Bedaquiline

Manufactured by Johnson & Johnson

Sourced in Belgium

Bedaquiline is a laboratory-produced compound that is used as an active pharmaceutical ingredient. It is designed to inhibit the ATP synthase enzyme in certain types of bacteria, which can help in the treatment of tuberculosis. The core function of Bedaquiline is to act as an antimicrobial agent, without further interpretation of its intended use.

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Lab products found in correlation

Clofazimine, by Merck Group (4 mentions) Kanamycin sulfate, by Thermo Fisher Scientific (4 mentions) Rifabutin, by Merck Group (4 mentions) Rifapentine, by Merck Group (3 mentions) Rifampin, by GoldBio (3 mentions) Isoniazid, by Merck Group (2 mentions) Hematoxylin andeosin stains, by Thermo Fisher Scientific (2 mentions) 9 aminoacridine 9 aa, by Merck Group (2 mentions) Superfrost plus slide, by Thermo Fisher Scientific (2 mentions) Pyrazinamide, by Merck Group (2 mentions) Bedaquiline, by Merck Group (1 mentions) Rifampin, by Merck Group (1 mentions) Streptomycin, by Merck Group (1 mentions) Ciprofloxacin, by Merck Group (1 mentions) Prism 5, by GraphPad (1 mentions) Rifampin, by Sandoz (1 mentions) Rifapentine, by Biosynth (1 mentions) N methyl pyrrolidone (nmp), by Thermo Fisher Scientific (1 mentions) Bedaquiline fumarate salt, by Johnson & Johnson (1 mentions) 2 5 dihydroxybenzoic acid, by Thermo Fisher Scientific (1 mentions)

Spelling variants of this product

Bedaquiline fumarate salt (2 citations)

11 protocols using bedaquiline

Antimicrobial Compounds Acquisition

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Bedaquiline was obtained from Janssen, Pharmaceutical Companies of Johnson &
Johnson. Aurachin D was a kind gift from Dr. Jennifer Herrmann (Helmholtz Centre
for Infection Research and Pharmaceutical Biotechnology, Saarbrücken).
All other chemicals were bought from Sigma unless indicated otherwise.

Lu P., Heineke M.H., Koul A., Andries K., Cook G.M., Lill H., van Spanning R, & Bald D. (2015). The cytochrome bd-type quinol oxidase is important for survival of Mycobacterium smegmatis under peroxide and antibiotic-induced stress. Scientific Reports, 5, 10333.

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In-vitro Evolution of Drug-Resistant Mycobacteria

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In-vitro evolution experiments were done with the H37Rv reference strain (ATCC 27294). Bedaquiline was purchased from Janssen-Cilag (Neuss, Germany) and clofazimine from Sigma (C8895-1G; Darmstadt, Germany) and both were reconstituted from powder in dimethyl sulphoxide and stored at –20°C.
Bacteria were exposed in liquid culture to Bedaquiline or clofazimine concentrations that were lower than the corresponding MICs, over five bacterial passages (appendix 1 p 12). The bacteria were plated on selective agar plates supplemented with the MIC of Bedaquiline or clofazimine. Mutant colonies were selected from these plates for population sequencing and characterisation. Further details are given in appendix 1 (p 2).

Sonnenkalb L., Carter J.J., Spitaleri A., Iqbal Z., Hunt M., Malone K.M., Utpatel C., Cirillo D.M., Rodrigues C., Nilgiriwala K.S., Fowler P.W., Merker M, & Niemann S. (2023). Bedaquiline and clofazimine resistance in Mycobacterium tuberculosis: an in-vitro and in-silico data analysis. The Lancet. Microbe, 4(5), e358-e368.

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Antimicrobial Susceptibility of M. smegmatis

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Sensitivity of wild-type and ΔfbiC strains of M. smegmatis to bedaquiline (Janssen Infectious Diseases & Vaccines), isoniazid (Sigma), streptomycin (Sigma), rifampin (Sigma), and ciprofloxacin (Sigma) was determined using a broth microdilution assay (45 (link)). Aliquots (2 ml) of 7H9 liquid medium containing 2-fold serial dilutions of bedaquiline, isoniazid, rifampin, streptomycin, or ciprofloxacin were inoculated with 2 ml of mid-exponential-phase cultures of M. smegmatis to a final OD₆₀₀ of ~0.002. OD₆₀₀ values were determined after 24 h of incubation at 37°C with aeration. Sigmoidal dose-response (variable slope) nonlinear fit was calculated using GraphPad Prism 5.0 (GraphPad Software).

Maglica Ž., Özdemir E, & McKinney J.D. (2015). Single-Cell Tracking Reveals Antibiotic-Induced Changes in Mycobacterial Energy Metabolism. mBio, 6(1), e02236-14.

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Mycobacterial Drug Preparation Protocols

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Bedaquiline was provided by Janssen (Beerse, Belgium). The other compounds were purchased from the following manufacturers: rifampin from Sandoz (Holzkirchen, Germany), isoniazid from Galien (Nevers, France), pyrazinamide from Sanofi (Paris, France), moxifloxacin from Eurogenerics (Manila, the Phillipines), clofazimine from Sigma (St Louis, MO, USA) and rifapentine from Carbosynth (Compton, UK). Drugs were diluted in water containing 0.05% agar, except for Bedaquiline, which was diluted in aqueous 20% 2-hydroxypropyl-β-cyclodextrin.
Drug suspensions were prepared weekly, except for rifampin (once every 2 weeks) and Bedaquiline (once for the whole experiment), and were stored at 4°C.

Kort F., Fournier Le Ray L., Chauffour A., Jarlier V., Lounis N., Andries K., Aubry A., Guglielmetti L, & Veziris N. (2020). Fully weekly antituberculosis regimen: a proof-of-concept study. The European respiratory journal, 56(3).

