Sirturo (bedaquiline) / J&J, Pharmstandard - LARVOL DELTA

Clinical evaluation of a commercial culture-free targeted next-generation sequencing test for diagnosis of drug-resistant tuberculosis. (PubMed, Microbiol Spectr) - P=N/A | "The ABL tNGS workflow showed ≥95% sensitivity for rifampicin, isoniazid, and levofloxacin; 92%-93% for pyrazinamide and moxifloxacin; 88% for ethambutol; and 72%-82% for bedaquiline and clofazimine. Further refinement in sample preparation may expand its use to specimens with lower bacterial counts. This study is registered with ClinicalTrials.gov as NCT04239326."

Journal • Next-generation sequencing • Infectious Disease • Pulmonary Disease • Respiratory Diseases • Tuberculosis

Extensively Drug-Resistant Tuberculosis with Conflicting Resistance Testing Results, Lesotho. (PubMed, Emerg Infect Dis) - "A patient with extensively drug-resistant tuberculosis in Lesotho recovered successfully after failed treatment with bedaquiline, delamanid, linezolid, and clofazimine. Whole-genome sequencing and broth microdilution testing results were not in agreement, illustrating the urgent need for studies that correlate phenotypic and genotypic resistance testing with clinical response."

Journal • Infectious Disease • Pulmonary Disease • Respiratory Diseases • Tuberculosis

Host oxidative stress primes mycobacteria for rapid antibiotic resistance evolution. (PubMed, Res Sq) - "Independently, reanalysis of genome-wide CRISPRi screens revealed that the OSR network and high Bayes probability genes are functionally associated with treatment escape and survival with multiple antibiotics, including isoniazid, rifampicin, ethambutol, bedaquiline, vancomycin, clarithromycin, linezolid, and streptomycin. Our findings that host-imposed oxidative stress and inadequate drug penetration may synergistically prime Mtb populations for rapid resistance evolution suggest that targeting pre-resistance mechanisms, such as oxidative stress defenses, could help slow the emergence of antibiotic resistance in tuberculosis."

Journal • Infectious Disease • Pulmonary Disease • Respiratory Diseases • Tuberculosis

Laboratory strengthening strategies to advance drug susceptibility testing for BPaL regimens in TB treatment. (PubMed, Public Health Action) - "Our study highlights the need for continued investment in training and infrastructure to integrate DST into routine diagnostics and to support scale-up of BPaL regimens in high TB-burden settings."

Journal • Infectious Disease • Pulmonary Disease • Respiratory Diseases • Tuberculosis

QUANTUM: A Study of Quabodepistat-containing Regimens for the Treatment of Drug-resistant Pulmonary Tuberculosis (clinicaltrials.gov) - P3 | N=532 | Recruiting | Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease • Pulmonary Disease • Respiratory Diseases • Tuberculosis

Bedaquiline Resistance: A Looming Global Threat in Tuberculosis Management. (PubMed, Curr Microbiol) - "Consequently, it is imperative to mitigate the burden of MDR-TB and bedaquiline resistance. Herein, this article emphasizes structural features, mechanism of action, emergence of underlying resistance mechanisms, pharmacokinetic & pharmacodynamic properties, clinical toxicity, and strategies to combat resistance associated with bedaquiline."

Journal • Review • Infectious Disease • Pulmonary Disease • Respiratory Diseases • Tuberculosis

Whole-Genome and Targeted Sequencing of 75 Drug-Resistant Mycobacterium tuberculosis Clinical Isolates in South Korea. (PubMed, Ann Lab Med) - "Specifically, we analyzed mutations associated with resistance against isoniazid (INH), rifampicin (RIF), moxifloxacin (MFX), pyrazinamide (PZA), pretomanid (PMD), delamanid (DLM), linezolid (LZD), and bedaquiline (BDQ) and compared them with those in the 2023 WHO mutation catalog. However, PZA results were discrepant for 16 isolates. Our findings highlight the potential of WGS and targeted sequencing as powerful tools for diagnosing TB drug resistance and emphasize the need for further validation before their routine implementation in clinical settings."

Journal • Infectious Disease • Pulmonary Disease • Respiratory Diseases • Tuberculosis

Real-world safety profile of novel anti-multidrug-resistant tuberculosis drugs: a disproportionality analysis based on the FAERS database. (PubMed, BMJ Open) - "Our study highlights the differences in common ADEs of BDQ, DLM and Pa, as well as the differences in these ADEs among genders and age groups, providing valuable insights for clinical application."

