Bedaquiline (TMC207) | Anti-tuberculosis Agent

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Structure of Bedaquiline
CAS No.: 843663-66-1

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Bedaquiline, a diarylquinoline antibiotic that targets ATP synthase, is effective for the treatment of Mycobacterium tuberculosis infections.

Synonyms: R207910; TMC207

4.5 *For Research Use Only !

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Quality Control of Bedaquiline Purity: 99% SDS Specification

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Proton gradient controls the lateral rearrangement of inner membrane domains in response to membrane fluidizer stress in Mycobacterium smegmatis

Prithviraj, Malavika ; Shivangi, FNU ; Freundlich, Joel S ; Morita, Yasu S ;

DOI: 10.1016/j.jbc.2025.110361 PubMed ID: 40513951 JBC,2025,110361.

Abstract: Mycobacterium smegmatis partitions its plasma membrane into two distinct regions: the inner membrane domain (IMD) and the conventional plasma membrane. IMD, enriched in the subpolar regions of actively growing rod-shaped cell, contains many membrane proteins involved in cell envelope biosynthesis. Dibucaine, a membrane fluidizer, disrupts plasma membrane integrity and de-partitions the IMD from the sub-polar regions. We do not know what governs the de-partitioning of the IMD in response to dibucaine stress. In this study, we investigated the stress response of the IMD under respiration defect. We first depleted MenG, a key enzyme in the menaquinone biosynthesis, by CRISPRi and observed that the IMD does not respond to dibucaine-induced membrane stress. CRISPRi-induced knockdown of qcrC, a gene encoding a component of an electron transport chain cytochrome, corroborated the results of menG knockdown. In contrast, neither CRISPRi knockdown of atpD, a gene encoding a component of the ATP synthase nor inhibition of ATP synthase by bedaquiline inhibited the dibucaine-induced de-partitioning of sub-polar IMD as robustly as CRISPRi knockdowns of menG and qcrC. A pretreatment with the protonophore carbonyl cyanide m-chlorophenyl hydrazone (CCCP) prevented dibucaine-induced IMD de-partitioning. Furthermore, a pretreatment with nigericin, which acts as a H⁺/K⁺ antiporter and disrupts the proton gradient without affecting membrane potential, also inhibited the IMD de-partitioning in a way similar to CCCP. Taken together, our findings suggest that membrane stress-induced IMD delocalization is not a passive lipid dispersion but an active membrane rearrangement dependent on an electrochemical gradient of proton.

Keywords: membrane fluidity ; Mycobacterium ; plasma membrane ; proton motive force ; stress response

Purchased from AmBeed: 843663-66-1

Potency of omadacycline against Mycobacteroides abscessus clinical isolates in vitro and in a mouse model of pulmonary infection

Nicklas, Danielle A ; Maggioncalda, Emily C ; Story-Roller, Elizabeth ; Eichelman, Benjamin ; Tabor, Chavis ; Serio, Alisa W , et al.

DOI: 10.1128/AAC.01704-21 PubMed ID: 34662184 Antimicrob. Agents Chemother.,2022,66(1):e01704-21.

Abstract: The incidence of nontuberculous mycobacterial diseases in the United States is rising and has surpassed that of tuberculosis. Most notable among the nontuber culous mycobacteria is Mycobacteroides abscessus, an emerging environmental opportunis tic pathogen capable of causing chronic infections. M. abscessus disease is difficult to treat, and the current treatment recommendations include repurposed antibiotics, several of which are associated with undesirable side effects. In this study, we have evaluated the activity of omadacycline, a new tetracycline derivative, against M. abscessus using in vitro and in vivo approaches. Omadacycline exhibited an MIC90 of 0.5 mg/mL against a panel of 32 contemporary M. abscessus clinical isolates, several of which were resistant to antibiotics that are commonly used for treatment of M. abscessus disease. Omadacycline combined with clarithromycin, azithromycin, cefdinir, rifabutin, or linezolid also exhibited synergism against several M. abscessus strains and did not exhibit antagonism when com bined with an additional nine antibiotics also commonly considered to treat M. abscessus disease. Concentration-dependent activity of omadacycline was observed in time-kill assessments. Efficacy of omadacycline was evaluated in a mouse model of lung infection against four M. abscessus strains. A dose equivalent to the 300-mg standard oral human dose was used. Compared to the untreated control group, within 4 weeks of treatment, 1 to3 log10 fewer M. abscessus CFU were observed in the lungs of mice treated with omadacycline. Treatment outcome was biphasic, with bactericidal activity observed after the first 2 weeks of treatment against all four M. abscessus strains.

Keywords: omadacycline ; Mycobacterium abscessus ; pulmonary infection

Purchased from AmBeed: 843663-66-1

In vitro assessment of 17 antimicrobial agents against clinical Mycobacterium avium complex isolates

Lin, Siran ; Hua, Wenya ; Wang, Shiyong ; Zhang, Yu ; Chen, Xinchang ; Liu, Hong , et al.

DOI: 10.1186/s12866-022-02582-2 PubMed ID: 35804298 BMC Microbiol.,2022,22(1):175.

Abstract: Background Recently, Mycobacterium avium complex (MAC) infections have been increasing, especially in immunocompromised and older adults. The rapid increase has triggered a global health concern due to limited therapeutic strategies and adverse effects caused by long-term medication. To provide more evidence for the treatment of MAC, we studied the in vitro inhibitory activities of 17 antimicrobial agents against clinical MAC isolates. Results A total of 111 clinical MAC isolates were enrolled in the study and they were identified as M. intracellulare, M. avium, M. marseillense, M. colombiense, M. yongonense, and two isolates could not be identified at the species level. MAC strains had relatively low (0–21.6%) resistance to clarithromycin, amikacin, bedaquiline, rifabutin, streptomycin, and clofazimine, and the resistant rates to isoniazid, rifampin, linezolid, doxycycline, and ethionamide were very high (72.1–100%). In addition, M. avium had a significantly higher resistance rate than that of M. intracellulare for ethambutol (92.3% vs 40.7%, P < 0.001), amikacin (15.4% vs 1.2%, P = 0.049), and cycloserine (69.2% vs 25.9%, P = 0.004). Conclusions Our results supported the current usage of macrolides, rifabutin, and aminoglycosides in the regimens for MAC infection, and also demonstrated the low resistance rate against new drugs, such as clofazimine, tedizolid, and bedaquiline, suggesting the possible implementation of these drugs in MAC treatment.

