Drugs / Indocyanine Green
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Indocyanine Green

Diagnostic / imaging agent

Developed for
chronic periodontitis · cutaneous melanoma · sarcoma · prostate adenocarcinoma · aphthous stomatitis · bile duct disorder · lymphocele · metastatic malignant neoplasm
+3 more · periodontitis · ulcerative stomatitis · periodontal disorder
Investigated by
National Cancer Institute (NCI) · Jules Bordet Institute · M.D. Anderson Cancer Center · Massachusetts General Hospital · Abramson Cancer Center at Penn Medicine · City of Hope Medical Center
+168 more · Dana-Farber Cancer Institute · Fujian Medical University · National Institutes of Health (NIH) · Stanford University · University of Pennsylvania · Zhujiang Hospital · Beth Israel Deaconess Medical Center · Brigham and Women's Hospital · Chinese Academy of Sciences · Fujian Medical University Union Hospital · Oxford University Hospitals NHS Trust · St. Joseph's Healthcare Hamilton · The University of Texas Health Science Center, Houston · University Health Network, Toronto · University of Rochester · Alrijne Hospital · Birmingham Women's and Children's NHS Foundation Trust · Catholic University of the Sacred Heart · Centre Hospitalier Universitaire Saint Pierre · Emory University · Fifth Affiliated Hospital, Sun Yat-Sen University · Gustave Roussy, Cancer Campus, Grand Paris · Insel Gruppe AG, University Hospital Bern · Institut de Cancérologie de Lorraine · Instituto de Investigación Biomédica de Salamanca · King Saud University · Leiden University Medical Center · Memorial Sloan Kettering Cancer Center · Milton S. Hershey Medical Center · National Cancer Center, Korea · National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) · Ohio State University · OnLume Inc. · Shanghai Jiao Tong University Affiliated Sixth People's Hospital · Society of University Surgeons · St. Jude Children's Research Hospital · Stryker Nordic · The University of Hong Kong · University Hospital Erlangen · University Hospital of Saint-Etienne · University Medical Center Groningen · University of Alabama at Birmingham · University of Wisconsin, Madison · VPIX Medical · Affiliated Cancer Hospital of Shantou University Medical College · Akorn, Inc. · American Cancer Society, Inc. · American Society for Surgery of the Hand · Amphia Hospital · Ankara University · Association GEGO · Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria · Azienda Policlinico Umberto I · Barretos Cancer Hospital · Baylor College of Medicine · Başakşehir Çam & Sakura City Hospital · Beijing Digital Precesion Medicine Company · Beijing Friendship Hospital · Boston Children's Hospital · Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Canisius-Wilhelmina Hospital · Cardiox Corporation · Catharina Ziekenhuis Eindhoven · Centre Hospitalier Universitaire Vaudois · Centro di Riferimento Oncologico - Aviano · Chinese PLA General Hospital · Ciusss de L'Est de l'Île de Montréal · Damon Runyon Cancer Research Foundation · Dartmouth-Hitchcock Medical Center · Diakonessenhuis, Utrecht · Dijklander Ziekenhuis · Duke University · Erasmus Medical Center · Eva MedTech, Inc. · all 174 on the full record

Regulatory milestones approvals, filings & regulatory actions · 3 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Label expansion US (FDA) IC-GREEN — 2024-12-05 fda.gov ↗
Label expansion US (FDA) SPY AGENT GREEN KIT — 2023-06-05 fda.gov ↗
Approved US (FDA) IC-GREEN — 1959-02-09 fda.gov ↗

