Data updated: May 26, 2026
SPY AGENT GREEN KIT (indocyanine green)
Other
Approved 2018-11-21
Indocyanine Green for Injection USP is indicated: Indocyanine Green for Injection USP a tricarbocyanine dye, is indicated: • For visual assessment of blood vessels, blood flow and related tissue perfusion with OLYMPUS infrared compatible endoscopic imaging system • For visual assessment of the major extrahepatic bile ducts with OLYMPUS infrared imaging endoscopic imaging system • For viewing intra-operative blood flow in the cerebral area with OLYMPUS infrared compatible video microscopic imagin...
Source: FDA Label • NOVADAQ TECH
2
Indications
--
Phase 3 Trials
7
Years on Market
Details
- Status
- Prescription
- First Approved
- 2018-11-21
- Patent Cliff
- 2039
- Routes
- INTRAVENOUS, INTERSTITIAL
- Dosage Forms
- POWDER
SPY AGENT GREEN KIT Approval History
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
4 FDA actions from 2018 to 2023 · 1 indication expansions
What SPY AGENT GREEN KIT Treats
2 FDA approvalsOriginally approved for its first indication in 2018 . Covers 2 distinct patient populations.
- Other (2)
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Clinical Trial Registry
60 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06169735 | IRB-300011872 Stryker | Ph 4 | terminated | Does Fluorescence With or Without Indocyanine Green Improve Parathyroid Identification and Preservation |
| NCT04084067 | ICGLOW NCI-2019-06146 | Ph 1 | recruiting | Indocyanine Green (ICG) Guided Tumor Resection |
| NCT04752137 | 2020P003481 | Ph 2 | recruiting | Intraoperative Tumor Margin Identification With ICG Dye Imaging |
| NCT04723810 | 844554 | Ph 1, Ph 2 | recruiting | TumorGlow Intraoperative Molecular Imaging (IMI) |
| NCT05038098 | 2021-0410 NCI-2021-08919, 2021-0410 | Ph 1 | not yet recruiting | Magnetic Sentinel Lymph Node Mapping in Gastric Cancer |
| NCT06327490 | UF-BRE-012 IRB202400626, OCR44989 | Ph 2 | recruiting | A Study Evaluating the Feasibility and Compliance of Manual Lymphatic Drainage Comparing Indocyanine-Green (ICG) Guided vs. Traditional Guided in Patients Undergoing Axillary Node Dissection for the Treatment of Breast Cancer |
| NCT02570815 | BFCRS-RP-001-1504-29 101 | Ph 1 | recruiting | Near-Infrared Fluorescence Guided Robotic Pulmonary Segmentectomy for Early Stage Lung Cancer |
| NCT03262636 TumorGlow(TM) | 0822231 | Ph 1 | completed | Two-Part Study to Evaluate the Safety and Efficacy of Image Guided Surgery Using Indocyanine Green for Intramolecular Imaging of Nervous System Tumors Compared to Standard of Care, (TumorGlow) |
| NCT07315841 ICG-TGCT | 2025-147 2025-147 | Ph 4 | recruiting | Accuracy of Indocyanine Green (ICG) Fluorescence Imaging in Tenosynovial Giant Cell Tumor Surgery |
| NCT07315828 ICG-GCTB | 2025-146 2025-146 | Ph 4 | recruiting | Accuracy of Indocyanine Green (ICG) Fluorescence Imaging in Giant Cell Tumor of Bone Surgery |
| NCT06939946 | IRB00224302 | Ph 1 | terminated | Intraoperative Parathyroid Gland (PTG) Identification Using a Hand-Held Imager (HHI) |
| NCT05808140 | Yuanlong Xie | Ph 1, Ph 2 | completed | Fluorescence Imaging With Indocyanine Green(ICG) in Endoscopic Spinal Surgery |
| NCT07254845 | cCeLL_II_2025_Cedars | Ph 1 | not yet recruiting | A PROSPECTIVE, SINGLE-CENTERED, ASSESSOR-BLINDED STUDY TO EVALUATE THE CLINICAL EFFICACY OF THE PROPOSED CELL/TISSUE HISTOPATHOLOGY PROCESSOR CCELL (CONFOCAL FLUORESCENCE ENDOMICROSCOPY) FOR INTRAOPERATIVE DIAGNOSIS IN BRAIN TUMORS |
