Bedaquiline · Sirturo

What is Bedaquiline?

Bedaquiline is a diarylquinoline antimycobacterial small molecule that binds to ATP synthase subunit c of Mycobacterium tuberculosis, inhibiting ATP synthesis and blocking bacterial energy metabolism.

Summary written with AI from the sources listed at the end of this page.

At a glance

Also known as

Sirturo

Drug type

Small molecule

Targets

Mycobacterium tuberculosis ATP synthase subunit c

Mechanism

Inhibitor of Mycobacterium tuberculosis ATP synthase subunit c

Pathways

ATP synthesis, energy metabolism

Therapy area

Infectious disease

Developer

Janssen Therap

In trials of

INVA, IQV

FDA status

Approved as Sirturo (December 28, 2012), NDA204384 · FDA label

✅ FDA-approved uses

• Pulmonary tuberculosis due to Mycobacterium tuberculosis resistant to at least rifampin and isoniazid

From the indications section of the FDA label (version of Oct 17, 2025). Read the full label for the exact wording, limitations and safety information.

🧪 Clinical trials

Trials of the companies BioRadar tracks, from ClinicalTrials.gov, most advanced phase first.

Conditions studied

Mycobacterium Abscessus InfectionMycobacterium Abscessus Pulmonary DiseaseNon-Tuberculous Mycobacteria Pulmonary DiseaseNon-Tuberculous Mycobacterial (NTM) InfectionsDrug Susceptible Pulmonary Tuberculosis

Sources

• FDA label (DailyMed)
• FDA label Sirturo (2025-10-17), indications
• NCI Thesaurus
• ClinicalTrials.gov NCT07485010
• ClinicalTrials.gov NCT07517445
• ClinicalTrials.gov NCT07517445
• ClinicalTrials.gov NCT07517445

Updated Oct 3, 2026.