PharmaKB logo
Company Reports
Company Reports
Drug Reports
Drug Reports
Disease Reports
Disease Reports
Sets
Sets
Favorites
Favorites
Log in
Log in
AboutPricing
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.
Download report
Favorite
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
Plot placeholder
Mock data
Subscribe for the real data
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 Application2024-11-15
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
43 clinical trials
View more details
Plot placeholder
Mock data
Subscribe for the real data
Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
TuberculosisD014376EFO_0000774A15-A19101261228
Multidrug-resistant tuberculosisD018088EFO_0007381—1891216
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Pulmonary tuberculosisD014397EFO_1000049A15—1710——22
Extensively drug-resistant tuberculosisD054908———45——6
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
HypersensitivityD006967EFO_0003785T78.40—1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Renal insufficiencyD051437—N191————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Hiv infectionsD015658EFO_0000764B20————11
Type 2 diabetes mellitusD003924EFO_0001360E11————11
Epidemiology
Epidemiological information for investigational and approved indications
View more details
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:
Plot placeholder
Mock data
Subscribe for the real data
Additional graphs summarizing 2,652 documents
View more details
Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
Plot placeholder
Mock data
Subscribe for the real data
487 adverse events reported
View more details
© 2020-2025 Collaborative Drug Discovery Inc. (CDD) | Terms of Use