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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
Pretomanid
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
Brand Name
Status
Last Update
pretomanidNew Drug Application2022-12-28
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
extensively drug-resistant tuberculosis—D054908—
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
38 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
TuberculosisD014376EFO_0000774A15-A19101792235
Multidrug-resistant tuberculosisD018088EFO_0007381—1571111
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Pulmonary tuberculosisD014397EFO_1000049A15—169——21
Extensively drug-resistant tuberculosisD054908———34——4
HypersensitivityD006967HP_0012393T78.40—32——4
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_0000083N191————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Hiv infectionsD015658EFO_0000764B20————11
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 2,217 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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235 adverse events reported
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