IC-Green

(Indocyanine Green)

ApprovedSmall molecule

Indocyanine Green is a dye used to help doctors see blood flow and take better images during eye exams and certain surgical procedures. It's injected into the bloodstream and shows up brightly under special infrared light, allowing doctors to visualize blood vessels and tissues.[2] IC-Green is currently approved and in use across 51 indications[4].[1]

IC-Green is one of 629 small molecule programs targeting Lung Cancer. It is currently in Approved.

Indications

166

Total Trials

Active Trials

628

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Lung CancerTerminated

ParagangliomaActive, not recruiting

Metastatic Colorectal CancerActive, not recruiting

Head and Neck Malignant NeoplasiaActive, not recruiting

Liver CancerActive, not recruiting

Gastrointestinal DiseaseActive, not recruiting

Rectum CancerApproved

Head and Neck CarcinomaApproved

Renal Cell CarcinomaApproved

Bone NeoplasmApproved

Lung CancerPhase 1

Terminated

ParagangliomaPreclinical

Active, not recruiting

Metastatic Colorectal CancerPreclinical

Active, not recruiting

Head and Neck Malignant NeoplasiaPreclinical

Active, not recruiting

Liver CancerPreclinical

Active, not recruiting

Gastrointestinal DiseaseApproved

Active, not recruiting

Rectum CancerApproved

Approved

Head and Neck CarcinomaApproved

Approved

Renal Cell CarcinomaApproved

Approved

Bone NeoplasmApproved

Approved

Showing 10 of 48 indications

Competition

Competitive Landscape

744 competitors in Breast Cancer

#DrugCompanyPhaseTrials

IC-Green

PProvepharm SAS

Approved

21 2

Methylthioninium Chloride

PProvepharm SAS

Preclinical

3 3

Tricor

JJagotec

Preclinical

1 4

Acupan

YYonsei University

Preclinical

1 5

Duragesic

CCephalon

Preclinical

1 6

Rilvegostomig

AstraZeneca

Preclinical

1 7

Paracetamol

GSK

Preclinical

1 8

Ablavar

LLantheus Medical Imaging

Preclinical

2 9

Gadolinium-Chelate

MM.D. Anderson Cancer Center

Preclinical

1 10

4SCAR T Cells

SShenzhen Geno-Immune Medical Institute

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 3Active, not recruiting

Gastric Cancer

NCT04611997

Phase 2Recruiting

Intraoperative

NCT04752137

Phase 3Recruiting

Stage I Uterine Corpus Carcinoma or Carcinosarcoma AJCC V8

NCT05646316

Phase 2Recruiting

Indocyanine Green

NCT04842162

Post-ApprovalRecruiting

Giant Cell Tumor

NCT07315828

Phase 1Recruiting

Lung Cancer

NCT02570815

Clinical

Trials by Indication[1]

Breast Cancer21 trials

Indocyanine Green Fluoroscopy and SPY Angiography for the Assessment of Lymphatic Structure in Breast Cancer Patients at Risk for Breast Cancer-Related Lymphedema

Withdrawn·—·N/A·NCT06672224

Axillary Reverse Mapping Using Near-infrared Imaging in Invasive Breast Cancer: Predictors of Nodal Positivity

Completed·GGustave Roussy, Cancer Campus, Grand Paris·N/A·NCT02994225·120 enrolled

Lymphatic Function in Patients Who Have Undergone Breast Cancer Treatment

Unknown status·UUniversity of Aarhus·N/A·NCT03572998·28 enrolled

Show 18 more trials

ICG-fluorescence Imaging for Intraoperative Breast Cancer Margins Evaluation: a Dose-timing Study

Recruiting·JJules Bordet Institute·N/A·NCT06227338·250 enrolled

A French Observational Study of Indocyanine Green for Patients With Breast Cancer Having a Sentinel Lymph Node Biopsy.

Completed·BBTG International Inc.··NCT06024213·101 enrolled

Clinical Application of Dual Sentinel Lymph Node Staining Method in Breast Cancer Patients

Completed·NNational Cancer Center, Korea·Phase 2·NCT02479997·130 enrolled

Comparison of Use of Indocyanine Green and 99mTc-labeled Radiotracer for Axillary Lymphatic Mapping in Patients With Breast Cancer

Completed·—·N/A·NCT02419807·102 enrolled

Clinical Application of Near-infrared Fluorescence Guided Localization on Breast Surgery in Breast Cancer

Unknown status·NNational Cancer Center, Korea·Phase 2·NCT02473159·5 enrolled

Application of Surgical Navigation System in Sentinel Lymph Node of Breast Cancer Research

Completed·CChinese Academy of Sciences·N/A·NCT02084784·98 enrolled

A Prospective Clinical Study for Evaluation of Safe Resection Margin in Breast Conserving Surgery in Breast Cancer

Unknown status·NNational Cancer Center, Korea·Phase 2·NCT02817334·149 enrolled

Selective Lymph Node Dissection Using Fluorescent Dye in Node-positive Breast Cancer

Unknown status·SSamsung Medical Center·Phase 4·NCT02781259·150 enrolled

Study Assessing The Interest of Indocyanine Green Fluorescence Imaging With Radioisotope Method For Sentinel Lymph Node Biopsy in Patients With Breast Cancer

Completed·—·Phase 3·NCT02279108·99 enrolled

Pilot Indocyanine Green Imaging for Mapping of Arm Draining Lymphatics & Nodes in Breast Cancer

Completed·SStanford University·Phase 2·NCT01771666·23 enrolled

Study of the ICG Distribution in the Margins of Breast Cancer After Tumorectomy

Completed·JJules Bordet Institute·Phase 2·NCT02027818·20 enrolled

ICG Distribution Using NIF Imaging After IV Injection of ICG in Benign and Malignant Breast Cancer Tissue.

