uridine triacetate indications/contra

Stem definitionDrug idCAS RN
uridine derivatives used as antiviral agents and as antineoplastics 5029 4105-38-8

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • uridine triacetate
  • PN401
  • xuriden
  • vistogard
Uridine triacetate is an acetylated form of uridine. Following oral administration, uridine triacetate is deacetylated by nonspecific esterases present throughout the body, yielding uridine in the systemic circulation of patients with hereditary orotic aciduria who cannot synthesize adequate quantities of uridine due to a genetic defect in uridine nucleotide synthesis.
  • Molecular weight: 356.29
  • Formula: C14H16N2O9
  • CLOGP: -0.59
  • LIPINSKI: 1
  • HAC: 11
  • HDO: 1
  • TPSA: 137.54
  • ALOGS: -1.26
  • ROTB: 7

Drug dosage:

None

Approvals:

DateAgencyCompanyOrphan
Sept. 4, 2015 FDA WELLSTAT THERAPEUTICS CORP

FDA Adverse Event Reporting System

None

Pharmacologic Action:

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SourceCodeDescription
ATC A16AX13 ALIMENTARY TRACT AND METABOLISM
OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS
OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS
Various alimentary tract and metabolism products
CHEBI has role CHEBI:50266 prodrug
CHEBI has role CHEBI:63726 neuroprotective agent
CHEBI has role CHEBI:71031 orphan drug
FDA EPC N0000191809 Pyrimidine Analog
FDA Chemical/Ingredient N0000007587 Pyrimidines
FDA Chemical/Ingredient N0000175452 Analogs/Derivatives

Drug Use (View source of the data)

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DiseaseRelationSNOMED_IDDOID
Hereditary orotic aciduria indication 16242007
Antimetabolite overdose indication 295696001

Acid dissociation constants calculated using MoKa v3.0.0

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Dissociation levelDissociation constantType (acidic/basic)
pKa1 9.68 acidic

Orange Book patent data (new drug applications)

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Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
10GM/PACKET VISTOGARD WELLSTAT THERAP N208159 Dec. 11, 2015 RX GRANULE ORAL 7776838 Aug. 17, 2027 EMERGENCY TREATMENT OF ADULT & PEDIATRIC PATIENTS FOLLOWING FLUOROURACIL OR CAPECITABINE OVERDOSE,OR WHO EXHIBIT EARLY-ONSET,SEVERE OR LIFE-THREATENING CARDIAC OR CNS TOXICITY OR UNUSUALLY SEVERE ADVERSE REACTIONS WITHIN 96 HOURS

Orange Book exclusivity data (new drug applications)

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Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
10GM/PACKET VISTOGARD WELLSTAT THERAP N208159 Dec. 11, 2015 RX GRANULE ORAL Dec. 11, 2018 NEW PRODUCT
10GM/PACKET VISTOGARD WELLSTAT THERAP N208159 Dec. 11, 2015 RX GRANULE ORAL Sept. 4, 2020 NEW CHEMICAL ENTITY
2GM/PACKET XURIDEN WELLSTAT THERAP N208169 Sept. 4, 2015 RX GRANULE ORAL Sept. 4, 2020 NEW CHEMICAL ENTITY
2GM/PACKET XURIDEN WELLSTAT THERAP N208169 Sept. 4, 2015 RX GRANULE ORAL Sept. 4, 2022 TREATMENT OF HEREDITARY OROTIC ACIDURIA
10GM/PACKET VISTOGARD WELLSTAT THERAP N208159 Dec. 11, 2015 RX GRANULE ORAL Dec. 11, 2022 EMERGENCY TX OF PTS FOLLOWING A FU OR CAPECITABINE OD, OR WHO EXHIBIT EARLY-ONSET, SEVERE OR LIFE-THREATENING TOXICITY AFFECTING THE CARDIAC SYSTEM OR CNS, AND/OR EARLY-ONSET, UNUSUALLY SEVERE AR W/IN 96 HRS FOLLOWING THE END OF FU OR CAPECITABINE ADMIN.

Bioactivity Summary:

None

External reference:

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IDSource
CHEBI:90914 CHEBI
2WP61F175M UNII
9204 INN_ID
1665222 RXNORM
016442 NDDF
31371 MMSL
4035399 VANDF
N0000192397 NDFRT
CHEMBL100259 ChEMBL_ID
C000609666 MESH_SUPPLEMENTAL_RECORD_UI
DB09144 DRUGBANK_ID
CHEMBL2107381 ChEMBL_ID
58-96-8 SECONDARY_CAS_RN
D014529 MESH_DESCRIPTOR_UI
DB02745 DRUGBANK_ID
20058 PUBCHEM_CID

Pharmaceutical products:

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ProductCategoryIngredientsNDCFormQuantityRoute MarketingLabel
VISTOGARD HUMAN PRESCRIPTION DRUG LABEL 1 69468-151 GRANULE 951 mg ORAL NDA 16 sections
XURIDEN HUMAN PRESCRIPTION DRUG LABEL 1 69468-152 GRANULE 951 mg ORAL NDA 16 sections