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Drug

Pretomanid

Approved · EMA
Emerging researchLate-stage development
RxNorm2198359ChEMBLCHEMBL227875ATCJ04AK08UNII2XOI31YC4N
1
Research papers
9
Active clinical trials
1
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

A Phase 2b, Randomised, Multi-center, Partially Blinded Trial Assessing the Safety and Efficacy of Regimens Containing Sorfequiline, Pretomanid and Linezolid in Adults With Newly Diagnosed, Drug-sensitive, Smear Positive Pulmonary Tuberculosis

Clinical trial2026-06-30Results expected Q2 2027 · ClinicalTrials.gov

A Phase 2, Partially-blinded, Randomised Trial Assessing the Safety and Efficacy of TBAJ-876 or Bedaquiline, in Combination With Pretomanid and Linezolid in Adult Participants With Newly Diagnosed, Drug-sensitive, Smear-positive Pulmonary Tuberculosis

Clinical trial2026-06-24Results posted · ClinicalTrials.gov

A Phase 2 Randomized, Adaptive, Dose-Ranging, Open-Label Trial of Novel Regimens for the Treatment of Pulmonary Tuberculosis

Clinical trial2026-06-23Results expected Q4 2026 · ClinicalTrials.gov

A Parallel Group, Phase 2A, Randomised, Open Label Treatment Study to Assess the Early Bactericidal Activity, Safety and Tolerability of GSK3036656 Administered as a Two Drug Combination With Novel and Established Antitubercular Agents, or Standard of Care in Adults With Rifampicin-susceptible Pulmonary Tuberculosis

Clinical trial2026-06-17Results posted · ClinicalTrials.gov

Phase I Study of the Pharmacokinetics, Safety, and Acceptability of a Single Dose of Pretomanid Added to an Optimized Background Regimen in Children With Rifampicin-Resistant Tuberculosis

Clinical trial2026-04-28Completed · ClinicalTrials.gov

Program for Rifampicin-Resistant Disease With Stratified Medicine for Tuberculosis (PRISM-TB)

Clinical trial2026-01-20Results expected Q3 2031 · ClinicalTrials.gov

A Novel 4-month Pan-TB Regimen Targeting Both Host and Microbe (panTB-HM)

Clinical trial2026-01-01Primary completion · ClinicalTrials.gov

A Pan-Ultrashort Regimen for Drug-susceptible and Drug-resistant Pulmonary Tuberculosis: A Multi-Center Randomized Controlled Trial

Clinical trial2025-12-01Results expected Q1 2029 · ClinicalTrials.gov

A Multiple-arm, Multiple-stage (MAMS), Phase 2B/C, Open-label, Randomized, Controlled Platform Trial to Evaluate Experimental Arms Including Optimised Use of Existing and Introduction of Novel Anti-tuberculosis Drugs, in Adults With Newly Diagnosed, Drug-sensitive, Smear-positive Pulmonary Tuberculosis

Clinical trial2025-10-07Results expected Q4 2027 · ClinicalTrials.gov

A Seamless Phase 2B/C Platform Trial to Evaluate Multiple Regimens and Durations of Treatment in Pulmonary Tuberculosis

Clinical trial2025-10-06Results expected Q1 2027 · ClinicalTrials.gov

New Antibiotics for Multidrug-Resistant Bacterial Strains: Latest Research Developments and Future Perspectives.

Research2021-05-02Molecules (Basel, Switzerland)

Approval: Dovprela (previously Pretomanid FGK) (EMA)

Regulatory2020-07-31EMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Pretomanid
RxNorm CUI
2198359
ChEMBL ID
CHEMBL227875
ATC codes
J04AK08
UNII
2XOI31YC4N
Regulatory jurisdictions
ema

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2020-07-31
Latest approval
2020-07-31
Authorities
EMA
Total events
1
emaEuropean Medicines Agency· 1 event
2020-07-31Approval
Approval: Dovprela (previously Pretomanid FGK) (EMA)
Indication: Dovprela is indicated in combination with bedaquiline and linezolid, in adults, for the treatment of pulmonary extensively drug resistant (XDR), or treatment-intolerant or… Show full indication

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.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

19 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
19
registered trials across all phases
LATEST COMPLETION 2026
9
Active studies
7
Recruiting
10
Late-stage (III+)
8
Completed
2
Discontinued
PHASE DISTRIBUTIONn = 19
Phase 12Phase 27Phase 2 / 36Phase 33Phase N / A1

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Program for Rifampicin-Resistant Disease With Stratified Medicine for Tuberculosis (PRISM-TB)

RecruitingPH II/IIIUniversity of California, San Franciscon=4002031

A Pan-Ultrashort Regimen for Drug-susceptible and Drug-resistant Pulmonary Tuberculosis: A Multi-Center Randomized Controlled Trial

