Flucytosine
Ancobon, Flucytosine (flucytosine) is a small molecule pharmaceutical. Flucytosine was first approved as Ancobon on 1982-01-01. It is used to treat aids-related opportunistic infections, aspergillosis, candidiasis, chromoblastomycosis, and cryptococcal meningitis amongst others in the USA.
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Commercial
Therapeutic Areas
Trade Name
FDA
EMA
Ancobon, Flucytosine (discontinued: Flucytosine)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Flucytosine
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| ANCOBON | Bausch Health Companies | N-017001 RX | 1982-01-01 | 2 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| ancobon | New Drug Application | 2022-02-02 |
| flucytosine | ANDA | 2024-07-22 |
Indications
FDA
EMA
Agency Specific
FDA
EMA
No data
Patent Expiration
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ATC Codes
D: Dermatologicals
— D01: Antifungals for dermatological use
— D01A: Antifungals for topical use
— D01AE: Other antifungals for topical use in atc
— D01AE21: Flucytosine
J: Antiinfectives for systemic use
— J02: Antimycotics for systemic use
— J02A: Antimycotics for systemic use
— J02AX: Other antimycotics for systemic use in atc
— J02AX01: Flucytosine
HCPCS
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Clinical
Clinical Trials
48 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Meningitis | D008581 | HP_0001287 | G03 | 1 | 6 | 4 | 1 | 9 | 19 |
| Cryptococcal meningitis | D016919 | EFO_0007228 | B45.1 | 1 | 6 | 4 | 1 | 9 | 19 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Glioblastoma | D005909 | EFO_0000515 | — | 10 | 7 | 2 | — | — | 13 |
| Hiv infections | D015658 | EFO_0000764 | B20 | 1 | 2 | 1 | — | 6 | 10 |
| Astrocytoma | D001254 | EFO_0000271 | — | 6 | 3 | 2 | — | — | 9 |
| Oligodendroglioma | D009837 | EFO_0000631 | — | 5 | 1 | 1 | — | — | 6 |
| Hiv | D006678 | — | — | — | 2 | 2 | — | — | 2 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Glioma | D005910 | EFO_0000520 | — | 6 | 2 | — | — | — | 6 |
| Neoplasms | D009369 | — | C80 | 5 | 4 | — | — | — | 5 |
| Brain neoplasms | D001932 | EFO_0003833 | C71 | 4 | 2 | — | — | — | 4 |
| Recurrence | D012008 | — | — | 3 | 1 | — | — | — | 3 |
| Gliosarcoma | D018316 | — | — | 3 | 1 | — | — | — | 3 |
| Colorectal neoplasms | D015179 | — | — | 3 | 2 | — | — | — | 3 |
| Suicide | D013405 | — | — | 1 | 1 | — | — | — | 2 |
| Gastrointestinal neoplasms | D005770 | — | C26.9 | 2 | 1 | — | — | — | 2 |
| Germ cell and embryonal neoplasms | D009373 | — | — | 1 | 1 | — | — | — | 1 |
| Digestive system neoplasms | D004067 | — | — | 1 | 1 | — | — | — | 1 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | 3 | — | — | — | — | 3 |
| Urinary bladder neoplasms | D001749 | — | C67 | 2 | — | — | — | — | 2 |
| Non-small-cell lung carcinoma | D002289 | — | — | 2 | — | — | — | — | 2 |
| Adenocarcinoma | D000230 | — | — | 1 | — | — | — | — | 1 |
| Non-muscle invasive bladder neoplasms | D000093284 | — | — | 1 | — | — | — | — | 1 |
| Lung neoplasms | D008175 | HP_0100526 | C34.90 | 1 | — | — | — | — | 1 |
| Adenoviridae infections | D000257 | EFO_1001259 | B34.0 | 1 | — | — | — | — | 1 |
| Ovarian neoplasms | D010051 | EFO_0003893 | C56 | 1 | — | — | — | — | 1 |
| Triple negative breast neoplasms | D064726 | — | — | 1 | — | — | — | — | 1 |
| Head and neck neoplasms | D006258 | — | — | 1 | — | — | — | — | 1 |
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Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Food-drug interactions | D018565 | — | — | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Flucytosine |
| INN | flucytosine |
| Description | Flucytosine is an organofluorine compound that is cytosine that is substituted at position 5 by a fluorine. A prodrug for the antifungal 5-fluorouracil, it is used for the treatment of systemic fungal infections. It has a role as a prodrug. It is an organofluorine compound, a pyrimidone, an aminopyrimidine, a nucleoside analogue and a pyrimidine antifungal drug. It is functionally related to a cytosine. |
| Classification | Small molecule |
| Drug class | — |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | Nc1nc(=O)[nH]cc1F |
Identifiers
| PDB | — |
| CAS-ID | 2022-85-7 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1463 |
| ChEBI ID | 5100 |
| PubChem CID | 3366 |
| DrugBank | DB01099 |
| UNII ID | D83282DT06 (ChemIDplus, GSRS) |
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Safety
Black-box Warning
Black-box warning for: Ancobon, Flucytosine
Adverse Events
Top Adverse Reactions
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673 adverse events reported
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