Deltyba (delamanid) / Otsuka, R-Pharm - LARVOL DELTA

Clofazimine pharmacokinetics in novel rifampicin-resistant tuberculosis regimens: an analysis of the endTB and endTB-Q trials. (PubMed, medRxiv) - "Co-administration with delamanid and HIV co-infection resulted in a 37% increase and 20% decrease in clofazimine bioavailability, respectively. We estimated that clofazimine remained present in the body for longer than two years in over half of participants following 9 months of treatment. Follow-up studies are recommended to confirm these associations before adjusting clofazimine dose or clinical care decisions."

Journal • PK/PD data • Diabetes • Human Immunodeficiency Virus • Infectious Disease • Metabolic Disorders • Pulmonary Disease • Respiratory Diseases • Tuberculosis

Development, Validation, and Clinical Application of a Simultaneous Quantification Method of Seventeen Antituberculosis Drugs in Plasma, Serum, or Saliva Using LC-MS/MS. (PubMed, Ther Drug Monit) - "This validated LC-MS/MS method allows simultaneous analysis of multiple anti-TB drugs in plasma, serum, and saliva, facilitating clinical and research applications. The method has been successfully applied in clinical practice."

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

The safety and efficacy of different anti-tuberculosis regimens containing Lzd for RR/MDR/Pre-XDR-TB patients in China. (PubMed, Medicine (Baltimore)) - "Patients were divided into 3 groups: linezolid (Lzd) + bedaquiline (Bdq) containing group (regimen A), Lzd + delamanid (Dlm) containing group (regimen B), and Lzd + other drugs containing group (regimen C, not containing Bdq or Dlm)...88.2% (30/34) of the Dlm group used Lzd-Dlm-clofazimine (Cfz)-cycloserine (Cs) containing regimens...Lzd-Dlm-Cfz-Cs containing regimens may serve as promising candidate regimens for future research on rifampicin-resistant tuberculosis. Multicenter prospective studies with longer follow-up and definitive treatment outcomes are needed to establish comparative effectiveness or treatment superiority of these regimens."

Journal • Retrospective data • Cardiovascular • Heart Failure • Human Immunodeficiency Virus • Infectious Disease • Pulmonary Disease • Respiratory Diseases • Tuberculosis

Adherence to New Drug Regimens in MDR-TB Programmatic Management: Insights from a Retrospective Mixed-Method Study in Bangladesh (ERS 2026) - "Bedaquiline (BDQ) and delamanid (DLM), conditionally approved for MDR-TB, offer new opportunities to improve outcomes...Rifampicin-resistant patients underwent confirmation and second-line DST or LPA before enrollment...These findings demonstrate the feasibility and effectiveness of BDQ- and DLM-based regimens under programmatic conditions, despite notable AEs. Strengthened pharmacovigilance and patient-centred monitoring remain essential to optimize MDR/XDR-TB management and guide future policy decisions."

Adherence • Retrospective data • Acute Kidney Injury • Hematological Disorders • Infectious Disease • Nephrology • Renal Disease • Respiratory Diseases • Tuberculosis

A Pilot Study on the Utility of Whole Genome Sequencing for Detecting Drug Resistance in Mycobacterium tuberculosis in the Current Scenario. (PubMed, Indian J Med Microbiol) - "Resistance detected by WGS was as follows: Isoniazid 23(39.6%), Rifampicin 21(36.2%), FQs 21(36.2%), Ethambutol 18(31%), Linezolid 12(20.6%), Streptomycin 8(13.8%), Kanamycin 6(10.3%), Amikacin and Capreomycin 5(8.6%), Para-amino salicylic acid 1(1.7%) and Ethionamide 1(1.7%). No resistance was detected to Pyrazinamide, Bedaquiline, Clofazimine, Delamanid and Pretomanid...Intermediate Resistance (IR) and potential novel mutations were observed in a few cases, Overall accuracy for first-line drugs between pDST vs WGS was >98% &pDST vs LPA >95%, while for second-line drugs accuracy was >96% and >90% respectively. IR and potential novel mutations should be followed up closely to understand their clinical significance."

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

Efficacy of quabodepistat alone and in combination with delamanid and bedaquiline against Mycobacterium tuberculosis in an NHP model evaluated by [18F] FDG PET/CT and bacterial burden. (PubMed, Antimicrob Agents Chemother) - "Bedaquiline (B), delamanid (D), and pretomanid (P) are used in combination regimens with other anti-TB drugs for MDR-TB; however, agents with novel mechanisms of action are needed...Additionally, the activities of D and P monotherapies were similar in this model. The evaluation of these agents in the marmoset TB model supports further investigation of Q as a component of shorter TB regimens."