Completed·JJules Bordet Institute·Phase 1/2·NCT01993576·10 enrolled

Intraoperative Imaging of Breast Cancer With Indocyanine Green

Completed·—·Phase 1·NCT01796041·10 enrolled

Lymphovenous Bypass Procedure Before Underarm Lymph Node Surgery in Preventing Lymphedema in Patients With Inflammatory or Locally Advanced Non-inflammatory Breast Cancer or Melanoma

Recruiting·MM.D. Anderson Cancer Center·N/A·NCT03941756·252 enrolled

Sentinel Lymph Node Biopsy in Breast Cancer Surgery Using ICG

Completed·CChinese Academy of Sciences·N/A·NCT03579979·130 enrolled

Permanence of Indocyanine Green in Axillary Lymph Nodes 3 Weeks After Subdermal Injection in Patients With Breast Cancer and Metastatic Lymph Nodes

Not yet recruiting·CCentro di Riferimento Oncologico - Aviano·N/A·NCT06347354·10 enrolled

A Pilot 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

Recruiting·UUniversity of Florida·Phase 2·NCT06327490·30 enrolled

Implementation of Fluorescence Imaging Using Indocyanine Green to Identify Sentinel Lymph Nodes During Surgery for Breast Cancer

Recruiting·IIsabelle Henskens·Preclinical·NCT07146295·1,760 enrolled

Indocyanine Green21 trials

Near-Infrared Fluorescence Imaging With Indocyanine Green to Evaluate Bowel Anastomoses in Gynecologic Oncology Surgery

Not yet recruiting·IIstanbul University·Phase 4·NCT06871787·50 enrolled

The Impact of Indocyanine Green-enhanced Fluorescence Imaging on Bowel Transection in Left-sided Colorectal Resection

Unknown status·TThe University of Hong Kong·N/A·NCT02669485·30 enrolled

Does Fluorescence With or Without Indocyanine Green Improve Parathyroid Identification and Preservation

Recruiting·UUniversity of Alabama at Birmingham·Phase 4·NCT06169735·417 enrolled

Show 18 more trials

Diagnostic Accuracy Study of Indocyanine Green for Parathyroid Perfusion Assessment

Completed·UUniversity Health Network, Toronto·Phase 4·NCT03969108·10 enrolled

Near InfraRed Fluorescence Using Indocyanine Green and Magnetic Resonance Lymphography of Lymphatic Transport

Completed·UUniversity of Rochester·Phase 1·NCT04046146·2 enrolled

Real-time Navigation for Laparoscope Liver Resections Using Fusion 3D Imaging and Indocyanine Green Fluorescence Imaging

Unknown status·ZZhujiang Hospital·Phase 2·NCT03811704·50 enrolled

The Role of Indocyanine Green Angiography Fluorescence on Intestinal Resections in Pediatric Surgery.

Completed·SSt. Justine's Hospital·N/A·NCT04020939·35 enrolled

Fluorescence Imaging With Indocyanine Green(ICG) in Endoscopic Spinal Surgery

Completed·ZZhongnan Hospital·Phase 1/2·NCT05808140·40 enrolled

Indocyanine Green Fluorescent Molecular Imaging of the Gastrointestinal Tract

Completed·MMassachusetts General Hospital·N/A·NCT01112514·4 enrolled

Use of Indocyanine Green During Primary Repair of Oesophageal Atresia and Distal Tracheo-oesophageal Fistula

Recruiting·BBirmingham Women's and Children's NHS Foundation Trust·N/A·NCT05735964·20 enrolled

Study Evaluating Near-infrared Imaging Coupled With Indocyanine Green for Intraoperative Control of Resection Margins in ENT Surgery

Recruiting·GGustave Roussy, Cancer Campus, Grand Paris·Phase 2·NCT04842162·65 enrolled

Single Session Of Antimicrobial Photodynamic Therapy Using Indocyanine Green

Completed·SSVS Institute of Dental Sciences·Phase 2·NCT02043340·30 enrolled

Interest of Indocyanine Green in Neoplastic Prostatic Tissue

Withdrawn·—·Phase 3·NCT02260349

Detection of Upper Gastrointestinal Tumour Depth and Demarcation Using Systemic Administration of Indocyanine Green During Endoscopic Submucosal Dissection

Recruiting·UUniversity Medical Center Groningen·Phase 1/2·NCT07108855·10 enrolled

