Sirturo

(Bedaquiline)

ApprovedSmall molecule

Bedaquiline is used to treat drug-resistant tuberculosis, a serious lung infection that doesn't respond to standard tuberculosis medications.[2] Sirturo is currently approved and in use across 13 indications[4].[1]

Sirturo is one of 244 small molecule programs targeting MDR-TB. It is currently in Approved.

Indications

Total Trials

Active Trials

243

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

MDR-TBRecruiting

Liver DiseaseApproved

Drug-Resistant TuberculosisActive, not recruiting

Tuberculosis, Multidrug-ResistantActive, not recruiting

Tuberculosis, PulmonaryActive, not recruiting

Tuberculosis, LatentRecruiting

DrugCompleted

TreatmentCompleted

Multidrug-Resistant TuberculosisUnknown status

Pulmonary TuberculosisActive, not recruiting

MDR-TBPhase 3

Recruiting

Liver DiseaseApproved

Approved

Drug-Resistant TuberculosisPreclinical

Active, not recruiting

Tuberculosis, Multidrug-ResistantPhase 2

Active, not recruiting

Tuberculosis, PulmonaryPhase 2

Active, not recruiting

Tuberculosis, LatentPreclinical

Recruiting

DrugPhase 3

Completed

TreatmentPreclinical

Completed

Multidrug-Resistant TuberculosisApproved

Unknown status

Pulmonary TuberculosisPhase 3

Active, not recruiting

Showing 10 of 13 indications

Competition

Competitive Landscape

350 competitors in Treatment

#DrugCompanyPhaseTrials

Sirturo

WWim Janssens

Approved

1 2

Dexilant

Takeda

Preclinical

2 3

Alfenta

Jazz Pharmaceuticals

Preclinical

1 4

Niclocide

Bayer

Preclinical

1 5

Hivid

CConrado Roberto Hoffmann Filho

Preclinical

6 6

Foscavir

CClinigen, Inc.

Preclinical

6 7

Valium

Akero Therapeutics

Preclinical

2 8

Aurlumyn

BBTG International Inc.

Preclinical

1 9

Lotemax

PPharmos

Preclinical

1 10

Norpramin

VValidus Pharmaceuticals

Preclinical

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

Timeline

Expected Milestones

Q4 2026

Phase 3Recruiting

Pulmonary Tuberculosis

NCT05824871

Phase 3Active, not recruiting

Tuberculosis

NCT06081361

Q1 2027

Phase 2Active, not recruiting

Tuberculosis, Pulmonary

NCT05556746

Phase 2Active, not recruiting

Pulmonary TB

NCT06058299

Q2 2027

Phase 2Active, not recruiting

Tuberculosis, Multidrug-Resistant

NCT03828201

Phase 3Active, not recruiting

Tuberculosis

NCT06649721

Clinical

Trials by Indication[1]

Tuberculosis9 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

Two-month Regimens Using Novel Combinations to Augment Treatment Effectiveness for Drug-sensitive Tuberculosis

Completed·UUniversity College, London·Phase 2/3·NCT03474198·675 enrolled

Innovating Shorter, All- Oral, Precised Treatment Regimen for Rifampicin Resistant Tuberculosis：BDLL Chinese Cohort

Active, not recruiting·HHuashan Hospital·Phase 3·NCT06649721·120 enrolled

Show 6 more trials

Building Evidence for Advancing New Treatment for Rifampicin Resistant Tuberculosis (RR-TB) Comparing a Short Course of Treatment (Containing Bedaquiline, Delamanid and Linezolid) With the Current South African Standard of Care

Completed·WWits Health Consortium (Pty) Ltd·Phase 3·NCT04062201·402 enrolled

Innovating Shorter, All- Oral, Precised, Individualized Treatment Regimen for Rifampicin Resistant Tuberculosis：Contezolid, Delamanid and Bedaquiline Cohort

