Pretomanid
Highest phase reached
Approved
Drug type
Small molecule
First approval year
2019
- First approval year
- 2019
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Small molecule
- Drug name
- Pretomanid
- Molecular weight
- 359.26
- Structure (SMILES)
- O=[N+]([O-])c1cn2c(n1)OC[C@@H](OCc1ccc(OC(F)(F)F)cc1)C2
- Dovprela (previously pretomanid fgk)
- dovprela previously pretomanid fgk
- (3S)-3-(4-TRIFLUOROMETHOXYBENZYLOXY)-6-NITRO-2H-3,4-DIHYDROIMIDAZO(2,1-B)OXAZINE
- 3s 3 4 trifluoromethoxybenzyloxy 6 nitro 2h 3 4 dihydroimidazo 2 1 b oxazine
- dovprela
- Dovprela
- pa 824
- PA 824
- PA-824
- PA-824 (PA)
- PA-824 1000 mg
- PA-824 200mg
- PA-824 50mg
- pa824
- PA824
- pretomanid
- Pretomanid
- Pretomanid (Pa)
- pretomanid [INN]
- PRETOMANID [MI]
- PRETOMANID [ORANGE BOOK]
- PRETOMANID [USAN]
- Pretomanid [WHO-DD]
- Pretomanid 200mg
- pretomanid inn
- pretomanid mi
- pretomanid orange book
And 2 more, listed on the interactive page.
- CAS registry numbers
- 187235-37-6
- ChEMBL ID
- CHEMBL227875
- InChIKey
- ZLHZLMOSPGACSZ-NSHDSACASA-N
- PubChem compound IDs
- 456199
- RxNorm IDs (RxCUI)
- 2198359
- FDA ingredient codes (UNII)
- 2XOI31YC4N
- J04
- J04AK08
Sources for recorded values
- Applicant
- MYLAN IRELAND LTD
- Approval date
- 14 Aug 2019
- Application number
- NDA212862
- Status
- Authorised
- Status date
- 31 Jul 2020
- Authorisation date
- 31 Jul 2020
- Approved indications
- Dovprela is indicated in combination with bedaquiline and linezolid, in adults, for the treatment of pulmonary extensively drug resistant (XDR), or treatment-intolerant or nonresponsive multidrug-resistant (MDR) tuberculosis (TB). Consideration should be given to official guidance on the appropriate use of antibacterial agents.
- Product number
- EMEA/H/C/005167
- Authorisation holder
- Mylan IRE Healthcare Limited
- Priority medicines scheme
- No
- Generic
- No
- Biosimilar
- No
- Generic medicines
- 0
- Biosimilar medicines
- 0
- Advanced therapy
- No
- Conditional approval
- No
- Additional monitoring
- Yes
- Accelerated assessment
- No
- Exceptional circumstances
- No
Therapeutic areas
- Tuberculosis, Multidrug-Resistant
European medicines record
- Patents
- 0
- Designations
- 3
- Earliest recorded loss of exclusivity
- 14 Aug 2029
- First in class
- Yes
- Fast track
- Yes
- Breakthrough designation
- No
- Orphan designation
- Yes
- Priority review
- Yes
- Orphan exclusivity
- No
- Accelerated approval
- No
- Availability
- Prescription only
- Pharmacology name
- pretomanid
- Type
- Synthetic organic
- Drug name stem
- -manid
- Approval recorded by Guide to Pharmacology
- Yes
Administration routes
- Oral
- Condition
- Tuberculosis, Multidrug-Resistant
- Highest recorded phase
- 4
- Condition identifier
- EFO:0007381
- Subject identifier
- D018088
- Condition
- Tuberculosis, Pulmonary
- Highest recorded phase
- 4
- Condition identifier
- EFO:1000049
- Subject identifier
- D014397
- Condition
- Tuberculosis
- Highest recorded phase
- 4
- Condition identifier
- MONDO:0018076
- Subject identifier
- D014376
- Condition
- Tuberculosis, Multidrug-Resistant
- Highest recorded phase
- 4
- Condition identifier
- MONDO:0041806
- Subject identifier
- D018088
- Condition identifier
- EFO_0007381
- Condition identifier
- EFO_0009429
- Highest recorded phase
- 3
- Condition identifier
- EFO_1000049
- Condition identifier
- MONDO_0005109
- Highest recorded phase
- 1
- Condition identifier
- MONDO_0005861
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0006042
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0006052
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0018076
- Condition identifier
- MONDO_0018076
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0041806
- Highest recorded phase
- 3
- Event
- drug-induced liver injury
- Reports
- 6
- Reporting signal score
- 18.9208
- Event
- hepatotoxicity
- Reports
- 10
- Reporting signal score
- 40.1751
- NCT00567840
- NCT00944021
- NCT01215851
- NCT01498419
- NCT01691534
- NCT02256696
- NCT02333799
- NCT05971602
- NCT06058299
- NCT06114628
- NCT06192160
- NCT01571414
- NCT01674218
- NCT01768273
- NCT01828827
- NCT01830439
- NCT02193776
- NCT02342886
- NCT02422524
- NCT03202693
- NCT05040126
- NCT05586230
- NCT05686356
- NCT02589782
- NCT03338621
And 3 more, listed on the interactive page.
