pretomanid 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| 5344 | 187235-37-6 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
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
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
None
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| S (Water solubility) | 0.01 mg/mL | Bocci G, Oprea TI, Benet LZ |
| BDDCS (Biopharmaceutical Drug Disposition Classification System) | 2 | Bocci G, Oprea TI, Benet LZ |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| July 31, 2020 | EMA | MYLAN IRELAND LIMITED | |
| Aug. 14, 2019 | FDA | MYLAN IRELAND LTD |
FDA Adverse Event Reporting System (Female)
None
FDA Adverse Event Reporting System (Male)
None
FDA Adverse Event Reporting System (Geriatric)
None
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | J04AK08 | ANTIINFECTIVES FOR SYSTEMIC USE ANTIMYCOBACTERIALS DRUGS FOR TREATMENT OF TUBERCULOSIS Other drugs for treatment of tuberculosis |
| FDA EPC | N0000175483 | Antimycobacterial |
| FDA MoA | N0000190111 | Organic Anion Transporter 3 Inhibitors |
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Extensively drug resistant tuberculosis | indication | 710106005 |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
| Dissociation level | Dissociation constant | Type (acidic/basic) |
|---|---|---|
| pKa1 | 5.39 | Basic |
Orange Book patent data (new drug applications)
None
Orange Book exclusivity data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| 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 COMBINATION REGIMEN WITH BEDAQUILINE AND LINEZOLID FOR THE TREATMENT OF ADULTS WITH PULMONARY 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:
| ID | Source |
|---|---|
| 2XOI31YC4N | UNII |
| C4310440 | UMLSCUI |
| CHEMBL227875 | ChEMBL_ID |
| 456199 | PUBCHEM_CID |
| DB05154 | DRUGBANK_ID |
| D10722 | KEGG_DRUG |
| 9871 | INN_ID |
| 11172 | IUPHAR_LIGAND_ID |
| 018085 | NDDF |
| 789316005 | SNOMEDCT_US |
| 789321008 | SNOMEDCT_US |
| 4038950 | VANDF |
| 2198359 | RXNORM |
| 321727 | MMSL |
| 37322 | MMSL |
| d09355 | MMSL |
| C410767 | MESH_SUPPLEMENTAL_RECORD_UI |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| Pretomanid | HUMAN PRESCRIPTION DRUG LABEL | 1 | 49502-476 | TABLET | 200 mg | ORAL | NDA | 30 sections |
| Pretomanid | HUMAN PRESCRIPTION DRUG LABEL | 1 | 49502-476 | TABLET | 200 mg | ORAL | NDA | 30 sections |