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Drug

Indocyanine Green

Approved · FDA
Emerging researchLate-stage development
RxNorm5775ChEMBLCHEMBL1646UNIIIX6J1063HV
2
Research papers
33
Active clinical trials
1
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Indocyanine Green (ICG) Guided Tumor Resection

Clinical trial2026-08-01Primary completion · ClinicalTrials.gov

Use of Indocyanine Green (ICG) for the Diagnosis of Biliary Atresia

Clinical trial2026-08-01Primary completion · ClinicalTrials.gov

Approval: INDOCYANINE GREEN (NDA218579)

Regulatory2026-07-10FDA

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

Clinical trial2026-07-08Results expected Q3 2026 · ClinicalTrials.gov

Intraoperative Molecular Imaging Using ICG for Head and Neck Tumors

Clinical trial2026-07-07Results expected Q2 2028 · ClinicalTrials.gov

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

Clinical trial2026-07-01Primary completion · ClinicalTrials.gov

A Prospective, Multi-Center, Assessor-Blinded Study on the Clinical Efficacy of CCeLL-In Vivo (Confocal Fluorescence Endomicroscopy) for Intraoperative Brain Tumor Diagnosis.

Clinical trial2026-06-30Primary completion · ClinicalTrials.gov

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

Clinical trial2026-06-22Results expected Q2 2028 · ClinicalTrials.gov

Comparing Intraoperative Indocyanine Green Fluorescence Imaging With Standard Clinical Assessment for Flap Perfusion in Head and Neck Reconstruction: A Randomised Controlled Trial (VISION Trial)

Clinical trial2026-06-09Results expected Q1 2029 · ClinicalTrials.gov

Near InfraRed Fluorescence Imaging of Lymphatic Transport Using Indocyanine Green: Phase II Pilot

Clinical trial2026-06-01Primary completion · ClinicalTrials.gov

Evidence and Consensus-based Imaging Guidelines in Birdshot Chorioretinopathy: Multimodal Imaging in Uveitis (MUV) Taskforce Report 8.

Research2025-06-20American journal of ophthalmology

Mild photothermal therapy potentiates anti-PD-L1 treatment for immunologically cold tumors via an all-in-one and all-in-control strategy.

Research2019-10-25Nature communications

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Indocyanine Green
RxNorm CUI
5775
ChEMBL ID
CHEMBL1646
UNII
IX6J1063HV
Regulatory jurisdictions
fda

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2026-07-10
Latest approval
2026-07-10
Authorities
FDA
Total events
1
fdaU.S. Food and Drug Administration· 1 event
2026-07-10Approval
Approval: INDOCYANINE GREEN (NDA218579)
Evidence ↗

Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).

Clinical trials

151 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
151
registered trials across all phases
LATEST COMPLETION 2025
33
Active studies
30
Recruiting
71
Late-stage (III+)
68
Completed
50
Discontinued
PHASE DISTRIBUTIONn = 151
Early Phase 111Phase 127Phase 1 / 213Phase 229Phase 2 / 33Phase 36Phase 422Phase N / A40

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Comparing Intraoperative Indocyanine Green Fluorescence Imaging With Standard Clinical Assessment for Flap Perfusion in Head and Neck Reconstruction: A Randomised Controlled Trial (VISION Trial)

Not yet recruitingPH IVRegion Skanen=2442029

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

RecruitingPH IVHospital Universitari Vall d'Hebron Research Instituten=1732028

Evaluation of Bowel Anastomoses During Gynecologic Oncology Surgery Using Near-Infrared Fluorescence Imaging With Indocyanine Green

Not yet recruitingPH IVIstanbul Universityn=502027

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

Active, not recruitingPH IVUniversity Health Network, Toronton=3002027

A Prospective Study on the Accuracy of Indocyanine Green Fluorescence Imaging for the Visualization of Residual Lesions in the Tumor Cavity During Surgery for Giant Cell Tumor of Bone

RecruitingPH IVShanghai Jiao Tong University Affiliated Sixth People's Hospitaln=402026

Recent completions

Trials that read out recently, adding to the completed evidence base.

Clinical Application of Indocyanine Green Fluorescence Imaging to Assist Identification of Nerve Roots in Endoscopic Spinal Surgery

CompletedPH I/IIZhongnan Hospitaln=402025

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

CompletedPH INYU Langone Healthn=202025

Near-Infrared Perfusion During Minimally Invasive Thoracic Surgery

CompletedPH I/IIMassachusetts General Hospitaln=382025

Intravenous Injection Versus Transhepatic Intracholecystic Injection of Indocyanine Green (ICG) to Outline Biliary Tree During Laparoscopic Cholecystectomy

CompletedPH IVTheodor Bilharz Research Instituten=602024

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

CompletedN/AUniversity Health Network, Toronton=12024

Comparison of the Fluorescent Visualization of the Extrahepatic Biliary Tract Between Two Injection Protocols

CompletedPH II/IIIZhujiang Hospitaln=1682023

Research activity

2 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time
20192025
Major research themes3
Chorioretinitis1Multimodal Imaging1Uveitis1
Journals, researchers & institutions
Top journals
  • American journal of ophthalmology1
  • Nature communications1
Leading researchers
  • Agarwal A1
  • Bodaghi B1
  • Brézin AP1
  • Ding Y1
  • Du Y1
  • Fawzi A1
  • Grewal DS1
  • Gupta V1
Leading institutions
free-text, unnormalised
  • Advanced Eye Centre (V.G.)1
  • Center for Clinical Trials and Evidence Synthesis1
  • Center for Research Development and Evaluation of Pharmaceutical Excipients and Generic Drugs1
  • Centre d'ophtalmologie de l'Assistance Publique - Hôpitaux de Paris (A.B.)1
  • Cleveland Clinic Foundation (S.S.)1
  • Duke University School of Medicine1
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.