Keywords: Mycobacterium avium complex (MAC) ; Drug susceptibility test ; Minimum inhibitory concentration (MIC) ; Mycobacterium intracellulare ; Mycobacterium avium

Purchased from AmBeed: 843663-66-1

Development, validation and clinical use of a LC-MS/MS method for the simultaneous determination of the nine main antituberculosis drugs in human plasma

David Fage ; Reda Brilleman ; Guillaume Deprez ; Marie-Christine Payen ; Frédéric Cotton ;

DOI: 10.1016/j.jpba.2022.114776 PubMed ID: 35462286 J. Pharmaceut. Biomed.,2022,215,114776.

Abstract: The treatment of tuberculosis, in particular the multi-drug resistant tuberculosis, remains a challenge mainly because of the therapy duration and the pharmacokinetic variability of the drugs included in the regimen. The monitoring of antituberculosis drugs is a recent tool that could improve the outcome of patients. We developed a LC-MS/MS method allowing the simultaneous quantification of the four first-line drugs (isoniazid, rifampicin, pyrazinamide and ethambutol), a metabolite of isoniazid (acetylisoniazid) and the five main second-line drugs (rifabutin, levofloxacin, moxifloxacin, linezolid and bedaquiline). An isotopologue standard was used for each drug. The protein precipitation was performed with acetonitrile and the separation was carried out using an EC-18 column and a gradient elution. The validated ranges for each drug were adapted to monitor the plasma concentration at 2 h (peak) and 6 h to evaluate their enteric absorption. The intermediate precision (CV) and the trueness at the limit of quantification were ≤ 10.1% and ≤ 10.7%, respectively. Preliminary data were obtained for 12 patients. The results showed that 38% of the patients had infra-therapeutic levels for both rifampicin and isoniazid, that the leading cause of an impaired oral absorption seemed to be malabsorption and that the effective concentrations for rifampicin were in the lower range of the therapeutic interval.

Keywords: Bedaquiline ; Rifampicin ; Acetylisoniazid ; Antituberculosis drugs ; Multi-drug resistant tuberculosis ; Liquid chromatography-tandem mass ; spectrometry

Purchased from AmBeed: 843663-66-1

Structure, Dynamics, and Therapeutic Potential of ATP Synthase

Guo, Hui ;

Abstract: Found in mitochondria, chloroplasts, and bacteria, ATP synthases are rotary enzymes that use energy from respiration to generate adenosine triphosphate (ATP). The dumbbell-shaped macromolecular complex consists of a soluble F1 motor and a membraneembedded FO motor connected by a shared central rotor. Studying the molecular mechanism of both motors and how they are coupled together to form a functional enzyme is critical for understanding bioenergetics and respiration. In this thesis, single particle electron cryomicroscopy (cryoEM) was employed to investigate the structure, dynamics, and therapeutic potential of ATP synthase. To improve cryoEM sample preparation and data storage, a grid freezing device and a movie storage file format were developed. Highresolution structures of both mitochondrial and bacterial ATP synthases demonstrate how proton translocation across the membrane via two proton half channels in the FO region drives rotation of the rotor. The dimeric mitochondrial ATP synthase structure also explains how the enzyme forms dimers, bends the mitochondrial inner membrane, and iii produces cristae—the characteristic structure of mitochondria. Structures of ATP synthase during rotary catalysis illustrate how the enzyme deforms under strain to achieve efficient coupling of the F1 and FO motors. Additionally, structures of ATP synthases bound to the tuberculosis drug bedaquiline and the antileukemia compound apoptolidin highlight the potential of ATP synthase as drug targets for treatment of bacterial infection and respiration-dependant cancer. Together, our results uncovered fundamental mechanisms that enable function of this fascinating molecular machine and explored how medicines targeting the enzyme might be harnessed to benefit human health.

Purchased from AmBeed: 843663-66-1

Structure of mycobacterial ATP synthase bound to the tuberculosis drug bedaquiline

Guo, Hui ; Courbon, Gautier M. ; Bueler, Stephanie A. ; Mai, Juntao ; Liu, Jun ; Rubinstein, John L.

DOI: 10.1038/s41586-020-3004-3 PubMed ID: 33299175 Nature,2021,589(7840):143-147.

Abstract: Tuberculosis-the world's leading cause of death by infectious disease-is increasingly resistant to current first-line antibiotics1. The bacterium Mycobacterium tuberculosis (which causes tuberculosis) can survive low-energy conditions, allowing infections to remain dormant and decreasing their susceptibility to many antibiotics2. Bedaquiline was developed in 2005 from a lead compound identified in a phenotypic screen against Mycobacterium smegmatis3. This drug can sterilize even latent M. tuberculosis infections4 and has become a cornerstone of treatment for multidrug-resistant and extensively drug-resistant tuberculosis1,5,6. Bedaquiline targets the mycobacterial ATP synthase3, which is an essential enzyme in the obligate aerobic Mycobacterium genus3,7, but how it binds the intact enzyme is unknown. Here we determined cryo-electron microscopy structures of M. smegmatis ATP synthase alone and in complex with bedaquiline. The drug-free structure suggests that hook-like extensions from the α-subunits prevent the enzyme from running in reverse, inhibiting ATP hydrolysis and preserving energy in hypoxic conditions. Bedaquiline binding induces large conformational changes in the ATP synthase, creating tight binding pockets at the interface of subunits a and c that explain the potency of this drug as an antibiotic for tuberculosis.

