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Spy Agent Green Kit (INDOCYANINE GREEN)
Spy Agent Green Kit (generic name: INDOCYANINE GREEN) is a Diagnostic Dye Small molecule drug developed by Renew Pharms. It is currently FDA-approved (first approved 1959) for Evaluation of vascular and tissue blood flow, Sentinel lymph node mapping in breast cancer, Sentinel lymph node mapping in malignant melanoma.
Spy Agent Green Kit is a small molecule intervention used in the assessment of amputation healing, specifically for conditions such as lower extremity amputation, above knee amputation, and below knee amputation. It is administered through the SPY Elite Imaging System, which is used to evaluate wound healing in patients undergoing amputation.
At a glance
| Generic name | INDOCYANINE GREEN |
|---|---|
| Sponsor | Renew Pharms |
| Drug class | Diagnostic Dye |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
| First approval | 1959 |
Approved indications
- Evaluation of vascular and tissue blood flow
- Sentinel lymph node mapping in breast cancer
- Sentinel lymph node mapping in malignant melanoma
Common side effects
- Anaphylactic or urticarial reactions
- Nausea
Key clinical trials
- Impact of Sentinel Lymph Node Mapping on Patient Reported Lower Extremity Limb Dysfunction in Stage I Endometrial Cancer (PHASE3)
- Indocyanine Green Fluorescence Angiography (ICG-FA) in Revisional Bariatric Surgery (NA)
- Fluorescence Guided Laparoscopic-Endoscopic Cooperative Sentinel Lymph Node Navigation Surgery Strategy for Early Gastric Cancer (NA)
- Real-Time Diagnosis of Life-Threatening Necrotizing Soft Tissue Infections (NSTI) Using Indocyanine Green (ICG) Kinetic Modeling
- Intraoperative Molecular Imaging Using ICG for Head and Neck Tumors (PHASE2)
- Contribution of ICG Angiography in the Detection of Parathyroids and the Prevention of Hypoparathyroidism Post Total Thyroidectomy (PHASE3)
- Acute Cholecystitis Biliary Complications - ICG (NA)
- Imaging Lymphatic Function in Normal Subjects and in Persons With Lymphatic Disorders
Patents
| Patent | Expiry | Type |
|---|---|---|
| 8647605 | 2029-02-11 | Method of Use |
| 8406860 | 2029-04-09 | Method of Use |
| 8185176 | 2028-06-04 | Method of Use |
| 10631746 | 2035-08-04 | Formulation |
| 11712320 | 2039-07-14 | Formulation |
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Spy Agent Green Kit CI brief — competitive landscape report
- Spy Agent Green Kit updates RSS · CI watch RSS
- Renew Pharms portfolio CI
Frequently asked questions about Spy Agent Green Kit
What is Spy Agent Green Kit?
What is Spy Agent Green Kit used for?
Who makes Spy Agent Green Kit?
What is the generic name of Spy Agent Green Kit?
What drug class is Spy Agent Green Kit in?
When was Spy Agent Green Kit approved?
What development phase is Spy Agent Green Kit in?
What are the side effects of Spy Agent Green Kit?
Related
- Drug class: All Diagnostic Dye drugs
- Manufacturer: Renew Pharms — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Evaluation of vascular and tissue blood flow
- Indication: Drugs for Sentinel lymph node mapping in breast cancer
- Indication: Drugs for Sentinel lymph node mapping in malignant melanoma
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing