Lamprene (clofazimine) / Novartis - 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

Challenges in causality assessment of renal dysfunction during sequential treatment for presumed rifampicin-resistant tuberculosis in an elderly patient. (PubMed, IDCases) - "Eighteen days after initiation of a long oral regimen (D2: levofloxacin, clofazimine, linezolid, pyrazinamide, and cycloserine), acute kidney injury developed, with serum creatinine increasing to 140 µmol/L and eGFR declining to 42.34 mL/min/1.73 m²...Advanced age, low BMI, frailty, and fluctuating hydration status should be considered when interpreting changes in renal function. Careful interpretation requires integration of the clinical course and available diagnostic information rather than reliance on temporal associations alone."

Journal • Acute Kidney Injury • Infectious Disease • Nephrology • Pulmonary Disease • Renal Disease • Respiratory Diseases • Tuberculosis

Omadacycline as an alternative to macrolides within maintenance regime for Mycobacterium abscessus pulmonary disease in children with Cystic Fibrosis: Adapting pharmacotherapy in response to emerging macrolide resistance (ERS 2026) - "BACKGROUND: Mycobacterium abscessus infection in children with cystic fibrosis (CF) presents major therapeutic challenges, including inducible(erm gene) resistance to macrolide antibiotics (e.g. Azithromycin) which have bacteriostatic action and may negatively impact the bactericidal action of aminoglycosides when used in combination. Omadacycline, a novel tetracycline antibiotic with activity against non-tuberculous mycobacteria (NTM), offers an effective alternative to macrolides...Following an intensification regime of 3 weeks of intravenous cefoxitin, meropenem and amikacin, omadacycline was incorporated into maintenance therapy alongside clofazimine and nebulised amikacin... Emerging evidence of inducible resistance in M.abscessus isolates may impact success of eradication when using macrolides. Omadacycline appears to be an effective alternative to macrolides in achieving successful culture conversion when used in maintenance therapy for NTM-PD."

Clinical • Chronic Cough • Cough • Cystic Fibrosis • Genetic Disorders • Immunology • Infectious Disease • Nontuberculous Mycobacterial Disease • Pulmonary Disease • Respiratory Diseases

Clofazimine enteropathy - a case series and literature review (ERS 2026) - "Early clinician recognition of clofazimine enteropathy is essential as symptoms typically resolve with drug cessation. Endoscopic features are not always seen and the diagnosis should be considered in the presence of consistent symptoms Figure 1: Patient 11 terminal ileum demonstrating villous distortion and dark pigmentation of villi"

Clinical • Review • Infectious Disease • Nontuberculous Mycobacterial Disease • Respiratory Diseases

Clofazimine use for nontuberculous mycobacterial infections: 10-year experience in Belgium (ERS 2026) - "While generally well-tolerated, 20% discontinued treatment early due to side effects. Sustained efforts for reimbursement ultimately resulted to national approval of clofazimine coverage for NTM management."

Nontuberculous mycobacteria • Gastrointestinal Disorder • Infectious Disease • Nontuberculous Mycobacterial Disease • Pruritus • Pulmonary Disease • Respiratory Diseases

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

Macrolide-resistant Mycobacterium avium complex pulmonary disease: A narrative review. (PubMed, J Clin Tuberc Other Mycobact Dis) - "The combination of lung resection surgery with or without amikacin, along with continued ethambutol use, has been associated with improved outcomes relative to regimens without these...For instance, clofazimine and minocycline have both been proposed as a replacement for rifampicin. Bedaquiline has also been suggested as rescue therapy. This narrative clinical review describes the prevalence of MR-MAC-PD, resistance mechanisms, clinical management strategies, and provides a brief overview of the drug pipeline for MAC-PD, aiming to inform clinical practice and guide evidence-based management."