Journal • Real-world evidence • Retrospective data • Cardiovascular • Congestive Heart Failure • Heart Failure • Hematological Disorders • Hepatology • Infectious Disease • Inflammation • Liver Failure • Pain • Pancreatitis • Pulmonary Disease • Respiratory Diseases • Tuberculosis • ROR1

Direct targeted next-generation sequencing for diagnosis of drug-resistant tuberculosis from clinical samples - An update. (PubMed, Indian J Tuberc) - "For respiratory samples with rifampicin resistance, tNGS could be used for the rapid detection of additional drug resistance including newer and repurposed drugs like Bedaquiline, Delamanid, Pretomanid, Linezolid and Clofazimine for which no rapid molecular tests are currently available. tNGS could be performed using different platforms like Illumina, Oxford Nanopore Technology and/or Ion torrent and diverse bio-informatic pipeline options. Positioning of a tNGS with portability system in the current TB diagnostic algorithm and its use in the clinical management of patients' needs further evaluation and efforts."

Biomarker • Journal • Next-generation sequencing • Review • Infectious Disease • Pulmonary Disease • Respiratory Diseases • Tuberculosis

Whole genome sequencing-based detection of extensively drug-resistant tuberculosis from Ethiopia. (PubMed, Commun Med (Lond)) - "Whole-genome sequencing identifies dominant mutations in genes such as gyrA, atpE, and Rv067 that are associated with resistance to second-line anti-tuberculosis drugs. Significant cross-resistance is observed between key second-line drugs, bedaquiline and clofazimine, as well as delamanid and pretomanid. This finding highlights the need for routine genomic surveillance to detect drug resistance early, improve treatment outcomes, and prevent transmission."

Journal • Infectious Disease • Pulmonary Disease • Respiratory Diseases • Tuberculosis

Exploring the anti-tuberculosis activity mechanism of OTB-658: Multi-omics analysis. (PubMed, J Pharm Biomed Anal) - "OTB-658, a novel oxazolidinone for tuberculosis, is designed to provide improved efficacy and safety compared to linezolid (LZD) in combination with bedaquiline and pretomanid (BPaL). Through an integrative approach combining whole genome, proteomics, transcriptomics, the results suggest that OTB-658 exerts its antimicrobial effects by targeting the 50S ribosomal subunit, thereby disrupting bacterial protein synthesis. This study is significant for advancing the drug's clinical trial research process and the application of OTB-658 in the treatment."

Journal • Infectious Disease • Pulmonary Disease • Respiratory Diseases • Tuberculosis

A PAN-USR TB Multi-Center Trial (clinicaltrials.gov) - P3 | N=610 | Recruiting | Sponsor: Shenzhen Third People's Hospital | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease • Pulmonary Disease • Respiratory Diseases • Tuberculosis

BREACH-TB: Bedaquiline Roll-out Evidence in Contacts and People Living With HIV to Prevent TB (clinicaltrials.gov) - P2/3 | N=2530 | Not yet recruiting | Sponsor: Johns Hopkins University | Phase classification: P3 ➔ P2/3

Phase classification • Human Immunodeficiency Virus • Infectious Disease • Pulmonary Disease • Respiratory Diseases • Tuberculosis

Multi-biomarker Integration in Predicting Bedaquiline Treatment Response among Diabetic MDR-TB Patients. (PubMed, J Infect Chemother) - "Multi-biomarker integration effectively predicts bedaquiline treatment response in diabetic MDR-TB patients. The synergistic relationship between adequate drug exposure and glycemic control underscores the necessity for integrated therapeutic drug monitoring and diabetes management strategies in this high-risk population."

Biomarker • Journal • Diabetes • Infectious Disease • Metabolic Disorders • Pulmonary Disease • Respiratory Diseases • Tuberculosis • IL6 • TNFA

Management of non-tuberculous mycobacterial pulmonary disease (NTM-PD): a European wide NTM-NET survey (BTS WM 2025) - "The most frequently used were amikacin (100%), tigecycline (61%) and imipenem (50%). Second-line agents including nebulised amikacin, linezolid and clofazimine were used by 68%(n=23), 74%(n=25) and 76%(n=26) respondents, respectively...Ten (29%) centres prescribed Bedaquiline for NTM-PD...Use of injectable and second-line therapy is increasing with limited international/national guidance available. Ensuring access to evidence-based guidelines incorporating these anti-microbials and expert advisory groups is essential to ensure consistent, high-quality NTM-PD care."

Nontuberculous mycobacteria • Nontuberculous Mycobacterial Disease • Pulmonary Disease • Respiratory Diseases

Fulminant hepatitis during treatment for per-extensively drug-resistant tuberculosis: A case report and call for improved patient monitoring. (PubMed, Medicine (Baltimore)) - "This case report highlights the importance of regular liver function monitoring during antituberculosis therapy to ensure patient safety."

Journal • Hepatology • Infectious Disease • Inflammation • Liver Failure • Pulmonary Disease • Respiratory Diseases • Tuberculosis

Bedaquiline-induced eosinophilic pneumonitis in treatment-refractory mycobacterium avium complex (MAC) lung disease. (PubMed, BMJ Case Rep) - "This case highlights the need for heightened clinical awareness of novel adverse effects as bedaquiline use expands beyond its original indication for multidrug-resistant tuberculosis. Clinicians should consider eosinophilic pneumonitis in patients developing new respiratory symptoms and peripheral eosinophilia while on bedaquiline, ensuring timely diagnosis and management to prevent serious complications."