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

Guidelines for off-label use of anti-tuberculosis drugs (PubMed, Zhonghua Jie He He Hu Xi Za Zhi) - "NAT2 genotype-inferred acetylator phenotype may support individualized dose adjustment together with TDM, efficacy, and safety assessments (2, B).Recommendation 7: Off-label rifampicin use includes a 3-month regimen of isoniazid and rifampicin (3HR) (1, B) or a 4-month regimen of rifampicin (4R) (2, B) for tuberculosis preventive treatment; individualized high-dose use in TBM or investigational use in drug-susceptible pulmonary tuberculosis (2, C); local administration as adjunct therapy only (2, D); and use during pregnancy, including early pregnancy, after individualized benefit-risk assessment (2, C).Recommendation 8: Based on pharmacokinetic and safety data from Chinese populations, the 3H₂P₂ regimen-isoniazid 500-600 mg, plus rifapentine, 450-600 mg, twice weekly for 3 months-is recommended for tuberculosis preventive treatment (1, B).Recommendation 9: Levofloxacin is a key drug for fluoroquinolone-susceptible MDR/RR-TB (1, B); it may also be used for..."

Journal • Cardiovascular • CNS Disorders • Epilepsy • Heart Failure • Hepatology • Infectious Disease • Liver Failure • Metabolic Disorders • Pain • Pulmonary Disease • Renal Disease • Respiratory Diseases • Tuberculosis • NAT2

Mechanism of the M. tuberculosis DprE1-DprE2 epimerase complex and inhibition by anti-tubercular drugs. (PubMed, Nat Chem Biol) - "Pretomanid and delamanid are prodrugs, whose active derivatives have been reported to target decaprenylphosphoribose-2'-reductase, DprE2, while quabodepistat is a noncovalent inhibitor of decaprenylphosphoribose-2'-oxidase, DprE1. Quabodepistat binds to DprE1 with a unique mode. Our data reveal the mode of action of these drugs, allowing rational design of new derivatives for improved tuberculosis treatments."

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

Effectiveness of Bedaquiline-, Delamanid- and Linezolid-Containing Regimens in Improving Treatment Outcomes Among Pediatric and Adolescents With Drug-Resistant Tuberculosis in the Country of Georgia. (PubMed, Pediatr Infect Dis J) - "Children and adolescents treated for rifampicin-resistant TB with new and repurposed drugs had much better treatment outcomes than those treated with traditional SLDs."

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

Evaluation of a short, all oral treatment regimen including bedaquiline, delamanid, linezolid, clofazimine, and pyrazinamide named "Regimen C" for pre-XDR tuberculosis in Niger. (PubMed, Front Tuberc) - "Undernourished patients tended to have an increased risk of unfavorable treatment outcomes, although this association was not statistically significant (p = 0.18). These findings suggest that the regimen evaluated in this study appears to be effective for the management of pre-XDR tuberculosis in Niger, with a promising treatment success rate."

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

Implications of edge cases for antimicrobial susceptibility predictions for rifampin, delamanid, and pretomanid with the WHO Mycobacterium tuberculosis mutation catalog. (PubMed, Microbiol Spectr) - "However, we demonstrate that false-resistant results occur even using the WHO mutation catalog for rifampin, delamanid, and pretomanid. Similar exceptions linked to the additional grading rules of the catalog are possible for other drugs, underlining the importance of monitoring the performance of the catalog continuously."

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

Therapeutic drug monitoring in the treatment of patients with drug-resistant tuberculosis (PubMed, Ter Arkh) - "Therapeutic drug monitoring is a perspective tool for personalized approach to improve treatment outcomes in high-risk drug-resistant tuberculosis patients."

Journal • Infectious Disease • Pulmonary Disease • Respiratory Diseases • Tuberculosis • CYP3A5

Emergence of dual bedaquiline and linezolid resistance during treatment of pre-extensively drug-resistant tuberculosis: A case report from Zambia. (PubMed, IDCases) - "A 28-year-old HIV-positive Zambian man, virologically suppressed on tenofovir-lamivudine-dolutegravir, was initially treated for drug-sensitive pulmonary tuberculosis. Following relapse and treatment failure, rifampicin resistance was confirmed, and he was initiated on a second-line regimen...A six-month regimen of bedaquiline, pretomanid, and linezolid was commenced...A salvage regimen comprising delamanid, ethambutol, cycloserine, clofazimine, and meropenem was initiated, and the patient remains on treatment under close clinical and laboratory monitoring...The simultaneous acquisition of resistance to bedaquiline and linezolid significantly limits treatment options. Strengthening adherence support, improving laboratory turnaround times, and enhancing pharmacovigilance systems are essential to preserve the effectiveness of novel regimens in Zambia and similar settings."

