> Trialight public data. Index of pages: https://trialight.com/llms.txt
> Web page: https://trialight.com/data/asset/indocyanine-green-40d07fd3-bd63-41ea-90f6-5f6340b97253
> Record changed: 2026-10-13

# Indocyanine green

Highest phase reached

Approved

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1646)

Drug type

Small molecule

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1646)

First approval year

1959

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1646)

## Development status

**First approval year**

1959

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1646)

**Listing at source**

Listed

**Highest phase reached**

Approved

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1646)

## Names and chemistry

**Drug type**

Small molecule

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1646)

**Drug name**

Indocyanine green

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1646)

**Molecular weight**

774.98

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1646)

**Structure (SMILES)**

CC1(C)C(/C=C/C=C/C=C/C=C2\\N(CCCCS(=O)(=O)\[O-\])c3ccc4ccccc4c3C2(C)C)=\[N+\](CCCCS(=O)(=O)\[O-\])c2ccc3ccccc3c21.\[Na+\]

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1646)

### Brand names (6)

- ic green
- Ic-green
- indocyanine green
- Indocyanine green
- spy agent green kit
- Spy agent green kit

### Other names (56)

- 1h benz e indolium 2 7 1 3 dihydro 1 1 dimethyl 3 4 sulfobutyl 2h benz e indol 2 ylidene 1 3 5 heptatrienyl 1 1 dimethyl 3 4 sulfobutyl hydroxide inner salt sodium salt
- 1H-BENZ(E)INDOLIUM, 2-(7-(1,3-DIHYDRO-1,1-DIMETHYL-3-(4-SULFOBUTYL)-2H-BENZ(E)INDOL-2-YLIDENE)-1,3,5-HEPTATRIENYL)-1,1-DIMETHYL-3-(4-SULFOBUTYL)-, HYDROXIDE, INNER SALT, SODIUM SALT
- 2 7 1 1 dimethyl 3 4 sulfobutyl benz e indolin 2 ylidene 1 3 5 heptatrienyl 1 1 dimethyl 3 4 sulfobutyl 1h benz e indolium hydroxide inner salt sodium salt
- 2-\[7-\[1,1-Dimethyl-3-(4-sulfobutyl)benz\[E\]indolin-2-ylidene\]-1,3,5-heptatrienyl\]-1,1-dimethyl-3-(4-sulfobutyl)-1H-benz\[E\]indolium hydroxide, inner salt, sodium salt
- ic green
- IC Green
- IC-Green (ICG)
- ICG (Indocyanine Green)
- indocyanine green
- Indocyanine green
- Indocyanine Green
- Indocyanine Green (IC-Green)
- indocyanine green (ICG)
- Indocyanine green (ICG)
- Indocyanine Green (ICG)
- Indocyanine Green (ICG)-Assisted Ureteral Identification
- INDOCYANINE GREEN \[HSDB\]
- INDOCYANINE GREEN \[JAN\]
- INDOCYANINE GREEN \[MART.\]
- INDOCYANINE GREEN \[MI\]
- INDOCYANINE GREEN \[ORANGE BOOK\]
- INDOCYANINE GREEN \[USP MONOGRAPH\]
- INDOCYANINE GREEN \[USP-RS\]
- INDOCYANINE GREEN \[VANDF\]
- Indocyanine green \[WHO-DD\]

And 31 more, listed on the interactive page.

## Identifiers

**ATC classification codes**

- V04CX01

Sources for recorded values

Source: [mor.nlm.nih.gov](https://mor.nlm.nih.gov/RxNav/search?searchBy=RXCUI&searchTerm=5775)

**CAS registry numbers**

- 3599-32-4

**ChEMBL ID**

CHEMBL1646

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1646)

**InChIKey**

MOFVSTNWEDAEEK-UHFFFAOYSA-M

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1646)

**RxNorm IDs (RxCUI)**

- 5775

**FDA ingredient codes (UNII)**

- IX6J1063HV

### PubChem compound IDs (14)

- 19190
- 5282412
- 5284572
- 11967809
- 43835846
- 45101199
- 51063122
- 58606996
- 74764374
- 92132757
- 132274068
- 156599054
- 165411817
- 169410069

