{"id":"clofazimine-oral-product","safety":{"commonSideEffects":[{"rate":"75-90","effect":"Skin discoloration (red-brown to black pigmentation)"},{"rate":"30-50","effect":"Gastrointestinal disturbances (nausea, diarrhea, abdominal pain)"},{"rate":"25-40","effect":"Ichthyosis and dry skin"},{"rate":"10-20","effect":"Photosensitivity"},{"rate":"5-15","effect":"Hepatotoxicity"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Clofazimine accumulates in fatty tissues and mycobacterial cells, where it undergoes redox cycling to produce reactive oxygen species that damage bacterial DNA and proteins. It also has immunomodulatory properties, enhancing macrophage function and reducing inflammatory responses. The drug is particularly effective against Mycobacterium leprae and atypical mycobacteria.","oneSentence":"Clofazimine is a lipophilic antimycobacterial agent that generates reactive oxygen species and intercalates into mycobacterial DNA, disrupting bacterial replication and causing bacterial cell death.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T01:06:24.090Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Leprosy (Hansen's disease)"},{"name":"Atypical mycobacterial infections (MAC, M. marinum)"},{"name":"Tuberculosis (as adjunctive therapy in drug-resistant cases)"}]},"trialDetails":[{"nctId":"NCT07485010","phase":"PHASE2","title":"Testing a Novel Combination Treatment (Arm D) Versus Standard of Care for Intensive Phase Treatment for Mycobacterium Abscessus Pulmonary Disease in People With or Without Cystic Fibrosis in the Finding the Optimal Regimen for Mycobacterium Abscessus Treatment (FORMaT) Adaptive Platform Trial","status":"NOT_YET_RECRUITING","sponsor":"The University of Queensland","startDate":"2027-04","conditions":"Mycobacterium Abscessus Pulmonary Disease, Mycobacterium Abscessus Infection, Non-Tuberculous Mycobacterial (NTM) Infections","enrollment":300},{"nctId":"NCT04334070","phase":"","title":"Lamprene Multiple Patient Program","status":"AVAILABLE","sponsor":"Novartis Pharmaceuticals","startDate":"","conditions":"Non-Tuberculous Mycobacterial (NTM) Infections","enrollment":""},{"nctId":"NCT07198685","phase":"NA","title":"6 Months of Bedaquiline(BDQ), Delamanid(DLM), Linezolid(LZD) and Levofloxacin(LFX) in RR-TB Patients in Hubei Province","status":"NOT_YET_RECRUITING","sponsor":"Wuhan Pulmonary Hospital","startDate":"2025-09-30","conditions":"Treat to Target, Treatment Duration","enrollment":52},{"nctId":"NCT06649721","phase":"PHASE3","title":"Innovating Shorter, All- Oral, Precised Treatment Regimen for Rifampicin Resistant Tuberculosis：BDLL Chinese Cohort","status":"ACTIVE_NOT_RECRUITING","sponsor":"Huashan Hospital","startDate":"2024-11-27","conditions":"Drug-resistant Tuberculosis, Pulmonary Tuberculosis, Rifampin-resistant Tuberculosis","enrollment":120},{"nctId":"NCT07126639","phase":"NA","title":"A Study on the Short-course Treatment Regimen Containing Pretomanid for Drug-resistant Tuberculosis","status":"NOT_YET_RECRUITING","sponsor":"Wuhan Pulmonary Hospital","startDate":"2025-09-01","conditions":"Efficacy and Safety","enrollment":200},{"nctId":"NCT04310930","phase":"PHASE2, PHASE3","title":"Finding the Optimal Regimen for Mycobacterium Abscessus Treatment","status":"RECRUITING","sponsor":"The University of Queensland","startDate":"2020-03-02","conditions":"Pulmonary Disease Due to Mycobacteria (Diagnosis)","enrollment":300},{"nctId":"NCT05007821","phase":"PHASE2","title":"Linezolid Dosing Strategies in Drug-Resistant