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Formulation of Bedaquiline-Loaded PLGA Microspheres

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bedaquiline fumarate salt and 6-deuterium-labelled bedaquiline were manufactured internally at Janssen. PLGA5050A (L/G ratio 50/50, acid terminated, inherent viscosity (IV) 0.48 dL/g), PLGA7525A (L/G ratio 75/25, acid terminated, IV 0.48 dL/g), PLGA7525E (L/G ratio 75/25, ester terminated, IV 0.35 dL/g), PDLLA (poly(d,l-lactide), acid terminated, IV 0.71 dL/g), lactide, and glycolide were sourced from Ashland (Covington, KY, USA). Polyethylene glycol 400 (PEG400) was purchased from Clariant (Frankfurt am Main, Germany). NMP was sourced from Acros Organics (Geel, Belgium) and water for injections from Sterop Laboratoria (Brussels, Belgium) or Baxter (Lessines, Belgium). All other chemicals were purchased from commercial sources as reagent grade.

Van Hemelryck S., Wens R., van Poppel H., Luijks M., Shahidi K., Marczak M., Kahnt A., Holm R., Mannaert E, & Langguth P. (2021). In Vitro Evaluation of Poly(lactide-co-glycolide) In Situ Forming Gels for Bedaquiline Fumarate Salt and Pharmacokinetics Following Subcutaneous Injection in Rats. Pharmaceutics, 13(8), 1231.

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Procurement of Tuberculosis Drug Compounds

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9-Aminoacridine (9-AA) was purchased from Sigma-Aldrich. 2,5-Dihydroxybenzoic acid (DHB), hematoxylin and eosin stains, all high-performance liquid chromatography (HPLC)-grade solvents, and the Superfrost Plus slides were purchased from the Fisher Scientific Company. Rifampin was purchased from Gold Biotechnology. Kanamycin sulfate was purchased from Fisher Scientific. Rifapentine and rifabutin were purchased from Sigma-Aldrich. Bedaquiline was provided by Janssen Research and Development.

Wang N., Sarathy J.P., Zimmerman M., Kaya F., Wang H., Dartois V, & Carter C.L. (2021). On-Slide Heat Sterilization Enables Mass Spectrometry Imaging of Tissue Infected with High-Threat Pathogens Outside of Biocontainment: A Study Directed at Mycobacterium tuberculosis. Journal of the American Society for Mass Spectrometry, 32(11), 2664-2674.

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Reagents and Chemicals for Research

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9-Aminoacridine (9-AA) was purchased
from Sigma-Aldrich. 2,5-Dihydroxybenzoic acid (DHB), hematoxylin and
eosin stains, all high-performance liquid chromatography (HPLC)-grade
solvents, and the Superfrost Plus slides were purchased from the Fisher
Scientific Company. Rifampin was purchased from Gold Biotechnology.
Kanamycin sulfate was purchased from Fisher Scientific. Rifapentine
and rifabutin were purchased from Sigma-Aldrich. Bedaquiline was provided
by Janssen Research and Development.

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Preparation of Verapamil, Reserpine, and Bedaquiline

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Verapamil and reserpine were purchased from Sigma-Aldrich (St. Louis, MO, USA). Stock solution of Verapamil was dissolved in distilled water, whereas reserpine was prepared in dimethyl sulfoxide (DMSO). Bedaquiline was kindly provided by Janssen Pharmaceutica (Beerse, Belgium) and was dissolved in DMSO.

Martin A., Bouyakoub Y., Soumillion K., Mantu E.O.N., Colmant A, & Rodriguez-Villalobos H. (2020). Targeting bedaquiline mycobacterial efflux pump to potentially enhance therapy in Mycobacterium abscessus. International journal of mycobacteriology, 9(1).

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Preparation of TB Drug Compounds

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Moxifloxacin and linezolid were purchased from Sequoia Research Products (Pangbourne, United Kingdom), while rifapentine, rifabutin, pyrazinamide, clofazimine, and isoniazid were purchased from Sigma-Aldrich (MO, USA). Rifampin was purchased from Gold Biotechnology (MO, USA). Kanamycin sulfate was purchased from Fisher Scientific (NH, USA). Stock solutions for all compounds except kanamycin were prepared in dimethyl sulfoxide (DMSO) and stored at 4°C. Kanamycin solution was prepared in water. Rifalazil was synthetized by Bioduro (CA, USA). Bedaquiline was provided by Janssen Research and Development (NJ, USA).

Sarathy J.P., Via L.E., Weiner D., Blanc L., Boshoff H., Eugenin E.A., Barry CE I.I.I, & Dartois V.A. (2018). Extreme Drug Tolerance of Mycobacterium tuberculosis in Caseum. Antimicrobial Agents and Chemotherapy, 62(2), e02266-17.

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Bedaquiline, Sitafloxacin, and Clofazimine Protocol

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Bedaquiline (Janssen Pharmaceutical, Beerse, Belgium) and sitafloxacin (Daiichi Sankyo Company, Tokyo, Japan) were kindly provided by pharmaceutical companies. Clofazimine was from Tokyo Chemical Industry (Tokyo, Japan) and amikacin was from Sigma–Aldrich (St Louis MO, USA).

Asami T., Aono A., Chikamatsu K., Igarashi Y., Morishige Y., Murase Y., Yamada H., Takaki A, & Mitarai S. (2021). Efficacy estimation of a combination of triple antimicrobial agents against clinical isolates of Mycobacterium abscessus subsp. abscessus in vitro. JAC-Antimicrobial Resistance, 3(1), dlab004.

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