Flucytosine
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Also known as AlcobonAncobonAncotilAncobanFlucitosinaFlucytosinumFlourocytosineFluorocytosineNSC-103805RO-29915SID11112505SID8139861FlucytosinSID56424024SID405592SID144204066SID174006933SID170465407C0164520
Summary
Flucytosine (CHEMBL1463) is an approved small-molecule prodrug (ATC J02AX01); indicated across 15 conditions including infectious meningitis and candidiasis.
At a glance
- Status: Approved (max clinical phase 4)
- Modality: Small molecule
- ATC class: J02AX01 (+1 more)
- Indications: 15 conditions
- Clinical trials: 20
- Chemistry: 129.09 Da · C4H4FN3O
Identifiers
Drug identity and classification
| Field | Value |
|---|---|
| ChEMBL ID | CHEMBL1463 |
| Name | Flucytosine |
| Type | Small molecule |
| Max phase | 4 |
| FDA approved | yes |
| PubChem CID | 3366 |
| ChEBI | CHEBI:5100 |
| ATC | J02AX01, D01AE21 |
| Molecular formula | C4H4FN3O |
| Molecular weight | 129.09 |
| InChIKey | XRECTZIEBJDKEO-UHFFFAOYSA-N |
SMILES: C1=NC(=O)NC(=C1F)N
IUPAC name: 6-amino-5-fluoro-1H-pyrimidin-2-one
ChEBI definition: 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.
Pharmacological roles (ChEBI): prodrug.
Also known as: Alcobon, Ancobon, Ancotil, Ancoban, Flucitosina, Flucytosine, Flucytosinum, Flourocytosine, Fluorocytosine, NSC-103805, RO-29915, flucytosine
Patent coverage: 18,600 distinct patent families (69,472 SureChEMBL compound mentions), from 4 matched compound structure(s). One matched structure accounts for 42,836 (62%) of the total. Mentions count patents naming the compound (not distinct inventions), so promiscuous / reference molecules inflate the mention figure — families are the dedup metric.
Targets
Targets
Broader ChEMBL bioactivity targets: 1 (assay-derived). Sample: 4’-phosphopantetheinyl transferase ffp.
Bioactivity
No ChEMBL bioactivity rows at pChembl ≥ 5 (expected for biologics / antibodies).
Target pathways
No target-pathway data for this drug (no mapped target genes).
Indications & clinical
Indications
15 indications (3 at ChEMBL trial phase 4). Phase below is the highest clinical-trial phase recorded for this drug against each disease — not the molecule’s overall approval status (that is in the Summary).
| Indication | Trial phase | MONDO | EFO |
|---|---|---|---|
| infectious meningitis | 4 | MONDO:0004796 | EFO:0000584 |
| candidiasis | 4 | MONDO:0002026 | MONDO:0002026 |
| Cryptococcal meningitis | 2 | MONDO:0005723 | EFO:0007228 |
| intracranial hypertension | 2 | MONDO:0006810 | EFO:1000992 |
| hepatocellular carcinoma | 1 | MONDO:0007256 | EFO:0000182 |
| anaplastic astrocytoma | 1 | MONDO:0016684 | EFO:0002499 |
| anaplastic oligodendroglioma | 1 | MONDO:0016696 | EFO:0002501 |
| gliosarcoma | 1 | MONDO:0016681 | EFO:1001465 |
| colorectal neoplasm | 1 | MONDO:0005335 | EFO:0004142 |
| neoplasm | 1 | MONDO:0005070 | MONDO:0004992 |
| brain neoplasm | 1 | MONDO:0021211 | EFO:0003833 |
| digestive system neoplasm | 1 | MONDO:0021223 | EFO:0008549 |
| glioblastoma | 1 | MONDO:0018177 | MONDO:0020690 |
2 further indication records had no mapped disease name (EFO/MeSH-only) or were duplicates, and are omitted.
Clinical trials
Total trials: 20.