Purchased from AmBeed: 843663-66-1

Structure of mycobacterial ATP synthase with the TB drug bedaquiline

Hui Guo ; Gautier M. Courbon ; Stephanie A. Bueler ; Juntao Mai ; Jun Liu ; John L.

DOI: 10.1101/2020.08.06.225375 bioRxiv,2020.08.06.225375.

Abstract: Tuberculosis (TB), the leading cause of death by infectious disease worldwide, is increasingly resistant to first line antibiotics. Developed from a screen against Mycobacterium smegmatis, bedaquiline can sterilize even latent M. tuberculosis infections that may otherwise persist for decades and has become a cornerstone of treatment for multidrug resistant and extensively-drug resistant TB. Bedaquiline targets mycobacterial ATP synthase, an essential enzyme in the obligate aerobic Mycobacterium genus. However, how the drug binds the intact enzyme is unknown. We determined the structure of M. smegmatis ATP synthase with and without bedaquiline. The drug-free structure reveals hook-like extensions from the enzyme’s α subunits that inhibit ATP hydrolysis in low-energy conditions, such as during latent infections. Bedaquiline binding induces global conformational changes in ATP synthase, creating tight binding pockets at the interface of subunits a and c. These binding sites explain the drug’s structure-activity relationship and its potency as an antibiotic for TB.

Keywords: Bedaquiline ; Sirturo ; TMC207 ; T207910 ; ATP synthase ; mycobacteria ; tuberculosis ; cryoEM ; structure

Purchased from AmBeed: 843663-66-1

Product Details of Bedaquiline

CAS No. :	843663-66-1
Formula :	C₃₂H₃₁BrN₂O₂
M.W :	555.50
SMILES Code :	BrC1=CC=C(N=C(OC)C([C@H]([C@@](C2=CC=CC3=C2C=CC=C3)(O)CCN(C)C)C4=CC=CC=C4)=C5)C5=C1
Synonyms :	R207910; TMC207
MDL No. :	MFCD14635354
InChI Key :	QUIJNHUBAXPXFS-XLJNKUFUSA-N
Pubchem ID :	5388906

Safety of Bedaquiline

GHS Pictogram:
Signal Word:	Danger
Hazard Statements:	H301-H373-H410
Precautionary Statements:	P260-P264-P270-P273-P301+P310+P330-P314-P405-P501
Class:	6.1
UN#:	2811
Packing Group:	Ⅲ

Isoform Comparison

Biological Activity

In Vitro:

Cell Line Mycobacterium tuberculosis mc26230 Mycobacterium tuberculosis H37Rv Mycobacterium tuberculosis H37Rv Mycobacterium bovis BCG	Concentration	Treated Time	Description	References

Mycobacterium tuberculosis mc26230	300x MIC50	1 hour	To measure ROS production, finding that BDQ and Q203 do not increase ROS production	PMC4987515
Mycobacterium tuberculosis H37Rv	30x MIC50	16 hours	Evaluate the bactericidal effect of BTZ043 on M. tuberculosis H37Rv, showing significant killing effect within 72 hours	PMC4987515
Mycobacterium tuberculosis H37Rv	2.8 –4.2 µM	15 hours	Evaluate the bactericidal effect of BTZ043 on M. tuberculosis H37Rv, showing significant killing effect within 72 hours	PMC7799364
Mycobacterium bovis BCG	0.5 –1.6 µM	15 hours	Evaluate the effect of ND-011992 on intracellular ATP levels in the presence of Q203	PMC7799364

In Vivo:

Species BALB/c mice Mice Mice Mice Mice BALB/c mice	Animal Model Tuberculosis infection model Latent tuberculosis infection model Tuberculosis infection model TB meningitis model Chronic TB model Tuberculosis infection model	Administration	Dosage	Frequency	Description	References

BALB/c mice	Tuberculosis infection model	Oral	25 mg/kg	Once daily for 17 days	Evaluate the efficacy of Bedaquiline in combination with pretomanid and TBI-223	PMC11344811
Mice	Latent tuberculosis infection model	Oral	25 mg/kg	5 days per week for 3 months	To evaluate the bactericidal and sterilizing activity of TMC207 in a latent tuberculosis infection model, results showed that TMC207 alone has significant sterilizing activity and may enable treatment of DR-LTBI in 3–4 months	PMC3208599
Mice	Tuberculosis infection model	Oral	20 mg/kg/day	Once daily for 4 weeks	To evaluate the efficacy of the BPaL regimen (bedaquiline, pretomanid, linezolid) in chronically infected mice, results showed significantly enhanced bactericidal activity against the ΔcinA mutant	PMC9033802
Mice	TB meningitis model	Oral	25 mg/kg/day	Once daily for six weeks	Evaluate the efficacy of the BPaL regimen in the mouse model of TB meningitis, results showed that the bactericidal activity of bedaquiline was substantially inferior to the standard TB regimen	PMC9800570
Mice	Chronic TB model	Oral	25 mg/kg	5 days per week for 4 or 8 weeks	Evaluate the efficacy of PBTZ169 in combination with BDQ and PZA	PMC3958311
BALB/c mice	Tuberculosis infection model	Aerosol	12.5 and 25 mg/kg	5 days per week for 6 weeks	Evaluation of the bactericidal activity of bedaquiline against Mycobacterium tuberculosis, showing that bedaquiline is more potent than rifampicin.	PMC9303191

Clinical Trial:

NCT Number	Conditions	Phases	Recruitment	Completion Date	Locations

NCT00042289	HIV Infections	Phase 4	Recruiting	September 30, 2019	-
NCT03625739	-		Recruiting	December 31, 2026	China ... More >> Beijing Children's Hospital of Capital Medical University Recruiting Beijing, China Contact: Adong Shen, Master 13370115087 shenad16@hotmail.com Less <<
NCT03237182	Tuberculosis, Multidrug-Resist... More >>ant Less <<	Phase 4	Recruiting	December 2021	South Africa ... More >> King Dinuzulu Hospital Recruiting Durban, Kwa-Zulu Natal, South Africa Contact: Nesri Padayatchi, MBcHB 0312604550 nesri.padayatchi@caprisa.org Contact: Resha Boodhram, BTech 0828383651 resha.boodhram@caprisa.org Less <<
NCT02409290	MDR-TB	Phase 3	Recruiting	December 2021	China ... More >> Beijing Chest Hospital Not yet recruiting Beijing, China Wuhan Institute for TB control Not yet recruiting Wuhan, China Ethiopia Armauer Hanssen Research Institute Recruiting Addis Ababa, Ethiopia St. Peter's Tuberculosis Specializes Hospital Recruiting Addis Ababa, Ethiopia Georgia JSC National Center for Tuberculosis and Lung Diseases Recruiting Tbilisi, Georgia India BJ Medical College Civil Hospital Recruiting Ahmedabad, India The National Institute for Research in Tuberculosis Recruiting Chennai, India Indonesia RSUP Persahabatan Not yet recruiting Jakarta, Indonesia Moldova, Republic of Institute of Phthisiopneumology 'Chiril Draganiuc' Recruiting Chisinau, Moldova, Republic of Mongolia National Centre for Communicable Diseases Recruiting Ulaanbaatar, Mongolia South Africa King Dinizulu Hospital Recruiting Durban, South Africa Helen Joseph Hospital Recruiting Johannesburg, South Africa Sizwe Tropical Disease Hospital Active, not recruiting Johannesburg, South Africa Doris Goodwin Hospital Recruiting Pietermaritzburg, South Africa Empilweni TB Hospital Not yet recruiting Port Elizabeth, South Africa Uganda Makerere University Recruiting Kampala, Uganda Mulago National Referral Hospital Recruiting Kampala, Uganda Vietnam Pham Ngoc Thach Hospital Active, not recruiting Ho Chi Minh City, Vietnam Less <<
NCT03474198	Tuberculosis, Pulmonary	Phase 2 Phase 3	Recruiting	March 12, 2022	Philippines ... More >> De La Salle Health Sciences Institute Not yet recruiting Manila, Philippines Lung Center Philippines Recruiting Manila, Philippines Philippines Tuberculosis Society Incorporated (PTSI) Not yet recruiting Manila, Philippines Tropical Disease Foundation Not yet recruiting Manila, Philippines Singapore National University Hospital Not yet recruiting Singapore, Singapore Thailand King Chulalongkorn Memorial Hospital Not yet recruiting Bangkok, Thailand Less <<
NCT02754765	Tuberculosis, Multidrug-Resist... More >>ant Less <<	Phase 3	Recruiting	April 2021	Georgia ... More >> National Center for Tuberculosis and Lung Diseases Recruiting Tbilisi, Georgia, 0101 Contact: Nino Kiria, MD msff-tbilisi-endtb@paris.msf.org Principal Investigator: Nana Kiria, MD Kazakhstan National Center for Tuberculosis Problems Recruiting Almaty, Kazakhstan Contact: Kanat Khazhidinov, MD kkhazhidinov@pih.org Principal Investigator: Elmira Berikova, MD Kyrgyzstan Osh Oblast Tuberculosis Hospital Not yet recruiting Osh, Kyrgyzstan Contact: Arnol Samiev, MD msfch-osh-tb@geneva.msf.org Principal Investigator: Kauk Galina Vladimirovna, MD Lesotho Partners In Health Lesostho Recruiting Maseru, Lesotho Contact: Sesomo Mohale smohale@pih.org Principal Investigator: Lawrence Oyewusi, MBBS Peru Socios En Salud Recruiting Lima, Peru Contact: Fanny Garcia Velarde fgarcia_ses@pih.org Principal Investigator: Leo Lecca, MD South Africa Medecins Sans Frontieres Belgium Recruiting Khayelitsha, South Africa, 7784 Contact: Jared Borain msfocb-khayelitsha-endtb@brussels.msf.org Principal Investigator: Sean Wasserman, MD Less <<
NCT02454205	Tuberculosis ... More >>Multidrug Resistant Tuberculosis Extensively-drug Resistant Tuberculosis Less <<	Phase 2 Phase 3	Recruiting	January 2019	South Africa ... More >> Brooklyn Chest Hospital Recruiting Cape Town, Western Cape, South Africa, 7441 Contact: Ali Esmail, MD 0214047654 ext 6119 a.esmail@uct.ac.za Contact: Lynelle Mottay, MD 0214046119 ext 6119 lynelle.mottay@uct.ac.za Less <<
NCT01215851	-		Completed	-	-
NCT03338621	Tuberculosis, Pulmonary ... More >> Tuberculosis, Multidrug-Resistant Tuberculosis, MDR Tuberculosis Drug-Resistant Tuberculosis Less <<	Phase 2	Recruiting	January 31, 2022	Georgia ... More >> National Center for Tuberculosis and Lung Diseases Recruiting Tbilisi, Georgia, 0101 Contact: Marike Eristavi, MD +99 559 954 0393 ma.eristavi@gmail.com Contact: Nestan Tukvadze Less <<
