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Fialuridine
Fialuridine is a small molecule pharmaceutical. It is currently being investigated in clinical studies.
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Commercial
Therapeutic Areas
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Trade Name
FDA
EMA
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Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
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Labels
FDA
EMA
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Indications
FDA
EMA
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Agency Specific
FDA
EMA
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Patent Expiration
No data
ATC Codes
No data
HCPCS
No data
Clinical
Clinical Trials
1 clinical trials
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Indications Phases 4
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Indications Phases 3
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Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Hiv infectionsD015658EFO_0000764B20—1———1
Hepatitis bD006509—1———1
Herpes simplexD006561B00—1———1
Indications Phases 1
No data
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameFIALURIDINE
INNfialuridine
Description
Fialuridine, or 1-(2-deoxy-2-fluoro-1-D-arabinofuranosyl)-5-iodouracil (FIAU), is a nucleoside analogue that was investigated as a potential therapy for hepatitis B virus infection. In a 1993 clinical study at the NIH, unexpected toxicity led to the death of 5 out of 15 patients from liver failure alongside lactic acidosis; two further participants required liver transplantation. It is suspected that the toxicity of fialuridine was a result of mitochondrial damage caused by the incorporation of fialuridine into mitochondrial DNA via its 3'-hydroxyl moiety, leading to impaired DNA synthesis. This toxicity was unusual in that it was not predicted by animal studies.
Classification
Small molecule
Drug classantivirals; antineoplastics (uridine derivatives)
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
O=c1[nH]c(=O)n([C@@H]2O[C@H](CO)[C@@H](O)[C@@H]2F)cc1I
Identifiers
PDB—
CAS-ID69123-98-4
RxCUI—
ChEMBL IDCHEMBL271475
ChEBI ID—
PubChem CID50313
DrugBankDB15427
UNII ID53T7IN77LC (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 407 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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10 adverse events reported
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