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Drug ReportsPretomanid
Pretomanid, Dovprela (previously pretomanid fgk)(pretomanid)
Dovprela, Pretomanid (pretomanid) is a small molecule pharmaceutical. Pretomanid was first approved as Pretomanid on 2019-08-14. It is used to treat extensively drug-resistant tuberculosis in the USA. It has been approved in Europe to treat multidrug-resistant tuberculosis.
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FDA Novel Drug Approvals 2019
Events Timeline
Commercial
Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
infectionsD007239
Trade Name
FDA
EMA
No data
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Pretomanid
Tradename
Company
Number
Date
Products
PRETOMANIDMylanN-212862 RX2019-08-14
1 products, RLD, RS
Labels
FDA
EMA
No data
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
extensively drug-resistant tuberculosisD054908
Agency Specific
FDA
EMA
Expiration
Code
PRETOMANID, PRETOMANID, MYLAN IRELAND LTD
2029-08-14GAIN
2026-08-14ODE-253
2024-08-14NCE
Patent Expiration
No data
ATC Codes
J: Antiinfectives for systemic use
J04: Antimycobacterials
J04A: Drugs for treatment of tuberculosis
J04AK: Other drugs for treatment of tuberculosis in atc
J04AK08: Pretomanid
HCPCS
No data
Clinical
Clinical Trials
36 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Multidrug-resistant tuberculosisD018088EFO_000738116619
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Pulmonary tuberculosisD014397EFO_1000049A1515617
TuberculosisD014376EFO_0000774A15-A19944116
Extensively drug-resistant tuberculosisD054908344
Indications Phases 2
No data
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Renal insufficiencyD051437HP_0000083N1911
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Hiv infectionsD015658EFO_0000764B2011
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common namePretomanid
INNpretomanid
Description
Pretomanid is an antibiotic medication used for the treatment of multi-drug-resistant tuberculosis affecting the lungs. It is generally used together with bedaquiline and linezolid. It is taken by mouth.
Classification
Small molecule
Drug classmycolic acid inhibitors
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
O=[N+]([O-])c1cn2c(n1)OC[C@@H](OCc1ccc(OC(F)(F)F)cc1)C2
Identifiers
PDB
CAS-ID187235-37-6
RxCUI
ChEMBL IDCHEMBL227875
ChEBI ID
PubChem CID456199
DrugBankDB05154
UNII ID2XOI31YC4N (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 2,068 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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41 adverse events reported
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