Tuberculosis

Infectious Diseases
36
Pipeline Programs
12
Companies
47
Clinical Trials
2 recruiting
7
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
15
1
7
1
4
8
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Small Molecule
480%
Vaccine
120%
+ 32 programs with unclassified modality

On Market (7)

Approved therapies currently available

U
DEXAMETHASONEApproved
dexamethasone
Unknown Company
Corticosteroid [EPC]oral2024
U
DEXONE 0.5Approved
dexamethasone
Unknown Company
oral
U
DEXONE 0.75Approved
dexamethasone
Unknown Company
oral
U
DEXONE 1.5Approved
dexamethasone
Unknown Company
oral1975
U
DEXONE 4Approved
dexamethasone
Unknown Company
oral
U
DEXYCU KITApproved
dexamethasone
Unknown Company
Corticosteroid [EPC]intraocular2018
U
MAXIDEXApproved
dexamethasone
Unknown Company
Corticosteroid [EPC]ophthalmic1962

Competitive Landscape

12 companies ranked by most advanced pipeline stage

Sanofi
SanofiPARIS, France
3 programs
2
1
Rifapentine 600 mg and INH 300 mgPhase 41 trial
H4:IC31Phase 11 trial
rifapentinePhase 11 trial
Active Trials
NCT02378207Completed84Est. Dec 2016
NCT01690403Completed25Est. Mar 2014
NCT04703075Completed531Est. Jun 2024
Allergy Therapeutics
Allergy TherapeuticsUK - West Sussex
9 programs
1
1
2
1
Immediate anti-TB therapyPhase 31 trial
IsoniazidPhase 21 trial
MetronidazolePhase 2Small Molecule1 trial
BedaquilinePhase 1/21 trial
MoxifloxacinPhase 1Small Molecule1 trial
+4 more programs
Active Trials
NCT06338462CompletedEst. Sep 2024
NCT02840877CompletedEst. Oct 2023
NCT00608790UnknownEst. Apr 2013
+6 more trials
HB
HaiHe BiopharmaChina - Shanghai
3 programs
2
1
ESAT6-CFP10Phase 31 trial
1μg/ml ESAT6-CFP10 and tuberculin purified protein derivativePhase 21 trial
5μg/ml ESAT6-CFP10 in left arm and TB-PPD in right armPhase 21 trial
Active Trials
NCT02329730CompletedEst. Aug 2014
NCT02336542CompletedEst. Jul 2015
NCT02623556CompletedEst. Mar 2018
City Therapeutics
City TherapeuticsMA - Cambridge
2 programs
2
DexamethasonePhase 31 trial
DexamethasonePhase 31 trial
Active Trials
NCT03100786CompletedEst. Mar 2024
NCT03092817CompletedEst. Apr 2023
Alliance Pharmaceuticals
8 programs
6
1
1
SutezolidPhase 2/31 trial
MoxifloxacinPhase 2Small Molecule1 trial
PA-824Phase 15 trials
PA-824 200mgPhase 11 trial
SutezolidPhase 11 trial
+3 more programs
Active Trials
NCT02333799Completed109Est. Aug 2020
NCT02342886Completed284Est. May 2018
NCT02193776Completed240Est. Feb 2018
+10 more trials
Plus Therapeutics
2 programs
1
1
PBTZ169Phase 21 trial
PBTZ169 - 40 mgPhase 11 trial
Active Trials
NCT03036163CompletedEst. Nov 2016
NCT03334734TerminatedEst. Feb 2018
Bayer
BayerLEVERKUSEN, Germany
1 program
1
MoxifloxacinPhase 2Small Molecule
Novartis
NovartisBASEL, Switzerland
2 programs
2
Ag85B-ESAT6 fusion protein H1Phase 11 trial
RifampicinPhase 11 trial
Active Trials
NCT00440544Terminated9Est. Feb 2008
NCT00816426Completed19Est. Dec 2017
M&
Merck & Co.RAHWAY, NJ
1 program
1
BCG Vaccine USPPhase 1Vaccine1 trial
Active Trials
NCT05592223Completed20Est. Dec 2023
GC Biopharma
GC BiopharmaKorea - Yongin
1 program
1
GC3107Phase 11 trial
Active Trials
NCT03363178UnknownEst. Mar 2018
Pfizer
PfizerNEW YORK, NY
1 program
1
Myrin© 2Phase 11 trial
Active Trials
NCT01311505Completed21Est. May 2011
Heidelberg Pharma
Heidelberg PharmaGermany - Ladenburg
4 programs
Concentrated urine with Xpert UltraN/A1 trial
Novel mycobacterial culture techniquesN/A1 trial
Tongue swab-based molecular assaysN/A1 trial
Xpert MTB/XDRN/A1 trial
Active Trials
NCT04568967Completed1,172Est. Dec 2024
NCT04923958Recruiting26,436Est. May 2031
NCT05941052Recruiting1,350Est. Sep 2028
+1 more trials