NCT03259269	-		Recruiting	September 30, 2020	Armenia ... More >> National Treatment Centre for Tuberculosis, Abovian, Armenia Recruiting Abovyan, Armenia Contact: Naira Khachatryan, MD msff-erevan-medco@paris.msf.org Principal Investigator: Armen Hayrapetyan, MD Bangladesh National Institute of Diseases of the Chest and Hospital (NIDCH), Dhaka Recruiting Dhaka, Bangladesh Contact: Hamidah Hussain, MBBS, MSc hamidah.hussain@irdresearch.org Contact: Manzur ul-Alam, MD manzur.ulalam@irdresearch.org Belarus Republican Research and Practical Centre for Pulmonology and Tuberculosis Recruiting Minsk, Belarus, 220053 Contact: Yoseph Tassew, MD russia-medco@oca.msf.org Principal Investigator: Alena Skrahina, MD, PhD, DSc Ethiopia Bishoftu Hospital Recruiting Bishoftu, Ethiopia Contact: Andargachew Kumsa, MD AKumsa@pih.org Georgia National Center for Tuberculosis and Lung Diseases Recruiting Tbilisi, Georgia, 0101 Contact: Tinatin Kotrikadze, MD msff-tbilisi-medco@paris.msf.org Principal Investigator: Zara Avaliani, MPH, PhD Indonesia RS Islam Jakarta Cempaka Putih Not yet recruiting Jakarta, Indonesia Contact: Fauziah Asnely Putri, MD, MPH fauziah.putri@irdresearch.org Kazakhstan National Research Center for Phthisionpulmonology Recruiting Almaty, Kazakhstan, 050010 Contact: Yerkebulan Algozhin, MD ealgozhin@pih.org Principal Investigator: Elmira Berikova, MPH Kenya MSF Tuberculosis clinic, Mathare, Nairobi, Kenya Recruiting Nairobi, Kenya Contact: Stephen Wanjala, MD msff-nairobi-medco@paris.msf.org Principal Investigator: Maureen Kamene, MD, MBCHB Kyrgyzstan Kara-Suu District TB hospital Recruiting Kara-Suu, Kyrgyzstan Contact: Hayk Karakozian, MD MSFCH-Kyrgyzstan-Medco@geneva.msf.org Principal Investigator: Kadyrov Abdullaat, MD, PhD Lesotho Botshabelo Hospital Recruiting Maseru, Lesotho Contact: Kwonjune Seung, MD kjseung@pih.org Myanmar Aung San Tuberculosis Hospital Not yet recruiting Yangon, Myanmar Contact: Jarmila Kliescikova, MD myanmar-medco@oca.msf.org Principal Investigator: Si Tu Aung, MD Pakistan The Indus Hospital, Karachi Recruiting Karachi, Pakistan Contact: Rabia Mashkoor, MD rabia.mashkoor@ghd.ihn.org.pk Principal Investigator: Sana Adnan, MBBS, MSPH Institute of Chest Diseases, Kotri Recruiting Kotri, Pakistan Contact: Rabia Mashkoor, MD rabia.mashkoor@ghd.ihn.org.pk Principal Investigator: Sana Adnan, MBBS, MSPH Gulab Devi Chest Hospital, Lahore Recruiting Lahore, Pakistan Contact: Rabia Mashkoor, MD rabia.mashkoor@ghd.ihn.org.pk Principal Investigator: Sana Adnan, MBBS, MSPH Peru Socios en Salud Not yet recruiting Carabayllo, Peru Contact: Carmen Contreras, BS ccontreras_SES@pih.org Principal Investigator: Leonid Lecca, MD South Africa King Dinuzulu Hospital Recruiting Durban, South Africa Contact: Munira Khan, MBCHB munira.khan@irdresearch.org Less <<
NCT02589782	Tuberculosis, Multidrug-Resist... More >>ant Extensively Drug-Resistant Tuberculosis Tuberculosis, Pulmonary Less <<	Phase 2 Phase 3	Recruiting	March 2021	Belarus ... More >> Republican Scientific and Practical Centre for Pulmonology and Tuberculosis hospital Recruiting Minsk, Belarus Contact: Animesh Sinha, MD minsk-ct-mtl@oca.msf.org Principal Investigator: Alena Skrahina, MD South Africa Doris Goodwin Hospital Recruiting Pietermaritzburg, KwaZulu Natal, South Africa Contact: Suzanne Staples s.staples@thinksa.org.za Principal Investigator: Ronelle Moodliar, MBBS, MMed Don McKenzie Hospital Not yet recruiting Durban, KwaZulu-Natal, South Africa Contact: Suzanne Staples s.staples@thinksa.org.za Principal Investigator: Ronelle Moodliar, MBBS,MMed Uzbekistan Republican TB Hospital No. 2 Recruiting Nukus, Karakalpakstan, Uzbekistan Contact: Timur Gilmanov NukusCT-crc@oca.msf.org Principal Investigator: Tigay N Zinaida, MD Sh Alimov Republican Specialised Scientific-Practical Medical Centre for Phthysiology and Pulmonology Hospital Not yet recruiting Tashkent, Uzbekistan Contact: Viktoria Prymaka Principal Investigator: Irina Liverko, MD Less <<
NCT01215851	Pulmonary Tuberculosis	Phase 2	Completed	-	South Africa ... More >> Centre for Tuberculosis Research Innovation, UCT Lung Institute Cape Town, South Africa, 7700 Task Applied Science, Karl Bremer Hospital Cape Town, South Africa Less <<
NCT01691534	-		Completed	-	-
NCT00946842	Healthy	Phase 1	Completed	-	-
NCT01691534	Pulmonary Tuberculosis	Phase 2	Completed	-	South Africa ... More >> Centre for Tuberculosis Research Innovation, UCT Lung Institute Cape Town, South Africa Task Applied Science, Karl Bremer Hospita Cape Town, South Africa Less <<
NCT01600963	Multi-drug Resistant Tuberculo... More >>sis Less <<	Phase 3	Withdrawn(PhIII program revise... More >>d; TMC207-C210 cancelled) Less <<	November 2022	-
NCT01464762	Tuberculosis		APPROVED_FOR_MARKETING	-	Vilnius, Lithuania\|Arkhangelsk... More >>, Russian Federation\|Moscow, Russian Federation\|Orel, Russian Federation\|Saint-Petersburg, Russian Federation Less <<