Trials 180 · started per year

today
US approved 1959
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PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 016 trials
Phase 0 NCT07658768 Sep 2026 → May 2027 expected sarcoma Abramson Cancer Center at Penn Medicine Not yet recruiting No outcome recorded
Phase 0 NCT07250854 Jan 2026 → Mar 2027 expected biliary atresia University of Alabama at Birmingham Recruiting No outcome recorded
Phase 0 NCT07295262 Jan 2026 → Jul 2028 expected adult hepatocellular carcinoma West China Hospital Recruiting No outcome recorded
Phase 0 NCT06446648 Jul 2024 → Jul 2028 expected prostate adenocarcinoma University of California, Irvine Recruiting No outcome recorded
Phase 0 NCT05645523 Oct 2023 → Dec 2026 expected cancer St. Jude Children's Research Hospital Recruiting No outcome recorded
Phase 0 NCT05859971 Apr → Jun 2023 breast cancer University of Wisconsin, Madison Completed No outcome recorded
Phase 0 NCT05087264 Mar 2022 → Oct 2025 cervical carcinoma Fifth Affiliated Hospital, Sun Yat-Sen University Unknown No outcome recorded
Phase 0 NCT05075889 Nov 2021 → Apr 2022 bone benign neoplasm Dartmouth-Hitchcock Medical Center Completed No outcome recorded
Phase 0 NCT06579430 Nov 2020 → May 2024 hypoparathyroidism University Medical Center Groningen Completed No outcome recorded
Phase 0 NCT04051502 Aug 2019 → Dec 2025 ovarian cancer Memorial Sloan Kettering Cancer Center Completed No outcome recorded
Phase 133 trials
Phase 1 NCT05038098 Mar 2026 → Feb 2027 expected gastric adenocarcinoma M.D. Anderson Cancer Center Not yet recruiting No outcome recorded
Phase 1 NCT07254845 Dec 2025 → May 2026 overdue brain neoplasm VPIX Medical Not yet recruiting No outcome recorded
Phase 1 NCT06867978 Jun 2025 → Jun 2026 overdue brain neoplasm VPIX Medical Not yet recruiting No outcome recorded
Phase 1 NCT06994949 Jan 2025 → Jan 2029 expected hydrocephalus Eva Sevick Recruiting No outcome recorded
Phase 1 NCT05946837 Aug → Sep 2023 spondylosis, cervical The University of Texas Health Science Center, Houston Completed No outcome recorded
Phase 1 NCT05746104 Mar 2023 → Feb 2027 expected nervous system neoplasm Abramson Cancer Center at Penn Medicine Enrolling by invitation No outcome recorded
Phase 1 NCT05197530 Dec 2021 → Jun 2026 overdue rheumatoid arthritis University of Rochester Recruiting No outcome recorded
Phase 1 NCT04340752 Jan 2021 → Sep 2025 rotator cuff syndrome NYU Langone Health Completed No outcome recorded
Phase 1 NCT04833569 Sep 2020 → Feb 2021 periodontitis King Saud University Completed No outcome recorded
Phase 1 NCT04393168 May → Jun 2020 lymphedema Nicole Lindenblatt Completed No outcome recorded
Phase 1/218 trials
Phase 1/2 NCT07108855 Sep 2025 → Jun 2027 expected carcinoma of esophagus, gastric carcinoma University Medical Center Groningen Recruiting No outcome recorded
Phase 1/2 NCT06647901 Aug 2024 → Aug 2026 overdue bone giant cell tumor Tang Xiaodong Recruiting No outcome recorded
Phase 1/2 NCT04723810 Aug 2024 → Jan 2027 expected — University of Pennsylvania Recruiting No outcome recorded
Phase 1/2 NCT07513038 Aug 2024 → Aug 2026 overdue biliary atresia Boston Children's Hospital Recruiting No outcome recorded
Phase 1/2 NCT05808140 Apr 2023 → Dec 2025 lumbar disk disease Zhongnan Hospital Completed No outcome recorded
Phase 1/2 NCT03953144 Dec 2022 → Sep 2026 overdue non-small cell lung carcinoma St. Joseph's Healthcare Hamilton Recruiting No outcome recorded
Phase 1/2 NCT05092750 Sep 2021 → Aug 2023 colorectal cancer M.D. Anderson Cancer Center Withdrawn No outcome recorded Stop: Enrollment
Phase 1/2 NCT05346380 Oct 2020 → Jun 2025 esophageal disorder, lung neoplasm Massachusetts General Hospital Completed No outcome recorded