| NCT05346380 | 2020P000835 | Ph 1, Ph 2 | completed | Near-Infrared Perfusion During Minimally Invasive Thoracic Surgery Download |
| NCT04842162 MAGNOLIA | 2019-002442-20 2019/2886 | Ph 2 | recruiting | Study Evaluating Near-infrared Imaging Coupled With Indocyanine Green for Intraoperative Control of Resection Margins in ENT Surgery |
| NCT06002906 | 20-5008 | Ph 4 | active not recruiting | The Use of Indocyanine Green to Visualize Blood Flow to the Gastrojejunostomy During Bariatric Surgery. |
| NCT04340752 | 18-01995 | Ph 1 | active not recruiting | Optimal Dosing of IC-Green for Visualization of Rotator Cuff Vascularity Using Advanced Imaging Modality Arthroscopy |
| NCT05197530 | STUDY6830 2R01AR056702-11A1 | Ph 1 | recruiting | Imaging of Lymphatic Vessels in People with Rheumatoid Arthritis (RA) |
| NCT06871787 INOCA | 07.01.2025-3097444 | Ph 4 | not yet recruiting | Near-Infrared Fluorescence Imaging With Indocyanine Green to Evaluate Bowel Anastomoses in Gynecologic Oncology Surgery |
| NCT06867978 PRECISION | cCeLL_II_2024 Republic of Korea | Ph 1 | not yet recruiting | Multi-center Study on CCeLL-In Vivo's Clinical Efficacy for Intraoperative Brain Tumor Diagnosis. |
| NCT06164392 | STU00220008 | Ph 4 | withdrawn | Evaluation of Neuroma Perfusion with Indocyanine Green Fluorescence Angiography |
| NCT03584633 results posted | 201803867 | Ph 4 | completed | Effect of Exercise on Indocyanine Green (ICG) Lymphography Imaging |
| NCT06629415 ICG | PT (657) | Ph 4 | completed | Using Indocyanine Green (ICG) to Outline Biliary Tree During Laparoscopic Cholecystectomy |
| NCT06398028 | LIVERGREEN | Ph 4 | recruiting | The Preoperative Administration of ICG Improves Tumor Detection in Patients Undergoing Minimally Invasive Hepatic Resection Guided by Conventional Intraoperative Ultrasound. |
| NCT05354856 | H-20027060 | Ph 4 | terminated | The Effect of Chemoradiotherapy on Gastric Perfusion in Patients With Gastric Cancer. |
| NCT05687617 | MP-20-2023-6524 | Ph 2 | terminated | Near-infrared Imaging With Indocyanine Green for Detection of Peritoneal Metastases for Gastric Adenocarcinoma. |
| NCT05926856 HQFC | 20230420 | Ph 2, Ph 3 | completed | High Quality Fluorescent Cholangiography |
| NCT02027818 | BR-TUM-ICG-IV | Ph 2 | completed | Study of the ICG Distribution in the Margins of Breast Cancer After Tumorectomy |
| NCT04891185 VIPIDO | S65525 2021-002449-13 | Ph 2 | terminated | Visualisation of Indocyanine Green in Primary and Interval Debulking for Ovarian Cancer |
| NCT04611997 | FUGES-020 | Ph 3 | active not recruiting | IGG Using in Laparoscopic Gastrectomy for Locally Advanced Gastric Cancer After Neoadjuvant Chemotherapy |
| NCT04942665 ICG results posted | IRB202100388 OCR40380, PRO00043219 | Ph 2 | completed | Low Dose ICG for Biliary Tract and Tumor Imaging |
| NCT04854018 | 20/BC/SME/PO/473 | Ph 4 | completed | Indo-cyanine Green (ICG) in Paediatric Oncology MIS |
| NCT04591028 | 20-002747 | Ph 4 | withdrawn | A Study to Evaluate Indocyanine Green Lymphangiography to Improve Lymphadenectomy in Gastric Cancer Patients |
| NCT05332405 | 21-01449 | Ph 4 | withdrawn | SPY Angiography To Assist With Ulnar Nerve Transposition at the Elbow |
| NCT02479997 | NCC-1410201-2 | Ph 2 | completed | Clinical Application of Dual Sentinel Lymph Node Staining Method in Breast Cancer Patients |