- Dose
- 200mg
- Route
- Oral
- How often
- Once daily for 26 weeks
Conditions of use
- Take with food
- Hydrogen bond acceptors
- 7
- Hydrogen bond donors
- 0
- Polar surface area
- 88.65
- Calculated partition coefficient (ALogP)
- 2.67
- Calculated partition coefficient (XLogP)
- 2.8
- Prodrug
- No
- Chirality
- Single enantiomer
- Inorganic
- No
- Rule-of-five violations
- 0
- Rotatable bonds
- 5
- Heavy atoms
- 25
- Molecular formula
- C14H12F3N3O5
- Monoisotopic mass
- 359.07290498
- Natural product
- No
- 49502-476
- Recorded assays
- 1,161
- Active assays
- 148
- Confirmatory
- Screening
These details could not be displayed.
Related records
Trials (50)
- A Pan-TB Regimen Targeting Host and Microbe
- A PAN-USR TB Multi-Center Trial
- A Phase 2 to Evaluate the Efficacy, Safety and Tolerability of Combinations of Bedaquiline, Moxifloxacin, PA-824 and Pyrazinamide in Adult Subjects With Drug-Sensitive or Multi Drug-Resistant Pulmonary Tuberculosis.
- A Phase 3 Trial Assessing Safety and Efficacy of B-Pa-L in Participants With DR-TB
- A Study of the Safety, Tolerability, and Absorption, Metabolism, and Excretion of PA-824 in Healthy Adult Male Subjects.
- A Study on the Short-course Treatment Regimen Containing Pretomanid for Drug-resistant Tuberculosis
- A Trial to Evaluate the Male Reproductive Safety of Pretomanid in Adult Male Participants With Drug Resistant Pulmonary Tuberculosis
- Assessing PA-824 for Tuberculosis (the APT Trial)
- Bactericidal Activity and Safety of Nicotinamide in Combination With Bedaquiline, Pretomanid, and Linezolid in Drug-susceptible Pulmonary Tuberculosis
- Bactericidal Activity of TBD09 in Combination With Other Drugs in Pulmonary Tuberculosis
- Biodistribution and Pharmacokinetics of Pretomanid in Tuberculosis Patients Using 18F-Pretomanid PET
- Early Bactericidal Activity, Safety & Tolerability of Oral GSK3036656 in a Dual Combination With Novel and Established Antitubercular Agents, or Standard of Care in Adults With Rifampicin Susceptible Pulmonary Tuberculosis
- Economic Evaluation of New MDR TB Regimens
- Effect of PA-824 and of PA-824 Plus Moxifloxacin on the QTc Interval in Healthy Volunteers
- Efficacy and Safety Evaluation of Two to Four Months of Treatment With the Combination Regimens of DBOS and PBOS in Adults With Pulmonary Tuberculosis
- Evaluating the Safety and Drug Interaction of PA-824, an Investigational Tuberculosis Medication, Together With Efavirenz, Ritonavir-Boosted Lopinavir, or Rifampin
- Evaluation of 8 Weeks of Treatment With the Combination of Moxifloxacin, PA-824 and Pyrazinamide in Patients With Drug Sensitive and Multi Drug-Resistant Pulmonary Tuberculosis (TB) (NC-002)
- Evaluation of Early Bactericidal Activity in Pulmonary Tuberculosis (CL-010)
- Evaluation of Early Bactericidal Activity in Pulmonary Tuberculosis With Clofazimine (C)-TMC207 (J)-PA-824 (Pa)-Pyrazinamide (Z)
- Evaluation of Early Bactericidal Activity in Pulmonary Tuberculosis With(J-M-Pa-Z) (NC-001)
Approved for (4)
- Drug-resistant tuberculosis
- Multidrug-resistant tuberculosis
- Pulmonary tuberculosis
- Tuberculosis