Pretomanid
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Also known as Dovprela (previously pretomanid fgk)PA 824PA-824PA824MMV688755C0237411C0088552
Summary
Pretomanid (CHEMBL227875) is an approved small molecule (ATC J04AK08); indicated across 4 conditions including pulmonary tuberculosis and multidrug-resistant tuberculosis.
At a glance
- Status: Approved (max clinical phase 4)
- Modality: Small molecule
- ATC class: J04AK08
- Indications: 4 conditions
- Clinical trials: 36
- Chemistry: 359.26 Da · C14H12F3N3O5
Identifiers
Drug identity and classification
| Field | Value |
|---|---|
| ChEMBL ID | CHEMBL227875 |
| Name | Pretomanid |
| Type | Small molecule |
| Max phase | 4 |
| FDA approved | yes |
| PubChem CID | 456199 |
| ATC | J04AK08 |
| Molecular formula | C14H12F3N3O5 |
| Molecular weight | 359.26 |
| InChIKey | ZLHZLMOSPGACSZ-NSHDSACASA-N |
SMILES: C1[C@@H](COC2=NC(=CN21)[N+](=O)[O-])OCC3=CC=C(C=C3)OC(F)(F)F
IUPAC name: (6S)-2-nitro-6-[[4-(trifluoromethoxy)phenyl]methoxy]-6,7-dihydro-5H-imidazo[2,1-b][1,3]oxazine
Also known as: Dovprela (previously pretomanid fgk), PA 824, PA-824, PA824, Pretomanid, PRETOMANID, MMV688755, pretomanid, C0237411, C0088552
Patent coverage: 296 distinct patent families (621 SureChEMBL compound mentions), from 1 matched compound structure(s). Mentions count patents naming the compound (not distinct inventions), so promiscuous / reference molecules inflate the mention figure — families are the dedup metric.
Targets
Targets
Broader ChEMBL bioactivity targets: 1 (assay-derived). Sample: Muscarinic acetylcholine receptor M1.
Bioactivity
No ChEMBL bioactivity rows at pChembl ≥ 5 (expected for biologics / antibodies).
Target pathways
No target-pathway data for this drug (no mapped target genes).
Indications & clinical
Indications
4 indications (4 at ChEMBL trial phase 4). Phase below is the highest clinical-trial phase recorded for this drug against each disease — not the molecule’s overall approval status (that is in the Summary).
| Indication | Trial phase | MONDO | EFO |
|---|---|---|---|
| pulmonary tuberculosis | 4 | MONDO:0006052 | EFO:1000049 |
| multidrug-resistant tuberculosis | 4 | MONDO:0005861 | EFO:0007381 |
| tuberculosis | 4 | MONDO:0018076 | MONDO:0018076 |
1 further indication record had no mapped disease name (EFO/MeSH-only) or were duplicates, and are omitted.
Clinical trials
Total trials: 36.
Phase distribution
| Phase | Trials |
|---|---|
| PHASE2 | 12 |
| PHASE1 | 10 |
| PHASE2/PHASE3 | 6 |
| PHASE3 | 5 |
| Not specified | 3 |
Top trials by phase / activity
| NCT | Phase | Status | Title |
|---|---|---|---|
| NCT05686356 | PHASE2/PHASE3 | ACTIVE_NOT_RECRUITING | A Pan-TB Regimen Targeting Host and Microbe |
| NCT06441006 | PHASE2/PHASE3 | RECRUITING | Program for Rifampicin-Resistant Disease With Stratified Medicine for Tuberculosis |
| NCT06905522 | PHASE3 | RECRUITING | A PAN-USR TB Multi-Center Trial |
| NCT02333799 | PHASE3 | COMPLETED | A Phase 3 Trial Assessing Safety and Efficacy of B-Pa-L in Participants With DR-TB |
| NCT02342886 | PHASE3 | COMPLETED | Shortening Treatment by Advancing Novel Drugs |
| NCT02589782 | PHASE2/PHASE3 | COMPLETED | Pragmatic Clinical Trial for a More Effective Concise and Less Toxic MDR-TB Treatment Regimen(s) |
| NCT03086486 | PHASE3 | COMPLETED | Various Doses and Durations of Linezolid Plus Bedaquiline & Pretomanid in Participants With Drug Resistant Tuberculosis |
| NCT03338621 | PHASE2/PHASE3 | COMPLETED | Trial to Evaluate the Efficacy, Safety and Tolerability of BPaMZ in Drug-Sensitive (DS-TB) Adult Patients and Drug-Resistant (DR-TB) Adult Patients |
| NCT04081077 | PHASE2/PHASE3 | UNKNOWN | PRACTECAL-PKPD Sub Study |
| NCT04207112 | PHASE2/PHASE3 | COMPLETED | Economic Evaluation of New MDR TB Regimens |
| NCT05040126 | PHASE3 | UNKNOWN | Modified BPaL Regimen for Managing Pre-XDR TB and MDR (TI/NR) TB in India |