Indocyanine Green for Solid Tumors

Completed·UUniversity of Pennsylvania·Phase 1·NCT02280954·48 enrolled

Potential Use of Indocyanine Green as a Fluorescent Agent for Definition of Surgical Margins in Cancer

Completed·EEmory University·Phase 1·NCT01884584·24 enrolled

Minimally Invasive Imagery With Indocyanine Green

Completed·UUniversity of Pennsylvania·Phase 1·NCT02621268·48 enrolled

Parathyroid Vascularization During Total Thyroidectomy Using Indocyanine Green Angiography

Terminated·IIRCCS San Raffaele··NCT05328076·22 enrolled

Intraoperative Imaging of Thoracic Malignancies With Indocyanine Green

Completed·UUniversity of Pennsylvania·Phase 1·NCT01335893·10 enrolled

Monocentric Prospective Pilot Study Evaluating the Value of Indocyanine Green (ICG, Indocyanine Green) During a Surgical Resection of Cancerous Lesions Peritoneal Colorectal Origin.

Completed·—··NCT01982227·10 enrolled

ICG Indocyanine Green in Reconstructive Surgery

Unknown status·AAmsterdam UMC, location VUmc··NCT06129669·160 enrolled

Intraoperative8 trials

Multi-center Study on CCeLL-In Vivo's Clinical Efficacy for Intraoperative Brain Tumor Diagnosis.

Not yet recruiting·VVPIX Medical·Phase 1·NCT06867978·100 enrolled

The Preoperative Administration of ICG Improves Tumor Detection in Patients Undergoing Minimally Invasive Hepatic Resection Guided by Conventional Intraoperative Ultrasound.

Recruiting·HHospital Universitari Vall d'Hebron Research Institute·Phase 4·NCT06398028·173 enrolled

Intraoperative Tumor Margin Identification With ICG Dye Imaging

Recruiting·MMassachusetts General Hospital·Phase 2·NCT04752137·100 enrolled

Show 5 more trials

Intraoperative Fluorescence With Augmented Reality

Completed·—··NCT03888014·7 enrolled

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

Not yet recruiting·VVPIX Medical·Phase 1·NCT07254845·30 enrolled

Intraoperative Parathyroid Gland (PTG) Identification Using a Hand-Held Imager (HHI)

Terminated·OOPTOSURGICAL, LLC·Phase 1·NCT06939946·20 enrolled

TumorGlow Intraoperative Molecular Imaging (IMI)

Recruiting·UUniversity of Pennsylvania·Phase 1/2·NCT04723810·500 enrolled

Intraoperative Evaluation of Axillary Lymphatics

Completed·UUniversity of Wisconsin, Madison·N/A·NCT05094102·9 enrolled

Endometrial Cancer6 trials

To Assess and Compare the Performance Two Approach for Sentinel Lymph Node (SNLD) Biopsy for Endometrial Cancer

Unknown status·HHaseki Training and Research Hospital··NCT04514289·106 enrolled

Lymph Node Mapping in Patients With Newly Diagnosed Endometrial Cancer Undergoing Surgery

Terminated·—·N/A·NCT01939028·58 enrolled

Lymph Node Mapping in Patients With Endometrial Cancer

Completed·OOhio State University Comprehensive Cancer Center·N/A·NCT01818739·204 enrolled

Show 3 more trials

PET/CT and Lymph Node Mapping in Finding Lymph Node Metastasis in Patients With High-Risk Endometrial Cancer

Active, not recruiting·MM.D. Anderson Cancer Center·N/A·NCT01737619·101 enrolled

Accuracy of Sentinel Lymph Node Biopsy in Nodal Staging of High Risk Endometrial Cancer

Completed·UUniversity Health Network, Toronto·N/A·NCT01886066·156 enrolled

Concurrent Use Lymphoseek & Indocyanine Green in Sentinel Lymph Node Detection in Endometrial Cancer

Terminated·SStanford University·Phase 2·NCT04511026·6 enrolled

Fluorescence5 trials

NIR Fluorescence Imaging of Lymphatic Transport Using ICG

Completed·UUniversity of Rochester·Phase 1·NCT02680067·23 enrolled

Sentinel Lymph Node Mapping of Oral Cancer Using Near-Infrared Fluorescence Imaging

Completed·UUniversity Health Network, Toronto·N/A·NCT02478138·1 enrolled

Fluorescence Imaging in Finding Tumors in Patients With Kidney Tumors

Completed·—·Phase 1·NCT01281488·28 enrolled

Show 2 more trials

Fluorescence Imaging on the da Vinci Surgical System for Intra-operative Near Infrared Imaging of the Biliary Tree (up to 2-weeks Post-operatively)

Completed·IIntuitive Surgical·N/A·NCT01410734·72 enrolled

Fluorescence Targeted Pelvic Lymph Node Mapping

Terminated·OOxford University Hospitals NHS Trust·Phase 1/2·NCT03204994·1 enrolled

69 more indications

Gastric Cancer4 trials

IGG Using in Laparoscopic Gastrectomy for Locally Advanced Gastric Cancer After Neoadjuvant Chemotherapy

Active, not recruiting·FFujian Medical University·Phase 3·NCT04611997·240 enrolled

Indocyanine Green Tracer Using in Laparoscopic Distal Gastrectomy for Early Gastric Cancer

Not yet recruiting·FFujian Medical University·Phase 2·NCT04973475·180 enrolled

A Study to Evaluate Indocyanine Green Lymphangiography to Improve Lymphadenectomy in Gastric Cancer Patients

Withdrawn·MMayo Clinic·Phase 4·NCT04591028

Show 1 more trial

The Effect of Chemoradiotherapy on Gastric Perfusion in Patients With Gastric Cancer.

