MedPath

Bedaquiline

Generic Name
Bedaquiline
Brand Names
Sirturo
Drug Type
Small Molecule
Chemical Formula
C32H31BrN2O2
CAS Number
843663-66-1
Unique Ingredient Identifier
78846I289Y

Overview

Bedaquiline is a bactericidal antimycobacterial drug belonging to the class of diarylquinoline. The quinolinic central heterocyclic nucleus with alcohol and amine side chains is responsible for bedaquiline-mediated antimycobacterial activity. Although it is closely related to fluoroquinolones, bedaquiline does not affect DNA gyrase; instead, bedaquiline inhibits the c subunit of ATP synthase responsible for synthesizing ATP. Consequently, bedaquiline can be used to treat mycobacterial infection, particularly tuberculosis (TB). Although the current standard of TB treatment of anti-TB drugs for 2 months, including 2 key drugs isoniazid and rifampin, is highly effective, the emergence of multidrug-resistant TB (MDR-TB) to isoniazid and rifampin has substantially worsened patients outcome. Bedaquiline was approved by the FDA on December 28, 2012, to treat pulmonary MDR-TB, following favorable results in multiple pre-clinical and clinical studies. It is the first drug that was approved in the last 40 years by the FDA for TB unresponsive to current treatments on the market. Currently, bedaquiline is the last-line anti-TB drug and must only be used in an appropriate combination regimen.

Indication

Bedaquiline is indicated as part of combination therapy in the treatment of adult and pediatric patients (5 years and older and weighing at least 15 kg) with pulmonary multi-drug resistant tuberculosis (MDR-TB). Reserve SIRTURO for use when an effective treatment regimen cannot otherwise be provided. This indication is approved under FDA accelerated approval based on time to sputum culture conversion. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Associated Conditions

  • Pulmonary Multi-Drug Resistant Tuberculosis (MDR-TB)

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2025/07/22
Not Applicable
Not yet recruiting
Shenzhen Third People's Hospital
2025/04/01
Phase 3
Not yet recruiting
Shenzhen Third People's Hospital
2024/10/21
Phase 3
Recruiting
2024/08/23
Phase 3
Not yet recruiting
2024/06/04
Not Applicable
Not yet recruiting
2024/01/05
Phase 2
Suspended
2023/11/02
Phase 2
Recruiting
2023/10/13
Phase 3
Active, not recruiting
Beijing Chest Hospital
2023/09/28
Phase 2
Active, not recruiting
2023/07/03
Phase 2
Recruiting
Michael Hoelscher

FDA Drug Approvals

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No FDA approvals found for this drug.

EMA Drug Approvals

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No EMA approvals found for this drug.

HSA Drug Approvals

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No HSA approvals found for this drug.

NMPA Drug Approvals

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No NMPA approvals found for this drug.

PPB Drug Approvals

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No PPB approvals found for this drug.

TGA Drug Approvals

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No TGA approvals found for this drug.

Health Canada Drug Approvals

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No Health Canada approvals found for this drug.

CIMA AEMPS Drug Approvals

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No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

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No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

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No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

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No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

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No UK EMC drug information found for this drug.

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