Phase 1/2 NCT03745690 Dec 2018 → Jun 2021 head and neck carcinoma Jonsson Comprehensive Cancer Center Withdrawn No outcome recorded Stop: Enrollment
Phase 1/2 NCT03292757 Dec 2017 → Aug 2018 esophageal cancer Oxford University Hospitals NHS Trust Completed No outcome recorded
Phase 229 trials · 1 missed
Phase 2 NCT07650656 May 2027 → May 2028 expected sarcoma City of Hope Medical Center Recruiting No outcome recorded
Phase 2 NCT07149207 May 2026 → Apr 2028 expected head and neck squamous cell carcinoma Medical University of South Carolina Recruiting No outcome recorded
Phase 2 NCT07518485 Apr 2026 → Mar 2027 expected head and neck cancer, oral cavity cancer Centre Hospitalier Universitaire Vaudois Not yet recruiting No outcome recorded
Phase 2 NCT07316023 Jan → Jun 2026 overdue chronic periodontitis Nada Mahmoud Soliman Recruiting No outcome recorded
Phase 2 NCT07060443 Jul 2025 → Dec 2028 expected — Pusan National University Yangsan Hospital Recruiting No outcome recorded
Phase 2 NCT05687617 Dec 2022 → Mar 2024 gastric adenocarcinoma, peritoneal carcinomatosis Laval University Terminated No outcome recorded Stop: Enrollment
Phase 2 NCT04752137 May 2022 → Apr 2028 expected benign neoplasm, cancer Massachusetts General Hospital Recruiting No outcome recorded
Phase 2 NCT04891185 Oct 2021 → Oct 2023 ovarian cancer Universitaire Ziekenhuizen KU Leuven Terminated No outcome recorded
Phase 2 NCT04942665 Sep 2021 → Sep 2022 cholecystitis, hepatocellular carcinoma University of Florida Completed No outcome recorded
Phase 2 NCT04973475 Jul 2021 → Jul 2023 overdue gastric carcinoma Fujian Medical University Not yet recruiting No outcome recorded
Phase 2/34 trials
Phase 2/3 NCT05926856 Aug → Dec 2023 bile duct disorder Zhujiang Hospital Completed No outcome recorded
Phase 2/3 NCT04857346 Jun → Dec 2020 chronic periodontitis, prediabetes syndrome, type 2 diabetes mellitus King Saud University Completed No outcome recorded
Phase 2/3 NCT02910726 Sep 2016 → Sep 2022 childhood malignant neoplasm Memorial Sloan Kettering Cancer Center Completed No outcome recorded
Phase 2/3 NCT01693484 Apr 2013 → Mar 2015 — Louisiana State University Health Sciences Center Shreveport Terminated No outcome recorded
Phase 313 trials · 2 missed
Phase 3 NCT07406815 Jun → Jul 2026 overdue esophageal cancer Fujian Medical University Union Hospital Not yet recruiting No outcome recorded
Phase 3 NCT07303231 Jan 2026 → Aug 2027 expected esophageal cancer Fujian Medical University Union Hospital Not yet recruiting No outcome recorded
Phase 3 NCT06755554 Jan 2025 → Jan 2026 overdue gastric carcinoma Ukrainian Society of Clinical Oncology Recruiting No outcome recorded
Phase 3 NCT05117853 Nov 2021 → Oct 2024 hypoparathyroidism, thyroid gland disorder Onze Lieve Vrouw Hospital Unknown No outcome recorded
Phase 3 NCT04785443 Jun 2021 → Jun 2026 overdue thyroid gland disorder University Hospital, Brest Recruiting No outcome recorded
Phase 3 NCT04904081 Jun 2021 → Jun 2024 Hirschsprung disease, anorectal malformation London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's Unknown No outcome recorded
Phase 3 NCT04611997 Nov 2020 → Oct 2026 expected gastric cancer, metastatic malignant neoplasm in the lymph nodes Fujian Medical University Active not recruiting No outcome recorded
Phase 3 NCT04712032 Jul 2020 → Jul 2022 Crohn disease, colorectal carcinoma Leiden University Medical Center Unknown Missed primary
Phase 3 NCT04219332 Dec 2019 → Nov 2020 gastric cancer Fujian Medical University Unknown Missed primary
Phase 3 NCT02997553 Nov 2017 → Sep 2022 anus cancer, breast carcinoma, cervical carcinoma, cutaneous melanoma +5 Institut de Cancérologie de Lorraine Completed No outcome recorded