Terminated·RRigshospitalet, Denmark·Phase 4·NCT05354856·11 enrolled

Endometriosis4 trials

Prospective Evaluation of Near-infrared Fluorescence Imaging Use as a Supportive Tool in Deep Infiltrating Endometriosis Surgery

Completed·—·Phase 2·NCT03935165·51 enrolled

Diagnostic Value of ICG in Endometriosis

Completed·IInsel Gruppe AG, University Hospital Bern·Phase 1·NCT03850158·63 enrolled

Near-infrared Fluorescence Imaging as a Supportive Tool for Localisation of Deep Infiltrating Endometriosis During Laparoscopy

Completed·—·Phase 2·NCT03332004·27 enrolled

Show 1 more trial

Estimation of Vascularization After Treatment of Deep Rectovaginal Endometriosis Node by Rectal Shaving

Unknown status·UUniversity Hospital, Clermont-Ferrand·Phase 4·NCT03080558·30 enrolled

Melanoma4 trials

Lymph Node Mapping Using Indocyanine Green Solution in Diagnosing Patients With Malignant Melanoma

Completed·SStanford University·N/A·NCT01898403·50 enrolled

Fluorescence Surgery for Sentinel Node Identification in Melanoma

Unknown status·—·N/A·NCT02142244·318 enrolled

Imiquimod and Laser Therapy With or Without a Green Dye in Treating Patients With Stage III or Stage IV Melanoma That Has Spread to Other Parts of the Skin

Completed·UUniversity of Oklahoma·Phase 1·NCT00453050·11 enrolled

Show 1 more trial

Nuclear and Near-Infrared (NIR) Imaging in Melanoma

Completed·MM.D. Anderson Cancer Center·Phase 1·NCT01295931·20 enrolled

Indocyanine Green (ICG)4 trials

Micro-dosing Indocyanine Green (ICG) in Children

Recruiting·GGreat Ormond Street Hospital for Children NHS Foundation Trust·N/A·NCT06421103·90 enrolled

Determination of Parathyroid Function by Fluorescence With Indocyanine Green (ICG) After Total Thyroidectomy

Unknown status·—·Phase 4·NCT04012476·40 enrolled

Effect of Exercise on Indocyanine Green (ICG) Lymphography Imaging

Completed·UUniversity of Iowa·Phase 4·NCT03584633·9 enrolled

Show 1 more trial

Indocyanine Green (ICG) Guided Sentinel Lymph Node Mapping for Pediatric Visceral Solid Tumors

Recruiting·SSt. Jude Children's Research Hospital·Phase 1·NCT05645523·25 enrolled

Lymphedema3 trials

Early Detection of Lymphedema After Cancer Treatments

Unknown status·—·N/A·NCT02415725·120 enrolled

Lymphatic and Systemic Immunity Changes in Post-radiation Lymphedema Development

Completed·TThe University of Texas Health Science Center, Houston·Phase 1·NCT02949726·80 enrolled

Sentinel and/or Axillary Lymph Node Biopsy With or Without Axillary Reverse Mapping in Reducing Incidence and Severity of Arm Lymphedema in Stage 0-2 Patients.

Terminated·UUniversity of Southern California·Phase 2·NCT01276054·4 enrolled

Cholecystitis3 trials

Near Infrared Fluorescence Cholangiography (NIRF-C) During Cholecystectomy -- Use in Acute Cholecystitis Sub-Study

Completed·OOhio State University·Phase 1·NCT02070627·6 enrolled

Use of Indocyanine Green in Acute Cholecystitis

Unknown status·CCorporacion Parc Tauli·Phase 4·NCT05709548·440 enrolled

Indocyanine Green to Visualize Critical View of Safety During Laparoscopic Cholecystectomy for Acute Cholecystitis

Unknown status·HHamad Medical Corporation·Phase 4·NCT04624841·80 enrolled

Surgery3 trials

Validation of ICG to Identify the Urethra During Rectal Surgery

Terminated·OOxford University Hospitals NHS Trust·Phase 1/2·NCT03204201·5 enrolled

ICG Anastomotic Control in Digestive System Surgery

Unknown status·SShandong Linglong Yingcheng Hospital··NCT06270745·200 enrolled

ENB Robotic ICG Guided Surgery: A Novel Technique for Targeting Small Lung Tumors

Withdrawn·SSt. Joseph's Healthcare Hamilton·Phase 1·NCT02570958

Lung Cancer3 trials

A Multimodality Image-guided System for Peripheral Lung Cancer Diagnosis and Therapy

Terminated·TThe Methodist Hospital Research Institute·Phase 1·NCT02111824·7 enrolled

Pilot Study of Novel Fluorescence Endoscopic Device for Sentinel Lymph Node Mapping in Lung Cancer

Withdrawn·—·N/A·NCT02423148

Near-Infrared Fluorescence Guided Robotic Pulmonary Segmentectomy for Early Stage Lung Cancer

Recruiting·SSt. Joseph's Healthcare Hamilton·Phase 1·NCT02570815·250 enrolled

Bariatric Surgery2 trials

The Use of Indocyanine Green to Visualize Blood Flow to the Gastrojejunostomy During Bariatric Surgery.

