical Center | ||
2024/10/07 | Phase 4 | Completed | |||
2024/06/06 | Early Phase 1 | Recruiting | |||
2024/05/03 | Phase 4 | Recruiting | |||
2024/10/11 | Phase 2 | Not yet recruiting | |||
2024/03/25 | Phase 2 | Recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
Novadaq Technologies, Inc. | 69450-701 | INTRAVENOUS | 25 mg in 1 1 | 3/2/2015 | |
Novadaq Technologies Inc. | 75874-424 | INTRAVENOUS | 25 mg in 1 1 | 11/18/2011 | |
Novadaq Technologies Inc. | 49673-424 | INTRAVENOUS | 25 mg in 1 1 | 5/22/2012 | |
Novadaq Technologies Inc. | 66259-424 | INTRAVENOUS | 25 mg in 1 1 | 11/11/2015 | |
Novadaq Technologies Inc. | 66259-701 | INTRAVENOUS | 25 mg in 1 1 | 9/17/2013 | |
Novadaq Technologies Inc. | 75874-701 | INTRAVENOUS | 25 mg in 1 1 | 8/30/2013 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
---|---|---|---|
No EMA approvals found for this drug. |
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 |
---|---|---|---|---|---|
DIAGNOGREEN FOR INJ 25MG/VIAL | N/A | N/A | N/A | 11/10/1988 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
SPY AGENT GREEN Indocyanine green | 369670 | Medicine | A | 2/28/2024 | |
VERDYE indocyanine green 25 mg powder for injection vial | 391356 | Medicine | A | 3/15/2024 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
---|---|---|---|---|---|
INDOCYANINE GREEN FOR INJECTION, USP | diagnostic green limited | 02485796 | Powder For Solution - Intravenous | 25 MG / VIAL | 6/11/2019 |
SPY AGENT GREEN LYMPHATICS KIT FOR ADVANCED IMAGING MODALITY (AIM) AND PINPOINT | Novadaq Technologies ULC | 02483696 | Kit
,
Powder For Solution - Interstitial | 25 MG / VIAL | 6/4/2019 |
INDOCYANINE GREEN FOR INJECTION KIT | diagnostic green limited | 02485818 | Powder For Solution
,
Kit - Intravenous | 25 MG / VIAL | N/A |
IC-GREEN | 02014793 | Powder - Intravenous | 25 MG / VIAL | 12/31/1994 | |
SPY AGENT GREEN KIT FOR SPY ELITE | Novadaq Technologies ULC | 02483661 | Powder For Solution
,
Kit - Intravenous | 25 MG / VIAL | 6/4/2019 |
SPY AGENT GREEN KIT FOR ADVANCED IMAGING MODALITY (AIM) AND PINPOINT | Novadaq Technologies ULC | 02527839 | Powder For Solution
,
Kit - Intravenous | 25 MG / VIAL | 2/15/2023 |
SPY AGENT GREEN | Novadaq Technologies ULC | 02483653 | Powder For Solution - Intradermal
,
Interstitial
,
Intravenous | 25 MG / VIAL | 6/4/2019 |
SPY AGENT GREEN KIT FOR ADVANCED IMAGING MODALITY (AIM) AND PINPOINT | Novadaq Technologies ULC | 02483688 | Kit
,
Powder For Solution - Intravenous | 25 MG / VIAL | 6/4/2019 |
SPY AGENT GREEN KIT FOR SPY-PHI | Novadaq Technologies ULC | 02498677 | Kit
,
Powder For Solution - Intradermal
,
Interstitial
,
Intravenous | 25 MG / VIAL | 12/3/2020 |
INDOCYANINE GREEN FOR INJECTION KIT | diagnostic green limited | 02485826 | Powder For Solution
,
Kit - Intravenous | 25 MG / VIAL | 6/11/2019 |
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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