Active, not recruiting·—·Phase 3·NCT06081361·186 enrolled

An Open-label RCT to Evaluate a New Treatment Regimen for Patients With Multi-drug Resistant Tuberculosis

Completed·UUniversity of Cape Town·Phase 2/3·NCT02454205·154 enrolled

Short-Course Regimen With Bedaquiline, Moxifloxacin and Pyrazinamide for Early Bactericidal Activity in Drug-Susceptible Tuberculosis

Not yet recruiting·SShanghai Pulmonary Hospital, Shanghai, China·Phase 2·NCT07129629·45 enrolled

The Evaluation of a Standard Treatment Regimen of Anti-tuberculosis Drugs for Patients With MDR-TB

Completed·IIUATLD, Inc·Phase 3·NCT02409290·588 enrolled

A Phase I/II, Open-Label, Single Arm Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Bedaquiline (BDQ) Given in Combination With an Individualized Rifampin-Resistant Tuberculosis (RR-TB) Therapy in Infants, Children, and Adolescents With RR-TB Disease, Living With or Without HIV

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Preclinical·NCT02906007·54 enrolled

Pulmonary Tuberculosis8 trials

Short-course Regimens for the Treatment of Pulmonary Tuberculosis

Active, not recruiting·CCenters for Disease Control and Prevention·Phase 2/3·NCT05766267·288 enrolled

Early Bactericidal Activity, Safety & Tolerability of Oral GSK3036656 in a Dual Combination With Novel and Established Antitubercular Agents, or Standard of Care in Adults With Rifampicin Susceptible Pulmonary Tuberculosis

Completed· GSK logo

GSK·Phase 2·NCT05382312·127 enrolled

Evaluating the Safety, Tolerability, and Pharmacokinetics of Bedaquiline and Delamanid, Alone and in Combination, For Drug-Resistant Pulmonary Tuberculosis

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT02583048·84 enrolled

Show 5 more trials

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.

Completed·GGlobal Alliance for TB Drug Development·Phase 2·NCT02193776·240 enrolled

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

Evaluation of Early Bactericidal Activity and Safety in Pulmonary Tuberculosis With WX-081

Completed·SShanghai Jiatan Pharmatech Co., Ltd·Phase 2·NCT04608955·99 enrolled

A Phase III Study of Oral Sudapyridine (WX-081) Tablets in Rifampicin-Resistant Pulmonary Tuberculosis Patients

Recruiting·SShanghai Jiatan Pharmatech Co., Ltd·Phase 3·NCT05824871·450 enrolled

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

Recruiting·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT06192160·315 enrolled

Tuberculosis, Pulmonary3 trials

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

A Phase IIc, Open-Label, Randomized Controlled Trial of Ultra-Short Course Bedaquiline, Clofazimine, Pyrazinamide and Delamanid Versus Standard Therapy for Drug-Susceptible Tuberculosis (PRESCIENT)

Active, not recruiting·BBrigham and Women's Hospital·Phase 2·NCT05556746·94 enrolled

Drug2 trials

Evaluating Newly Approved Drugs for Multidrug-resistant TB

Completed·MMédecins Sans Frontières, France·Phase 3·NCT02754765·754 enrolled

Linezolid Dosing Strategies in Drug-Resistant TB

Active, not recruiting·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT05007821·138 enrolled

Abscess2 trials

Finding the Optimal Regimen for Mycobacterium Abscessus Treatment

Recruiting·TThe University of Queensland·Phase 2/3·NCT04310930·300 enrolled

Bacteriophage Therapy for Mycobacterium Abscessus Pulmonary Infection

Enrolling by invitation·VVancouver Coastal Health·Phase 1·NCT07228702·1 enrolled

25 more indications

Tuberculosis, Multidrug-Resistant2 trials

TMC207-TIDP59-C211: A Phase 2, Open-label, Multicenter, Single-arm Study to Evaluate the Pharmacokinetics, Safety, Tolerability and Anti-mycobacterial Activity of TMC207 in Combination With a Background Regimen (BR) of Multidrug Resistant Tuberculosis (MD

