Drugs / Pretomanid
last change Jul 2026 re-read 2 minutes ago

Pretomanid

Small molecule

Developed for
pulmonary tuberculosis · multidrug-resistant tuberculosis · tuberculosis · extensively drug-resistant tuberculosis · meningeal tuberculosis · rifampicin-resistant tuberculosis
Investigated by
Global Alliance for TB Drug Development · National Institute of Allergy and Infectious Diseases (NIAID) · University of California, San Francisco · London School of Hygiene and Tropical Medicine · University College, London · University of Liverpool
+71 more · Wits Health Consortium (Pty) Ltd · GlaxoSmithKline · Medecins Sans Frontieres, Netherlands · Ministry of Health, Republic of Uzbekistan · Ministry of Public Health, Republic of Belarus · THINK TB & HIV Investigative Network · Drugs for Neglected Diseases · Johns Hopkins University · Ludwig-Maximilians - University of Munich · Otsuka Pharmaceutical Development & Commercialization, Inc. · Radboud University Medical Center · Swiss Tropical & Public Health Institute · TB Alliance · World Health Organization · eResearch Technology, Inc. · Asan Medical Center · Centre for the AIDS Programme of Research in South Africa · Chonnam National University Hospital · Chungbuk National University Hospital · Click-TB Consortium · Critical Path Institute · DongGuk University · Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · European Lung Foundation · European Respiratory Society · Find · Gates Medical Research Institute · German Center for Infection Research · Hackensack Meridian Health · Helmholtz Zentrum München · Incheon St.Mary's Hospital · Infectious Diseases Institute · Instituto Nacional de Saúde, Mozambique · Instituto de Saude Publica da Universidade do Porto · Janssen Pharmaceuticals · Janssen, LP · KNCV Tuberculosis Foundation · LigaChem Biosciences, Inc. · Lygature · Michael Hoelscher · Minsk Republican Research and Practical Centre for Pulmonology and Tuberculosis · National Institute for Medical Research, Tanzania · National Institute of Mental Health (NIMH) · National Medical Center, Seoul · Otsuka Pharmaceutical Co., Ltd. · Pusan National University Hospital · Research Center Borstel · Research Institute for Development · Rutgers, The State University of New Jersey · Samsung Medical Center · Seoul National University Hospital · Sequella, Inc. · Severance Hospital · Soon Chun Hyang University · Stichting Katholieke Universiteit · TASK Applied Science · The Aurum Institute NPC · The Catholic University of Korea · Tuberculosis Network European Trialsgroup · Ulsan University Hospital · University of Cambridge · University of Cape Town · University of Hamburg-Eppendorf · University of Milano · University of Minnesota · University of Oxford · University of St Andrews · University of Stellenbosch · Uppsala University · Vita-Salute San Raffaele University · Wuhan Pulmonary Hospital

Regulatory milestones approvals, filings & regulatory actions · 3 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Label expansion US (FDA) PRETOMANID 2024-11-22 fda.gov
Approved EU (EMA) Dovprela (previously Pretomanid FGK) 2020-07-31 europa.eu
Approved US (FDA) PRETOMANID 2019-08-14 fda.gov