Active, not recruiting·UUniversity Health Network, Toronto·Phase 4·NCT06002906·300 enrolled

Indocyanine Green Test in Bariatric Surgery

Completed·UUniversity of Foggia··NCT05476159·30 enrolled

Prostate Cancer2 trials

Use of Indocyanine Green During Pelvic Lymph Node Dissection in Prostate Cancer.

Unknown status·TTC Erciyes University·Phase 4·NCT04882618·50 enrolled

ICG-based Fluorescence Imaging in Localization of Prostate Cancer and Metastatic Lymph Nodes

Unknown status·TThird Affiliated Hospital, Sun Yat-Sen University·Phase 1·NCT02840617·50 enrolled

Occlusion2 trials

Determining Occlusion Pressure in Lymphatic Vessels

Completed·—·Phase 1·NCT02359578·32 enrolled

Lymphatic Occlusion Pressure in Lower Limb

Unknown status·—·Phase 1·NCT02405559·32 enrolled

Head and Neck Cancer2 trials

Interest of Fluorescence in Salvage Surgery for Recurrence of Head and Neck Cancer in Irradiated Area

Completed·IInstitut de Cancérologie de Lorraine·N/A·NCT02920216·10 enrolled

NIR Fluorescence Imaging During Neck Dissection in Head and Neck Cancer Patients After iv Injection of ICG

Unknown status·JJules Bordet Institute·Phase 2·NCT02027831·10 enrolled

Thoracic Surgery2 trials

Near-Infrared Perfusion During Minimally Invasive Thoracic Surgery Download

Completed·MMassachusetts General Hospital·Phase 1/2·NCT05346380·38 enrolled

NIR Fluorescence Imaging Technique in Thoracic Surgery With ICG

Completed·CChinese Academy of Sciences·Phase 1·NCT02611245·36 enrolled

Colorectal Cancer2 trials

Magnetic Particle-ICG Lymph Node Mapping in Colorectal Cancer

Withdrawn·MM.D. Anderson Cancer Center·Phase 1/2·NCT05092750

Near-Infrared Imaging of Peritoneal Carcinomatosis From Colorectal Cancer

Completed·JJules Bordet Institute·Phase 2·NCT02032485·10 enrolled

Laparoscopic Cholecystectomy2 trials

The Use of Fluorescent Imaging for Intraoperative Cholangiogram During Laparoscopic Cholecystectomy

Completed·MMaimonides Medical Center·N/A·NCT01424215·100 enrolled

Using Indocyanine Green (ICG) to Outline Biliary Tree During Laparoscopic Cholecystectomy

Completed·TTheodor Bilharz Research Institute·Phase 4·NCT06629415·60 enrolled

Giant Cell Tumor2 trials

Accuracy of Indocyanine Green (ICG) Fluorescence Imaging in Giant Cell Tumor of Bone Surgery

Recruiting·SShanghai Jiao Tong University Affiliated Sixth People's Hospital·Phase 4·NCT07315828·40 enrolled

Accuracy of Indocyanine Green (ICG) Fluorescence Imaging in Tenosynovial Giant Cell Tumor Surgery

Recruiting·SShanghai Jiao Tong University Affiliated Sixth People's Hospital·Phase 4·NCT07315841·40 enrolled

Gastric Adenocarcinoma2 trials

Near-infrared Imaging With Indocyanine Green for Detection of Peritoneal Metastases for Gastric Adenocarcinoma.

Terminated·LLaval University·Phase 2·NCT05687617·11 enrolled

Magnetic Sentinel Lymph Node Mapping in Gastric Cancer, Safety and Feasibility Clinical Trial

Not yet recruiting·MM.D. Anderson Cancer Center·Phase 1·NCT05038098·20 enrolled

Imaging1 trial

Low Dose ICG for Biliary Tract and Tumor Imaging

Completed·UUniversity of Florida·Phase 2·NCT04942665·60 enrolled

Carotid Artery Plaque1 trial

Indocyanine Green Fluorescence Uptake in Human Carotid Artery Plaque

Completed·MMassachusetts General Hospital·Phase 1·NCT01873716·5 enrolled

Neoadjuvant Therapy1 trial

Study of the ICG Distribution in Breast Tumours or in Axillary Lymph Nodes of Patients After Neoadjuvant Therapy

Unknown status·JJules Bordet Institute·Phase 2·NCT02032563·20 enrolled

Gastrointestinal1 trial

Advanced Gastrointestinal Endoscopic Imaging

Terminated·SStanford University·N/A·NCT01034670·3 enrolled

Systemic Sclerosis1 trial

Intraoperative ICG for Systemic Sclerosis

Withdrawn·—·Phase 4·NCT03155464

Intelligence1 trial

Artificial Intelligence Analysis of Fluorescence Image to Intraoperatively Detect Metastatic Sentinel Lymph Node.