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
2028
2029
2030
2031
SanofiRifapentine 600 mg and INH 300 mg
Allergy TherapeuticsImmediate anti-TB therapy
City TherapeuticsDexamethasone
City TherapeuticsDexamethasone
HaiHe BiopharmaESAT6-CFP10
Alliance PharmaceuticalsPA-824
Alliance PharmaceuticalsPA-824
Alliance PharmaceuticalsSutezolid
Plus TherapeuticsPBTZ169
HaiHe Biopharma5μg/ml ESAT6-CFP10 in left arm and TB-PPD in right arm
Alliance PharmaceuticalsPA-824
Allergy TherapeuticsIsoniazid
HaiHe Biopharma1μg/ml ESAT6-CFP10 and tuberculin purified protein derivative
Alliance PharmaceuticalsPA-824
Alliance PharmaceuticalsPA-824

Showing 15 of 47 trials with date data

Clinical Trials (47)

Total enrollment: 32,673 patients across 47 trials

NCT04703075SanofiRifapentine 600 mg and INH 300 mg

Ultra Curto (Ultra Short) TB Prevention Therapy

Start: Mar 2022Est. completion: Jun 2024531 patients
Phase 4Completed
NCT04618198Allergy TherapeuticsImmediate anti-TB therapy

Early Empiric Anti-Mycobacterium Tuberculosis Therapy for Sepsis in Sub-Saharan Africa

Start: Dec 2021Est. completion: Jun 2025
Phase 3Unknown
NCT03100786City TherapeuticsDexamethasone

Leukotriene A4 Hydrolase Stratified Trial of Adjunctive Corticosteroids for HIV-uninfected Adults With Tuberculous Meningitis

Start: Feb 2018Est. completion: Mar 2024
Phase 3Completed
NCT03092817City TherapeuticsDexamethasone

Adjunctive Corticosteroids for Tuberculous Meningitis in HIV-infected Adults (The ACT HIV Trial)

Start: May 2017Est. completion: Apr 2023
Phase 3Completed
NCT02623556HaiHe BiopharmaESAT6-CFP10

Clinical Study of Recombinant Mycobacterium Tuberculosis ESAT6-CFP10 Allergen

Start: Dec 2015Est. completion: Mar 2018
Phase 3Completed
NCT02333799Alliance PharmaceuticalsPA-824

A Phase 3 Trial Assessing Safety and Efficacy of B-Pa-L in Participants With DR-TB

Start: Mar 2015Est. completion: Aug 2020109 patients
Phase 3Completed
NCT02342886Alliance PharmaceuticalsPA-824

Shortening Treatment by Advancing Novel Drugs

Start: Feb 2015Est. completion: May 2018284 patients
Phase 3Completed
NCT05686356Alliance PharmaceuticalsSutezolid

A Pan-TB Regimen Targeting Host and Microbe

Start: Jul 2023Est. completion: Jan 2026352 patients
Phase 2/3Active Not Recruiting
NCT03334734Plus TherapeuticsPBTZ169

Phase 2a Study of PBTZ169

Start: Dec 2016Est. completion: Feb 2018
Phase 2Terminated
NCT02336542HaiHe Biopharma5μg/ml ESAT6-CFP10 in left arm and TB-PPD in right arm

Phase IIb Clinical Study of Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10

Start: Nov 2014Est. completion: Jul 2015
Phase 2Completed
NCT02193776Alliance PharmaceuticalsPA-824

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.

