Tuberculosis, Pulmonary

Infectious Diseases
7
Pipeline Programs
5
Companies
13
Clinical Trials
2 recruiting
3
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
0
1
1
0
1
4
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Vaccine
1100%
+ 5 programs with unclassified modality

On Market (3)

Approved therapies currently available

U
DOW-ISONIAZIDApproved
isoniazid
Unknown Company
oral1971
U
LANIAZIDApproved
isoniazid
Unknown Company
oral1986
U
STANOZIDEApproved
isoniazid
Unknown Company
oral1972

Competitive Landscape

5 companies ranked by most advanced pipeline stage

HB
HaiHe BiopharmaChina - Shanghai
1 program
1
IsoniazidPhase 41 trial
Active Trials
NCT02901288UnknownEst. Dec 2018
Alliance Pharmaceuticals
1 program
1
PretomanidPhase 35 trials
Active Trials
NCT06192160Recruiting315Est. Aug 2027
NCT06058299Active Not Recruiting309Est. Jun 2026
NCT05586230Recruiting72Est. Jan 2026
+2 more trials
Allergy Therapeutics
Allergy TherapeuticsUK - West Sussex
2 programs
1
ID93 + GLA-SE vaccinePhase 2Vaccine1 trial
Utility of MODS for Diagnosis of MDR-TB and Second-Line Antituberculous Drug Susceptibility Testing N/A1 trial
Active Trials
NCT01381757TerminatedEst. Mar 2013
NCT06205589Not Yet RecruitingEst. Oct 2029
Bristol Myers Squibb
1 program
1
Azacitidine InjectionPhase 1/21 trial
Active Trials
NCT03941496Withdrawn0Est. May 2023
BioVersys
BioVersysSwitzerland - Basel
1 program
Plasma samplesN/A1 trial
Active Trials
NCT05258877Completed30Est. Sep 2023

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
2028
2029
HaiHe BiopharmaIsoniazid
Alliance PharmaceuticalsPretomanid
Alliance PharmaceuticalsPretomanid
Alliance PharmaceuticalsPretomanid
Allergy TherapeuticsID93 + GLA-SE vaccine
Alliance PharmaceuticalsPretomanid
Alliance PharmaceuticalsPretomanid
Alliance PharmaceuticalsPretomanid
Bristol Myers SquibbAzacitidine Injection
Alliance PharmaceuticalsPretomanid
Alliance PharmaceuticalsPretomanid
BioVersysPlasma samples
Allergy TherapeuticsUtility of MODS for Diagnosis of MDR-TB and Second-Line Antituberculous Drug Susceptibility Testing

Clinical Trials (13)

Total enrollment: 1,988 patients across 13 trials

NCT02901288HaiHe BiopharmaIsoniazid

Shortened Regimens for Drug-susceptible Pulmonary Tuberculosis

Start: Aug 2016Est. completion: Dec 2018
Phase 4Unknown
NCT03086486Alliance PharmaceuticalsPretomanid

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

Start: Nov 2017Est. completion: Feb 2022181 patients
Phase 3Completed
NCT03338621Alliance PharmaceuticalsPretomanid

Trial to Evaluate the Efficacy, Safety and Tolerability of BPaMZ in Drug-Sensitive (DS-TB) Adult Patients and Drug-Resistant (DR-TB) Adult Patients

Start: Jul 2018Est. completion: Jun 2022455 patients
Phase 2/3Completed
NCT02589782Alliance PharmaceuticalsPretomanid

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

Start: Jan 2017Est. completion: Aug 2022552 patients
Phase 2/3Completed
NCT06205589Allergy TherapeuticsID93 + GLA-SE vaccine

Therapeutic ID93 + GLA-SE Vaccination in Participants With Rifampicin-Susceptible Pulmonary TB

Start: Feb 2026Est. completion: Oct 2029
Phase 2Not Yet Recruiting
NCT06192160Alliance PharmaceuticalsPretomanid

Trial of Novel Regimens for the Treatment of Pulmonary Tuberculosis

Start: Mar 2025Est. completion: Aug 2027315 patients
Phase 2Recruiting
NCT06058299Alliance PharmaceuticalsPretomanid

Phase 2 Trial Assessing TBAJ876 or Bedaquiline, with Pretomanid and Linezolid in Adults with Drug-sensitive Pulmonary Tuberculosis

Start: Oct 2023Est. completion: Jun 2026309 patients
Phase 2Active Not Recruiting
NCT04179500Alliance PharmaceuticalsPretomanid

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

Start: Sep 2021Est. completion: Jul 202426 patients
Phase 2Completed
NCT03941496Bristol Myers SquibbAzacitidine Injection

Azacytidine During Anti-tuberculosis Therapy

Start: Oct 2022Est. completion: May 20230
Phase 1/2Withdrawn
NCT05586230Alliance PharmaceuticalsPretomanid

Study of a Single Dose of Pretomanid Added to an Optimized Background Regimen in Children With Rifampicin-Resistant Tuberculosis

Start: Oct 2023Est. completion: Jan 202672 patients
Phase 1Recruiting
NCT04309656Alliance PharmaceuticalsPretomanid

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

Start: Jan 2020Est. completion: Feb 202048 patients
Phase 1Completed
NCT05258877BioVersysPlasma samples

Pharmacokinetics of Ethionamide and Ethionamide Sulfoxide in Patients Established on Treatment for Tuberculosis.

Start: Jun 2022Est. completion: Sep 202330 patients
N/ACompleted
NCT01381757Allergy TherapeuticsUtility of MODS for Diagnosis of MDR-TB and Second-Line Antituberculous Drug Susceptibility Testing

Utility of MODS for Diagnosis of MDR-TB and Second-Line Antituberculous Drug Susceptibility Testing in Mali

Start: May 2011Est. completion: Mar 2013
N/ATerminated

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Phase Legend

Preclinical— Lab & animal studies
Phase 1— Safety & dosing
Phase 2— Efficacy testing
Phase 3— Large-scale trials
On Market— Approved & available

Key Insights

1 late-stage (Phase 3) programs — potential near-term approvals
2 actively recruiting trials targeting 1,988 patients
5 companies competing in this space

Related Indications

HIV Infections(449)COVID-19(223)Hepatitis C(191)Influenza(173)HIV(138)HIV-1-infection(115)Hepatitis C, Chronic(94)Chronic Hepatitis B(93)Chronic Hepatitis C(91)Covid19(79)