Phase 424 trials
Phase 4 NCT07635420 Sep 2026 → Jan 2029 expected head and neck cancer Region Skane Recruiting No outcome recorded
Phase 4 NCT07195331 Feb → Nov 2026 expected — Instituto de Investigación Biomédica de Salamanca Recruiting No outcome recorded
Phase 4 NCT07315828 Jan → Dec 2026 expected bone giant cell tumor Shanghai Jiao Tong University Affiliated Sixth People's Hospital Recruiting No outcome recorded
Phase 4 NCT07315841 Jan → Dec 2026 expected tenosynovial giant cell tumor Shanghai Jiao Tong University Affiliated Sixth People's Hospital Recruiting No outcome recorded
Phase 4 NCT07144904 Oct 2025 → Feb 2026 overdue endometriosis of pelvic peritoneum, ovarian endometriosis Baylor College of Medicine Not yet recruiting No outcome recorded
Phase 4 NCT06871787 Sep 2025 → Sep 2027 expected cervical cancer, endometrial cancer, intestinal perforation, ovarian cancer +1 Istanbul University Not yet recruiting No outcome recorded
Phase 4 NCT06164392 Dec 2024 neuroma Northwestern University Withdrawn No outcome recorded Stop: Enrollment
Phase 4 NCT06169735 Apr 2024 → May 2026 parathyroid gland adenoma University of Alabama at Birmingham Terminated No outcome recorded Stop: Business
Phase 4 NCT06258486 Feb 2024 → Feb 2026 lymphocele, prostate cancer Kaiser Permanente Unknown No outcome recorded
Phase 4 NCT06398028 Aug 2023 → Mar 2026 overdue liver and intrahepatic bile duct neoplasm Hospital Universitari Vall d'Hebron Research Institute Recruiting No outcome recorded
Phase not applicable43 trials · 1 met primary · 1 missed
— NCT07808957 Oct → Dec 2026 expected — Research Inc Not yet recruiting No outcome recorded
— NCT07593339 Jun 2026 → Dec 2027 expected malignant epithelial tumor of ovary Başakşehir Çam & Sakura City Hospital Not yet recruiting No outcome recorded
— NCT07638956 Jun 2026 → Sep 2027 expected colon carcinoma Tanta University Not yet recruiting No outcome recorded
— NCT07146295 Apr 2025 → Jul 2026 overdue breast cancer, metastatic malignant neoplasm in the lymph nodes Isabelle Henskens Recruiting No outcome recorded
— NCT07551388 Jan → Apr 2025 acute cholecystitis Peking Union Medical College Hospital Completed No outcome recorded
— NCT06840418 Jan 2025 → Dec 2027 expected cervical cancer Obstetrics & Gynecology Hospital of Fudan University Recruiting No outcome recorded
— NCT06347354 Sep 2024 → Aug 2025 breast cancer Centro di Riferimento Oncologico - Aviano Unknown No outcome recorded
— NCT06421103 Jun 2024 → Aug 2028 expected digestive system disorder Great Ormond Street Hospital for Children NHS Foundation Trust Recruiting No outcome recorded
— NCT06227338 Feb 2024 → Jan 2026 overdue breast cancer Jules Bordet Institute Recruiting No outcome recorded
— NCT06222645 Nov 2023 → Apr 2026 overdue colorectal cancer, gastric cancer Saint Petersburg State University, Russia Recruiting No outcome recorded
Comparator or background therapy24 trials
Phase 0 NCT07613931 Background Jul → Sep 2026 overdue lymphedema Tactile Medical Recruiting No outcome recorded
Phase 0 NCT02851368 Background Nov 2016 → Nov 2017 pulmonary coin lesion University of Pittsburgh Completed No outcome recorded
Phase 0 NCT02359578 Background Aug → Nov 2014 — Centre Hospitalier Universitaire Saint Pierre Completed No outcome recorded
Phase 1 NCT05937269 Background Oct 2023 → Feb 2026 overdue head and neck cancer, lymphedema The University of Texas Health Science Center, Houston Enrolling by invitation No outcome recorded
Phase 1 NCT06939946 Background Sep 2023 → Aug 2025 parathyroid gland disorder, thyroid gland disorder OPTOSURGICAL, LLC Terminated No outcome recorded Stop: Business