Start: Oct 2014Est. completion: Feb 2018240 patients
Phase 2Completed
NCT01936831Allergy TherapeuticsIsoniazid

High-Dose Isoniazid Among Adult Patients With Different Genetic Variants of INH-Resistant Tuberculosis (TB)

Start: Aug 2014Est. completion: Oct 2021
Phase 2Completed
NCT02329730HaiHe Biopharma1μg/ml ESAT6-CFP10 and tuberculin purified protein derivative

Phase IIa Clinical Study of Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10

Start: Feb 2014Est. completion: Aug 2014
Phase 2Completed
NCT01691534Alliance PharmaceuticalsPA-824

Evaluation of Early Bactericidal Activity in Pulmonary Tuberculosis With Clofazimine (C)-TMC207 (J)-PA-824 (Pa)-Pyrazinamide (Z)

Start: Oct 2012Est. completion: May 2013105 patients
Phase 2Completed
NCT01498419Alliance PharmaceuticalsPA-824

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)

Start: Mar 2012Est. completion: Jul 2013207 patients
Phase 2Completed
NCT01215851Alliance PharmaceuticalsPA-824

Evaluation of Early Bactericidal Activity in Pulmonary Tuberculosis With(J-M-Pa-Z) (NC-001)

Start: Oct 2010Est. completion: Aug 201185 patients
Phase 2Completed
NCT00944021Alliance PharmaceuticalsPA-824

Evaluation of Early Bactericidal Activity in Pulmonary Tuberculosis (CL-010)

Start: Aug 2009Est. completion: May 201069 patients
Phase 2Completed
NCT00567840Alliance PharmaceuticalsPA-824

PA-824-CL-007: Phase IIa Evaluation of Early Bactericidal Activity in Pulmonary Tuberculosis

Start: Aug 2007Est. completion: Dec 200769 patients
Phase 2Completed
NCT00425113Allergy TherapeuticsMetronidazole

Metronidazole for Pulmonary Tuberculosis (South Korea)

Start: Dec 2006Est. completion: Feb 2013
Phase 2Completed
NCT00144417Alliance PharmaceuticalsMoxifloxacin

TBTC Study 28: Moxifloxacin Versus Isoniazid for TB Treatment

Start: Feb 2006Est. completion: Dec 2007433 patients
Phase 2Completed
NCT02906007Allergy TherapeuticsBedaquiline

Evaluating the Pharmacokinetics, Safety, and Tolerability of Bedaquiline in Infants, Children, and Adolescents With Multidrug-Resistant Tuberculosis, Living With or Without HIV

Start: Sep 2017Est. completion: Apr 2025
Phase 1/2Completed
NCT05592223Merck & Co.BCG Vaccine USP

Phase I Open Label BCG Clinical Trial Assessing TB Drugs and Vaccines

Start: Dec 2022Est. completion: Dec 202320 patients
Phase 1Completed
NCT04865536Alliance PharmaceuticalsTBI-223 1800 mg

Study to Evaluate Safety, Tolerability, and the PK Profile of TBI-223 in Healthy Subjects

Start: Feb 2021Est. completion: May 202228 patients
Phase 1Completed
NCT04890535Alliance PharmaceuticalsTBAJ-587

Evaluation of the Safety, Tolerability, PK of TBAJ-587 in Healthy Adults

Start: Dec 2020Est. completion: Feb 2023106 patients
Phase 1Completed
NCT03363178GC BiopharmaGC3107

Study to Investigate the Safety and Efficacy of GC3107 (BCG Vaccine) in Healthy Adults

Start: Dec 2017Est. completion: Mar 2018
Phase 1Unknown
NCT03199313Alliance PharmaceuticalsSutezolid

Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Sutezolid

Start: Sep 2017Est. completion: Dec 201732 patients
Phase 1Completed
NCT03036163Plus TherapeuticsPBTZ169 - 40 mg

Phase 1 Study of PBTZ169

Start: Jan 2016Est. completion: Nov 2016
Phase 1Completed
NCT02606214Alliance PharmaceuticalsTBA-354

A Multiple Ascending Dose Study With a Dose Formulation Comparison Cohort to Evaluate the Safety, Tolerability, and Pharmacokinetics of TBA-354 in Healthy Adult Subjects

Start: Nov 2015Est. completion: Dec 201618 patients
Phase 1Terminated
NCT02378207SanofiH4:IC31

Safety and Immunogenicity Study of BCG, H4:IC31, and H56:IC31 Revaccination in Healthy Adolescents

Start: May 2015Est. completion: Dec 201684 patients
Phase 1Completed
NCT02288481Alliance PharmaceuticalsTBA-354

A Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TBA-354 in Healthy Adult Subjects