Suspended· Johnson & Johnson logo

Johnson & Johnson·Phase 2·NCT02354014·60 enrolled

Prospective, Randomized, Partially Blinded, Phase 2 Study of the Efficacy and Tolerability of Bedaquiline, Delamanid, Levofloxacin, Linezolid, and Clofazimine for Treatment of Patients With MDR-TB

Active, not recruiting·BBoston University·Phase 2·NCT03828201·271 enrolled

Pulmonary TB2 trials

A Multicenter, Phase 2b/c, Open-label, Randomized, Dose-finding Trial to Evaluate the Safety and Efficacy of a 4 Month Regimen of OPC-167832 in Combination With Delamanid and Bedaquiline in Subjects With Drug-susceptible Pulmonary Tuberculosis in Comparison With Standard Treatment

Completed· Otsuka logo

Otsuka·Phase 2·NCT05221502·122 enrolled

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

Meropenem1 trial

Evaluating the EBA of Meropenem With Amoxicillin/Clavulanate and Pyrazinamide or Bedaquiline in Adults With PTB

Completed·TTASK Applied Science·Phase 2·NCT04629378·22 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

Trial1 trial

A PAN-USR TB Multi-Center Trial

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

Fluoroquinolone1 trial

Evaluating Newly Approved Drugs in Combination Regimens for Multidrug-Resistant TB With Fluoroquinolone Resistance (endTB-Q)

Completed·MMédecins Sans Frontières, France·Phase 3·NCT03896685·323 enrolled

Adult1 trial

A Study of Bedaquiline 100 Milligram (mg) Tablets Administered as Different Test Formulations Compared to the Commercial Tablet Formulation (F001) in Healthy Adult Participants

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT04087759·36 enrolled

Leprosy1 trial

A Study to Evaluate the Efficacy and Safety of Bedaquiline (TMC207) in Participants With Multibacillary Leprosy

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 2·NCT03384641·11 enrolled

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

Interaction1 trial

A Study to Assess the Drug-Drug Interaction Between Bedaquiline and Clarithromycin in Healthy Adult Participants

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT03800550·16 enrolled

Safety and Efficacy1 trial

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

Completed·GGlobal Alliance for TB Drug Development·Phase 3·NCT02333799·109 enrolled

Lung Disease1 trial

A Study of Bedaquiline Administered as Part of a Treatment Regimen With Clarithromycin and Ethambutol in Adult Patients With Treatment-refractory Mycobacterium Avium Complex-lung Disease (MAC-LD)

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 2/3·NCT04630145·129 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

Treatment1 trial

Refining MDR-TB Treatment (T) Regimens (R) for Ultra(U) Short(S) Therapy(T)-PLUS

Completed·HHuashan Hospital·N/A·NCT04717908·89 enrolled

ESS1 trial

Platform Assessing Regimens and Durations In a Global Multisite Consortium for TB

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

Elderly1 trial

Ultra-Short Regimen for Elderly DS-TB

Not yet recruiting·SShenzhen Third People's Hospital·Phase 3·NCT07076225·300 enrolled

Cystic Fibrosis1 trial

Testing a Novel Combination Treatment (Arm D) Versus Standard of Care for Intensive Phase Treatment for Mycobacterium Abscessus Pulmonary Disease in People With or Without Cystic Fibrosis in the Finding the Optimal Regimen for Mycobacterium Abscessus Treatment (FORMaT) Adaptive Platform Trial

Not yet recruiting·TThe University of Queensland·Phase 2·NCT07485010·300 enrolled

Female1 trial

TASK-002: Bioequivalence of Bedaquiline 400mg Administered in Crushed Form Compared to Tablet Form in Healthy Male and Female Adults Under Fed Conditions (BDQ Crush Study)

Completed·IInternational Maternal Pediatric Adolescent AIDS Clinical Trials Group·Phase 1·NCT03032367·24 enrolled

