nifurtimox Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
5-nitrofuran derivatives 1929 23256-30-6

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • BAY A2502
  • lampit
  • Bayer 2502
  • nifurtimox
A nitrofuran thiazine that has been used against TRYPANOSOMIASIS.
  • Molecular weight: 287.29
  • Formula: C10H13N3O5S
  • CLOGP: 0.02
  • LIPINSKI: 0
  • HAC: 8
  • HDO: 0
  • TPSA: 106.02
  • ALOGS: -3
  • ROTB: 3

  • Status: ONP

  • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
0.70 g O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 2 Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 1 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 52.21 ┬ÁM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD

Approvals:

DateAgencyCompanyOrphan
June 8, 2020 FDA BAYER HEALTHCARE
Jan. 1, 1967 YEAR INTRODUCED

FDA Adverse Event Reporting System (Female)

None

FDA Adverse Event Reporting System (Male)

None

Pharmacologic Action:

SourceCodeDescription
ATC P01CC01 ANTIPARASITIC PRODUCTS, INSECTICIDES AND REPELLENTS
ANTIPROTOZOALS
AGENTS AGAINST LEISHMANIASIS AND TRYPANOSOMIASIS
Nitrofuran derivatives
MeSH PA D000890 Anti-Infective Agents
MeSH PA D000977 Antiparasitic Agents
MeSH PA D000981 Antiprotozoal Agents
MeSH PA D014344 Trypanocidal Agents

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Infection by Trypanosoma cruzi indication 77506005

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 3.17 Basic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
120MG LAMPIT BAYER HEALTHCARE N213464 Aug. 6, 2020 RX TABLET ORAL Aug. 6, 2025 NEW CHEMICAL ENTITY
30MG LAMPIT BAYER HEALTHCARE N213464 Aug. 6, 2020 RX TABLET ORAL Aug. 6, 2025 NEW CHEMICAL ENTITY
120MG LAMPIT BAYER HEALTHCARE N213464 Aug. 6, 2020 RX TABLET ORAL Aug. 6, 2027 INDICATED IN PEDIATRIC PATIENTS (BIRTH TO LESS THAN 18 YEARS OF AGE AND WEIGHING AT LEAST 2.5 KG) FOR THE TREATMENT OF CHAGAS DISEASE (AMERICAN TRYPANOSOMIASIS) CAUSED BY TRYPANOSOMA CRUZI
30MG LAMPIT BAYER HEALTHCARE N213464 Aug. 6, 2020 RX TABLET ORAL Aug. 6, 2027 INDICATED IN PEDIATRIC PATIENTS (BIRTH TO LESS THAN 18 YEARS OF AGE AND WEIGHING AT LEAST 2.5 KG) FOR THE TREATMENT OF CHAGAS DISEASE (AMERICAN TRYPANOSOMIASIS) CAUSED BY TRYPANOSOMA CRUZI

Bioactivity Summary:

None

External reference:

IDSource
N0000167141 NUI
D00833 KEGG_DRUG
C0877961 UMLSCUI
CHEBI:7566 CHEBI
CHEMBL290960 ChEMBL_ID
D009547 MESH_DESCRIPTOR_UI
DB11820 DRUGBANK_ID
6842999 PUBCHEM_CID
2615 INN_ID
M84I3K7C2O UNII
2397986 RXNORM
200338 MMSL
29363 MMSL
d08076 MMSL
007487 NDDF
24869004 SNOMEDCT_US
714397006 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
LAMPIT HUMAN PRESCRIPTION DRUG LABEL 1 50419-750 TABLET, FILM COATED 30 mg ORAL NDA 27 sections
LAMPIT HUMAN PRESCRIPTION DRUG LABEL 1 50419-751 TABLET, FILM COATED 120 mg ORAL NDA 27 sections