Fluorescein
Ak-fluor, Altafluor Benox, Fluorescein, Fluorescite (fluorescein) is a small molecule pharmaceutical. Fluorescein was first approved as Funduscein-25 on 1982-01-01.
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Commercial
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Trade Name
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Ak-fluor, Fluorescite (discontinued: Funduscein)
CombinationsAltafluor benox
Drug Products
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EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Benoxinate hydrochloride
+
Fluorescein sodium
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| ALTAFLUOR BENOX | Altaire Pharmaceuticals | N-208582 RX | 2017-12-14 | 1 products, RLD, RS |
| FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE | Bausch Health Companies | N-211039 RX | 2020-03-09 | 1 products, RLD, RS |
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FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| ak-fluor | New Drug Application | 2024-08-15 |
| altafluor | New Drug Application | 2017-12-30 |
| bioglo | unapproved drug other | 2024-01-01 |
| dry eye test | unapproved drug other | 2019-12-23 |
| fluorecein sodium and proparacaine hydrochloride | unapproved drug other | 2014-07-17 |
| fluorescein | ANDA | 2023-10-25 |
| fluorescein sodium and benoxinate hydrochloride | NDA authorized generic | 2023-03-16 |
| fluorescein sodium and proparacaine hydrochloride | unapproved drug other | 2022-10-28 |
| fluorescite | New Drug Application | 2023-12-14 |
| ful-glo | unapproved drug other | 2022-09-12 |
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Indications
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Agency Specific
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Clinical
Clinical Trials
303 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Retinal diseases | D012164 | HP_0000479 | H35.9 | 3 | 3 | 1 | 3 | 12 | 21 |
| Macular degeneration | D008268 | EFO_0001365 | H35.30 | 1 | 4 | 4 | 1 | 12 | 20 |
| Dry eye syndromes | D015352 | — | H04.12 | — | 3 | — | 1 | 16 | 20 |
| Diabetic retinopathy | D003930 | EFO_0003770 | — | 4 | 2 | 1 | 2 | 11 | 19 |
| Macular edema | D008269 | — | — | 2 | 3 | 3 | 3 | 6 | 16 |
| Keratoconjunctivitis sicca | D007638 | EFO_1000906 | — | — | 2 | — | 1 | 12 | 15 |
| Edema | D004487 | HP_0000969 | R60.9 | 2 | 3 | 2 | 2 | 5 | 13 |
| Syndrome | D013577 | — | — | — | 1 | — | 1 | 7 | 9 |
| Brain neoplasms | D001932 | EFO_0003833 | C71 | 1 | 2 | — | 2 | 3 | 7 |
| Central serous chorioretinopathy | D056833 | — | H35.71 | — | 1 | 1 | 1 | 4 | 6 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Retinal vein occlusion | D012170 | EFO_1001157 | H34.81 | 1 | — | 3 | — | 6 | 10 |
| Choroidal neovascularization | D020256 | — | — | 1 | 3 | 4 | — | 1 | 8 |
| Pathologic neovascularization | D009389 | — | — | 1 | 3 | 4 | — | 1 | 8 |
| Myopia | D009216 | EFO_0003927 | H52.1 | 1 | 1 | 1 | — | 1 | 4 |
| Glioblastoma | D005909 | EFO_0000515 | — | — | — | 1 | — | 3 | 4 |
| Telangiectasis | D013684 | — | — | 2 | — | 1 | — | — | 3 |
| Wet macular degeneration | D057135 | EFO_0004683 | — | — | 1 | 1 | — | 2 | 3 |
| Covid-19 | D000086382 | — | — | — | 1 | 1 | — | 2 | 3 |
| Keratoconus | D007640 | EFO_0004223 | H18.6 | — | 2 | 2 | — | 1 | 3 |
| Contraception | D003267 | — | — | 1 | 1 | 1 | — | — | 2 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neoplasms | D009369 | — | C80 | 8 | 3 | — | — | 6 | 15 |
