Last reviewed 2026-04-20 · How we verify

Sirturo (bedaquiline)

Sirturo works by blocking the potassium voltage-gated channel subfamily H member 2, which is essential for the survival of Mycobacterium tuberculosis bacteria.

Sirturo (bedaquiline) is a diarylquinoline antimycobacterial small molecule developed by Janssen Therapeutics, targeting the potassium voltage-gated channel subfamily H member 2. It is FDA-approved for the treatment of drug-resistant tuberculosis and pulmonary tuberculosis. Sirturo is a patented medication with no generic manufacturers available. Key safety considerations include potential cardiac effects and interactions with other medications. As a result, its use should be carefully monitored.

At a glance

Mechanism of action

Bedaquiline is diarylquinoline antimycobacterial drug [see Microbiology (12.4)].

Approved indications

• Drug resistant tuberculosis
• Pulmonary tuberculosis

Boxed warnings

• 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 )

Common side effects

• Nausea
• Arthralgia
• Headache
• Hemoptysis
• Chest Pain
• Anorexia
• Rash
• Blood Amylase Increased
• Abdominal Pain
• Elevation in Liver Enzymes
• Increased Transaminases
• ALT Increased

Drug interactions

• High Risk QT Prolonging Agents
• amiodarone
• artemether
• asenapine
• atazanavir
• bepridil
• boceprevir
• carbamazepine
• cisapride
• clarithromycin
• cobicistat
• conivaptan

Key clinical trials

• Bedaquiline Roll-out Evidence in Contacts and People Living With HIV to Prevent TB (PHASE2,PHASE3)
• Feasibility of the Application of a New Six-month Treatment for Multidrug-resistant Tuberculosis (MDR-TB) Patients in France (FAST-MDR) (PHASE3)
• 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 (PHASE2)
• Trial of Novel Regimens for the Treatment of Pulmonary Tuberculosis (PHASE2)
• Pharmacokinetic Study to Evaluate Anti-mycobacterial Activity of TMC207 in Combination With Background Regimen (BR) of Multidrug Resistant Tuberculosis (MDR-TB) Medications for Treatment of Children/Adolescents With Pulmonary MDR-TB (PHASE2)
• Ultra-Short Course Bedaquiline, Clofazimine, Pyrazinamide and Delamanid Versus Standard Therapy for Drug-Susceptible TB (PHASE2)
• A Study of Quabodepistat-containing Regimens for the Treatment of Drug-resistant Pulmonary Tuberculosis (PHASE3)
• Pharmacokinetics of Antituberculosis Drugs in Breastfeeding Women (PHASE1)

Patents

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• Sirturo CI brief — competitive landscape report
• Sirturo updates RSS · CI watch RSS
• Janssen Therap portfolio CI