Phase distribution
| Phase | Trials |
|---|---|
| Not specified | 6 |
| PHASE2 | 4 |
| PHASE1/PHASE2 | 4 |
| PHASE1 | 3 |
| PHASE3 | 2 |
| PHASE2/PHASE3 | 1 |
Top trials by phase / activity
| NCT | Phase | Status | Title |
|---|---|---|---|
| NCT06525389 | PHASE3 | NOT_YET_RECRUITING | Liposomal Amphotericin B and Flucytosine Antifungal Strategy for Talaromycosis (LAmB-FAST) |
| NCT01715922 | PHASE2/PHASE3 | UNKNOWN | Study Evaluating Efficiency and Tolerance of High-dose Fluconazole Associated With Flucytosine as Induction Therapy for Cryptococcal Meningitis Associated With HIV in Sub-saharan Africa |
| NCT04140461 | PHASE3 | UNKNOWN | AmB Dose for Cryptococcal Meningitis |
| NCT00000776 | PHASE2 | COMPLETED | Dexamethasone in Cryptococcal Meningitis |
| NCT00012467 | PHASE2 | COMPLETED | Safety and Antifungal Activity of Recombinant Interferon-Gamma 1b (rIFN-Gamma 1b) Given With Standard Therapy in Patients With Cryptococcal Meningitis |
| NCT01562132 | PHASE2 | TERMINATED | Safety Study of Fluconazole in Combination With Flucytosine for the Treatment of Early Cryptococcal Infection |
| NCT01562626 | PHASE1/PHASE2 | SUSPENDED | Phase I/II Study of APS001F With Flucytosine and Maltose in Solid Tumors |
| NCT03294486 | PHASE1/PHASE2 | UNKNOWN | Safety and Efficacy of the ONCOlytic VIRus Armed for Local Chemotherapy, TG6002/5-FC, in Recurrent Glioblastoma Patients |
| NCT03724071 | PHASE1/PHASE2 | TERMINATED | Study of TG6002 (VV TK-RR-FCU1) in Combination With 5-FC in Patients With Advanced Gastro-intestinal Tumors. |
| NCT04194034 | PHASE1/PHASE2 | TERMINATED | Study of Intrahepatic Arterial Infusion of TG6002 in Combination With 5-FC in Patients With Metastatic Colorectal Cancer |
| NCT06414512 | PHASE2 | COMPLETED | Optimizing the Dose of Flucytosine for the Treatment of Cryptococcal Meningitis |
| NCT00978107 | PHASE1 | COMPLETED | Trial of TG4023 Combined With Flucytosine in Liver Tumors |
| NCT01172964 | PHASE1 | COMPLETED | A Pilot Feasibility Study of Oral 5-Fluorocytosine and Genetically-Modified Neural Stem Cells Expressing E.Coli Cytosine Deaminase for Treatment of Recurrent High Grade Gliomas |
| NCT02015819 | PHASE1 | COMPLETED | Genetically Modified Neural Stem Cells, Flucytosine, and Leucovorin for Treating Patients With Recurrent High-Grade Gliomas |
| NCT00000639 | Not specified | COMPLETED | A Randomized Double Blind Protocol Comparing Amphotericin B With Flucytosine to Amphotericin B Alone Followed by a Comparison of Fluconazole and Itraconazole in the Treatment of Acute Cryptococcal Meningitis |
| NCT00000708 | Not specified | COMPLETED | Multi-center Comparison of Fluconazole (UK-49,858) and Amphotericin B as Treatment for Acute Cryptococcal Meningitis |
| NCT00002075 | Not specified | COMPLETED | Multicenter Comparison of Fluconazole (UK-49,858) and Amphotericin B as Treatment for Acute Cryptococcal Meningitis |
| NCT00002113 | Not specified | COMPLETED | A Pilot Study of Fluconazole Plus Flucytosine for the Treatment of AIDS Patients With Acute Cryptococcal Meningitis. |
| NCT00002305 | Not specified | COMPLETED | A Comparison of Fluconazole and Amphotericin B in the Treatment of Cryptococcal Meningitis |
| NCT05471063 | Not specified | UNKNOWN | Clinical Study of ABCD in the Treatment of Cryptococcal Meningitis |
Clinical evidence (CIViC)
No CIViC predictive evidence (expected for non-precision-medicine drugs).
Pharmacology
Pharmacogenomics
PharmGKB dosing guidelines (1) — CPIC / DPWG genotype-guided dosing for this drug (drug × pharmacogene):
| Guideline | Source | Gene(s) | Dosing | Recommendation |
|---|---|---|---|---|
| Annotation of DPWG Guideline for flucytosine and DPYD | DPWG | DPYD | yes |
Related molecules
Related molecules
No competitor molecules sharing a primary target (ChEMBL phase ≥2 or PubChem drug-class).
Related Atlas pages
- Diseases: infectious meningitis, candidiasis