| NCT05807399 | PHASE2 | RECRUITING | PanACEA - STEP2C -01 |
| NCT06058299 | PHASE2 | ACTIVE_NOT_RECRUITING | Phase 2 Trial Assessing TBAJ876 or Bedaquiline, with Pretomanid and Linezolid in Adults with Drug-sensitive Pulmonary Tuberculosis |
| NCT06114628 | PHASE2 | RECRUITING | Platform Assessing Regimens and Durations In a Global Multisite Consortium for TB |
| NCT06192160 | PHASE2 | RECRUITING | Trial of Novel Regimens for the Treatment of Pulmonary Tuberculosis |
| NCT07517445 | PHASE2 | RECRUITING | Bactericidal Activity and Safety of Nicotinamide in Combination With Bedaquiline, Pretomanid, and Linezolid in Drug-susceptible Pulmonary Tuberculosis |
| NCT00567840 | PHASE2 | COMPLETED | PA-824-CL-007: Phase IIa Evaluation of Early Bactericidal Activity in Pulmonary Tuberculosis |
| NCT00944021 | PHASE2 | COMPLETED | Evaluation of Early Bactericidal Activity in Pulmonary Tuberculosis (CL-010) |
| NCT01215851 | PHASE2 | COMPLETED | Evaluation of Early Bactericidal Activity in Pulmonary Tuberculosis With(J-M-Pa-Z) (NC-001) |
| NCT01691534 | PHASE2 | COMPLETED | Evaluation of Early Bactericidal Activity in Pulmonary Tuberculosis With Clofazimine (C)-TMC207 (J)-PA-824 (Pa)-Pyrazinamide (Z) |
| NCT02193776 | PHASE2 | COMPLETED | 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. |
| NCT02256696 | PHASE2 | COMPLETED | Assessing PA-824 for Tuberculosis (the APT Trial) |
| NCT04179500 | PHASE2 | COMPLETED | A Trial to Evaluate the Male Reproductive Safety of Pretomanid in Adult Male Participants With Drug Resistant Pulmonary Tuberculosis |
| NCT01571414 | PHASE1 | COMPLETED | Evaluating the Safety and Drug Interaction of PA-824, an Investigational Tuberculosis Medication, Together With Efavirenz, Ritonavir-Boosted Lopinavir, or Rifampin |
| NCT01674218 | PHASE1 | COMPLETED | Effect of PA-824 and of PA-824 Plus Moxifloxacin on the QTc Interval in Healthy Volunteers |
| NCT01768273 | PHASE1 | COMPLETED | Evaluation of the Pharmacokinetic Interaction Between PA-824 and Midazolam |
| NCT01828827 | PHASE1 | COMPLETED | Food Effect Study on the Bioavailability and PK of PA-824 Tablets in Healthy Adult Subjects |
| NCT01830439 | PHASE1 | COMPLETED | Food Effect Study on the Bioavailability and PK of PA-824 Tablets in Healthy Adult Subjects (CL-009) |
| NCT02422524 | PHASE1 | TERMINATED | Pretomanid in Adults With Hepatic Impairment |
| NCT03202693 | PHASE1 | COMPLETED | A Study of the Safety, Tolerability, and Absorption, Metabolism, and Excretion of PA-824 in Healthy Adult Male Subjects. |
| NCT03896750 | PHASE1 | COMPLETED | Single-Dose Study to Evaluate the PKs of Pretomanid in Participants With Renal Impairment Compared to Participants With Normal Renal Function |
| NCT04309656 | PHASE1 | COMPLETED | Single-dose Study in Two Panels of Healthy Adult Participants to Assess Immediate-Release and Dispersible Formulations of Pretomanid |
| NCT05586230 | PHASE1 | COMPLETED | Study of a Single Dose of Pretomanid Added to an Optimized Background Regimen in Children With Rifampicin-Resistant Tuberculosis |
| NCT07126639 | Not specified | NOT_YET_RECRUITING | A Study on the Short-course Treatment Regimen Containing Pretomanid for Drug-resistant Tuberculosis |
| NCT00042289 | Not specified | COMPLETED | Pharmacokinetic Study of Antiretroviral Drugs and Related Drugs During and After Pregnancy |
| NCT03942354 | Not specified | COMPLETED | Patient-reported Experiences and Quality of Life Outcomes in the TB-PRACTECAL Clinical Trial |
Clinical evidence (CIViC)
No CIViC predictive evidence (expected for non-precision-medicine drugs).
Pharmacology
Pharmacogenomics
No PharmGKB pharmacogenomic data curated for this drug.
Related molecules
Related molecules
No competitor molecules sharing a primary target (ChEMBL phase ≥2 or PubChem drug-class).