News releases announcing trial results or a regulatory action · 1

DateIssuerRelease
2026-08-04 Zydus Lifesciences Limited Regulatory Zydus announces Final Approval from the USFDA for Indocyanine Green for Injection with 180-Days CGT exclusivity zyduslife.com ↗
Zydus Lifesciences Limited (Zydus) announces the receipt of final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Indocyanine Green for Injection, USP, 25 mg/vial, a sterile lyophilised powder for reconstitution.

All press releases naming this drug 1 release

DateIssuerRelease

Evidence & citations 15 cited values

Every value below carries the sentence it was read from. 213 sources stand behind the page.

FieldValueCited text
Known as indocyanine green “The indocyanine green in 5% human albumin solution (tracer) (50 μL) will be injected intradermally in both forearms or both lower legs using MicronJet600 microneedles paying...” NCT04393168 ↗
202

“The purpose of this research study is to assess the feasibility of using a different dye and imaging device, indocyanine green (ICG)-fluorescent imaging through the Asimov...” NCT05859971 ↗

“Near-infrared Fluorescence Lymphatic Imaging following the off-label use of Indocyanine Green as a lymph contrast agent and the use of a custom designed fluorescence imager to...” NCT02946021 ↗

“Patients enrolled in the study will undergo peritumoral injection of near-infrared dye indocyanine green around the lung lesion or within the adjacent segmental bronchus at the...” NCT03097575 ↗

“Clinical, bacterial, and inflammatory outcomes of indocyanine green-mediated photodynamic therapy for treating periimplantitis among diabetic patients: A randomized controlled...” NCT04833569 ↗

“The intraoperative use of indocyanine green angiography has recently been described as a reliable means of detecting parathyroid and predicting the risk of postoperative...” NCT04785443 ↗

“We therefore aimed to evaluate the efficacy of real-time assessment with near-infrared (NIR) fluorescence imaging with indocyanine green (ICG) in the prevention of anastomotic leakage.” PMID 39151436 ↗ Aug 2024

“This intervention involves the intravenous injection of the fluorescent contrast agent Indocyanine Green (ICG), followed by imaging with a near-infrared fluorescence camera system.” NCT06222645 ↗

“Feasibility Study of the (Intravenously Injected) Indocyanine Green (ICG) Imaging of Tumoral Implants in Patients With Peritoneal Carcinomatosis From Ovarian Carcinoma” NCT01834469 ↗

“Intraoperative fluorescence imaging using indocyanine green has proven to be a feasible and reproducible technique for real-time perfusion assessment.” NCT06845306 ↗

“they will receive a dermal injection of indocyanine green (ICG) 0.3-1.0 ml at the melanoma tumor site or subareola if breast cancer” NCT03294330 ↗

Show 192 more sources

Known as IC-Green “Indocyanine Green (IC-Green)” NCT07108855 ↗
4

“Indocyanine Green (IC-Green)” NCT07613931 ↗

“Indocyanine Green (IC-Green)” NCT01295931 ↗

NCT01673022 ↗

NCT03953144 ↗

Known as ICG “Several cohort studies have shown that indocyanine green (ICG) combined with fluorescent near-infrared imaging is a feasible and reproducible technique for real-time...” PMID 35365509 ↗ Apr 2022
78

