SIRTURO (bedaquiline fumarate)
SIRTURO is indicated for the treatment of Pulmonary Tuberculosis.
How SIRTURO Works
Bedaquiline is a diarylquinoline that inhibits mycobacterial ATP (adenosine 5'-triphosphate) synthase, an enzyme essential for energy generation in *Mycobacterium tuberculosis*. It specifically binds to the oligomeric subunit c of the ATP synthase complex, disrupting the proton pump mechanism and leading to bacterial cell death.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2012-12-28
- Patent Cliff
- 2029
- Routes
- ORAL
- Dosage Forms
- TABLET
SIRTURO Approval History
What SIRTURO Treats
1 indicationsSIRTURO is approved for 1 conditions since its original approval in 2012. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Pulmonary Tuberculosis
SIRTURO Boxed Warning
QTc PROLONGATION QTc prolongation can occur with SIRTURO. Use with drugs that prolong the QTc interval may cause additive QTc prolongation. Monitor ECGs. Discontinue SIRTURO if significant ventricular arrhythmia or QTc interval greater than 500 ms develops [see Warnings and Precautions (5.1) ] . WARNING: QTc PROLONGATION See full prescribing information for complete boxed warning. QTc Prolongation QTc prolongation can occur with SIRTURO. Use with drugs that prolong the QTc interval may cause add...
WARNING: QTc PROLONGATION QTc prolongation can occur with SIRTURO. Use with drugs that prolong the QTc interval may cause additive QTc prolongation. Monitor ECGs. Discontinue SIRTURO if significant ventricular arrhythmia or QTc interval greater than 500 ms develops [see Warnings and Precautions (5.1) ] . WARNING: QTc PROLONGATION See full prescribing information for complete boxed warning. QTc Prolongation QTc prolongation can occur with SIRTURO. Use with drugs that prolong the QTc interval may cause additive QTc prolongation. Monitor ECGs. Discontinue SIRTURO if significant ventricular arrhythmia or QTc interval greater than 500 ms develops. ( 5.1 )
SIRTURO Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to SIRTURO
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Clinical Trial Registry
31 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06568484 BREACH-TB | IRB00443418 7200AA22CA00005 | Ph 2, Ph 3 | recruiting | Bedaquiline Roll-out Evidence in Contacts and People Living With HIV to Prevent TB |
| NCT04310930 FORMaT | U1111-1209-0672 | Ph 2, Ph 3 | recruiting | Finding the Optimal Regimen for Mycobacterium Abscessus Treatment |
| NCT04630145 results posted | CR108897 TMC207NTM3002 | Ph 2, Ph 3 | completed | 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) |
| NCT06192160 RAD-TB | A5409 DOH-27-032024-5399 | Ph 2 | recruiting | Trial of Novel Regimens for the Treatment of Pulmonary Tuberculosis |
| NCT03828201 DRAMATIC | H39017 U01AI152980 | Ph 2 | active not recruiting | Efficacy and Tolerability of Bedaquiline, Delamanid, Levofloxacin, Linezolid, and Clofazimine to Treat MDR-TB |
| NCT07485010 FORMaT-EVOLVE | FORMaT002 | Ph 2 | not yet recruiting | 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 |
| NCT05556746 PRESCIENT | 2022p003075 U01AI170426 | Ph 2 | active not recruiting | Ultra-Short Course Bedaquiline, Clofazimine, Pyrazinamide and Delamanid Versus Standard Therapy for Drug-Susceptible TB |
| NCT06441006 PRISM-TB | 7200AA22CA00005 7200AA22CA00005 | Ph 2, Ph 3 | recruiting | Program for Rifampicin-Resistant Disease With Stratified Medicine for Tuberculosis |
| NCT05382312 | 214912 | Ph 2 | completed | 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 |
| NCT05766267 CRUSH-TB | 7406 | Ph 2, Ph 3 | active not recruiting | Short-course Regimens for the Treatment of Pulmonary Tuberculosis |
| NCT02333799 results posted | Nix-TB-(B-L-Pa) | Ph 3 | completed | A Phase 3 Trial Assessing Safety and Efficacy of B-Pa-L in Participants With DR-TB |
| NCT02906007 results posted | P1108 11884, IMPAACT P1108 | Ph 1, Ph 2 | completed | Evaluating the Pharmacokinetics, Safety, and Tolerability of Bedaquiline in Infants, Children, and Adolescents With Multidrug-Resistant Tuberculosis, Living With or Without HIV |