NCT01341184	Tuberculosis	Phase 1	Completed	-	United States, Ohio ... More >> Case Western Reserve University - Case Medical Center - Infectious Disease & HIV Medicine Cleveland, Ohio, United States, 44106-1716 Less <<
NCT01291563	Healthy Volunteer	Phase 1	Completed	-	-
NCT00449644	-		Completed	-	-
NCT00449644	Tuberculosis	Phase 2	Completed	-	Brazil ... More >> Rio De Janeiro, Brazil India Chennai, India New Delhi, India Latvia Stopinu Region, Latvia Peru Lima, Peru Philippines Quezon City, Philippines Russian Federation Moscow, Russian Federation South Africa Bethelsdorp, South Africa Cape Town, South Africa Durban, South Africa George, South Africa Klerksdorp, South Africa Sandringham, South Africa Thailand Chiang Mai, Thailand Nakhon, Thailand Nonthaburi, Thailand Less <<
NCT00828529	Tuberculosis\|HIV	PHASE1	COMPLETED	2025-05-09	-
NCT01215110	Pulmonary Tuberculosis	Phase 2	Completed	-	South Africa ... More >> Karl Bremer Hospital Belville, Cape Town, South Africa, 7531 Less <<
NCT00910806	HIV Infections	Phase 1	Completed	-	South Africa ... More >> George, South Africa Less <<
NCT01215110	-		Completed	-	-
NCT00910871	Tuberculosis	Phase 2	Completed	-	-
NCT02193776	Tuberculosis	Phase 2	Completed	-	South Africa ... More >> The Aurum Institute: Tembisa Hospital Tembisa, Gauteng, South Africa, 1632 Klerksdorp Tshepong Hospital Jouberton, Klerksdorp, South Africa, 2570 TASK Applied Science Cape Town, South Africa, 7531 University of Cape Town Lung Institute (Pty) Ltd Cape Town, South Africa, 7937 THINK: Tuberculosis & HIV Investigative Network of KwaZulu-Natal Durban, South Africa CHRU Themba Lethu Clinic Johannesburg, South Africa University of Witwatersrand, Clinical HIV Research Unit (CHRU), Helen Joseph Hospital Johannesburg, South Africa Tanzania Ifakara Health Institute Bagamoyo, Tanzania NIMR-Mbeya Medical Research Centre (MMRC) Mbeya, Tanzania Uganda Uganda Case Western Reserve University Research Collaboration Kampala, Uganda Less <<
NCT00992069	Tuberculosis ... More >>HIV Less <<	Phase 1	Completed	-	United States, California ... More >> Ucsf Aids Crs San Francisco, California, United States, 94110 United States, Maryland Johns Hopkins Adult AIDS CRS Baltimore, Maryland, United States, 21287 United States, North Carolina Unc Aids Crs Chapel Hill, North Carolina, United States, 27514 United States, Ohio The Ohio State Univ. AIDS CRS Columbus, Ohio, United States, 43210 United States, Tennessee Vanderbilt Therapeutics CRS Nashville, Tennessee, United States, 37232-2582 Less <<
NCT01012284	Moderate Hepatic Impairment	PHASE1	COMPLETED	2025-01-11	-
NCT03086486	Tuberculosis, Pulmonary ... More >> Tuberculosis, Multidrug-Resistant Tuberculosis, MDR Tuberculosis Extensively Drug-Resistant Tuberculosis Pre-XDR-TB Less <<	Phase 3	Recruiting	January 2022	Georgia ... More >> National Center for Tuberculosis and Lung Diseases Recruiting Tbilisi, Georgia, 0101 Contact: Lali Mikiashvili Principal Investigator: Lali Mikiashvili Moldova, Republic of Institute of Phthisiopneumology Chiril Draganiuc Not yet recruiting Chisinau, Moldova, Republic of, 2025 Contact: Elena Tudor, MD Principal Investigator: Elena Tudor, MD Russian Federation Central TB Research Institute of the Federal Agency of Scientific Organizations Moscow Not yet recruiting Moscow, Russian Federation, 107564 Contact: Tatevik Bagdasaryan Principal Investigator: Tatevik Bagdasaryan Research Institute of Phthisiopulmonology of I.M. Sechenov First Moscow State Medical University Not yet recruiting Moscow, Russian Federation Contact: Anastasia Samoilova Principal Investigator: Anastasia Samoilova FSBI "Saint-Petersburg Research Institute of Phthisiopulmonology" Recruiting Saint Petersburg, Russian Federation, 191036 Contact: Petr Yablonskiy, MD Principal Investigator: Petr Yablonskiy, MD Ural Research Institute of Phthisiopulmonology Not yet recruiting Yekaterinburg, Russian Federation, 620039 Contact: Sergey Skornyakov, MD Principal Investigator: Sergey Skornyakov, MD South Africa Tshepong Hospital Recruiting Klerksdorp, North - West, South Africa, 2574 Contact: Ebrahim Variava Principal Investigator: Ebrahim Variava King DinuZulu Hospital Complex Recruiting Durban, South Africa, 4015 Contact: Nosipho Ngubane Principal Investigator: Nosipho Ngubane Clinical HIV Research Unit (CHRU) Sizwe Tropical Diseases Hospital Recruiting Johannesburg, South Africa, 2131 Contact: Pauline Howell, MD Principal Investigator: Pauline Howell, MD Empilweni TB Hospital Not yet recruiting Johannesburg, South Africa, 2194 Contact: Francesca Conradie, MBBS Principal Investigator: Francesca Conradie, MBBS Less <<
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Protocol

