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Data updated: Sep 20, 2026

ZYOGREEN (indocyanine green) · PROVEPHARM SAS

Approved 2026-07-10
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
0
Years on Market

Details

Status
Prescription
First Approved
2026-07-10
Routes
INTRAVENOUS, INTERSTITIAL
Dosage Forms
SOLUTION

Companies

PROVEPHARM SAS
Active Ingredient: INDOCYANINE GREEN

ZYOGREEN Approval History

Original
New Indication
New Form
Label Update
1 FDA actions from 2026 to 2026
Jul 2026 ORIGINAL
New Form · Type 3 - New Dosage Form
FDA Letter Label

What ZYOGREEN Treats

1 FDA approvals

Originally approved for its first indication in 2026 .

  • Other (1)
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Clinical Trial Registry

62 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 completed 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 completed 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 62 trials

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Active Pipeline

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

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.

ZYOGREEN FDA Label Details

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Data Sources

FDA Approval: NDA218579 → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.