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

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

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

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

DRESS To Kill: A Case of Severe Drug Reaction Eosinophilia Systemic Symptoms Recurrence with Second-Line anti-Tuberculosis Medication in a 44-Year-Old Asian Woman (APSR 2025) - "Case Report : We report a presentation of DRESS in a 44-year-old Asian female with Multi-Drug Rifampicin Resistant Tuberculosis (MDR-TB)...Cessation of anti-TB drugs and initiation of oral methylprednisolone resulted in clinical improvement and was discharged on a corticosteroid regimen over 14 days. Rechallenging treatment using a graded protocol with second- line MDR-TB agents (Linezolid, Delamanid, Cycloserine, and Levofloxacin) caused recurrence of symptoms, including rash with desquamation, eosinophilia, and elevated liver enzymes...Prednisone was carefully tapered over six months...Knowledge, early recognition, early cessation, prompt management are of important to minimize morbidity and mortality. Furthermore, outpatient follow up is vital to prevent relapses and long-term sequelae including organ damage, infections, and mental health complications."

Clinical • Autoimmune Hepatitis • Eosinophilia • Hematological Disorders • Hepatology • Immunology • Infectious Disease • Inflammation • Respiratory Diseases • Tuberculosis

A Prospective Cohort Study on the Usage, Safety, and Efficacy of Delamanid in Patients With Pulmonary Multidrug-Resistant Tuberculosis in South Korea. (PubMed, Open Forum Infect Dis) - "Delamanid has demonstrated potential in the treatment of multidrug-resistant (MDR) or rifampicin-resistant tuberculosis (TB); however, real-world data on its effectiveness and safety remain limited. The overall treatment success rate was 86.9%. Delamanid demonstrated favorable safety and efficacy profiles for MDR-TB treatment under programmatic conditions, providing valuable and up-to-date evidence supporting its promising role in MDR-TB management."

Clinical • Journal • Dermatology • Infectious Disease • Pruritus • Pulmonary Disease • Respiratory Diseases • Tuberculosis

Discrepancies between Genotypic Resistance Based on WGS and Phenotypic Resistance to Bedaquiline, Delamanid, Pretomanid, and Linezolid in Drug-Resistant M. tuberculosis Isolates from South Korea (AMP 2025) - "These findings indicate the existence of resistance mechanisms not yet included in the current WHO mutation catalogue. The mismatch between pDST and whole-genome sequencing results highlights the need to combine phenotypic and genetic methods, and to continuously improve resistance mutation classification for more accurate prediction of drug resistance."

Infectious Disease • Respiratory Diseases • Tuberculosis

Treatment of Drug-Resistant Tuberculosis (DR-TB) in Germany, Austria and Switzerland - Updated Recommendations Based on the WHO Guidelines 2025 (PubMed, Pneumologie) - "DR-TB includes resistant forms of Mycobacterium tuberculosis, including isoniazid monoresistance, multidrug-resistant/rifampicin-resistant TB (MDR/RR-TB), pre-extensively drug-resistant TB (pre-XDR-TB) and extensively drug-resistant TB (XDR-TB). For MDR/RR-TB and pre-XDR-TB without additional resistance to bedaquiline and/or linezolid, two 6-month, purely oral short-term regimens are recommended (BPaLM or BDLLfx for MDR/RR-TB and BPaL or BDLC for pre-XDR-TB [*B = bedaquiline, C = clofazimine, D = delamanid, L = linezolid, Lfx = levofloxacin; M = moxifloxacin; Pa = pretomanid])...Due to the low number of cases, treatment in specialized centers or in cooperation with them is recommended. The aim is to provide effective, tolerable therapy that is adapted to the resistance situation in order to ensure therapeutic success and prevent further development of drug-resistance."

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

A Multicenter, Open-label, Randomized, Active-controlled Clinical Study to Compare the Efficacy and Safety of Different Combination Regimens of JDB0131 Benzenesulfonate Tablets with Delamanid in Patients with Rifampin-resistant Tuberculosis (JD-RISE) (ChiCTR) - P2 | N=60 | Not yet recruiting | Sponsor: Beijing Chest Hospital, Capital Medical University; WestVac Biopharma Co., Ltd.