Bio Calculators

Preparing Stock Solutions

1mg

5mg

10mg

1 mM

5 mM

10 mM

1.80mL

0.36mL

0.18mL

9.00mL

1.80mL

0.90mL

18.00mL

3.60mL

1.80mL

References

[1]Jang JC, Jung YG, et al. Bedaquiline susceptibility test for totally drug-resistant tuberculosis Mycobacterium tuberculosis. J Microbiol. 2017 Jun;55(6):483-487.

[2]Chahine EB, Karaoui LR, et al. Bedaquiline: a novel diarylquinoline for multidrug-resistant tuberculosis. Ann Pharmacother. 2014 Jan;48(1):107-15.

[3]Lakshmanan M, Xavier AS. Bedaquiline - The first ATP synthase inhibitor against multi drug resistant tuberculosis. J Young Pharm. 2013;5(4):112-115. doi:10.1016/j.jyp.2013.12.002

[4]Fiorillo M, Lamb R, Tanowitz HB, et al. Bedaquiline, an FDA-approved antibiotic, inhibits mitochondrial function and potently blocks the proliferative expansion of stem-like cancer cells (CSCs). Aging (Albany NY). 2016;8(8):1593-1607. doi:10.18632/aging.100983

Precautionary Statements-General
Code	Phrase
P101	If medical advice is needed,have product container or label at hand.
P102	Keep out of reach of children.
P103	Read label before use
Prevention
Code	Phrase
P201	Obtain special instructions before use.
P202	Do not handle until all safety precautions have been read and understood.
P210	Keep away from heat/sparks/open flames/hot surfaces. - No smoking.
P211	Do not spray on an open flame or other ignition source.
P220	Keep/Store away from clothing/combustible materials.
P221	Take any precaution to avoid mixing with combustibles
P222	Do not allow contact with air.
P223	Keep away from any possible contact with water, because of violent reaction and possible flash fire.
P230	Keep wetted
P231	Handle under inert gas.
P232	Protect from moisture.
P233	Keep container tightly closed.
P234	Keep only in original container.
P235	Keep cool
P240	Ground/bond container and receiving equipment.
P241	Use explosion-proof electrical/ventilating/lighting/equipment.
P242	Use only non-sparking tools.
P243	Take precautionary measures against static discharge.
P244	Keep reduction valves free from grease and oil.
P250	Do not subject to grinding/shock/friction.
P251	Pressurized container: Do not pierce or burn, even after use.
P260	Do not breathe dust/fume/gas/mist/vapours/spray.
P261	Avoid breathing dust/fume/gas/mist/vapours/spray.
P262	Do not get in eyes, on skin, or on clothing.
P263	Avoid contact during pregnancy/while nursing.
P264	Wash hands thoroughly after handling.
P265	Wash skin thouroughly after handling.
P270	Do not eat, drink or smoke when using this product.
P271	Use only outdoors or in a well-ventilated area.
P272	Contaminated work clothing should not be allowed out of the workplace.
P273	Avoid release to the environment.
P280	Wear protective gloves/protective clothing/eye protection/face protection.
P281	Use personal protective equipment as required.
P282	Wear cold insulating gloves/face shield/eye protection.
P283	Wear fire/flame resistant/retardant clothing.
P284	Wear respiratory protection.
P285	In case of inadequate ventilation wear respiratory protection.
P231 + P232	Handle under inert gas. Protect from moisture.
P235 + P410	Keep cool. Protect from sunlight.
Response
Code	Phrase
P301	IF SWALLOWED:
P304	IF INHALED:
P305	IF IN EYES:
P306	IF ON CLOTHING:
P307	IF exposed:
P308	IF exposed or concerned:
P309	IF exposed or if you feel unwell:
P310	Immediately call a POISON CENTER or doctor/physician.
P311	Call a POISON CENTER or doctor/physician.
P312	Call a POISON CENTER or doctor/physician if you feel unwell.
P313	Get medical advice/attention.
P314	Get medical advice/attention if you feel unwell.
P315	Get immediate medical advice/attention.
P320
P302 + P352	IF ON SKIN: wash with plenty of soap and water.
P321
P322
P330	Rinse mouth.
P331	Do NOT induce vomiting.
P332	IF SKIN irritation occurs:
P333	If skin irritation or rash occurs:
P334	Immerse in cool water/wrap n wet bandages.
P335	Brush off loose particles from skin.
P336	Thaw frosted parts with lukewarm water. Do not rub affected area.
P337	If eye irritation persists:
P338	Remove contact lenses, if present and easy to do. Continue rinsing.
P340	Remove victim to fresh air and keep at rest in a position comfortable for breathing.
P341	If breathing is difficult, remove victim to fresh air and keep at rest in a position comfortable for breathing.
P342	If experiencing respiratory symptoms:
P350	Gently wash with plenty of soap and water.
P351	Rinse cautiously with water for several minutes.
P352	Wash with plenty of soap and water.
P353	Rinse skin with water/shower.
P360	Rinse immediately contaminated clothing and skin with plenty of water before removing clothes.
P361	Remove/Take off immediately all contaminated clothing.
P362	Take off contaminated clothing and wash before reuse.
P363	Wash contaminated clothing before reuse.
P370	In case of fire:
P371	In case of major fire and large quantities:
P372	Explosion risk in case of fire.
P373	DO NOT fight fire when fire reaches explosives.
P374	Fight fire with normal precautions from a reasonable distance.
P376	Stop leak if safe to do so. Oxidising gases (section 2.4) 1
P377	Leaking gas fire: Do not extinguish, unless leak can be stopped safely.
P378
P380	Evacuate area.
P381	Eliminate all ignition sources if safe to do so.
P390	Absorb spillage to prevent material damage.
P391	Collect spillage. Hazardous to the aquatic environment
P301 + P310	IF SWALLOWED: Immediately call a POISON CENTER or doctor/physician.
P301 + P312	IF SWALLOWED: call a POISON CENTER or doctor/physician IF you feel unwell.
P301 + P330 + P331	IF SWALLOWED: Rinse mouth. Do NOT induce vomiting.
P302 + P334	IF ON SKIN: Immerse in cool water/wrap in wet bandages.
P302 + P350	IF ON SKIN: Gently wash with plenty of soap and water.
P303 + P361 + P353	IF ON SKIN (or hair): Remove/Take off Immediately all contaminated clothing. Rinse SKIN with water/shower.
P304 + P312	IF INHALED: Call a POISON CENTER or doctor/physician if you feel unwell.
P304 + P340	IF INHALED: Remove victim to fresh air and Keep at rest in a position comfortable for breathing.
P304 + P341	IF INHALED: If breathing is difficult, remove victim to fresh air and keep at rest in a position comfortable for breathing.
P305 + P351 + P338	IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
P306 + P360	IF ON CLOTHING: Rinse Immediately contaminated CLOTHING and SKIN with plenty of water before removing clothes.
P307 + P311	IF exposed: call a POISON CENTER or doctor/physician.
P308 + P313	IF exposed or concerned: Get medical advice/attention.
P309 + P311	IF exposed or if you feel unwell: call a POISON CENTER or doctor/physician.
P332 + P313	IF SKIN irritation occurs: Get medical advice/attention.
P333 + P313	IF SKIN irritation or rash occurs: Get medical advice/attention.
P335 + P334	Brush off loose particles from skin. Immerse in cool water/wrap in wet bandages.
P337 + P313	IF eye irritation persists: Get medical advice/attention.
P342 + P311	IF experiencing respiratory symptoms: call a POISON CENTER or doctor/physician.
P370 + P376	In case of fire: Stop leak if safe to Do so.
P370 + P378	In case of fire:
P370 + P380	In case of fire: Evacuate area.
P370 + P380 + P375	In case of fire: Evacuate area. Fight fire remotely due to the risk of explosion.
P371 + P380 + P375	In case of major fire and large quantities: Evacuate area. Fight fire remotely due to the risk of explosion.
Storage
Code	Phrase
P401
P402	Store in a dry place.
P403	Store in a well-ventilated place.
P404	Store in a closed container.
P405	Store locked up.
P406	Store in corrosive resistant/ container with a resistant inner liner.
P407	Maintain air gap between stacks/pallets.
P410	Protect from sunlight.
P411
P412	Do not expose to temperatures exceeding 50 oC/ 122 oF.
P413
P420	Store away from other materials.
P422
P402 + P404	Store in a dry place. Store in a closed container.
P403 + P233	Store in a well-ventilated place. Keep container tightly closed.
P403 + P235	Store in a well-ventilated place. Keep cool.
P410 + P403	Protect from sunlight. Store in a well-ventilated place.
P410 + P412	Protect from sunlight. Do not expose to temperatures exceeding 50 oC/122oF.
P411 + P235	Keep cool.
Disposal
Code	Phrase
P501	Dispose of contents/container to ...
P502	Refer to manufacturer/supplier for information on recovery/recycling

