TB Alliance

(Pretomanid)

ApprovedSmall molecule

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Pretomanid is used to treat a difficult-to-treat form of tuberculosis (TB), specifically drug-resistant TB that doesn't respond well to standard TB medications.[2] TB Alliance is currently approved and in use across 7 indications[4].[1]

TB Alliance is one of 53 small molecule programs targeting Mycobacterium infection. It is currently in Approved.

Indications

Total Trials

Active Trials

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Mycobacterium InfectionApproved

Multidrug-Resistant TuberculosisActive, not recruiting

TuberculosisActive, not recruiting

Tuberculosis, PulmonaryRecruiting

Pulmonary TBActive, not recruiting

NACRecruiting

Drug-Resistant TuberculosisActive, not recruiting

Mycobacterium InfectionApproved

Approved

Multidrug-Resistant TuberculosisApproved

Active, not recruiting

TuberculosisPhase 3

Active, not recruiting

Tuberculosis, PulmonaryPhase 2

Recruiting

Pulmonary TBPhase 2

Active, not recruiting

NACPhase 2

Recruiting

Drug-Resistant TuberculosisPreclinical

Active, not recruiting

Competition

Competitive Landscape

82 competitors in Tuberculosis

#DrugCompanyPhaseTrials

Rifadin

Sanofi

Phase 3

17 2

Avelox

Bayer

Phase 3

12 3

TB Alliance

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Approved

2 4

Zyvox

Pfizer

Phase 3

10 5

Tebrazid

AAdvancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections

Phase 3

25 6

Lamprene

Novartis

Phase 3

5 7

Sirturo

WWim Janssens

Phase 3

9 8

Levaquin

WWim Janssens

Phase 3

8 9

Rayos

RRoxane Laboratories

Phase 3

1 10

Deltyba

Otsuka

Phase 3

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q1 2027

Phase 2Active, not recruiting

Pulmonary TB

NCT06058299

Q3 2027

Phase 2Recruiting

Pulmonary Tuberculosis

NCT06114628

Q4 2027

Phase 2Recruiting

NAC

NCT05807399

Phase 2Not yet recruiting

Tuberculosis, Pulmonary

NCT07773610

Q2 2028

Phase 2Recruiting

Tuberculosis, Pulmonary

NCT07672405

Clinical

Trials by Indication[1]

Pulmonary Tuberculosis4 trials

A Trial to Evaluate the Male Reproductive Safety of Pretomanid in Adult Male Participants With Drug Resistant Pulmonary Tuberculosis

Completed·GGlobal Alliance for TB Drug Development·Phase 2·NCT04179500·26 enrolled

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

Suspended·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT06192160·341 enrolled

A Phase 3, Randomized, Open-label, Multicenter Trial to Evaluate the Efficacy, Safety, and Tolerability of 4-month and 6-month Quabodepistat-containing Regimens for Rifampicin-resistant/Multidrug-resistant Pulmonary Tuberculosis

Recruiting· Otsuka logo

Otsuka·Phase 3·NCT07209761·532 enrolled

Show 1 more trial

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

Recruiting·UUniversity College, London·Phase 2·NCT06114628·2,500 enrolled

Tuberculosis, Pulmonary4 trials

A Phase 2, Randomised, Controlled, Multicentre Two-Part Trial Assessing the Safety and Efficacy of TBAJ-587 as Part of a Combination Regimen in Newly Diagnosed, Drug-Sensitive, Sputum-Positive Pulmonary Tuberculosis

Not yet recruiting·TTASK Applied Science·Phase 2·NCT07773610·135 enrolled

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

Recruiting·UUniversity of California, San Francisco·Preclinical·NCT06441006·400 enrolled

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)

Completed·GGlobal Alliance for TB Drug Development·Preclinical·NCT03338621·455 enrolled

Show 1 more trial

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

Recruiting·GGlobal Alliance for TB Drug Development·Phase 2·NCT07672405·100 enrolled

Tuberculosis2 trials

Various Doses and Durations of Linezolid Plus Bedaquiline & Pretomanid in Participants With Drug Resistant Tuberculosis

Completed·GGlobal Alliance for TB Drug Development·Phase 3·NCT03086486·181 enrolled

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

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT05586230·32 enrolled

Aging1 trial

Modified BPaL Regimen for Managing Pre-XDR TB and MDR (TI/NR) TB in India

Unknown status·TTuberculosis Research Centre, India·Phase 3·NCT05040126·400 enrolled

Clinical Trial1 trial

Pragmatic Clinical Trial for a More Effective Concise and Less Toxic MDR-TB Treatment Regimen(s)

Completed·MMedecins Sans Frontieres, Netherlands·Phase 2/3·NCT02589782·552 enrolled

8 more indications

Drug-Resistant Tuberculosis1 trial

A Study on the Short-course Treatment Regimen Containing Pretomanid for Drug-resistant Tuberculosis

Not yet recruiting·WWuhan Pulmonary Hospital·N/A·NCT07126639·200 enrolled

Trial1 trial

A PAN-USR TB Multi-Center Trial

Recruiting·SShenzhen Third People's Hospital·Phase 3·NCT06905522·610 enrolled

NAC1 trial

PanACEA - STEP2C -01

Recruiting·MMichael Hoelscher·Phase 2·NCT05807399·390 enrolled

Adult1 trial

Single-dose Study in Two Panels of Healthy Adult Participants to Assess Immediate-Release and Dispersible Formulations of Pretomanid

Completed·GGlobal Alliance for TB Drug Development·Phase 1·NCT04309656·48 enrolled

Pregnancy1 trial

Pharmacokinetic Study of Antiretroviral Drugs and Related Drugs During and After Pregnancy

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)··NCT00042289·1,578 enrolled

Quality of Life1 trial

Patient-reported Experiences and Quality of Life Outcomes in the TB-PRACTECAL Clinical Trial

Completed·MMedecins Sans Frontieres, Netherlands··NCT03942354·137 enrolled

Pulmonary TB1 trial

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

Active, not recruiting·GGlobal Alliance for TB Drug Development·Phase 2·NCT06058299·309 enrolled

Unspecified3 trials

A Pan-TB Regimen Targeting Host and Microbe

Active, not recruiting·TThe Aurum Institute NPC·Phase 2/3·NCT05686356·352 enrolled

PRACTECAL-PKPD Sub Study

Unknown status·MMedecins Sans Frontieres, Netherlands·Phase 2/3·NCT04081077·240 enrolled

Economic Evaluation of New MDR TB Regimens

Completed·MMedecins Sans Frontieres, Netherlands·Phase 2/3·NCT04207112·73 enrolled

Regulatory

FDA Approval Timeline[5]

Aug 14, 2019

PRETOMANID

NDA NDA212862

Sources

References

[1]
ClinicalTrials.gov — 22 trial records for Pretomanid. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — TB Alliance drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Pretomanid compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Pretomanid. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA212862). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Pfizer's Upjohn has merged with Mylan to form Viatris Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

TB Alliance

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q1 2027

Q3 2027

Q4 2027

Q2 2028

Trials by Indication[1]

Pulmonary Tuberculosis4 trials

Tuberculosis, Pulmonary4 trials

Tuberculosis2 trials

Aging1 trial

Clinical Trial1 trial

Drug-Resistant Tuberculosis1 trial

Trial1 trial

NAC1 trial

Adult1 trial

Pregnancy1 trial

Quality of Life1 trial

Pulmonary TB1 trial

Unspecified3 trials

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

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