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

Pharmacokinetics of clofazimine tablet formulation in children with rifampicin-resistant tuberculosis in CATALYST, a multi-site international trial. (PubMed, J Pediatric Infect Dis Soc) - "We evaluated the pharmacokinetics of a novel child-friendly 50 mg clofazimine tablet formulation that disperses quickly in water, compared to traditional gel capsules, in 36 children routinely treated for rifampicin-resistant tuberculosis. No substantial pharmacokinetic difference was observed between tablets and gel capsules, supporting the tablet formulation use for paediatric dosing."

Journal • PK/PD data • Infectious Disease • Pediatrics • Pulmonary Disease • Respiratory Diseases • Tuberculosis

Clofazimine Use in Non-Tuberculous Mycobacteria (NTM) Lung Infections (IDWeek 2026) - No abstract available

Nontuberculous mycobacteria • Infectious Disease • Nontuberculous Mycobacterial Disease

Addition of Clofazimine in Patients with Pulmonary Mycobacterium avium complex Infection Receiving Guideline-Based Treatment: An Observational, Retrospective Analysis of Real-World Data (IDWeek 2026) - No abstract available

Real-world • Real-world evidence • Retrospective data • Infectious Disease • Tuberculosis

Clofazimine as Adjunctive Therapy for Challenging Extrapulmonary Nontuberculous Mycobacterial Infections (IDWeek 2026) - No abstract available

Nontuberculous mycobacteria • Infectious Disease • Nontuberculous Mycobacterial Disease

Nitric oxide enhances antimicrobial effects of clofazimine against Mycobacterium abscessus (NACFC 2026) - "We also performed 3-D checkerboard assays in one laboratory strain (ATCC 19977) combining CFZ + dNO with seven antibiotics (amikacin, cefoxitin, linezolid, tedizolid, bedaquiline, omadacycline, and imipenem). Inhaled NO is a promising adjunctive therapy for MAB, particularly when combined with CFZ. However, NO-antibiotic interactions are complex, and further research is needed to guide the selection of optimal antibiotic regimens."

Cardiovascular • Infectious Disease • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases

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

A Case of Nontuberculous Mycobacterial Prosthetic Valve Endocarditis. (PubMed, Spartan Med Res J) - "This case highlights the difficulty of diagnosing NTM prosthetic valve endocarditis when echocardiography is unrevealing and illustrates how PET/CT contributes important diagnostic information in suspected prosthetic cardiac infection. It also adds to the limited literature on Mycobacterium smegmatis group endocarditis and demonstrates the successful incorporation of clofazimine within a multidisciplinary treatment strategy."

Journal • Cardiovascular • Infectious Disease • Nontuberculous Mycobacterial Disease • Respiratory Diseases

Using mixtures of linoleic acid, a long-chain polyunsaturated fatty acid, and its monoglyceride in lipid-based formulations to increase drug loading and enhance aqueous microemulsification. (PubMed, Int J Pharm) - "To demonstrate the versatility of the approach, a different LDP, another acid, linoleic acid (LA), and its monoglyceride, glyceryl monolinoleate (GML), were used at a 2:1 M ratio in the present study, with clofazimine (CFZ) as the model...LA showed a high CFZ solubility of 480 mg/g, comparable to OA, and performed better in LBFs, with the developed formulation (100 mg/g) dispersing as microemulsions at intestinal pH, with particle sizes <250 nm, much smaller than the 400 nm observed for OA. High drug solubility and a smaller microemulsion particle size could increase in vivo drug release and absorption."

Journal • Gastrointestinal Disorder

Chronic erythema nodosum leprosum in Hansen's disease: a challenging clinical management. (PubMed, Trans R Soc Trop Med Hyg) - "Corticosteroids, thalidomide, azathioprine, methotrexate, and anti-TNF-α therapy only provided incomplete control. After six years of recurrences requiring several hospitalizations, treatment with methylprednisolone, high-dose thalidomide, and clofazimine achieved a sustained remission, allowing gradual treatment discontinuation."

Journal • Dermatology • Oncology

The First Cases of Imported Leprosy in Romania After More than Four Decades of Absence of New Cases. (PubMed, Trop Med Infect Dis) - "Both patients have started multidrug therapy with dapsone, rifampicin and clofazimine provided by WHO. This publication underlines the risk of importing rare diseases in Romania and in other European countries and the delay in diagnosis due to insufficient awareness among occupational medicine doctors. Improved strategies are needed at national level in order to increase awareness on rare imported infectious diseases and introduce screening programs in migrant population from high-risk areas."

