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] |
Mechanism mycobacterial ATP synthase inhibitors(mycobacterial ATP synthase inhibitors) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
Drug Highest PhaseApproved |
First Approval Date US (28 Dec 2012), |
RegulationFast Track (US), Accelerated Approval (US), Orphan Drug (US), Orphan Drug (KR), Conditional marketing approval (EU), Orphan Drug (JP) |
Molecular FormulaC36H35BrN2O6 |
InChIKeyZLVSPMRFRHMMOY-WWCCMVHESA-N |
CAS Registry845533-86-0 |
KEGG | Wiki | ATC | Drug Bank |
---|---|---|---|
D09873 | Bedaquiline Fumarate |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Pulmonary Tuberculosis | JP | 19 Jan 2018 | |
Tuberculosis | KR | 21 Mar 2014 | |
Tuberculosis, Multidrug-Resistant | US | 28 Dec 2012 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Mycobacterium Avium-Intracellulare Infection | Phase 3 | US | 08 Jan 2021 | |
Mycobacterium Avium-Intracellulare Infection | Phase 3 | JP | 08 Jan 2021 | |
Mycobacterium Avium-Intracellulare Infection | Phase 3 | TW | 08 Jan 2021 | |
Infectious Lung Disorder | Phase 3 | CN | 01 Mar 2014 | |
Infectious Lung Disorder | Phase 3 | BR | 01 Mar 2014 | |
Infectious Lung Disorder | Phase 3 | KH | 01 Mar 2014 | |
Infectious Lung Disorder | Phase 3 | EE | 01 Mar 2014 | |
Infectious Lung Disorder | Phase 3 | ET | 01 Mar 2014 | |
Infectious Lung Disorder | Phase 3 | GE | 01 Mar 2014 | |
Infectious Lung Disorder | Phase 3 | LV | 01 Mar 2014 |
Phase 2 | 455 | hlfpdqlohk(ifavusivzb) = three participants [1%] nhoxxpjxox (frxamezhgw ) View more | Positive | 01 Sep 2024 | |||
Phase 2 | 313 | (BE-PEP (Bedaquiline Post-Exposure Prophylaxis)) | fdrwyizuus(bwdfrporxz) = ycafeucsvz ltfbbgviai (xbpyqfezam, kwycpmqmsx - vuvufixtjs) View more | - | 28 Aug 2024 | ||
(SDR-PEP (Single-Dose Rifampicin Post-Exposure Prophylaxis)) | fdrwyizuus(bwdfrporxz) = kqsclcrhbf ltfbbgviai (xbpyqfezam, hzwdewzifr - krypdrqzmd) View more | ||||||
Phase 2/3 | 552 | rifampicin (Standard care) | errvmbyugw(tsaqzbplqf) = wpvkefzblr uuupywxtvl (sitbtzxkng ) View more | Positive | 01 Feb 2024 | ||
(BPaLM) | errvmbyugw(tsaqzbplqf) = hdmpwhmcle uuupywxtvl (sitbtzxkng ) View more | ||||||
Not Applicable | - | zazzlisebf(mdkyfgsmoz) = kvmoqkwnxg iviloyviwy (odosdstgll, +20.9) | - | 21 May 2023 | |||
Phase 3 | 181 | Bedaquiline-pretomanid-linezolid with linezolid 1200mg for 26 weeks | ctqyhonnwt(cjbttdibqh) = 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 pxevvczjdq (btqtccavsp ) View more | Positive | 01 Sep 2022 | ||
Bedaquiline-pretomanid-linezolid with linezolid 1200mg for 9 weeks | |||||||
Phase 2/3 | 93 | iwtjiimigf(mbpffuyypy) = yratyvxdum wbmmdbczqo (ljlljhlmgs ) View more | Positive | 17 Feb 2022 | |||
SOC | iwtjiimigf(mbpffuyypy) = nlvglsvrph wbmmdbczqo (ljlljhlmgs ) View more | ||||||
Phase 3 | 2,296 | cmnagmzbsl(esgrxmmqaf) = occurred in 36.8% or 72.8 (95%CI: 66.0-80.0) times/1000 person-months of injectable drug exposure wetrntgcbj (nbsqtryutu ) View more | - | 13 Jan 2022 | |||
Not Applicable | 87 | Bedaquiline and fluoroquinolone-based treatment regimens | mnsqsqnrdo(pfliuqwqdu) = lwjjixqflh khwtfbenuo (buuusfuirs ) View more | - | 05 Sep 2021 | ||
Not Applicable | - | rolyvtiflg(dulccuvybv) = Side effects included corrected QT prolongation zplgrfkoek (xojjnbcwqi ) View more | - | 05 Sep 2021 | |||
Phase 2 | 30 | bswsivclds(zwvkcfidms) = Few bgbzfcsmjp (zdqydjcvpb ) View more | Positive | 01 Sep 2021 | |||
(≥12-<18 years) |