## Regulatory information

### United States

**Applicant**

PROVEPHARM SAS

**Approval date**

10 Jul 2026

**Application number**

NDA218579

### Other regulatory facts

**Patents**

5

**Designations**

0

**Earliest recorded loss of exclusivity**

14 Jul 2039

**First in class**

No

**Fast track**

No

**Breakthrough designation**

No

**Orphan designation**

No

**Priority review**

No

**Orphan exclusivity**

No

**Accelerated approval**

No

**Availability**

Prescription only

## Pharmacology

### Drug classification

**Pharmacology name**

indocyanine green

**Type**

Synthetic organic

#### Administration routes

- Parenteral

### Mechanisms of action

- **Action**  
Inhibition

**Action type**  
Inhibitor

**Target**  
OATP1B1

**Gene symbol**  
SLCO1B1

**Protein identifier**  
Q9Y6L6

### Investigated indications (31)

- **Condition**  
Carcinoma, Hepatocellular

**Highest recorded phase**  
1

**Condition identifier**  
EFO:0000182

**Subject identifier**  
D006528
- **Condition**  
Breast Neoplasms

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0000305

**Subject identifier**  
D001943
- **Condition**  
Melanoma

**Highest recorded phase**  
1

**Condition identifier**  
EFO:0000389

**Subject identifier**  
D008545
- **Condition**  
Stomach Neoplasms

**Highest recorded phase**  
3

**Condition identifier**  
EFO:0000503

**Subject identifier**  
D013274
- **Condition**  
Wounds and Injuries

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0000546

**Subject identifier**  
D014947
- **Condition**  
Neoplasms

**Highest recorded phase**  
1

**Condition identifier**  
EFO:0000616

**Subject identifier**  
D009369
- **Condition**  
Periodontitis

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0000649

**Subject identifier**  
D010518
- **Condition**  
Carcinoma, Renal Cell

**Highest recorded phase**  
1

**Condition identifier**  
EFO:0000681

**Subject identifier**  
D002292
- **Condition**  
Arthritis, Rheumatoid

**Highest recorded phase**  
1

**Condition identifier**  
EFO:0000685

**Subject identifier**  
D001172
- **Condition**  
Sarcoma

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0000691

**Subject identifier**  
D012509
- **Condition**  
Uterine Cervical Neoplasms

**Highest recorded phase**

0.5

**Condition identifier**  
EFO:0001061

**Subject identifier**  
D002583
- **Condition**  
Carcinoma, Non-Small-Cell Lung

**Highest recorded phase**  
1

**Condition identifier**  
EFO:0003060

**Subject identifier**  
D002289
- **Condition**  
Bone Neoplasms

**Highest recorded phase**

0.5

**Condition identifier**  
EFO:0003820

**Subject identifier**  
D001859
- **Condition**  
Brain Neoplasms

**Highest recorded phase**  
1

**Condition identifier**  
EFO:0003833

**Subject identifier**  
D001932
- **Condition**  
Stomach Neoplasms

**Highest recorded phase**  
3

**Condition identifier**  
EFO:0003897

**Subject identifier**  
D013274
- **Condition**  
Head and Neck Neoplasms

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0006859

**Subject identifier**  
D006258
- **Condition**  
Endometrial Neoplasms

**Highest recorded phase**  
3

**Condition identifier**  
EFO:0007532

**Subject identifier**  
D016889
- **Condition**  
Retinal Perforations

**Highest recorded phase**  
3

**Condition identifier**  
EFO:1001028

**Subject identifier**  
D012167
- **Condition**  
Rotator Cuff Injuries

**Highest recorded phase**  
1

**Condition identifier**  
EFO:1001250

**Subject identifier**  
D000070636
- **Condition**  
Endometrial Neoplasms

**Highest recorded phase**  
3

**Condition identifier**  
EFO:1001512

**Subject identifier**  
D016889
- **Condition**  
Stomach Neoplasms

**Highest recorded phase**  
3

**Condition identifier**  
MONDO:0001056

**Subject identifier**  
D013274
- **Condition**  
Head and Neck Neoplasms

**Highest recorded phase**  
2

**Condition identifier**  
MONDO:0002038

**Subject identifier**  
D006258
- **Condition**  
Periodontal Diseases

**Highest recorded phase**  
3

**Condition identifier**  
MONDO:0002635

**Subject identifier**  
D010510
- **Condition**  
Colorectal Neoplasms

**Highest recorded phase**  
3

**Condition identifier**  
MONDO:0005575

**Subject identifier**  
D015179
- **Condition**  
Breast Neoplasms

**Highest recorded phase**  
2

**Condition identifier**  
MONDO:0007254

**Subject identifier**  
D001943

And 6 more, listed on the interactive page.