| Carcinoma | D002277 | — | C80.0 | 2 | 1 | — | — | 3 | 6 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 2 | 3 | — | — | 3 | 6 |
| Melanoma | D008545 | — | — | 1 | 3 | — | — | 2 | 5 |
| Glioma | D005910 | EFO_0000520 | — | 2 | 1 | — | — | 2 | 4 |
| Liver cirrhosis | D008103 | EFO_0001422 | K74.0 | 3 | 1 | — | — | 1 | 4 |
| Liver diseases | D008107 | HP_0002910 | K70-K77 | 1 | 2 | — | — | 1 | 4 |
| Renal cell carcinoma | D002292 | EFO_0000376 | — | 1 | 1 | — | — | 1 | 3 |
| Uveitis | D014605 | HP_0000554 | H20.9 | — | 1 | — | — | 2 | 3 |
| Fibrosis | D005355 | — | — | 2 | 1 | — | — | 1 | 3 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 1 | — | — | — | 4 | 5 |
| Barrett esophagus | D001471 | EFO_0000280 | K22.7 | 2 | — | — | — | 2 | 4 |
| Lung neoplasms | D008175 | HP_0100526 | C34.90 | 1 | — | — | — | 3 | 4 |
| Colorectal neoplasms | D015179 | — | — | 1 | — | — | — | 3 | 4 |
| Adenocarcinoma | D000230 | — | — | 2 | — | — | — | — | 2 |
| Tuberculosis | D014376 | EFO_0000774 | A15-A19 | 1 | — | — | — | 1 | 2 |
| Sarcoma | D012509 | — | — | 1 | — | — | — | 1 | 2 |
| Gastroesophageal reflux | D005764 | EFO_0003948 | K21 | 1 | — | — | — | 1 | 2 |
| Squamous cell carcinoma of head and neck | D000077195 | — | — | 1 | — | — | — | 1 | 2 |
| Squamous cell carcinoma | D002294 | — | — | 1 | — | — | — | 1 | 2 |
Show 32 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Eye diseases | D005128 | EFO_0003966 | H44 | — | — | — | — | 7 | 7 |
| Stomach neoplasms | D013274 | EFO_0003897 | C16 | — | — | — | — | 6 | 6 |
| Recurrence | D012008 | — | — | — | — | — | — | 4 | 4 |
| Gastrointestinal diseases | D005767 | — | — | — | — | — | — | 4 | 4 |
| Digestive system diseases | D004066 | HP_0011024 | K92.9 | — | — | — | — | 4 | 4 |
| Crohn disease | D003424 | EFO_0000384 | K50 | — | — | — | — | 4 | 4 |
| Diabetes mellitus | D003920 | HP_0000819 | E08-E13 | — | — | — | — | 4 | 4 |
| Inflammatory bowel diseases | D015212 | EFO_0003767 | — | — | — | — | — | 3 | 3 |
| Hemorrhage | D006470 | MP_0001914 | R58 | — | — | — | — | 3 | 3 |
| Rectal neoplasms | D012004 | — | — | — | — | — | — | 3 | 3 |
Show 127 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Fluorescein |
| INN | — |
| Description | Fluorescein (lactone form) is a xanthene dye that is highly fluorescent, detectable even when present in minute quantities. Used forensically to detect traces of blood, in analytical chemistry as an indicator in silver nitrate titrations and in microscopy. It has a role as a radioopaque medium and a fluorescent dye. It is a xanthene dye, a gamma-lactone, a polyphenol, an oxaspiro compound, a member of 2-benzofurans and an organic heteropentacyclic compound. It is functionally related to a fluorescein (acid form). |
| Classification | Small molecule |
| Drug class | — |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | O=C1C=CC2C(=C1)Oc1cc(O)ccc1C21OC(=O)c2ccccc21 |
Identifiers
| PDB | — |
| CAS-ID | 2321-07-5 |
| RxCUI | — |
| ChEMBL ID | CHEMBL4297067 |
| ChEBI ID | — |
| PubChem CID | 16850 |
| DrugBank | DB00693 |
| UNII ID | — |
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Fluorescein
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Safety
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955 adverse events reported
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