Journal • Eosinophilia • Immunology • Infectious Disease • Inflammation • Nontuberculous Mycobacterial Disease • Pneumonia • Pulmonary Disease • Respiratory Diseases • Tuberculosis

A 6 to 9-month oral regimen for rifampicin-resistant tuberculosis: a randomised open-label non-inferiority trial in China. (PubMed, Clin Microbiol Infect) - "The all-oral regimen was non-inferior to the 9-month injectable-containing regimen, offering an alternative for patients lacking access to bedaquiline, delamanid or pretomanid. However, its efficacy against the latest WHO-recommended bedaquiline-containing regimens requires further validation."

Head-to-Head • Journal • Hepatology • Infectious Disease • Pulmonary Disease • Respiratory Diseases • Tuberculosis

Remission spectroscopy resolves the mechanism of action of bedaquiline within living mycobacteria. (PubMed, Nat Commun) - "Applying the same approach to human cells did not detect bedaquiline-induced inhibition of mitochondrial function despite such inhibition being seen in isolated systems. Overall, we clarify how bedaquiline works, why different models for its action developed, and the mechanisms underlying the synergy of bedaquiline in combination regimes."

Journal • Infectious Disease • Pulmonary Disease • Respiratory Diseases • Tuberculosis

Correlation of Timika scoring with microbiological burden in multi-drug resistant tuberculosis patients initiated on bedaquiline treatment. (PubMed, Trop Doct) - No abstract available

Journal • Infectious Disease • Pulmonary Disease • Respiratory Diseases • Tuberculosis

Efficacies of sequenced monotherapies of Mycobacterium avium lung infection in mouse. (PubMed, bioRxiv) - "Mice were treated with either the standard triple-drug regimen of clarithromycin, ethambutol, and rifampicin or with sequential monotherapy: clarithromycin, bedaquiline, and clofazimine, with only one drug administered at a time for four-week intervals. These findings provide the first experimental evidence that sequential monotherapy can deliver efficacy comparable to multidrug therapy for M. avium disease without promoting resistance. This proof-of-concept supports further investigation of sequencing strategies as a potentially more tolerable alternative to current regimens."

Journal • Preclinical • Infectious Disease • Nontuberculous Mycobacterial Disease • Pulmonary Disease • Respiratory Diseases • Tuberculosis

Design, Synthesis, and Biological Evaluation of Mono- and Diamino-Substituted Squaramide Derivatives as Potent Inhibitors of Mycobacterial Adenosine Triphosphate (ATP) Synthase. (PubMed, J Med Chem) - "Like the approved drug bedaquiline, these compounds achieve efficacy by inhibiting mycobacterial ATP synthase...Compared to earlier squaramides, several analogues demonstrated micromolar activity against M. tuberculosis, improved microsomal stability in vitro, and reduced cytotoxicity. These properties contribute to the preclinical development of this class of compound."

Journal • Infectious Disease • Pulmonary Disease • Respiratory Diseases • Tuberculosis

Quantitation of Plasma Bedaquiline Concentrations in Indian MDR-TB Patients Using Liquid Chromatography-Tandem Mass Spectrometry. (PubMed, Biomed Chromatogr) - "The median Cmax attained was 1.59 mg/L with a Tmax around 6 h for most of our patients. This method was successfully developed and validated for a pilot PK study in Indian MDR-TB patients."

Journal • Infectious Disease • Pulmonary Disease • Respiratory Diseases • Tuberculosis

High loss to follow-up on a bedaquiline-based regimen for rifampicin-resistant TB. (PubMed, IJTLD Open) - No abstract available

Journal • Infectious Disease • Pulmonary Disease • Respiratory Diseases • Tuberculosis

WITHDRAWN Evaluating lineage specific response to tuberculosis treatment regimens using clinical Mycobacterium tuberculosis Complex Isolates (ASTMH 2025) - "The IC50 of first line drugs like rifampicin varied up to 4fold between Mtb lineage 4 and Maf lineage 6...Trial1 (bedaquiline, linezolid, rifapentine) and Trial2 (bedaquiline, clofazimine, moxifloxacin) were most effective against Mtb lineage 2, while SimpliciTB (bedaquiline, pretomanid, moxifloxacin, pyrazinamide) and Trial1 showed superior activity against Mtb lineage 4...MTBC lineage diversity significantly impacts regimen efficacy. Trial1 and End TB showed enhanced activity against specific lineages, underscoring the potential of lineage-tailored treatments to shorten therapy and improve TB control."

Clinical • Infectious Disease • Respiratory Diseases • Tuberculosis