Trials 39 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 110 trials
Phase 1 NCT03896750 Apr → Aug 2024 impaired renal function disease, tuberculosis National Institute of Allergy and Infectious Diseases (NIAID) Completed No outcome recorded
Phase 1 NCT05586230 Oct 2023 → Apr 2026 rifampicin-resistant tuberculosis National Institute of Allergy and Infectious Diseases (NIAID) Completed No outcome recorded
Phase 1 NCT04309656 Jan → Feb 2020 multidrug-resistant tuberculosis Global Alliance for TB Drug Development Completed No outcome recorded
Phase 1 NCT02422524 Mar 2018 → Aug 2023 tuberculosis National Institute of Allergy and Infectious Diseases (NIAID) Terminated No outcome recorded
Phase 1 NCT01674218 Sep → Dec 2012 tuberculosis National Institute of Allergy and Infectious Diseases (NIAID) Completed No outcome recorded
Phase 1 NCT01571414 May 2012 → May 2013 tuberculosis National Institute of Allergy and Infectious Diseases (NIAID) Completed No outcome recorded
Phase 1 NCT01768273 Dec 2009 → Jan 2010 tuberculosis Global Alliance for TB Drug Development Completed No outcome recorded
Phase 1 NCT01830439 Sep 2009 → Jan 2010 tuberculosis Global Alliance for TB Drug Development Completed No outcome recorded
Phase 1 NCT01828827 Mar 2007 tuberculosis Global Alliance for TB Drug Development Completed No outcome recorded
Phase 1 NCT03202693 Mar → May 2006 tuberculosis Global Alliance for TB Drug Development Completed No outcome recorded
Phase 216 trials
Phase 2 NCT07227779 Jul 2026 → Aug 2030 expected meningeal tuberculosis University of Minnesota Not yet recruiting No outcome recorded
Phase 2 NCT07672405 Jul 2026 → May 2027 expected pulmonary tuberculosis Global Alliance for TB Drug Development Recruiting No outcome recorded
Phase 2 NCT06192160 Mar 2025 → Nov 2026 expected pulmonary tuberculosis National Institute of Allergy and Infectious Diseases (NIAID) Recruiting No outcome recorded
Phase 2 NCT06114628 Jan 2024 → Feb 2027 expected pulmonary tuberculosis University College, London Recruiting No outcome recorded
Phase 2 NCT06058299 Oct 2023 → Dec 2024 overdue pulmonary tuberculosis Global Alliance for TB Drug Development Active not recruiting No outcome recorded
Phase 2 NCT05971602 Jul 2023 → Feb 2025 pulmonary tuberculosis Gates Medical Research Institute Terminated No outcome recorded
Phase 2 NCT05807399 Apr 2023 → Oct 2027 expected pulmonary tuberculosis Michael Hoelscher Recruiting No outcome recorded
Phase 2 NCT05382312 Jul 2022 → May 2025 tuberculosis GlaxoSmithKline Completed No outcome recorded
Phase 2 NCT04179500 Sep 2021 → Jun 2023 multidrug-resistant tuberculosis, pulmonary tuberculosis Global Alliance for TB Drug Development Completed No outcome recorded
Phase 2 NCT02256696 Apr 2015 → May 2022 pulmonary tuberculosis Johns Hopkins University Completed No outcome recorded
Phase 2/36 trials
Phase 2/3 NCT06441006 Oct 2025 → Aug 2031 expected multidrug-resistant tuberculosis, pulmonary tuberculosis University of California, San Francisco Recruiting No outcome recorded
Phase 2/3 NCT05686356 Jul 2023 → Jan 2026 overdue tuberculosis The Aurum Institute NPC Active not recruiting No outcome recorded
Phase 2/3 NCT04207112 Oct 2020 → Aug 2022 extensively drug-resistant tuberculosis, multidrug-resistant tuberculosis, pulmonary tuberculosis Medecins Sans Frontieres, Netherlands Completed No outcome recorded
Phase 2/3 NCT04081077 Aug 2019 → Sep 2022 extensively drug-resistant tuberculosis, multidrug-resistant tuberculosis, pulmonary tuberculosis Medecins Sans Frontieres, Netherlands Unknown No outcome recorded
Phase 2/3 NCT03338621 Jul 2018 → Jul 2021 multidrug-resistant tuberculosis, pulmonary tuberculosis Global Alliance for TB Drug Development Completed No outcome recorded
Phase 2/3 NCT02589782 Jan 2017 → Aug 2022 extensively drug-resistant tuberculosis, multidrug-resistant tuberculosis, pulmonary tuberculosis Medecins Sans Frontieres, Netherlands Completed No outcome recorded
Phase 34 trials
Phase 3 NCT07209761 Oct 2025 → May 2027 expected pulmonary tuberculosis Otsuka Pharmaceutical Development & Commercialization, Inc. Recruiting No outcome recorded
Phase 3 NCT03086486 Nov 2017 → Feb 2021 extensively drug-resistant tuberculosis, multidrug-resistant tuberculosis, pulmonary tuberculosis Global Alliance for TB Drug Development Completed No outcome recorded
Phase 3 NCT02333799 Mar 2015 → Jan 2019 pulmonary tuberculosis Global Alliance for TB Drug Development Completed No outcome recorded
Phase 3 NCT02342886 Feb 2015 → Jan 2018 multidrug-resistant tuberculosis, pulmonary tuberculosis Global Alliance for TB Drug Development Completed No outcome recorded
Phase 42 trials
Phase 4 NCT05381194 Dec 2022 → Dec 2027 expected multidrug-resistant tuberculosis Asan Medical Center Recruiting No outcome recorded
Phase 4 NCT03237182 Jun 2017 → Dec 2022 multidrug-resistant tuberculosis Centre for the AIDS Programme of Research in South Africa Terminated No outcome recorded
Phase not applicable1 trial
NCT07126639 Sep 2025 → Sep 2027 expected Wuhan Pulmonary Hospital Not yet recruiting No outcome recorded
Also used as a comparator or background therapy in 4 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 22 trials
Phase 2 NCT07517445 Comparator Apr 2026 → Jun 2027 expected primary pulmonary tuberculosis Gates Medical Research Institute Recruiting No outcome recorded
Phase 2 NCT07525427 Background Apr → Nov 2026 expected pulmonary tuberculosis Gates Medical Research Institute Recruiting No outcome recorded
Phase 32 trials
Phase 3 NCT06905522 Comparator Jun 2025 → Jan 2029 expected pulmonary tuberculosis Shenzhen Third People's Hospital Recruiting No outcome recorded
Phase 3 NCT05040126 Background Oct 2021 → Dec 2024 multidrug-resistant tuberculosis Tuberculosis Research Centre, India Unknown No outcome recorded