Unknown status·—··NCT05623280·40 enrolled

Cholestasis1 trial

The Use of Near-Infrared Fluorescence Cholangiography With Indocyanine Green (ICG) in the Work Up of Neonatal Cholestasis

Recruiting·UUniversity of Alabama at Birmingham·Phase 1·NCT07250854·15 enrolled

Completed·WWen-zhao ZHONG·N/A·NCT04056923·47 enrolled

Vulvar Cancer1 trial

SLN Mapping and ICG Dye for Vulvar Cancer

Not yet recruiting·TTufts Medical Center··NCT06035068·10 enrolled

Thyroid1 trial

Does Indocyanine Imaging Scoring Predicts Postoperative Parathormone Levels at 24 Hours After Total Thyroidectomy

Completed·—··NCT03910049·60 enrolled

Laparoscopic1 trial

Fluorescent Lymphography-Guided Lymphadenectomy In Laparoscopic Proctectomy

Unknown status·FFudan University·N/A·NCT03854890·100 enrolled

Patients With Advanced Solid Tumors1 trial

Vinorelbine in Treating Patients With Advanced Solid Tumors That Have Not Responded to Treatment and Liver Dysfunction

Completed·—·Phase 1/2·NCT00540982·47 enrolled

Colorectal Surgery1 trial

Feasibility of Use of Indocyanine Green in Pediatric Colorectal Surgery

Recruiting·LLondon Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's·Phase 3·NCT04904081·12 enrolled

Safety and Efficacy1 trial

Investigation Into the Safety and Efficacy of ICG-Labeled Fluorescence Imaging Technology in Guiding the Resection of Bone and Soft Tissue Tumors

Not yet recruiting·GGuangdong Provincial People's Hospital··NCT06979115·40 enrolled

Necrosis1 trial

Fluorescence-based Detection of Inflammation and Necrosis to Inform Surgical Decision-making and Enhance Outcomes

Active, not recruiting·UUniversity of Wisconsin, Madison··NCT05593523·100 enrolled

Fasciitis1 trial

Detection and Delineation of Necrotizing Fasciitis Via a Vascular Perfusion Fluorophore

Completed·—··NCT04839302·18 enrolled

Turner syndrome1 trial

Lymphedema, Low-grade Inflammation and the Vasculature in Turner Syndrome

Recruiting·UUniversity of Aarhus··NCT06325618·150 enrolled

Microcirculation1 trial

Microcirculation in Perforator Flaps. Enhancing Tissue Survival

Unknown status·OOslo University Hospital·Phase 1·NCT01204554·50 enrolled

Non-Small Cell Lung Cancer1 trial

Robotic Bronchoscopy With Cone CT and Indocyanine Green to Aid Removal of Lung Lesions in Patients With Stage I Non-small Cell Lung Cancer or Lung Metastases, REPLACING Study

Withdrawn·MM.D. Anderson Cancer Center·Phase 2·NCT04987281

Laparoscopic Sleeve Gastrectomy1 trial

Indocyanine Green Test for Evaluation of Perfusion of Staple Line of the Stomach During Laparoscopic Sleeve Gastrectomy

Completed·UUniversity of Foggia··NCT05337644·1 enrolled

Pediatric Cancers1 trial

A Study Comparing Green Fluorescent Dye and Radioactive Dye for Sentinel Lymph Node Biopsy in Pediatric Cancers

Completed·MMemorial Sloan Kettering Cancer Center·Phase 2/3·NCT02910726·6 enrolled

Rectal Cancer1 trial

Sentinel Lymph Node Biopsy in Rectal Cancer

Unknown status·NNational Cancer Center, China·N/A·NCT05830890·87 enrolled

Central Nervous System Tumor1 trial

Indocyanine Green for Central Nervous System Tumors

Completed·—·Phase 1/2·NCT02710240·336 enrolled

Lymph Node Dissection1 trial

The Value of Lymph Node Dissection of Indocyanine Green-guided Near-infrared Fluorescent Imaging in Esophagectomy

Unknown status·FFujian Medical University Union Hospital·N/A·NCT04615806·40 enrolled

Transplantation1 trial

Measurements of Kidney Perfusion After Transplantation by Intraoperative Fluorescence Angiography

Completed·UUniversity Hospital Erlangen·Phase 2·NCT02775838·128 enrolled

Near Infrared Fluorescence Imaging1 trial

Near Infrared Fluorescence Imaging With Indocyanine Green

Completed·UUniversity of Pittsburgh·Phase 1·NCT02851368·25 enrolled

Cerebral ischemia1 trial

Detection of Cerebral Ischemia With a Noninvasive Neurometabolic Optical Monitor

Completed·UUniversity of Pennsylvania··NCT02983786·29 enrolled

Mastectomy1 trial

Study to Assess Perfusion and Patient Satisfaction in Nipple-Areola Mastectomy With Immediate Reconstruction

