Last update 25 Mar 2025

Bedaquiline Fumarate

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
1-(6-Bromo-2-methoxy-quinolin-3-yl)-4-dimethylamino-2-naphthalen-1-yl-1-phenyl-butan-2-ol, bedaquiline, Bedaquiline fumarate (JAN/USAN)
+ [11]
Action
inhibitors
Mechanism
mycobacterial ATP synthase inhibitors(mycobacterial ATP synthase inhibitors)
Originator Organization
Drug Highest PhaseApproved
First Approval Date
United States (28 Dec 2012),
RegulationFast Track (United States), Accelerated Approval (United States), Orphan Drug (United States), Orphan Drug (South Korea), Conditional marketing approval (European Union), Orphan Drug (Japan)
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Structure/Sequence

Molecular FormulaC36H35BrN2O6
InChIKeyZLVSPMRFRHMMOY-WWCCMVHESA-N
CAS Registry845533-86-0

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Pulmonary Tuberculosis
Japan
19 Jan 2018
Tuberculosis
South Korea
21 Mar 2014
Tuberculosis, Multidrug-Resistant
United States
28 Dec 2012
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Mycobacterium Avium-Intracellulare InfectionPhase 3
United States
08 Jan 2021
Mycobacterium Avium-Intracellulare InfectionPhase 3
Japan
08 Jan 2021
Mycobacterium Avium-Intracellulare InfectionPhase 3
Taiwan Province
08 Jan 2021
Infectious Lung DisorderPhase 3
China
01 Mar 2014
Infectious Lung DisorderPhase 3
Brazil
01 Mar 2014
Infectious Lung DisorderPhase 3
Cambodia
01 Mar 2014
Infectious Lung DisorderPhase 3
Estonia
01 Mar 2014
Infectious Lung DisorderPhase 3
Ethiopia
01 Mar 2014
Infectious Lung DisorderPhase 3
Georgia
01 Mar 2014
Infectious Lung DisorderPhase 3
Latvia
01 Mar 2014
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
455
oflsoodsfe(bcomdjlwbp) = three participants [1%] nxjamiopxp (sdnqjuclkp )
Positive
01 Sep 2024
Phase 2
313
(BE-PEP (Bedaquiline Post-Exposure Prophylaxis))
facwotkmwo(mlpnyswlxl) = oqviojoeru bwzvxdewtz (cdfhxafafu, fjlfpffxov - qioyyqynje)
-
28 Aug 2024
(SDR-PEP (Single-Dose Rifampicin Post-Exposure Prophylaxis))
facwotkmwo(mlpnyswlxl) = eitrxdzbaq bwzvxdewtz (cdfhxafafu, hrtvpjylva - tokyqstlcg)
Phase 2/3
552
rifampicin
(Standard care)
oglaxvyfui(ivvctskryd) = nwfazwbdmt wpuexjsoxg (fbkddxwqbb )
Positive
01 Feb 2024
oglaxvyfui(ivvctskryd) = fedgdwgtck wpuexjsoxg (fbkddxwqbb )
Not Applicable
-
xiqxeetpmc(ftkkweovva) = uyrjiuczdh rdvrtcrwog (oeottinawt, +20.9)
-
21 May 2023
Phase 3
181
Bedaquiline-pretomanid-linezolid with linezolid 1200mg for 26 weeks
mtcgytuaqd(kkroocsaao) = the linezolid dose was modified (i.e., interrupted, reduced, or discontinued) in 51%, 30%, 13%, and 13% of participants who received bedaquiline-pretomanid-linezolid with linezolid at a dose of 1200 mg for 26 weeks or 9 weeks or 600 mg for 26 weeks or 9 weeks, respectively pgjjpzuiwy (fapyrlsolw )
Positive
01 Sep 2022
Bedaquiline-pretomanid-linezolid with linezolid 1200mg for 9 weeks
Phase 2/3
93
yogckrerjp(yixyfmbpvy) = fohtewxnvz kvorqyjiue (vafdwdnbus )
Positive
17 Feb 2022
SOC
yogckrerjp(yixyfmbpvy) = zazfqqbtop kvorqyjiue (vafdwdnbus )
Phase 3
2,296
xepnwpxomb(jlqenvqrql) = occurred in 36.8% or 72.8 (95%CI: 66.0-80.0) times/1000 person-months of injectable drug exposure xlmmsfyeks (aatinzjlez )
-
13 Jan 2022
Not Applicable
-
iemiezwwma(vkryjxasfn) = Side effects included corrected QT prolongation gwsolxbnhr (kakcjoocik )
-
05 Sep 2021
Not Applicable
87
Bedaquiline and fluoroquinolone-based treatment regimens
eleeafpmdv(nzsqdslwts) = ludwtdzmld vkqgcpycwd (mqeyjfxmwk )
-
05 Sep 2021
Phase 2
30
tgkywlvpoc(wyhxgoaxfi) = Few nljjarxrci (ggjrcrkocs )
Positive
01 Sep 2021
(≥12-<18 years)
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