RecruitingPH IIIShenzhen Third People's Hospitaln=6102029

A Novel 4-month Pan-TB Regimen Targeting Both Host and Microbe (panTB-HM)

Active, not recruitingPH II/IIIThe Aurum Institute NPCn=3522026

Evaluate the Effectiveness, Safety and Tolerability of Various Doses of Linezolid in Combination With Bedaquiline and Pretomanid in Adults With Pre-Extensively Drug-Resistant (Pre-XDR), Or Treatment Intolerant/Non-responsive Multidrug-Resistant (MDRTI/NR) Pulmonary Tuberculosis in India

Unknown statusPH IIITuberculosis Research Centre, Indian=4002024

Pharmacokinetics and Pharmacodynamics Sub-study for TB-PRACTECAL Clinical Trial ( PRACTECAL-PKPD)

Unknown statusPH II/IIIMedecins Sans Frontieres, Netherlandsn=2402022

Recent completions

Trials that read out recently, adding to the completed evidence base.

Phase I Study of the Pharmacokinetics, Safety, and Acceptability of a Single Dose of Pretomanid Added to an Optimized Background Regimen in Children With Rifampicin-Resistant Tuberculosis

CompletedPH INational Institute of Allergy and Infectious Diseases (NIAID)n=322026

A Parallel Group, Phase 2A, Randomised, Open Label Treatment Study to Assess the Early Bactericidal Activity, Safety and Tolerability of GSK3036656 Administered as a Two Drug Combination With Novel and Established Antitubercular Agents, or Standard of Care in Adults With Rifampicin-susceptible Pulmonary Tuberculosis

CompletedPH IIGlaxoSmithKlinen=1272025

An Open-Label Phase 2 Trial to Evaluate the Male Reproductive Safety of a 6-Month Combination Treatment for Pulmonary Tuberculosis (TB) of Bedaquiline Plus Pretomanid Plus Moxifloxacin Plus Pyrazinamide (BPaMZ) in Adult Male Participants With Drug Resistant Pulmonary TB

CompletedPH IIGlobal Alliance for TB Drug Developmentn=262024

Economic Evaluation of New MDR TB Regimens (PRACTECAL EE)

CompletedPH II/IIIMedecins Sans Frontieres, Netherlandsn=732022

A Randomised, Controlled, Open-Label, Phase II-III Trial to Evaluate the Safety and Efficacy of Regimens Containing Bedaquiline and Pretomanid for the Treatment of Adult Patients With Pulmonary Multidrug Resistant Tuberculosis

CompletedPH II/IIIMedecins Sans Frontieres, Netherlandsn=5522022

An Open-Label, Partially Randomized Trial to Evaluate the Efficacy, Safety and Tolerability of a 4-month Treatment of Bedaquiline Plus Pretomanid Plus Moxifloxacin Plus Pyrazinamide (BPaMZ) Compared to a 6-month Treatment of HRZE/HR (Control) in Adult Participants With Drug-Sensitive Smear-Positive Pulmonary Tuberculosis (DS-TB) and a 6-month Treatment of BPaMZ in Adult Participants With Drug Resistant, Smear-Positive Pulmonary Tuberculosis (DR-TB)

CompletedPH II/IIIGlobal Alliance for TB Drug Developmentn=4552022

Research activity

1 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Major research themes2
Drug Design1Drug Resistance, Multiple, Bacterial1
Journals, researchers & institutions
Top journals
  • Molecules (Basel, Switzerland)1
Leading researchers
  • Pregnolato M1
  • Taccani M1
  • Terreni M1
Leading institutions
free-text, unnormalised
  • University of Pavia1

Related drugs

7 matches

Drugs sharing diseases, protein targets and literature with this one. Ranked by graph evidence (shared targets + diseases weighted above co-mentions).

Cefiderocol

Studied across 2 of the same disease areas as Pretomanid in the shared literature.

2 shared diseases1 shared paper
Delafloxacin

Studied across 2 of the same disease areas as Pretomanid in the shared literature.

2 shared diseases1 shared paper
Eravacycline

Studied across 2 of the same disease areas as Pretomanid in the shared literature.

2 shared diseases1 shared paper
Meropenem

Studied across 2 of the same disease areas as Pretomanid in the shared literature.

2 shared diseases1 shared paper
Plazomicin

Studied across 2 of the same disease areas as Pretomanid in the shared literature.

2 shared diseases1 shared paper
Sisomicin

Studied across 2 of the same disease areas as Pretomanid in the shared literature.

2 shared diseases1 shared paper
Vaborbactam

Studied across 2 of the same disease areas as Pretomanid in the shared literature.

2 shared diseases1 shared paper
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.