Physical hazards
Code	Phrase
H200	Unstable explosive
H201	Explosive; mass explosion hazard
H202	Explosive; severe projection hazard
H203	Explosive; fire, blast or projection hazard
H204	Fire or projection hazard
H205	May mass explode in fire
H220	Extremely flammable gas
H221	Flammable gas
H222	Extremely flammable aerosol
H223	Flammable aerosol
H224	Extremely flammable liquid and vapour
H225	Highly flammable liquid and vapour
H226	Flammable liquid and vapour
H227	Combustible liquid
H228	Flammable solid
H229	Pressurized container: may burst if heated
H230	May react explosively even in the absence of air
H231	May react explosively even in the absence of air at elevated pressure and/or temperature
H240	Heating may cause an explosion
H241	Heating may cause a fire or explosion
H242	Heating may cause a fire
H250	Catches fire spontaneously if exposed to air
H251	Self-heating; may catch fire
H252	Self-heating in large quantities; may catch fire
H260	In contact with water releases flammable gases which may ignite spontaneously
H261	In contact with water releases flammable gas
H270	May cause or intensify fire; oxidizer
H271	May cause fire or explosion; strong oxidizer
H272	May intensify fire; oxidizer
H280	Contains gas under pressure; may explode if heated
H281	Contains refrigerated gas; may cause cryogenic burns or injury
H290	May be corrosive to metals
Health hazards
Code	Phrase
H300	Fatal if swallowed
H301	Toxic if swallowed
H302	Harmful if swallowed
H303	May be harmful if swallowed
H304	May be fatal if swallowed and enters airways
H305	May be harmful if swallowed and enters airways
H310	Fatal in contact with skin
H311	Toxic in contact with skin
H312	Harmful in contact with skin
H313	May be harmful in contact with skin
H314	Causes severe skin burns and eye damage
H315	Causes skin irritation
H316	Causes mild skin irritation
H317	May cause an allergic skin reaction
H318	Causes serious eye damage
H319	Causes serious eye irritation
H320	Causes eye irritation
H330	Fatal if inhaled
H331	Toxic if inhaled
H332	Harmful if inhaled
H333	May be harmful if inhaled
H334	May cause allergy or asthma symptoms or breathing difficulties if inhaled
H335	May cause respiratory irritation
H336	May cause drowsiness or dizziness
H340	May cause genetic defects
H341	Suspected of causing genetic defects
H350	May cause cancer
H351	Suspected of causing cancer
H360	May damage fertility or the unborn child
H361	Suspected of damaging fertility or the unborn child
H361d	Suspected of damaging the unborn child
H362	May cause harm to breast-fed children
H370	Causes damage to organs
H371	May cause damage to organs
H372	Causes damage to organs through prolonged or repeated exposure
H373	May cause damage to organs through prolonged or repeated exposure
Environmental hazards
Code	Phrase
H400	Very toxic to aquatic life
H401	Toxic to aquatic life
H402	Harmful to aquatic life
H410	Very toxic to aquatic life with long-lasting effects
H411	Toxic to aquatic life with long-lasting effects
H412	Harmful to aquatic life with long-lasting effects
H413	May cause long-lasting harmful effects to aquatic life
H420	Harms public health and the environment by destroying ozone in the upper atmosphere

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CAS No.: 843663-66-1

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CAS No.: 843663-66-1

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