New P2 trial • Infectious Disease • Pulmonary Disease • Respiratory Diseases • Tuberculosis

Mycobacterium tuberculosis genomic surveillance in Mexico. Characterization of variants in drug resistance and efflux pump genes. (PubMed, Front Microbiol) - "In this study, we performed WGS analysis on 49 pulmonary tuberculosis isolates from Mexican patients to identify mutations conferring resistance to 11 key antimicrobial agents: four first-line drugs (isoniazid, rifampicin, ethambutol, and pyrazinamide) and 7 second line drugs (fluoroquinolones, ethionamide/prothionamide, amikacin, kanamycin, capreomycin, streptomycin, and bedaquiline). The identification of new resistance-associated variants (RAV) from clinical isolates underrepresented in global databases, contributes to develop improved diagnostic tools, optimize treatment regimens, and probably to elucidate antibiotic resistance mechanisms. Specifically, the identification of RAVs for new drugs like bedaquiline, pretomanid, delamanid, and linezolid, which are central to the most recent schemes of treatment (BPaLM, BPaL, BDLLfxC, BLMZ), is key to the improvement of patient outcomes and preventing the emergence of resistance to these critical therapeutic options."

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

Delamanid-containing regimens over 24 weeks for the treatment of multidrug-resistant/rifampicin-resistant tuberculosis: preliminary results from a single center in a multicenter, prospective, observational study. (PubMed, Front Med (Lausanne)) - P4 | "Single center preliminary results from a multicenter, prospective, observational study whose aims were to investigate the efficacy and safety of 24-week delamanid-containing regimens in Chinese multidrug-resistant/rifampicin-resistant tuberculosis (MDR/RR-TB) patients. A 24-week follow-up period of safety outcomes was basically consistent with the overall results of the multicenter investigation, and close monitoring of QT interval prolongation should in particular be carried out when delamanid is combined with clofazimine and levofloxacin. https://clinicaltrials.gov/study/NCT04421495, identifier NCT04421495."

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

Perinatal transmission and cure of extensively drug-resistant tuberculosis in an infant. (PubMed, Afr J Thorac Crit Care Med) - "The infant was successfully treated with an individualised all-oral multidrug regimen containing delamanid, a drug rarely described in the treatment of perinatal tuberculosis...Implications of the findings. The report highlights the need for evidence-based guidance on XDR-TB in this paediatric population, as well as further research on preventive strategies for mitigating mother-to-child transmission of TB."

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

Early Bactericidal Activity, Safety & Tolerability of Oral GSK3036656 in a Dual Combination With Novel and Established Antitubercular Agents, or Standard of Care in Adults With Rifampicin Susceptible Pulmonary Tuberculosis (clinicaltrials.gov) - P2 | N=127 | Completed | Sponsor: GlaxoSmithKline | Recruiting ➔ Completed | Trial completion date: Nov 2024 ➔ May 2025 | Trial primary completion date: Nov 2024 ➔ May 2025 | Recruiting ➔ Completed

Trial completion • Trial completion date • Trial primary completion date • Infectious Disease • Pulmonary Disease • Respiratory Diseases • Tuberculosis

BDLL: 6 Months of Bedaquiline(BDQ), Delamanid(DLM), Linezolid(LZD) and Levofloxacin(LFX) in RR-TB Patients in Hubei Province (clinicaltrials.gov) - P=N/A | N=52 | Not yet recruiting | Sponsor: Wuhan Pulmonary Hospital

New trial

Protecting households on exposure to newly diagnosed index multidrug-resistant tuberculosis patients: Study protocol for the PHOENIx phase 3 clinical trial. (PubMed, Contemp Clin Trials) - "Preventing MDR-TB is a global priority. Alternatives to levofloxacin-based TPT are needed since fluoroquinolone resistance is growing. PHOENIx, a phase 3 trial evaluating delamanid, is poised to inform WHO guidelines."

Journal • P3 data • Infectious Disease • Pulmonary Disease • Respiratory Diseases • Tuberculosis

In vitro exposure to clofazimine can select for delamanid and pretomanid resistance in Mycobacterium tuberculosis. (PubMed, Antimicrob Agents Chemother) - "Whether this is also possible in vivo and in an Rv0678 wild-type background has to be studied further. Based on the available evidence, however, we propose that nitroimidazole resistance should not be considered an exclusion criterion for the use of clofazimine."