TB","status":"ACTIVE_NOT_RECRUITING","sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","startDate":"2022-08-11","conditions":"Tuberculosis, Multidrug-Resistant, Tuberculosis, Tuberculosis, Pulmonary","enrollment":138},{"nctId":"NCT03828201","phase":"PHASE2","title":"Efficacy and Tolerability of Bedaquiline, Delamanid, Levofloxacin, Linezolid, and Clofazimine to Treat MDR-TB","status":"RECRUITING","sponsor":"Boston University","startDate":"2022-06-07","conditions":"Tuberculosis, Multidrug-Resistant","enrollment":220},{"nctId":"NCT05081401","phase":"PHASE3","title":"Innovating(IN) Shorter(S), All- Oral, Precised(P), Individualized(I) Treatment Regimen(RE) for Rifampicin Resistant Tuberculosis(INSPIRE-TB)","status":"RECRUITING","sponsor":"Huashan Hospital","startDate":"2022-05-23","conditions":"Multidrug Resistant Tuberculosis, Rifampicin Resistant Tuberculosis, Pre-XDR-TB","enrollment":1050},{"nctId":"NCT04717908","phase":"NA","title":"Refining MDR-TB Treatment (T) Regimens (R) for Ultra(U) Short(S) Therapy(T)-PLUS","status":"COMPLETED","sponsor":"Huashan Hospital","startDate":"2021-01-20","conditions":"Multidrug Resistant Tuberculosis","enrollment":89},{"nctId":"NCT03867136","phase":"PHASE4","title":"Refining MDR-TB Treatment (T) Regimens (R) for Ultra(U) Short(S) Therapy(T)","status":"COMPLETED","sponsor":"Huashan Hospital","startDate":"2020-06-01","conditions":"Multidrug Resistant Tuberculosis","enrollment":354},{"nctId":"NCT04062201","phase":"PHASE3","title":"Building Evidence for Advancing New Treatment for Rifampicin Resistant Tuberculosis (RR-TB) Comparing a Short Course of Treatment (Containing Bedaquiline, Delamanid and Linezolid) With the Current South African Standard of Care","status":"COMPLETED","sponsor":"Wits Health Consortium (Pty) Ltd","startDate":"2019-08-22","conditions":"Tuberculosis, Pre-XDR-TB, Extensively Drug-Resistant Tuberculosis","enrollment":402},{"nctId":"NCT02409290","phase":"PHASE3","title":"The Evaluation of a Standard Treatment Regimen of Anti-tuberculosis Drugs for Patients With MDR-TB","status":"COMPLETED","sponsor":"IUATLD, Inc","startDate":"2016-03","conditions":"MDR-TB","enrollment":588},{"nctId":"NCT02454205","phase":"PHASE2, PHASE3","title":"An Open-label RCT to Evaluate a New Treatment Regimen for Patients With Multi-drug Resistant Tuberculosis","status":"COMPLETED","sponsor":"University of Cape Town","startDate":"2015-11-12","conditions":"Tuberculosis, Multidrug Resistant Tuberculosis, Extensively-drug Resistant Tuberculosis","enrollment":154},{"nctId":"NCT01885611","phase":"PHASE1, PHASE2","title":"Virgin Coconut Oil Oral Supplementation for Leprosy Patients","status":"WITHDRAWN","sponsor":"Philippine Dermatological Society","startDate":"2013-06","conditions":"Hansen's Disease","enrollment":""}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":0,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Lamprene"],"phase":"phase_3","status":"active","brandName":"Clofazimine Oral Product","genericName":"Clofazimine Oral Product","companyName":"Wits Health Consortium (Pty) Ltd","companyId":"wits-health-consortium-pty-ltd","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Clofazimine is a lipophilic antimycobacterial agent that generates reactive oxygen species and intercalates into mycobacterial DNA, disrupting bacterial replication and causing bacterial cell death. Used for Leprosy (Hansen's disease), Atypical mycobacterial infections (MAC, M. marinum), Tuberculosis (as adjunctive therapy in drug-resistant cases).","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":1,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}