ArticleThe Journal of antimicrobial chemotherapy2020
Clofazimine pharmacokinetics in patients with TB: dosing implications.
Article in The Journal of antimicrobial chemotherapy, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 52 papers.
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Who cites it
52 citing papers in PubMed.
- A 3-month clofazimine-rifapentine-containing regimen for drug-susceptible tuberculosis versus standard of care (Clo-Fast): a randomised, open-label, phase 2c clinical trial.The Lancet. Infectious diseases · 2026Trial
- Pharmacokinetics and Safety of Clofazimine in Children With Rifampicin-Resistant Tuberculosis.The Journal of infectious diseases · 2025Trial
- A loading dose of clofazimine to rapidly achieve steady-state-like concentrations in patients with nontuberculous mycobacterial disease.The Journal of antimicrobial chemotherapy · 2024Trial
- QT prolongation in the STREAM Stage 1 Trial.The international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease · 2022Trial
- Effect of Clofazimine Concentration on QT Prolongation in Patients Treated for Tuberculosis.Antimicrobial agents and chemotherapy · 2021Trial
- Macrolide-resistantJournal of clinical tuberculosis and other mycobacterial diseases · 2026Review
- Letter Reply to "Mind the Postpartum Trough: Closing the Clofazimine Exposure Gap After Delivery in Rifampicin-Resistant Tuberculosis".The Journal of infectious diseases · 2026Article
- Pharmacokinetics of Clofazimine Tablet Formulation in Children with Rifampicin-Resistant Tuberculosis in CATALYST, a Multi-Site International Trial.Journal of the Pediatric Infectious Diseases Society · 2026Article
- Analytical Method Development and Validation for Clofazimine in Human Plasma and Application of LC-MS/MS Based Methods for Clofazimine and Bedaquiline in Indian MDR-TB Patients Stratified by HIV Coinfection.Journal of mass spectrometry : JMS · 2026Article
- Exposure-QTc modeling of bedaquiline, pretomanid, and clofazimine in adults with tuberculosis.Antimicrobial agents and chemotherapy · 2026Article
- Article
- Identification of non-oncology drugs with activity against inflammatory and triple-negative breast cancer cell lines.Oncology letters · 2026Article
- Pharmacokinetics and Safety of Clofazimine in Women With Rifampicin-resistant Tuberculosis During Pregnancy and the Postpartum Period: Results From IMPAACT P1026s.The Journal of infectious diseases · 2026Observational
- Pharmacokinetics of Inhaled Clofazimine Dry Powder in Healthy Mice.AAPS PharmSciTech · 2026Article
- Wild-type MIC distribution and evaluation of epidemiological cut-offs of second-line TB-drugs in susceptible and MDR-TB clinical isolates from Chennai, India.Frontiers in microbiology · 2026Article
- Cerebrospinal fluid penetration of cycloserine/terizidone and clofazimine in patients with pulmonary TB.Antimicrobial agents and chemotherapy · 2025Article
- Predictors of therapeutic exposure and pharmacokinetic variability of second-line anti-TB drugs in MDR-TB patients: a retrospective study.Infection · 2025Observational
- Analysis of Adverse Drug Reactions of Clofazimine Reported in the FDA Adverse Event Reporting System from 2004 to 2025 Q1.Infectious diseases and therapy · 2025Article
- Successful treatment of macrolide-resistantASM case reports · 2025Article
- An Update on the Clinical Management of HIV and Tuberculosis Co-Infection in Pregnancy: TB Preventative Therapy, Long-Acting ARVs, and Bedaquiline-Based Regimens.Current HIV/AIDS reports · 2025Review
Corrections and comments
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Authors and funding
12 authors.
Funding
Abstract
backgroundClofazimine is in widespread use as a key component of drug-resistant TB regimens, but the recommended dose is not evidence based. Pharmacokinetic data from relevant patient populations are needed to inform dose optimization.
objectivesTo determine clofazimine exposure, evaluate covariate effects on variability, and simulate exposures for different dosing strategies in South African TB patients. PATIENTS AND
methodsClinical and pharmacokinetic data were obtained from participants with pulmonary TB enrolled in two studies with intensive and sparse sampling for up to 6 months. Plasma concentrations were measured by LC-MS/MS and interpreted with non-linear mixed-effects modelling. Body size descriptors and other potential covariates were tested on pharmacokinetic parameters. We simulated different dosing regimens to safely shorten time to average daily concentration above a putative target concentration of 0.25 mg/L.
resultsWe analysed 1570 clofazimine concentrations from 139 participants; 79 (57%) had drug-resistant TB and 54 (39%) were HIV infected. Clofazimine pharmacokinetics were well characterized by a three-compartment model. Clearance was 11.5 L/h and peripheral volume 10 500 L for a typical participant. Lower plasma exposures were observed in women during the first few months of treatment, explained by higher body fat fraction. Model-based simulations estimated that a loading dose of 200 mg daily for 2 weeks would achieve average daily concentrations above a target efficacy concentration 37 days earlier in a typical TB participant.
conclusionsClofazimine was widely distributed with a long elimination half-life. Disposition was strongly influenced by body fat content, with potential dosing implications for women with TB.
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