### Open Targets indications (42)

- **Condition identifier**  
EFO\_0000546
- **Condition identifier**  
EFO\_0000616
- **Condition identifier**  
EFO\_0000649

**Highest recorded phase**  
2
- **Condition identifier**  
EFO\_0000681

**Highest recorded phase**  
1
- **Condition identifier**  
EFO\_0000685

**Highest recorded phase**  
1
- **Condition identifier**  
EFO\_0001061
- **Condition identifier**  
EFO\_0003060
- **Condition identifier**  
EFO\_0003820
- **Condition identifier**  
EFO\_0003833

**Highest recorded phase**  
1
- **Condition identifier**  
EFO\_0003897

**Highest recorded phase**  
3
- **Condition identifier**  
EFO\_0006859
- **Condition identifier**  
EFO\_0007176
- **Condition identifier**  
EFO\_0009527
- **Condition identifier**  
EFO\_0010282
- **Condition identifier**  
EFO\_0010282

**Highest recorded phase**  
4
- **Condition identifier**  
EFO\_1000453
- **Condition identifier**  
EFO\_1000657
- **Condition identifier**  
EFO\_1001250

**Highest recorded phase**  
1
- **Condition identifier**  
EFO\_1001390

**Highest recorded phase**  
1
- **Condition identifier**  
EFO\_1001480
- **Condition identifier**  
EFO\_1001512

**Highest recorded phase**  
3
- **Condition identifier**  
MONDO\_0001056

**Highest recorded phase**  
3
- **Condition identifier**  
MONDO\_0001528
- **Condition identifier**  
MONDO\_0002038
- **Condition identifier**  
MONDO\_0002635

**Highest recorded phase**  
3

And 17 more, listed on the interactive page.

### Reported adverse events (10)

- **Event**  
age-related macular degeneration

**Reports**  
2

**Reporting signal score**

10.2436
- **Event**  
anaphylactic shock

**Reports**  
5

**Reporting signal score**

16.201
- **Event**  
contrast media allergy

**Reports**  
3

**Reporting signal score**

16.5352
- **Event**  
haemangioma congenital

**Reports**  
8

**Reporting signal score**

58.2164
- **Event**  
low birth weight baby

**Reports**  
8

**Reporting signal score**

37.7889
- **Event**  
optic nerve disorder

**Reports**  
2

**Reporting signal score**

10.7887
- **Event**  
patent ductus arteriosus

**Reports**  
8

**Reporting signal score**

43.0468
- **Event**  
product label issue

**Reports**  
2

**Reporting signal score**

9.50693
- **Event**  
retinal injury

**Reports**  
2

**Reporting signal score**

11.9542
- **Event**  
retinal scar

**Reports**  
2

**Reporting signal score**

12.7775

### Trial references (46)

- NCT00453050  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00453050)
- NCT00540982  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00540982)
- NCT01083004  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01083004)
- NCT01095913  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01095913)
- NCT02027818  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02027818)
- NCT02462200  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02462200)
- NCT02473159  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02473159)
- NCT02479997  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02479997)
- NCT02817334  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02817334)
- NCT06327490  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06327490)
- NCT01281488  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01281488)
- NCT01335893  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01335893)
- NCT05346380  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05346380)
- NCT02043340  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02043340)
- NCT02570815  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02570815)
- NCT02570958  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02570958)
- NCT02598219  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02598219)
- NCT02680067  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02680067)
- NCT04046146  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04046146)
- NCT05197530  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05197530)
- NCT02949726  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02949726)
- NCT03050879  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03050879)
- NCT03262636  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03262636)
- NCT03557827  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03557827)
- NCT03745690  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03745690)

And 21 more, listed on the interactive page.

## Dosing

**Dose**

1.25 mg to 5 mg

**Route**

Intravenous

**How often**

As needed

### Conditions of use

- Immediately flush with 10 mL of 0.9% Sodium Chloride Injection

## Chemical properties

**Hydrogen bond acceptors**

6

**Hydrogen bond donors**

1

**Polar surface area**

117.82

**Calculated partition coefficient (ALogP)**

8.71

**Prodrug**

No

**Chirality**

Achiral

**Inorganic**

No

**Rule-of-five violations**

2

**Rotatable bonds**

14

**Heavy atoms**

54

**Molecular formula**

C43H47N2NaO6S2

**Monoisotopic mass**

774.27732385

**Natural product**

No

## National Drug Codes

- 25021-841

## Evidence counts

**Recorded assays**

456

**Active assays**

50

### Active assay types (3)

- Confirmatory
- Other
- Screening

## Pharmacologic actions

- Coloring Agents  
Source: [id.nlm.nih.gov](https://id.nlm.nih.gov/mesh/D004396.html)