Evidence & citations 5 cited values

Every value below carries the sentence it was read from. 45 sources stand behind the page.

FieldValueCited text
Known as Pretomanid “The objective of this study is to analyze the efficacy of a new regimen using Bedaquiline, Pretomanid, Linezolid, and Moxifloxacin for 24 weeks or Bedaquiline, Pretomanid,...” NCT05381194
28

“Bedaquiline 400 mg once daily for 2 weeks then 100 mg once daily for 15 weeks + Pretomanid 200 mg QD for 17 weeks + Quabodepistat 30 mg once daily for 17 weeks + Moxifloxacin...” NCT07209761

“One moxifloxacin (M) 400 mg tablet plus one Pretomanid (PA-824) 100 mg tablet plus three pyrazinamide 500 mg tablets taken once daily for 8 weeks” NCT01498419

“PA-824, a nitroimidazooxazine, used in prior studies of pretomanid is a novel TB treatment” NCT03896750

“bedaquiline, pretomanid, linezolid, moxifloxacin, and pyrazinamide” NCT07227779

Pretomanid (PA-824) is a nitroimidazooxazine.” NCT02422524

“terizidone, pretomanid, linezolid, sutezolid” NCT03237182

NCT07126639

NCT04179500

NCT04081077

NCT05382312

NCT07672405

NCT06441006

NCT03086486

NCT06114628

NCT05586230

NCT05807399

NCT06058299

NCT06905522

NCT03338621

NCT02589782

NCT07517445

NCT05971602

NCT07525427

NCT05040126

NCT05686356

NCT04309656

NCT04207112

NCT06192160

Known as Dovprela (previously pretomanid fgk) ChEMBL registry synonym — accepted as the source's own label CHEMBL227875
Known as PA-824 ClinicalTrials.gov intervention name — accepted as the source's own label NCT02193776
15

NCT01828827

NCT01768273

NCT02342886

NCT00944021

NCT01691534

NCT00567840

NCT02333799

NCT03202693

NCT02422524

NCT02256696

NCT03896750

NCT01674218

NCT01571414

NCT01215851

NCT01830439

Modality Small molecule “PA-824 is a novel antituberculosis nitroimidazole in late-phase clinical development.” PMID 24957823 Jun 2014
Route Oral “14 consecutive days of oral administration of PA-824” NCT00567840