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Label indication SIRTURO is a diarylquinoline antimycobacterial drug indicated as part of combination therapy in the treatment of adult and pediatric patients (2 years and older and weighing at least 8 kg) with pulmonary tuberculosis (TB) due to Mycobacterium tuberculosis resistant to at least rifampin and isoniazid. FDA label
Also known as Bedaquiline (Test formulation), Bedaquiline (TMC207), TMC207 (bedaquiline)
Bedaquiline · 2 trials · 2 indications
Number of participants with sputum culture conversion in MGIT at Week 24 was reported. Sputum culture conversion was defined as 3 consecutive negative sputum cultures taken at least 25 days apart.
Change from baseline in the odds of M. leprae growth in mouse footpads will be evaluated. M. leprae bacilli will be inoculated in footpads of mice, according to the method of Shepard. M. leprae growth will be determined by technologists trained and experienced in mouse footpad procedures, at 1 year after infection (or at mouse death or humane endpoint, if it occurs greater than or equal to \[\>=\] 6 months after footpad inoculation). The number of footpads with positive growth (\>=10\^5 M. leprae) will be counted and used to determine the odds of bacterial growth.
| Arm | Type | Description |
|---|---|---|
| Group A: Bedaquiline (BDQ) + Clarithromycin (CAM) + Ethambutol (EB) | EXPERIMENTAL | Participants will receive BDQ 400 milligrams (mg) (4\*100 mg tablets) once daily (qd) from Week 1-2 (loading phase), BDQ 200 mg (2\*100mg tablets) bi-weekly (biw) from Week 3 to 48 (maintenance phase) and CAM 400 mg or 500 mg twice daily (2\*200 mg tablets) along with EB 500-750 mg or 15 mg/kg once a day or maximum daily dose of 1.0 gram for up to Week 48. |
| Group B: Rifampicin (RFP) or Rifabutin (RBT) + CAM + EB | ACTIVE_COMPARATOR | Participants will receive maximum of 4 capsules of RFP 450 mg daily (or maximum daily dose of 600 mg), CAM 400 mg or 500 mg (2\*200 mg tablets) twice a day along with EB 500-750 mg daily or 15 mg/kg once a day or maximum daily dose of 1.0 gram for up to Week 48, followed by 2 capsules of RBT 300 mg or 150 mg once a day. |
| Bedaquiline | EXPERIMENTAL | Participants will receive bedaquiline 200 (milligram) mg (2\*100 mg tablets) once daily for 2 weeks followed by 100 mg tablet three times a week (tiw) for 6 weeks with at least 48 hours between doses. |
| Name | Type | Description |
|---|---|---|
| Bedaquiline | DRUG | Participants will receive BDQ tablets only/ |
| Clarithromycin | DRUG | Participants will receive CAM 400 or 500 mg twice a day. |
| Ethambutol | DRUG | Participants will receive 500 to 750 mg daily (maximum daily dose of 1.0 gram \[g\]) or 15 mg/kg once a day. |
| Rifampicin | DRUG | Participants will receive daily dose is 450 mg (maximum 600 mg) RFP capsule once a day. |
| Rifabutin | DRUG | Participants will receive daily dose of RBT 300 mg or 150 mg capsules once a day. |
| Bedaquiline 200 mg | DRUG | Participants will receive bedaquiline 200 mg (2\*100 mg tablets) once daily for 2 weeks followed by 100 mg tablet tiw for 6 weeks with at least 48 hours between doses. |
Inclusion Criteria: * Has body weight greater than or equal to (\>=) 40 kilograms (kg) at screening and on Day 1 * Has radiological evidence consistent with nontuberculous mycobacterial lung disease (NTM-LD) based on a chest Computed Tomography (CT) scan taken within 6 months prior to screening or ...
Bedaquiline is being studied for treatment-refractory Mycobacterium avium complex lung disease (MAC-LD) and for multibacillary leprosy. In MAC-LD it is given as part of a regimen with clarithromycin and ethambutol. Both uses are investigational, and the drug is in Phase 2 clinical development for these indications.
Bedaquiline targets ATP synthase, the enzyme that produces adenosine triphosphate in mycobacteria. By inhibiting this target, the drug interferes with the energy supply that mycobacterial cells need to survive. This mechanism underlies its activity against the mycobacterial infections being studied in its clinical program.
Bedaquiline is developed by Johnson & Johnson, which trades under the ticker JNJ. The company is the sponsor behind the clinical studies evaluating the drug in mycobacterial infections, including treatment-refractory Mycobacterium avium complex lung disease and multibacillary leprosy.
Bedaquiline is in Phase 2 clinical development for treatment-refractory Mycobacterium avium complex lung disease and multibacillary leprosy. It is investigational for these indications and has not been approved for them. The Phase 2 studies have been completed, and no trials are currently active.
Bedaquiline has been studied in two completed Phase 2 trials. NCT04630145 evaluated it with clarithromycin and ethambutol in 129 adults with treatment-refractory Mycobacterium avium complex lung disease across Japan, South Korea, and Taiwan. NCT03384641 evaluated its efficacy and safety in 11 adults with multibacillary leprosy in Brazil.