Completed·WWashington University School of Medicine·N/A·NCT01969448·79 enrolled

Gastrectomy1 trial

Effect of CNSI vs. ICG in Lymph Node Tracing During Gastrectomy

Unknown status·HHebei Medical University·Phase 2·NCT05229874·96 enrolled

Cervical Cancer1 trial

Clinical Study of Indocyanine Green Displaying Pelvic Nerve in Radical Operation of Cervical Cancer

Unknown status·FFifth Affiliated Hospital, Sun Yat-Sen University·Phase 1·NCT05087264·86 enrolled

Chronic Periodontitis1 trial

Antimicrobial Photodynamic Therapy in Chronic Periodontitis and Diabetes Mellitus

Completed·KKing Saud University·Phase 2/3·NCT04857346·80 enrolled

Liver Transplant1 trial

Indocyanine Green Clearance Test in Liver Transplantation (LivInG)

Unknown status·FFondazione Policlinico Universitario Agostino Gemelli IRCCS·N/A·NCT05228587·162 enrolled

Nervous System Tumor1 trial

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)

Completed·UUniversity of Pennsylvania·Phase 1·NCT03262636·363 enrolled

Pilot Study1 trial

FLOTOR Pilot Study

Completed·OOxford University Hospitals NHS Trust·Phase 1/2·NCT03292757·21 enrolled

Rheumatoid Arthritis1 trial

Imaging of Lymphatic Vessels in People with Rheumatoid Arthritis (RA)

Recruiting·UUniversity of Rochester·Phase 1·NCT05197530·40 enrolled

Neuroma1 trial

Evaluation of Neuroma Perfusion with Indocyanine Green Fluorescence Angiography

Withdrawn·NNorthwestern University·Phase 4·NCT06164392

Ovarian Cancer1 trial

Visualisation of Indocyanine Green in Primary and Interval Debulking for Ovarian Cancer

Terminated·UUniversitaire Ziekenhuizen KU Leuven·Phase 2·NCT04891185·14 enrolled

Tumors1 trial

Utility of ICG in Benign Bone Tumors

Completed·—·Phase 1·NCT05075889·2 enrolled

Cholecystectomy1 trial

Fluorescence Cholangiography During Cholecystectomy - a RCT

Completed·HHvidovre University Hospital·N/A·NCT02344654·120 enrolled

Head and Neck Squamous Cell Carcinoma1 trial

Low-Dose Incremental First-Window Indocyanine Green With Near Infrared Imaging for Intraoperative Visualization of Head and Neck Squamous Cell Carcinoma

Not yet recruiting·WWashington University School of Medicine··NCT07825597·25 enrolled

Neoplastic Disease1 trial

Indocyanine Green (ICG) Guided Tumor Resection

Completed·SSt. Jude Children's Research Hospital·Phase 1·NCT04084067·215 enrolled

Soft Tissue1 trial

Randomized Evaluation of Indocyanine Green Fluorescence Angiography-Guided Versus Standard Clinical Perfusion Assessment During Gluteal Permanent Synthetic Filler Removal

Not yet recruiting·RResearch Inc·Preclinical·NCT07808957·300 enrolled

Breast Carcinoma1 trial

Reliability of Indocyanine Green Use in Sentinel Lymph Node Identification in Cancer Surgery

Completed·IInstitut de Cancérologie de Lorraine·Phase 3·NCT02997553·744 enrolled

Stage IIA Prostate Cancer1 trial

A Prospective Investigation of Near Infrared Fluorescence Imaging of Pelvic Lymph Nodes Using Indocyanine Green on the da Vinci Surgical System During Radical Prostatectomy and Pelvic Lymphadenectomy for Localized Prostate Cancer

Completed·CCity of Hope Medical Center·Phase 1·NCT02119858·20 enrolled

Lower Extremity Lymphedema1 trial

A Pilot Study to Evaluate and Compare Lymphatic Transport in Patients With Lower Extremity Lymphedema Between Flexitouch Plus® and Flexitouch Plus® With Novel Multi-Chamber Firmware

Recruiting·TTactile Medical·Phase 1·NCT07613931·5 enrolled

Stage I Uterine Corpus Carcinoma or Carcinosarcoma AJCC v81 trial

A Phase III Trial Of The Impact Of Sentinel Lymph Node Mapping On Patient Reported Lower Extremity Limb Dysfunction In Endometrial Cancer

Recruiting·NNRG Oncology·Phase 3·NCT05646316·428 enrolled

Rotator Cuff Tears1 trial

Optimal Dosing of IC-Green for Visualization of Rotator Cuff Vascularity Using Advanced Imaging Modality Arthroscopy: A Prospective, Randomized Trial

Completed·NNYU Langone Health·Phase 1·NCT04340752·20 enrolled

Squamous Cell Carcinoma Head and Neck Cancer (HNSCC)1 trial

Intraoperative Molecular Imaging Using ICG for Head and Neck Tumors

Recruiting·MMedical University of South Carolina·Phase 2·NCT07149207·30 enrolled

Sarcoma1 trial

SarcoSIGHT: A Randomized-Control Trial of Fluorescence Guided Sarcoma Surgery Versus the Standard of Care