Journal • Human Immunodeficiency Virus • Infectious Disease • Pulmonary Disease • Respiratory Diseases • Tuberculosis

Mitigating intellectual property barriers to HIV and comorbidities treatment in Eurasian Patent Organization countries: programme results and policy implications (AIDS 2026) - "The drugs included tenofovir/emtricitabine (Armenia, Russia), rilpivirine (Russia), long-acting rilpivirine, islatravir, lenacapavir (EAPO); sofosbuvir (Russia); molnupiravir (EAPO, Russia), nirmatrelvir (EAPO); pretomanid in bedaquiline/pretomanid/linezolid regimen, pretomanid granulate, pretomanid amorphous form (EAPO), bedaquiline (Belarus, Kazakhstan, Kyrgyzstan). EECA communities developed expertise on patent challenges, successfully opposed patents, and revealed and addressed systemic barriers to CSO engagement in access-related IP work. The programme has potential for expansion, as demonstrated by a CBO opposition in Uzbekistan in December 2025 (delamanid). Results from the structural barrier analysis call for legal reform to enhance community involvement in mitigating IP barriers and improving access to medicines."

Hepatitis C • Hepatology • Human Immunodeficiency Virus • Infectious Disease • Inflammation • Novel Coronavirus Disease • Respiratory Diseases • Tuberculosis

Isolated Forearm Abscess with Bilateral Psoas Abscesses: An Unusual Presentation of Extrapulmonary Preextensively Drug-resistant Tuberculosis without Pulmonary Involvement. (PubMed, Ann Afr Med) - "GeneXpert MTB/RIF performed on pus aspirated from both sites confirmed M. tuberculosis complex with rifampicin resistance; a line-probe assay subsequently documented additional resistance to isoniazid and fluoroquinolones - fulfilling the definition of preextensively drug-resistant (XDR) TB. An all-oral modified longer regimen comprising cycloserine, linezolid, clofazimine, bedaquiline, and delamanid was initiated, with steady clinical recovery. Pre-XDR TB may manifest as disseminated soft-tissue disease at unconventional sites - forearm and paravertebral musculature - even when the lungs are radiologically clear. Early molecular resistance testing on pus aspirates shortened the interval to appropriate second-line therapy and likely shaped the favourable trajectory observed here."

Journal • Anorexia • Cough • Infectious Disease • Pain • Pulmonary Disease • Respiratory Diseases • Tuberculosis

Systematic monitoring of patent applications and pre-grant oppositions as highly effective tools against evergreening practices (AIDS 2026) - "Within one and a half years of systematic monitoring of patent applications in Ukraine eight pre-grant oppositions were filed with the Ukrainian Patent Office by 100% LIFE under Make Medicines Affordable campaign, targeting the following medicines: rilpivirine, lenacapavir, delamanid, bedaquiline long-acting formulations, the HPV vaccine, and pembrolizumab. Following the filing of one of the oppositions concerning rilpivirine in 2024 substantive examination of the related patent application has not commenced and is not expected to commence. The remaining oppositions and corresponding patent applications are currently under examination by the Ukrainian Patent Office."

Grant • Gene Therapies • Human Immunodeficiency Virus • Infectious Disease

Synergism in drug combination of new tuberculosis antibiotics for drug-resistant Mycobacterium tuberculosis in vitro. (PubMed, Microbiol Spectr) - "Novel antituberculosis drugs such as bedaquiline (BDQ), pretomanid (Pa824), and delamanid (DLM) offer a promising treatment for DR-TB...In this research, we evaluated the synergistic effects of two dual-drug combinations (BDQ-Pa824 and BDQ-DLM) and four triple-drug combinations (BDQ-DLM-clofazimine [CFZ], BDQ-DLM-linezolid [LZD], BDQ-Pa824-CFZ, and BDQ-Pa824-LZD) against 30 Mycobacterium tuberculosis (MTB) strains isolated from TB patients...In this research, we evaluated the synergistic antimycobacterial efficacy of the new optimized antituberculosis regimen (BDQ-DLM-LZD or BDQ-DLM-CFZ) and the standard regimen (BDQ-Pa824-LZD or BDQ-Pa824-CFZ) for TB strains. This highlights the therapeutic substitutability of BDQ-DLM or BDQ-Pa824-based triple-drug regimens for TB strains."

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

Anti-tuberculous drug-induced DRESS syndrome in pregnancy with hepatitis E and autoimmune overlap: A case report. (PubMed, Medicine (Baltimore)) - "This case highlights the complexity of diagnosing and managing DRESS in pregnancy, particularly in tuberculosis-endemic regions. Coexisting viral hepatitis and autoimmune disorders may mimic or exacerbate the syndrome, underlining the importance of high clinical suspicion, timely drug withdrawal, and individualized therapy."