“Dosage Form: Intravenous injection Dosage: 0.1 - 0.5 mg/kg of Indocyanine Green (ICG) Frequency: Single administration during surgery Duration: Real-time imaging performed...” NCT07254845 ↗

“Because endometriosis is associated with hypervascularisation the visualization of tissue perfusion by additional use of near infrared (NIR) fluorescence imaging with...” NCT03850158 ↗

“PURPOSE: To carry out a prospective investigation of the functional and morphological outcome of idiopathic epiretinal membrane (IEM) surgery with or without the assistance of...” PMID 17186261 ↗ Dec 2006

“This study aims to look at babies having a primary or delayed primary oesophageal repair for OA with dTOF to evaluate if using Indocyanine green (ICG) and near infrared...” NCT05735964 ↗

“The purpose of this research study is to assess the feasibility of using a different dye and imaging device, indocyanine green (ICG)-fluorescent imaging through the Asimov...” NCT05859971 ↗

“Indocyanine Green (ICG) is a non-radioactive, fluorescent compound with several clinical applications including angiography for ophthalmologic testing, visualization during...” NCT07513038 ↗

“a special type of fluorescent dye called indocyanine green (ICG) during surgery can help surgeons find the lymph nodes that the cancer is most likely to have spread to in...” NCT05092750 ↗

“Indocyanine green (ICG), administered intravenously at a dose of 2.5 mg/ml, will be used during surgery to evaluate bowel anastomosis perfusion through near-infrared...” NCT06871787 ↗

“This intervention involves the intravenous injection of the fluorescent contrast agent Indocyanine Green (ICG), followed by imaging with a near-infrared fluorescence camera system.” NCT06222645 ↗

“Background Near-infrared fluorescence guided surgery with indocyanine green (ICG) was introduced for parathyroid perfusion assessment during total thyroidectomy in 2016.” NCT06579430 ↗

Show 68 more sources

Known as ICG Dye “Drug: ICG Dye” NCT02516319 ↗
Known as indocyanine green (IC-Green). “indocyanine green (IC-Green).” NCT02111824 ↗
Known as Indocyanine green (ICG) “Indocyanine green (ICG)” NCT05419947 ↗
Known as Indocyanine Green Dye “2.0 mg/kg ICG (Indocyanine Green Dye) as per standard protocol” NCT04719156 ↗
Known as INFRACYANINE “indocyanine green (INFRACYANINE© 25mg/10mL).” NCT04842162 ↗
Known as Perio green “Indocyanine green (Perio green, Elexxion AG, Radolfzell, Germany) prepared and applied according to manufacturer's instructions steps (mixing, application, soaking phase,...” NCT06379438 ↗
Known as PULSION “0.25 mg /(kg BW) Indocyanine Green PULSION® - PULSION Medical Systems were administered intravenously” NCT03332004 ↗
1

“0.25 mg /(kg BW) Indocyanine Green PULSION®/ VERDYE Diagnostic Green®” NCT03935165 ↗

Known as SWIG “More recently, we described Second Window Indocyanine Green (SWIG) which targets neoplastic tissue through enhanced vascular permeability.” PMID 32514886 ↗ Oct 2020
Known as TumorGlow “Subjects will undergo infusion of 5 mg/kg indocyanine green, ICG ("TumorGlow") intravenously up to 5-days prior to surgery.” NCT07658768 ↗
Known as VERDYE Diagnostic Green “0.25 mg /(kg BW) Indocyanine Green PULSION®/ VERDYE Diagnostic Green®” NCT03935165 ↗
Modality Diagnostic / imaging agent “near-infrared-guided detection of tumor-specific sentinel lymph nodes” NCT00264602 ↗
Route Intravenous “IV administration of ICG” NCT00137254 ↗