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

Prevalence of pre-existing delamanid drug resistance in Multi-Drug Resistant (MDR) Mycobacterium tuberculosis clinical isolates from northern India (ERS 2025) - "Present study is the first to report the existence of pre-existing DLM-resistance among MDR- M.tuberculosis strains from North India. Study highlights the need for routine surveillance and monitoring to prevent the spread and increase of DLM resistance in India."

Clinical • Cough • Infectious Disease • Respiratory Diseases • Tuberculosis

Nanopore sequencing insights into bedaquiline, clofazimine, and delamanid resistance in drug-resistant mycobacterium tuberculosis isolates from treatment-naïve patients in north india (ERS 2025) - "Cross-resistance to Bedaquiline and Clofazimine in treatment-naïve patients is concerning. Nanopore sequencing enables early drug resistance detection"

Clinical • Infectious Disease • Respiratory Diseases • Tuberculosis

Clinico-demographic profile of pre-extensively drug-resistant pulmonary tuberculosis patients in India. (PubMed, Indian J Tuberc) - "Adults weighing more than 30 kg, aged 18 years or more diagnosed with pre extensively drug resistant TB (pre-XDR TB) were initiated on bedaquiline and linezolid based regimens along with pretomanid/delamanid as part of two multicentric clinical trials in India. Pre-XDR TB was defined as patients infected with M. tb strains resistant to rifampicin (may or may not be resistant to isoniazid) with additional resistance to fluoroquinolones and/or second line injectable as per the existing World Health Organization (WHO) definitions during the trial period...High rates of treatment failure during the earlier episodes of TB with increased disease severity and drug resistance during the current episode is a matter of grave concern. Improved treatment success during the management of drug sensitive TB, addressing the nutritional challenges are some of key areas of focus in the prevention of DRTB burden."

Journal • Cough • Diabetes • Infectious Disease • Metabolic Disorders • Pulmonary Disease • Respiratory Diseases • Tuberculosis

CRUSH-TB: Short-course Regimens for the Treatment of Pulmonary Tuberculosis (clinicaltrials.gov) - P2/3 | N=288 | Active, not recruiting | Sponsor: Centers for Disease Control and Prevention | Recruiting ➔ Active, not recruiting

Enrollment closed • Infectious Disease • Pulmonary Disease • Respiratory Diseases • Tuberculosis • CD4

Awareness of management of pulmonary multidrug-resistant tuberculosis (MDR-TB) among private practitioners in suburban areas of Pune city, India: Input for developing an educational tool. (PubMed, PLOS Glob Public Health) - "Less than a fourth of PPs knew about the second-line anti-TB drugs such as bedaquiline, delamanid or linezolid etc. and their availability either in the National TB Elimination Program (NTEP) or the private sector. Our study indicates considerable lack of awareness about pulmonary MDR-TB management among allopathic PPs in the study area and highlights the need for education and creating awareness about the same. It identified specific areas for developing an educational tool for PPs in India and elsewhere."

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

Global child-friendly anti-TB medicines - where do we stand? (PubMed, IJTLD Open) - "Despite progress in developing child-friendly antituberculosis formulations for drug-susceptible and drug-resistant TB, a single-medicine rifampicin dispersible tablet is still needed...Preparing extemporaneous formulations need pharmacies and trained staff. Therefore, a need remains for global collaboration to prioritise child-friendly solid, dispersible, functionally scored TB formulations and to ensure equal access for all children with TB globally."

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

Can 6-month long regimens become the standardized treatment for MDR-TB globally? (PubMed, Int J Infect Dis) - "Treatment for multidrug/rifampicin resistant (MDR/RR) tuberculosis (TB) was traditionally long and poorly tolerated...A key difference between the two regimens is the replacement of pretomanid with delamanid in the BDLLfxC...In this narrative review, we explore the use of 6-month regimens for MDR/RR-TB in specific populations - children, PBFW, people living with HIV, and those with challenging TB forms (e.g., CNS, bone, disseminated). The overall aim is to discuss how far we still are from the goal of a public health approach to the treatment of MDR-TB."

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