| NCT02997553 GASVERT | 2016-A00799-42 | Ph 3 | completed | Fluorescence for Sentinel Lymph Node Identification in Cancer Surgery |
| NCT02680067 NIR-ICG | RSRB 54038 R01AR056702 | Ph 1 | completed | NIR Fluorescence Imaging of Lymphatic Transport Using ICG |
| NCT04973475 | FUGES-023 | Ph 2 | not yet recruiting | Indocyanine Green Tracer Using in Laparoscopic Distal Gastrectomy for Early Gastric Cancer |
| NCT04857346 | KSU334 | Ph 2, Ph 3 | completed | Antimicrobial Photodynamic Therapy in Chronic Periodontitis and Diabetes Mellitus |
| NCT04046146 NIR-ICG MRL | STUDY3891 | Ph 1 | completed | Near InfraRed Fluorescence Using Indocyanine Green and Magnetic Resonance Lymphography of Lymphatic Transport |
| NCT03935165 GRE-Endo-2 | 736513. A 287 / C.E./2013 | Ph 2 | completed | Prospective Evaluation of Near-infrared Fluorescence Imaging Use as a Supportive Tool in Deep Infiltrating Endometriosis Surgery |
| NCT03155464 | Pro00078686 | Ph 4 | withdrawn | Intraoperative ICG for Systemic Sclerosis |
| NCT02775838 | SPY-Kidney | Ph 2 | completed | Measurements of Kidney Perfusion After Transplantation by Intraoperative Fluorescence Angiography |
| NCT03969108 | 19-5447 | Ph 4 | completed | Diagnostic Accuracy Study of Indocyanine Green for Parathyroid Perfusion Assessment |
| NCT03204994 | 12451 | Ph 1, Ph 2 | terminated | Fluorescence Targeted Pelvic Lymph Node Mapping |
| NCT01662752 results posted | C/32/2012 | Ph 2 | completed | Lymphatic Mapping for Sentinel Node Identification and Analysis |
| NCT03292757 FLOTOR | 12968 | Ph 1, Ph 2 | completed | FLOTOR Pilot Study |
| NCT02611245 | 2011CB707702 | Ph 1 | completed | NIR Fluorescence Imaging Technique in Thoracic Surgery With ICG |
| NCT02279108 FLUOTECH results posted | 1408153 2014-004005-32 | Ph 3 | completed | Study Assessing The Interest of Indocyanine Green Fluorescence Imaging With Radioisotope Method For Sentinel Lymph Node Biopsy in Patients With Breast Cancer |
| NCT02621268 ICG | 820766 | Ph 1 | completed | Minimally Invasive Imagery With Indocyanine Green |
Showing 50 of 60 trials
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Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
SPY AGENT GREEN KIT FDA Label Details
Indications & Usage
FDA Label (PDF)Indocyanine Green for Injection USP is indicated: Indocyanine Green for Injection USP a tricarbocyanine dye, is indicated: • For visual assessment of blood vessels, blood flow and related tissue perfusion with OLYMPUS infrared compatible endoscopic imaging system • For visual assessment of the major extrahepatic bile ducts with OLYMPUS infrared imaging endoscopic imaging system • For viewing intra-operative blood flow in the cerebral area with OLYMPUS infrared compatible video microscopic imaging system 1.1 Visual assessment of blood vessels, blood flow and related tissue perfusion For visual ...
View full patent landscape →
5 OB patents · 5 families ·
55 international docs across 8 countries
SPY AGENT GREEN KIT Patents & Exclusivity
Latest Patent: Jul 2039
Exclusivity: Jun 2026
Patents (5 active)
US11712320
Expires Jul 14, 2039
US10631746
Expires Aug 4, 2035
US8406860
Expires Apr 9, 2029
US8647605
Expires Feb 11, 2029
US8185176
Expires Jun 4, 2028
Exclusivity
I-911
Until Jun 2026
Source: FDA Orange Book
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- • Cliff: 2039
- • 6 active patents
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.