Journal • Eosinophilia • Immunology • Infectious Disease • Inflammation • Inflammatory Arthritis • Lupus • Pulmonary Disease • Respiratory Diseases • Systemic Lupus Erythematosus • Tuberculosis

No phenotypic resistance observed for most group-3 and -4 variants in Mycobacterium tuberculosis genes related to bedaquiline, clofazimine, delamanid, and pretomanid in a Central and West African context. (PubMed, Microbiol Spectr) - "Notably, mmpR5 variants associated with elevated bedaquiline/clofazimine MICs were identified in eight isolates, suggesting that some patients in this cohort may have harbored pre-existing resistance-associated variants yet remained potentially eligible for bedaquiline-containing regimens. These findings contribute to improving the interpretation of genomic resistance data and strengthening surveillance of resistance to bedaquiline, clofazimine, delamanid, and pretomanid."

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

Cost-effectiveness of BPaL-based and 9-month modified all-oral short treatment regimens for rifampicin-resistant tuberculosis in Belarus. (PubMed, PLOS Glob Public Health) - "We evaluated the cost-effectiveness of BPaL-based regimens containing bedaquiline, pretomanid, and linezolid with either moxifloxacin or clofazimine (BPaL(M/C)); mSTR composed of bedaquiline, levofloxacin, linezolid, clofazimine, cycloserine, or delamanid; and standard of care (SOC; ≥ 18-month regimens) for MDR/RR-TB and pre-XDR-TB in Belarus over a 20-year horizon using a cohort-based Markov model. The scale-up analysis showed that expanding use of shorter regimens in Belarus could generate annual TB programme budget savings exceeding USD 9.8 million. BPaL(M/C) and mSTR are cost-effective alternatives to SOC in Belarus, offering substantial economic benefits at both patient and programmatic levels."

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

Towards culture-free sequencing of Mycobacterium tuberculosis: evaluating new targeted and whole-genome approaches for genotyping and drug resistance profiling. (PubMed, Genome Med) - P2 | "In this predominantly drug-susceptible TB cohort, tNGS showed high overall agreement with cWGS for DR profiling with a LoD within the range of low-complexity automated assays used for initial diagnosis. dWGS, while requiring higher DNA input, enables robust culture-free genome-wide analysis, including transmission inference and exploration of candidate DR loci. Bacillary load-guided integration of both approaches may optimize DR-TB clinical management and genomic surveillance. Larger studies are needed to validate clinical and epidemiological predictive performance."

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

A Short-Course Regimen Containing Delamanid, Bedaquiline and Linezolid for the Treatment of Drug-Resistant Tuberculosis: A Retrospective Study from China. (PubMed, Infect Drug Resist) - "To assess the efficacy and safety of delamani (Dlm), bedaquiline (Bdq) and linezolid (Lzd) in multidrug-resistant tuberculosis (MDR-TB) and rifampicin-resistant tuberculosis (RR-TB). No baseline characteristics were associated with time to sputum culture conversion (P > 0.05). The Dlm-Bdq-Lzd regimen demonstrated favorable efficacy and safety in patients with MDR/RR-TB, and may represent a mechanistically distinct, shorter-course alternative to conventional regimens, while potential risks such as prolonged QTcF need to be noted."

Journal • Retrospective data • Hematological Disorders • Hepatitis B • Infectious Disease • Inflammation • Pulmonary Disease • Respiratory Diseases • Tuberculosis

Rapid detection of treatment-emergent resistance to bedaquiline and pretomanid in Mycobacterium tuberculosis using TM4::GeNL reporter mycobacteriophages. (PubMed, Microbiol Spectr) - "Susceptibility to BDQ, pretomanid (PMD), delamanid (DLM), and linezolid (LZD) was assessed by luminescence retention after TM4::GeNL infection compared to no-drug control, with conventional pDST and whole-genome sequencing as the reference standard. TM4::GeNL reporter mycobacteriophage detected emerging resistance to bedaquiline and pretomanid within 48 h from a positive culture, with our results correlating well with conventional phenotypic drug susceptibility and whole-genome sequencing data. These findings support TM4::GeNL reporter mycobacteriophage as a rapid, multiplexed alternative drug-susceptibility test for DR-TB."

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

Rare emergence of delamanid resistance in multidrug-/rifampicin-resistant tuberculosis patients receiving delamanid-containing regimens: a prospective multicentric study in China. (PubMed, Ann Clin Microbiol Antimicrob) - "Primary DLM resistance was rare (0.76%), and resistance emergence during treatment was infrequent, though some cases of reduced susceptibility were observed."

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

MDR-ENDPlus: A 6-Month MDR-END Plus Regimen for Rifampicin-Resistant Tuberculosis (clinicaltrials.gov) - P3 | N=294 | Not yet recruiting | Sponsor: Seoul National University Hospital

New P3 trial • Infectious Disease • Pulmonary Disease • Respiratory Diseases • Tuberculosis • CD4