Start: Jan 2015Est. completion: Jun 201548 patients
Phase 1Completed
NCT01690403Sanofirifapentine

Interaction Study to Assess the Pharmacokinetic Interaction of Oral Administration of Rifapentine on ATRIPLA™ in HIV Patients

Start: Dec 2012Est. completion: Mar 201425 patients
Phase 1Completed
NCT01674218Allergy TherapeuticsMoxifloxacin

Effect of PA-824 and of PA-824 Plus Moxifloxacin on the QTc Interval in Healthy Volunteers

Start: Sep 2012Est. completion: Dec 2012
Phase 1Completed
NCT01311505PfizerMyrin© 2

Bioequivalence Study Comparing Rifampicin In A Fixed-Dose Combination (Rifampicin+Isoniazid, Myrin© 2) And The Reference Drug (Rifampicin, Rimactane®)

Start: Apr 2011Est. completion: May 201121 patients
Phase 1Completed
NCT01768273Alliance PharmaceuticalsPA-824

Evaluation of the Pharmacokinetic Interaction Between PA-824 and Midazolam

Start: Dec 2009Est. completion: Apr 201014 patients
Phase 1Completed
NCT01830439Alliance PharmaceuticalsPA-824 200mg

Food Effect Study on the Bioavailability and PK of PA-824 Tablets in Healthy Adult Subjects (CL-009)

Start: Sep 2009Est. completion: Jan 201032 patients
Phase 1Completed
NCT00816426NovartisRifampicin

Measurement of Anti-TB Drugs in Lung Tissue From Patients Having Surgery to Treat Tuberculosis

Start: Dec 2008Est. completion: Dec 201719 patients
Phase 1Completed
NCT01828827Alliance PharmaceuticalsPA-824

Food Effect Study on the Bioavailability and PK of PA-824 Tablets in Healthy Adult Subjects

Start: Mar 2007Est. completion: Mar 200716 patients
Phase 1Completed
NCT00440544NovartisAg85B-ESAT6 fusion protein H1

A Phase I Trial of a LTK63 Adjuvated Tuberculosis Nasal Subunit Vaccine (Ag85B-ESAT6)

Start: Jan 2007Est. completion: Feb 20089 patients
Phase 1Terminated
NCT03202693Alliance PharmaceuticalsPA-824

A Study of the Safety, Tolerability, and Absorption, Metabolism, and Excretion of PA-824 in Healthy Adult Male Subjects.

Start: Mar 2006Est. completion: May 20066 patients
Phase 1Completed
NCT06338462Allergy TherapeuticsChatbot

Cali Sin Tos Aim 2

Start: Mar 2024Est. completion: Sep 2024
N/ACompleted
NCT05941052Heidelberg PharmaTongue swab-based molecular assays

Assessing Diagnostics At Point-of-care for Tuberculosis

Start: Aug 2023Est. completion: Sep 20281,350 patients
N/ARecruiting
NCT04568967Heidelberg PharmaConcentrated urine with Xpert Ultra

TB-CAPT EXULTANT - HIV

Start: Sep 2022Est. completion: Dec 20241,172 patients
N/ACompleted
NCT04567368Heidelberg PharmaXpert MTB/XDR

TB-CAPT MTB/XDR Study

Start: May 2021Est. completion: Dec 2024753 patients
N/AActive Not Recruiting
NCT04923958Heidelberg PharmaNovel mycobacterial culture techniques

Rapid Research in Diagnostics Development for TB Network

Start: Apr 2021Est. completion: May 203126,436 patients
N/ARecruiting
NCT02840877Allergy TherapeuticsDOT Adherence Monitoring

The Impact of Alcohol Consumption on Tuberculosis Treatment Outcomes

Start: May 2017Est. completion: Oct 2023
N/ACompleted
NCT02534727Allergy TherapeuticsSputum Pharmacokinetics of TB Drugs and Bacterial Drug Resistance

Sputum Pharmacokinetics of TB Drugs and Bacterial Drug Resistance

Start: Jan 2016Est. completion: Dec 2020
N/ACompleted
NCT00608790Allergy TherapeuticsSalbutamol

Rapid Diagnosis of Pulmonary Tuberculosis

Start: Feb 2008Est. completion: Apr 2013
N/AUnknown

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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

4 late-stage (Phase 3) programs — potential near-term approvals
2 actively recruiting trials targeting 32,673 patients
12 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)