Pretomanid, Dovprela (previously pretomanid fgk)(pretomanid)
Dovprela (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
Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| infections | D007239 |
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 |
|---|---|---|---|---|
| PRETOMANID | Mylan | N-212862 RX | 2019-08-14 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| pretomanid | New Drug Application | 2020-04-15 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| extensively drug-resistant tuberculosis | — | D054908 | — |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
PRETOMANID, PRETOMANID, MYLAN IRELAND LTD | |||
| 2029-08-14 | GAIN | ||
| 2026-08-14 | ODE-253 | ||
| 2024-08-14 | NCE | ||
Patent Expiration
No data
HCPCS
No data
Clinical
Clinical Trials
29 clinical trials
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Indications Phases 4
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Tuberculosis | D014376 | EFO_0000774 | A15-A19 | 9 | 4 | 4 | — | 1 | 16 |
| Pulmonary tuberculosis | D014397 | EFO_1000049 | A15 | — | 10 | 6 | — | — | 12 |
| Multidrug-resistant tuberculosis | D018088 | EFO_0007381 | 1 | 6 | 6 | — | — | 8 | |
| Extensively drug-resistant tuberculosis | D054908 | — | 3 | 4 | — | — | 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 insufficiency | D051437 | HP_0000083 | N19 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hiv infections | D015658 | EFO_0000764 | B20 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | PRETOMANID |
| INN | pretomanid |
| 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 class | mycolic acid inhibitors |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | O=[N+]([O-])c1cn2c(n1)OC[C@@H](OCc1ccc(OC(F)(F)F)cc1)C2 |
Identifiers
| PDB | — |
| CAS-ID | 187235-37-6 |
| RxCUI | — |
| ChEMBL ID | CHEMBL227875 |
| ChEBI ID | — |
| PubChem CID | 456199 |
| DrugBank | DB05154 |
| UNII ID | 2XOI31YC4N (ChemIDplus, GSRS) |
Target
Agency Approved
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Alternate
No data
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 1,075 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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144,929 adverse events reported
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