Bedaquiline clinical trials
Bedaquiline is named as an intervention in 10 current clinical trials in our China, Canada, India, Japan, South Korea, France, Netherlands, Denmark, Taiwan, Singapore, Australia and Israel registers. 6 are recruiting patients now. The most common phase is Phase 3. The sponsor with the most trials is Otsuka Pharmaceutical Development & Commercialization, Inc (1). The most-studied condition is Pulmonary Tuberculosis.
Where Bedaquiline is approved
All regulators →Of the three regulators tracked here, the first to approve Bedaquiline was the US, on 28 Dec 2012. It is approved in 2 of the 3 regulators tracked here.
From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.
Bedaquiline patents and exclusivity
Expiry tracker →Protections still running for marketed products containing Bedaquiline, as listed by the regulators. Expired patents and exclusivities, and discontinued products, are not shown.
- 2 listed patents; the last listed expires 19 Mar 2029 (US 8546428).
- Latest patent on the drug substance itself: 19 Mar 2029 (US 8546428).
- Exclusivity NPP: New patient population, until 28 Jul 2028.
- Exclusivity M-306: Other exclusivity: revisions to the labeling to reflect the results of a clinical study to fulfill post marketing requirement 1988-001, until 21 Jun 2027.
- Exclusivity ODE-307: Orphan drug exclusivity: indicated as part of combination therapy in the treatment of pediatric patients 5 years and older to less than 12 …, until 27 May 2027.
Reproduced from the FDA Orange Book and Purple Book (checked 8 Nov 2026) and the European Commission's Union Register of medicinal products (CC BY 4.0; the EU expiry date is calculated exactly as the Commission's register displays it). Listed patents and dates are as submitted to or published by the regulator and may not reflect litigation, invalidation, settlements, lapsed fees or later extensions. This is not legal advice or a freedom-to-operate opinion, and it does not say when a generic or biosimilar will launch.
What health systems spend on Bedaquiline
All medicines →From NHSBSA Prescription Cost Analysis (Open Government Licence v3.0) and CMS State Drug Utilization Data. Both are gross amounts: neither system publishes its discounts or rebates per drug. Products combining several substances are not counted here.
How Bedaquiline works
All drug targets →- ATP synthase inhibitor InhibitorChEMBL only
- Drug-resistant tuberculosisPhase 3
- Pulmonary tuberculosisPhase 3
- Meningeal tuberculosisPhase 2
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL376488, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 11171, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.
Patient leaflets for Bedaquiline
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 2 products on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- EUEuropean Union: SirturoEMA product information: package leaflet and summary of product characteristics in every EU language.
- UKUnited Kingdom: Search MHRA ProductsPatient information leaflets and SmPCs for UK-licensed products.
- USUnited States: Search DailyMedFDA-approved labels, including patient and medication guides.
Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.
Reference identifiers for Bedaquiline
- ATC code
- J04AK05
- ChEMBL
- CHEMBL376488
- DrugBank
- DB08903
- PubChem CID
- 5388906
- CAS number
- 843663-66-1
- FDA UNII
- 78846I289Y
- Wikidata
- Q1257318
- Wikipedia
- Bedaquiline
Codes that identify this medicine in other databases, from Wikidata (CC0), matched by its ChEMBL ID. The ATC code is the WHO classification of what the medicine is used for.
Trials by status
Trials by phase
Clinical trials of Bedaquiline
10 trialsRegisters list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.
Bedaquiline across our data
Ireland · EU · USThe same active substance in our other registers, matched by its exact name. Each entry links to the register record it comes from.
Licensed in Ireland (HPRA)
2 single-substance products containing Bedaquiline on the HPRA medicines list.
- SIRTURO 100 mg tabletsJanssen-Cilag International NV · EU/1/13/901/001
- SIRTURO 20 mg tabletsJanssen-Cilag International NV · EU/1/13/901/003
Supply shortages
No entry for Bedaquiline in the EMA, FDA or German BfArM shortage lists we track.