## Related records

### Trials (269)

- 3D Printing for Nodule Localization
- A French Observational Study of Indocyanine Green for Patients With Breast Cancer Having a Sentinel Lymph Node Biopsy.
- A Multimodality Image-guided System for Peripheral Lung Cancer Diagnosis and Therapy
- A Pilot Study of Optical Molecular Imaging for Percutaneous Biopsy of Hepatocellular Carcinoma Using Indocyanine Green
- A Prospective Clinical Study for Evaluation of Safe Resection Margin in Breast Conserving Surgery in Breast Cancer
- 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
- A Randomized Controlled Trial to Improve the Therapeutic Effect of Robot-assisted Radical Prostatectomy (RARP) Using Indocyanine Green Fluorescence Imaging
- A Study Comparing Green Fluorescent Dye and Radioactive Dye for Sentinel Lymph Node Biopsy in Pediatric Cancers
- 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
- A Study to Evaluate Efficacy and Safety of Light Dose in Subjects With PWB Treated With Hemoporfin PDT
- A Study to Evaluate Indocyanine Green Lymphangiography to Improve Lymphadenectomy in Gastric Cancer Patients
- Accuracy of Indocyanine Green (ICG) Fluorescence Imaging in Giant Cell Tumor of Bone Surgery
- Accuracy of Indocyanine Green (ICG) Fluorescence Imaging in Tenosynovial Giant Cell Tumor Surgery
- Accuracy of Sentinel Lymph Node Biopsy in Nodal Staging of High Risk Endometrial Cancer
- Advanced Gastrointestinal Endoscopic Imaging
- Angiosome Perfusion After Tibial Bypass
- Antimicrobial Photodynamic Therapy in Chronic Periodontitis and Diabetes Mellitus
- Application of ICG in Lymph Node Dissection During Radical Resection of Rectal Cancer With Preserved Autonomic Nerves Around LCA and IMA
- Application of Indocyanine Green Angiography for Closed Operative Calcaneus Fractures
- Application of Surgical Navigation System in Sentinel Lymph Node of Breast Cancer Research

### In development for (31)

- Bone neoplasm Early phase 1
- [Brain neoplasm](https://trialight.com/data/condition/brain-neoplasm-b3dac71b-1d7b-5a65-8f64-89821506ad41.md) Phase 1
- [Breast cancer](https://trialight.com/data/condition/breast-cancer-8ac10da3-93bd-54c5-a93b-265bc6699689.md) Phase 2
- Breast carcinoma Phase 2
- Cervical carcinoma Early phase 1
- [Colorectal cancer](https://trialight.com/data/condition/colorectal-cancer-09c643cf-146c-5e27-a5b7-3c891b3368c2.md) Phase 3
- [Cutaneous melanoma](https://trialight.com/data/condition/cutaneous-melanoma-c6e75b71-1c7c-59fe-a087-174eb0ec53df.md) Phase 1
- [Endometrial cancer](https://trialight.com/data/condition/endometrial-cancer-4da2a0bc-7943-502b-a698-cc2beccbed8c.md) Phase 3
- [Endometrial carcinoma](https://trialight.com/data/condition/endometrial-carcinoma-d0794a04-ff16-5af6-8fb7-7b3d6bd6c537.md) Phase 3
- [Gastric adenocarcinoma](https://trialight.com/data/condition/gastric-adenocarcinoma-6bb74a55-7ba6-53e3-a113-22296a84d6ae.md) Phase 3
- [Gastric cancer](https://trialight.com/data/condition/gastric-cancer-3c1e2785-2672-5b3e-afce-9335f684c159.md) Phase 3
- [Gastric neoplasm](https://trialight.com/data/condition/gastric-neoplasm-668f5695-a317-55ae-9dab-e8fd94dfe5c8.md) Phase 3
- [Head and neck cancer](https://trialight.com/data/condition/head-and-neck-cancer-3a2645b9-a3db-5103-b6f8-5d2ec40c5339.md) Phase 2
- [Head and neck carcinoma](https://trialight.com/data/condition/head-and-neck-carcinoma-15d11e2c-18dd-5089-9c7b-487ae515e69c.md) Phase 2
- [Hepatocellular carcinoma](https://trialight.com/data/condition/hepatocellular-carcinoma-fc1014ac-5a3c-551d-98ea-95306009e299.md) Phase 1
- Injury Phase 2
- [Lung cancer](https://trialight.com/data/condition/lung-cancer-c4ca1fe0-9b3d-5957-a668-2d6cf26bd16a.md) Phase 1
- [Lung neoplasm](https://trialight.com/data/condition/lung-neoplasm-d4ce75ac-7517-5ab7-9f47-34c0f7b81786.md) Phase 1
- Lymphedema Phase 1
- Macular holes Phase 3

### Other linked conditions (6)

- Bone giant cell tumor
- [Cervical cancer](https://trialight.com/data/condition/cervical-cancer-10fb8f6c-5aac-5281-8f06-7238adeec443.md)
- Liver cancer
- Paraganglioma
- Rectal cancer
- Vulva cancer

---

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