Recruiting·CCity of Hope Medical Center·Phase 2·NCT07650656·22 enrolled

Unspecified8 trials

SPY Angiography To Assist With Ulnar Nerve Transposition at the Elbow

Withdrawn·NNYU Langone Health·Phase 4·NCT05332405

High Quality Fluorescent Cholangiography

Completed·ZZhujiang Hospital·Phase 2/3·NCT05926856·168 enrolled

Lymphatic Mapping for Sentinel Node Identification and Analysis

Completed·IImperial College London·Phase 2·NCT01662752·30 enrolled

Show 5 more trials

Evaluation of Two Techniques for the SLN Detection in BC Patients

Unknown status·JJules Bordet Institute·Phase 2·NCT02032498·214 enrolled

Fluorescent Dyes for Lymph Node Mapping

Completed·MM.D. Anderson Cancer Center·Phase 1·NCT01095913·30 enrolled

Infrared Lymphangiography as a Method of Sentinel Node Identification

Completed·MMilton S. Hershey Medical Center·N/A·NCT02057393·89 enrolled

ICG Use in Angiography for Nasoseptal Flap Harvest

Completed·OOhio State University·N/A·NCT02117310·5 enrolled

Angiosome Perfusion After Tibial Bypass

Completed·UUniversity Hospital Erlangen·Phase 2·NCT03012750·40 enrolled

Regulatory

FDA Approval Timeline[5]

Jan 1, 1982

IC-GREEN

NDA NDA011525

Nov 21, 2018

SPY AGENT GREEN KIT

NDA NDA211580

Jul 9, 2026

ZYOGREEN

NDA NDA218579

Sources

References

[1]
ClinicalTrials.gov — 166 trial records for Indocyanine Green. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — IC-Green drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Indocyanine Green compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Indocyanine Green. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA218579). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for IC-Green. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Provepharm SAS company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: PProvepharm SAS

Patent Landscape[6]

Patent Cliff

Jun 4, 2028

Earliest patent expiration — generic entry possible after this date

Patent #Expires

8185176Jun 4, 2028

8647605Feb 11, 2029

8406860Apr 9, 2029

10631746Aug 4, 2035

11712320Jul 14, 2039

IC-Green

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q4 2026

Trials by Indication[1]

Breast Cancer21 trials

Indocyanine Green21 trials

Intraoperative8 trials

Endometrial Cancer6 trials

Fluorescence5 trials

Gastric Cancer4 trials

Endometriosis4 trials

Melanoma4 trials

Indocyanine Green (ICG)4 trials

Lymphedema3 trials

Cholecystitis3 trials

Surgery3 trials

Lung Cancer3 trials

Bariatric Surgery2 trials

Prostate Cancer2 trials

Occlusion2 trials

Head and Neck Cancer2 trials

Thoracic Surgery2 trials

Colorectal Cancer2 trials

Laparoscopic Cholecystectomy2 trials

Giant Cell Tumor2 trials

Gastric Adenocarcinoma2 trials

Imaging1 trial

Carotid Artery Plaque1 trial

Neoadjuvant Therapy1 trial

Gastrointestinal1 trial

Systemic Sclerosis1 trial

Intelligence1 trial

Cholestasis1 trial

Oncology1 trial

Metabolism1 trial

Local1 trial

Vulvar Cancer1 trial

Thyroid1 trial

Laparoscopic1 trial

Patients With Advanced Solid Tumors1 trial

Colorectal Surgery1 trial

Safety and Efficacy1 trial

Necrosis1 trial

Fasciitis1 trial

Turner syndrome1 trial

Microcirculation1 trial

Non-Small Cell Lung Cancer1 trial

Laparoscopic Sleeve Gastrectomy1 trial

Pediatric Cancers1 trial

Rectal Cancer1 trial

Central Nervous System Tumor1 trial

Lymph Node Dissection1 trial

Transplantation1 trial

Near Infrared Fluorescence Imaging1 trial

Cerebral ischemia1 trial

Mastectomy1 trial

Gastrectomy1 trial

Cervical Cancer1 trial

Chronic Periodontitis1 trial

Liver Transplant1 trial

Nervous System Tumor1 trial

Pilot Study1 trial

Rheumatoid Arthritis1 trial

Neuroma1 trial

Ovarian Cancer1 trial

Tumors1 trial

Cholecystectomy1 trial

Head and Neck Squamous Cell Carcinoma1 trial

Neoplastic Disease1 trial

Soft Tissue1 trial

Breast Carcinoma1 trial

Stage IIA Prostate Cancer1 trial

Lower Extremity Lymphedema1 trial

Stage I Uterine Corpus Carcinoma or Carcinosarcoma AJCC v81 trial

Rotator Cuff Tears1 trial

Squamous Cell Carcinoma Head and Neck Cancer (HNSCC)1 trial

Sarcoma1 trial

Unspecified8 trials