Journal • Hematological Disorders • Infectious Disease • Metabolic Disorders • Rare Diseases

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

Country-level heterogeneity in MDR-TB drug susceptibility supports country-specific policy development. (PubMed, Front Tuberc) - "The correlation analysis revealed a relationship between bedaquiline and clofazimine MICs in six countries. Our research shows clear variations in drug susceptibility within M. tuberculosis across different countries and resistance classes, providing evidence of distinct drug-susceptibility dynamics per country. This expands the evidence for MDR-TB country differences and supports further country-specific policy development."

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

Small intestine melanosis caused by clofazimine: A case report. (PubMed, Medicine (Baltimore)) - "Intestinal melanosis is a rare disease that, in this case, may be related to long-term clofazimine use. Clinicians should consider this diagnosis in patients with unexplained intestinal pigmentation, particularly in those taking clofazimine. Further research is needed to elucidate its natural history and underlying mechanisms."

Journal • Infectious Disease • Inflammation • Pain • Pulmonary Disease • Rare Diseases • Respiratory Diseases • Tuberculosis

Activity of MMV Pandemic Response Box compounds against Mycobacterium ulcerans viability and mycolactone production. (PubMed, Microbiol Spectr) - "By combining this mycolactone-detecting assay with the routinely used resazurin microplate assay, we identified hits (such as pradigastat) that are potential starting points for further development of antivirulence drugs for BU...In addition, we reliably reidentified drugs known to be active against M. ulcerans (such as bedaquiline, Q203, clofazimine, sutezolid, and epetraborole), thus validating our screening approach.IMPORTANCEMycolactone is a key requirement in the pathogenesis of Buruli ulcer (BU)...Here, we used our screening platform, which comprises a simple mycolactone-detecting ELISA combined with a standard resazurin microplate assay, to identify a set of hits from the Medicines for Malaria Venture Pandemic Response Box that could reduce mycolactone expression even without affecting M. ulcerans viability. This screening methodology will contribute to further development of antivirulence drugs for BU."

Journal • Infectious Disease • Malaria

A rare invader on a cardiac stent: Mycobacterium abscessus mediastinitis managed with tedizolid after linezolid intolerance. (PubMed, IDCases) - "The patient received a multidrug regimen anchored by amikacin and an oxazolidinone...Because of early hematologic intolerance to linezolid, therapy was transitioned to tedizolid 200 mg once daily, with clofazimine later used as the companion oral agent after intolerance to minocycline...Serial imaging showed substantial regression of the mediastinal lesion without clinically significant FDG uptake at end of therapy. This case highlights three clinically relevant lessons: first, post-PCI M. abscesses stent-associated mediastinitis demands aggressive source control; second, tedizolid can serve as a viable salvage therapy after linezolid intolerance; third, serial cardiac PET-CT can assist treatment monitoring when repeat deep tissue sampling is impractical; and fourth, advanced multimodal imaging plays a critical role in diagnosis, surgical planning, and monitoring of complex post-cardiac surgical infections."

Journal • Cardiovascular • Coronary Artery Disease • Diabetes • Hematological Disorders • Hypertension • Infectious Disease • Metabolic Disorders • Nontuberculous Mycobacterial Disease • Pain • Respiratory Diseases

Pharmacokinetics and Safety of a Novel Clofazimine Formulation and Dosing Strategy in Children With Rifampicin-resistant Tuberculosis. (PubMed, J Infect Dis) - "The revised once-daily dosing with the 50-mg clofazimine tablet achieved the predefined exposure target. Clinically important adverse events support cautious use with ECG and laboratory monitoring and further evaluation before broad adoption."

Journal • PK/PD data • Hepatology • Infectious Disease • Liver Failure • Pediatrics • Pulmonary Disease • Respiratory Diseases • Tuberculosis • PER1