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

Stem definitionDrug idCAS RN
5344 187235-37-6

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • pretomanid
  • PA-824
Pretomanid Tablet is a nitroimidazooxazine antimycobacterial drug. Pretomanid kills actively replicating M. tuberculosis by inhibiting mycolic acid biosynthesis, thereby blocking cell wall production. Under anaerobic conditions, against non-replicating bacteria, pretomanid acts as a respiratory poison following nitric oxide release
  • Molecular weight: 359.26
  • Formula: C14H12F3N3O5
  • CLOGP: 2.79
  • LIPINSKI: 0
  • HAC: 8
  • HDO: 0
  • TPSA: 91.33
  • ALOGS: -4.49
  • ROTB: 6

  • Status: ONP

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

Drug dosage:

None

ADMET properties:

None

Approvals:

DateAgencyCompanyOrphan
Aug. 14, 2019 FDA MYLAN IRELAND LTD

FDA Adverse Event Reporting System (Female)

None

FDA Adverse Event Reporting System (Male)

None

Pharmacologic Action:

SourceCodeDescription
ATC J04AK08 ANTIINFECTIVES FOR SYSTEMIC USE
ANTIMYCOBACTERIALS
DRUGS FOR TREATMENT OF TUBERCULOSIS
Other drugs for treatment of tuberculosis

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Extensively drug resistant tuberculosis indication 710106005

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 5.39 Basic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
200MG PRETOMANID MYLAN IRELAND LTD N212862 Aug. 14, 2019 RX TABLET ORAL Aug. 14, 2024 NEW CHEMICAL ENTITY
200MG PRETOMANID MYLAN IRELAND LTD N212862 Aug. 14, 2019 RX TABLET ORAL Aug. 14, 2026 INDICATED AS PART OF A COMBINULLTION REGIMEN WITH BEDAQUILINE AND LINEZOLID FOR THE TREATMENT OF ADULTS WITH PULMONULLRY EXTENSIVELY DRUG RESISTANT (XDR) OR TREATMENT-INTOLERANT OR NONRESPONSIVE MULTIDRUG-RESISTANT (MDR) TUBERCULOSIS (TB)
200MG PRETOMANID MYLAN IRELAND LTD N212862 Aug. 14, 2019 RX TABLET ORAL Aug. 14, 2029 GENERATING ANTIBIOTIC INCENTIVES NOW

Bioactivity Summary:

None

External reference:

IDSource
4038950 VANDF
C3252041 UMLSCUI
CHEMBL227875 ChEMBL_ID
D10722 KEGG_DRUG
DB05154 DRUGBANK_ID
11172 IUPHAR_LIGAND_ID
C410767 MESH_SUPPLEMENTAL_RECORD_UI
9871 INN_ID
2XOI31YC4N UNII
456199 PUBCHEM_CID
2198359 RXNORM
321727 MMSL
37322 MMSL
d09355 MMSL
018085 NDDF
789316005 SNOMEDCT_US
789321008 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Pretomanid HUMAN PRESCRIPTION DRUG LABEL 1 49502-476 TABLET 200 mg ORAL NDA 29 sections