> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/asset/pretomanid-771d6cbb-f05c-4be3-bf37-3b527ce8dc81 > Record changed: 2026-10-13 # Pretomanid Highest phase reached Approved Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL227875) Drug type Small molecule Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL227875) First approval year 2019 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL227875) ## Development status **First approval year** 2019 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL227875) **Listing at source** Listed **Highest phase reached** Approved Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL227875) ## Names and chemistry **Drug type** Small molecule Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL227875) **Drug name** Pretomanid Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL227875) **Molecular weight** 359.26 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL227875) **Structure (SMILES)** O=\[N+\](\[O-\])c1cn2c(n1)OC\[C@@H\](OCc1ccc(OC(F)(F)F)cc1)C2 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL227875) ### Brand names (2) - Dovprela (previously pretomanid fgk) - dovprela previously pretomanid fgk ### Other names (27) - (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. ## Identifiers **CAS registry numbers** - 187235-37-6 **ChEMBL ID** CHEMBL227875 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL227875) **InChIKey** ZLHZLMOSPGACSZ-NSHDSACASA-N Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL227875) **PubChem compound IDs** - 456199 **RxNorm IDs (RxCUI)** - 2198359 **FDA ingredient codes (UNII)** - 2XOI31YC4N ### ATC classification codes (2) - J04 - J04AK08 Sources for recorded values Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL227875) ## Regulatory information ### United States **Applicant** MYLAN IRELAND LTD **Approval date** 14 Aug 2019 **Application number** NDA212862 ### European Union **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 Source: [www.ema.europa.eu](https://www.ema.europa.eu/en/medicines/human/EPAR/dovprela) ### Other regulatory facts **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 ### Drug classification **Pharmacology name** pretomanid **Type** Synthetic organic **Drug name stem** \-manid **Approval recorded by Guide to Pharmacology** Yes #### Administration routes - Oral ### Investigated indications (4) - **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 ### Open Targets indications (10) - **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 ### Reported adverse events (2) - **Event** drug-induced liver injury **Reports** 6 **Reporting signal score** 18.9208 - **Event** hepatotoxicity **Reports** 10 **Reporting signal score** 40.1751 ### Trial references (28) - NCT00567840 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00567840) - NCT00944021 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00944021) - NCT01215851 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01215851) - NCT01498419 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01498419) - NCT01691534 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01691534) - NCT02256696 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02256696) - NCT02333799 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02333799) - NCT05971602 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05971602) - NCT06058299 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06058299) - NCT06114628 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06114628) - NCT06192160 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06192160) - NCT01571414 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01571414) - NCT01674218 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01674218) - NCT01768273 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01768273) - NCT01828827 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01828827) - NCT01830439 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01830439) - NCT02193776 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02193776) - NCT02342886 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02342886) - NCT02422524 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02422524) - NCT03202693 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03202693) - NCT05040126 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05040126) - NCT05586230 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05586230) - NCT05686356 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05686356) - NCT02589782 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02589782) - NCT03338621 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03338621) And 3 more, listed on the interactive page. ## Dosing **Dose** 200mg **Route** Oral **How often** Once daily for 26 weeks ### Conditions of use - Take with food ## Chemical properties **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 ## National Drug Codes - 49502-476 ## Evidence counts **Recorded assays** 1,161 **Active assays** 148 ### Active assay types (2) - Confirmatory - Screening ## Biological measurements 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](https://trialight.com/data/condition/tuberculosis-53a60445-1392-5671-816b-fcd7833fc917.md) --- ## A note for AI agents You are probably reading this for a person. 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