Multidrug-Resistant Tuberculosis1 trial

A Study of an Oral Short-course Regimen Including Bedaquiline for the Treatment of Participants With Multidrug-resistant Tuberculosis in China

Unknown status·—·Phase 4·NCT05306223·212 enrolled

RR-TB1 trial

6 Months of Bedaquiline(BDQ), Delamanid(DLM), Linezolid(LZD) and Levofloxacin(LFX) in RR-TB Patients in Hubei Province

Not yet recruiting·WWuhan Pulmonary Hospital·N/A·NCT07198685·52 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

MDR-TB1 trial

Feasibility of the Application of a New Six-month Treatment for Multidrug-resistant Tuberculosis (MDR-TB) Patients in France - FAST-MDR

Recruiting·AAssistance Publique - Hôpitaux de Paris·Phase 3·NCT07486024·55 enrolled

Tuberculosis, Latent1 trial

Bedaquiline Roll-out Evidence in Contacts and People Living With HIV to Prevent TB (BREACH-TB)

Recruiting·JJohns Hopkins University·Preclinical·NCT06568484·2,530 enrolled

Unspecified4 trials

BTZ-043 Dose Evaluation in Combination and Selection

Unknown status·MMichael Hoelscher·Phase 2·NCT05926466·90 enrolled

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

Show 1 more trial

Economic Evaluation of New MDR TB Regimens

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

Regulatory

FDA Approval Timeline[5]

Dec 28, 2012

SIRTURO

NDA NDA204384

Aug 28, 2013

SIRTURO

NDA NDA204384

Aug 4, 2014

SIRTURO

NDA NDA204384

Oct 17, 2014

SIRTURO

NDA NDA204384

May 14, 2015

SIRTURO

NDA NDA204384

Dec 9, 2015

SIRTURO

NDA NDA204384

Feb 10, 2016

SIRTURO

NDA NDA204384

Aug 9, 2019

SIRTURO

NDA NDA204384

Aug 15, 2019

SIRTURO

NDA NDA204384

Dec 3, 2019

SIRTURO

NDA NDA204384

Jan 6, 2020

SIRTURO

NDA NDA204384

May 27, 2020

SIRTURO

NDA NDA204384

May 27, 2020

SIRTURO

NDA NDA204384

Sep 23, 2021

SIRTURO

NDA NDA204384

Oct 12, 2023

SIRTURO

NDA NDA204384

Jun 21, 2024

SIRTURO

NDA NDA204384

Jul 28, 2025

SIRTURO

NDA NDA204384

Sources

References

[1]
ClinicalTrials.gov — 54 trial records for Bedaquiline. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Sirturo drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Bedaquiline compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Bedaquiline. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA204384). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Sirturo. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Wim Janssens company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: ATP Synthase Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: WWim Janssens

Patent Landscape[6]

Patent Cliff

Dec 1, 2026

Earliest patent expiration — generic entry possible after this date

Patent #Expires

7498343Dec 1, 2026

8546428Mar 19, 2029

Sirturo

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2027

Q2 2027

Trials by Indication[1]

Tuberculosis9 trials

Pulmonary Tuberculosis8 trials

Tuberculosis, Pulmonary3 trials

Drug2 trials

Abscess2 trials

Tuberculosis, Multidrug-Resistant2 trials

Pulmonary TB2 trials

Meropenem1 trial

Aging1 trial

Trial1 trial

Fluoroquinolone1 trial

Adult1 trial

Leprosy1 trial

Drug-Resistant Tuberculosis1 trial

Interaction1 trial

Safety and Efficacy1 trial

Lung Disease1 trial

Clinical Trial1 trial

Treatment1 trial

ESS1 trial

Elderly1 trial

Cystic Fibrosis1 trial

Female1 trial

Multidrug-Resistant Tuberculosis1 trial

RR-TB1 trial

Pregnancy1 trial

Quality of Life1 trial

MDR-TB1 trial

Tuberculosis, Latent1 trial

Unspecified4 trials

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Patent Landscape[6]

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