| NCT06649721 INSPIRE-BDLL | INSPIRE-BDLL | Ph 3 | active not recruiting | Innovating Shorter, All- Oral, Precised Treatment Regimen for Rifampicin Resistant Tuberculosis：BDLL Chinese Cohort |
| NCT05824871 WISH | JYP0081M301 | Ph 3 | recruiting | A Phase III Study of Oral Sudapyridine (WX-081) Tablets in Rifampicin-Resistant Pulmonary Tuberculosis Patients |
| NCT05686356 panTB-HM | AUR1-1-312 24206, 6986 | Ph 2, Ph 3 | active not recruiting | A Pan-TB Regimen Targeting Host and Microbe |
| NCT06081361 INSPIRE-CODA | BJCH-202301 | Ph 3 | active not recruiting | Innovating Shorter, All- Oral, Precised, Individualized Treatment Regimen for Rifampicin Resistant Tuberculosis：Contezolid, Delamanid and Bedaquiline Cohort |
| NCT06058299 | NC-009 | Ph 2 | active not recruiting | Phase 2 Trial Assessing TBAJ876 or Bedaquiline, with Pretomanid and Linezolid in Adults with Drug-sensitive Pulmonary Tuberculosis |
| NCT02754765 endTB | MSF ERB-1555 | Ph 3 | completed | Evaluating Newly Approved Drugs for Multidrug-resistant TB |
| NCT03800550 | CR108570 2018-004302-25, TMC207NTM1001 | Ph 1 | completed | A Study to Assess the Drug-Drug Interaction Between Bedaquiline and Clarithromycin in Healthy Adult Participants |
| NCT04179500 PaSEM results posted | Pa-824-CL-012 | Ph 2 | completed | A Trial to Evaluate the Male Reproductive Safety of Pretomanid in Adult Male Participants With Drug Resistant Pulmonary Tuberculosis |
| NCT02589782 TB-PRACTECAL | 1541 | Ph 2, Ph 3 | completed | Pragmatic Clinical Trial for a More Effective Concise and Less Toxic MDR-TB Treatment Regimen(s) |
| NCT04207112 PRACTECAL-EE | PRACTECAL-EE | Ph 2, Ph 3 | completed | Economic Evaluation of New MDR TB Regimens |
| NCT03338621 results posted | SimpliciTB (B-Pa-M-Z) NC-008 | Ph 2, Ph 3 | completed | Trial to Evaluate the Efficacy, Safety and Tolerability of BPaMZ in Drug-Sensitive (DS-TB) Adult Patients and Drug-Resistant (DR-TB) Adult Patients |
| NCT02409290 STREAM results posted | 78372190/18148631 (Stage 1/2) | Ph 3 | completed | The Evaluation of a Standard Treatment Regimen of Anti-tuberculosis Drugs for Patients With MDR-TB |
| NCT04608955 WX-081 | JYB0201 | Ph 2 | completed | Evaluation of Early Bactericidal Activity and Safety in Pulmonary Tuberculosis With WX-081 |
| NCT03474198 TRUNCATE-TB | TRUNCATE-TB | Ph 2, Ph 3 | completed | Two-month Regimens Using Novel Combinations to Augment Treatment Effectiveness for Drug-sensitive Tuberculosis |
| NCT03086486 ZeNix results posted | ZeNix (B-Pa-L) NC-007 | Ph 3 | completed | Various Doses and Durations of Linezolid Plus Bedaquiline & Pretomanid in Participants With Drug Resistant Tuberculosis |
| NCT02583048 results posted | A5343 12005 | Ph 2 | completed | Evaluating the Safety, Tolerability, and Pharmacokinetics of Bedaquiline and Delamanid, Alone and in Combination, For Drug-Resistant Pulmonary Tuberculosis |
| NCT04629378 TB_COMBO_01 | TASK-005_TB_COMBO_01 | Ph 2 | completed | Evaluating the EBA of Meropenem With Amoxicillin/Clavulanate and Pyrazinamide or Bedaquiline in Adults With PTB |
| NCT02454205 NEXT | NExT-5001 | Ph 2, Ph 3 | completed | An Open-label RCT to Evaluate a New Treatment Regimen for Patients With Multi-drug Resistant Tuberculosis |
| NCT02193776 NC-005 results posted | NC-005-(J-M-Pa-Z) | Ph 2 | completed | 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. |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
SIRTURO FDA Label Details
Indications & Usage
FDA Label (PDF)SIRTURO is indicated for the treatment of Pulmonary Tuberculosis.
WARNING: QTc PROLONGATION QTc prolongation can occur with SIRTURO. Use with drugs that prolong the QTc interval may cause additive QTc prolongation. Monitor ECGs. Discontinue SIRTURO if significant ventricular arrhythmia or QTc interval greater than 500 ms develops [see Warnings and Precautions (5.1...
SIRTURO Patents & Exclusivity
Exclusivity
Pro Intelligence Preview
Deep insights for SIRTURO
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2029
- • 8 active patents
Trial Analysis
- • 31 total trials
- • Stage: Stable
Competitive Landscape
- • 2 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment