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.
Background
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.
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 |
|---|---|---|---|---|---|
| Indocyanine Green for Injection | 国药准字H20249557 | 化学药品 | 注射剂 | 12/1/2024 | |
| Indocyanine Green for Injection | 国药准字H20073073 | 化学药品 | 注射剂(冻干粉针剂) | 6/19/2020 | |
| Indocyanine Green for Injection | 国药准字H20249047 | 化学药品 | 注射剂 | 10/16/2024 | |
| Indocyanine Green for Injection | 丹东医创药业有限责任公司;杭州澳亚生物技术股份有限公司 | 国药准字H20055881 | 化学药品 | 注射剂 | 6/19/2020 |
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 |