Conditions studied with Bedaquiline
18 conditionsAll 18 conditions
| Condition (as registered) | Trials |
|---|---|
| Pulmonary Tuberculosis | 3 |
| Rifampicin-Resistant Pulmonary Tuberculosis | 1 |
| Multidrug-Resistant Pulmonary Tuberculosis | 1 |
| Rifampin-Resistant Pulmonary Tuberculosis | 1 |
| Tuberculosis, Multidrug-Resistant (MDR-TB) | 1 |
| Drug-resistant Tuberculosis | 1 |
| Rifampin-resistant Tuberculosis | 1 |
| Rifampicin-resistant Tuberculosis | 1 |
| Tuberculosis | 1 |
| MDR-TB | 1 |
| Tuberculosis Multi Drug Resistant Active | 1 |
| Antibiotic Resistance | 1 |
| Mycobacterium Tuberculosis | 1 |
| Pulmonary Disease Due to Mycobacteria (Diagnosis) | 1 |
| Tuberculosis, Pulmonary | 1 |
| Tuberculosis Infection | 1 |
| Non-Tuberculous Mycobacterial (NTM) Pneumonia | 1 |
| Mycobacterium Abscessus Infection | 1 |
Sponsors
lead sponsor per trial| Lead sponsor | Trials |
|---|---|
| Otsuka Pharmaceutical Development & Commercialization, Inc | 1 |
| Shanghai Jiatan Pharmatech Co., Ltd | 1 |
| Huashan Hospital | 1 |
| Shenzhen Third People's Hospital | 1 |
| Beijing Chest Hospital | 1 |
| Beijing Children's Hospital | 1 |
| Assistance Publique - Hôpitaux de Paris | 1 |
| The University of Queensland | 1 |
| Centers for Disease Control and Prevention | 1 |
| Vancouver Coastal Health | 1 |
By country register
A trial with sites in more than one country appears in each of those registers.
Related compounds
Questions about Bedaquiline trials
How many clinical trials are testing Bedaquiline?
10 current trials in our China, Canada, India, Japan, South Korea, France, Netherlands, Denmark, Taiwan, Singapore, Australia and Israel registers name Bedaquiline as a drug or biological intervention, as of the registry sync on 10 November 2026. Completed and withdrawn studies are not counted.
Are Bedaquiline trials recruiting patients?
Yes. 6 of the 10 trials are recruiting: 4 with sites in China, 1 with sites in India, 1 with sites in Japan, 1 with sites in South Korea, 1 with sites in France, 1 with sites in Netherlands, 1 with sites in Denmark, 1 with sites in Taiwan, 1 with sites in Singapore, 1 with sites in Australia and 1 with sites in Israel. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Who sponsors Bedaquiline clinical trials?
Otsuka Pharmaceutical Development & Commercialization, Inc (1), Shanghai Jiatan Pharmatech Co., Ltd (1), Huashan Hospital (1) and Shenzhen Third People's Hospital (1), among 10 lead sponsors in total. The number in brackets is how many trials each organisation leads.
Is Bedaquiline licensed in Ireland?
Yes. The HPRA medicines list includes 2 single-substance products containing Bedaquiline, for example SIRTURO 100 mg tablets (Janssen-Cilag International NV). A licence does not mean a product is currently marketed or reimbursed; see each product's record.
Is there a Bedaquiline shortage?
Not in the lists we track: Bedaquiline has no entry in the EMA, FDA or German BfArM shortage registers as of their latest sync.
Where does this information come from?
Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Bedaquiline works or whether it is effective, and it is not medical advice.
How this page is built
Everything on this page is copied from public ClinicalTrials.gov registry records — it is not written from memory, and nothing here describes how Bedaquiline works or whether it is effective. Each trial links to its own record so you can check it yourself.
- ClinicalTrials.gov (U.S. National Library of Medicine) ↗ Trial IDs, titles, intervention names and synonyms, phase, overall status, lead sponsor and conditions for every trial on this page
This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Bedaquiline (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 10 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.