{"id":"clofazimine","rwe":[],"tags":[{"label":"Antimycobacterial","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"ATP-binding cassette sub-family G member 2","category":"target"},{"label":"ABCG2","category":"gene"},{"label":"J04BA01","category":"atc"},{"label":"Off-Patent","category":"patent"},{"label":"Active","category":"status"},{"label":"Dapsone resistant leprosy","category":"indication"},{"label":"Erythema nodosum leprosum","category":"indication"},{"label":"Leprosy","category":"indication"},{"label":"Multibacillary leprosy","category":"indication"},{"label":"Pyoderma gangrenosum","category":"indication"},{"label":"Novartis","category":"company"},{"label":"Approved 1980s","category":"decade"},{"label":"Anti-Bacterial Agents","category":"pharmacology"},{"label":"Anti-Infective Agents","category":"pharmacology"},{"label":"Anti-Inflammatory Agents","category":"pharmacology"},{"label":"Leprostatic Agents","category":"pharmacology"}],"phase":"marketed","safety":{"safetySignals":[{"llr":1381.281,"date":"","count":507,"signal":"Electrocardiogram QT prolonged","source":"DrugCentral FAERS","actionTaken":"Reported 507 times (LLR=1381)"},{"llr":336.618,"date":"","count":52,"signal":"Type 2 lepra reaction","source":"DrugCentral FAERS","actionTaken":"Reported 52 times (LLR=337)"},{"llr":317.41,"date":"","count":150,"signal":"Drug resistance","source":"DrugCentral FAERS","actionTaken":"Reported 150 times (LLR=317)"},{"llr":300.276,"date":"","count":151,"signal":"Hepatotoxicity","source":"DrugCentral FAERS","actionTaken":"Reported 151 times (LLR=300)"},{"llr":282.466,"date":"","count":219,"signal":"Neuropathy peripheral","source":"DrugCentral FAERS","actionTaken":"Reported 219 times (LLR=282)"},{"llr":188.337,"date":"","count":278,"signal":"Anaemia","source":"DrugCentral FAERS","actionTaken":"Reported 278 times (LLR=188)"},{"llr":152.495,"date":"","count":413,"signal":"Off label use","source":"DrugCentral FAERS","actionTaken":"Reported 413 times (LLR=152)"},{"llr":143.314,"date":"","count":42,"signal":"Ototoxicity","source":"DrugCentral FAERS","actionTaken":"Reported 42 times (LLR=143)"},{"llr":131.893,"date":"","count":48,"signal":"Skin hyperpigmentation","source":"DrugCentral FAERS","actionTaken":"Reported 48 times (LLR=132)"},{"llr":129.572,"date":"","count":39,"signal":"Optic neuropathy","source":"DrugCentral FAERS","actionTaken":"Reported 39 times (LLR=130)"},{"llr":122.668,"date":"","count":176,"signal":"Product use in unapproved indication","source":"DrugCentral FAERS","actionTaken":"Reported 176 times (LLR=123)"},{"llr":119.393,"date":"","count":292,"signal":"Vomiting","source":"DrugCentral FAERS","actionTaken":"Reported 292 times (LLR=119)"},{"llr":118.107,"date":"","count":63,"signal":"Polyneuropathy","source":"DrugCentral FAERS","actionTaken":"Reported 63 times (LLR=118)"},{"llr":117.943,"date":"","count":144,"signal":"Intentional product use issue","source":"DrugCentral FAERS","actionTaken":"Reported 144 times (LLR=118)"},{"llr":102.164,"date":"","count":80,"signal":"Drug-induced liver injury","source":"DrugCentral FAERS","actionTaken":"Reported 80 times (LLR=102)"}],"commonSideEffects":[],"contraindications":["Breastfeeding (mother)","Diarrhea","Disease of liver","Disorder of digestive system","Gastrointestinal hemorrhage","Gastrointestinal obstruction","Nausea and vomiting","Splenic infarction"]},"trials":[],"aliases":[],"company":"Novartis","patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=clofazimine","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-19T23:40:45.576319+00:00"},"timeline":{"url":"https://en.wikipedia.org/wiki/Clofazimine","method":"deterministic","source":"Wikipedia","rawText":"","confidence":0.8,"sourceType":"wikipedia","retrievedAt":"2026-04-19T23:40:52.995333+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-19T23:40:51.414692+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=clofazimine","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-19T23:40:51.952392+00:00"},"mechanism.target_chembl":{"url":"","method":"api_direct","source":"ChEMBL mechanism: DNA inhibitor","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-19T23:40:52.995271+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL1292/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-19T23:40:52.653566+00:00"}},"allNames":"lamprene","offLabel":[],"synonyms":["lamprene","clofazimine","chlofazimine"],"timeline":[{"date":"1986-01-01","type":"neutral","source":"FDA Orange Book","milestone":"Rights transferred from NOVARTIS to Novartis"},{"date":"1986-12-15","type":"positive","source":"DrugCentral","milestone":"FDA approval (Novartis)"}],"aiSummary":"Lamprene (clofazimine) is a small molecule antimycobacterial drug developed by Novartis, targeting the ATP-binding cassette sub-family G member 2. It is approved for various leprosy-related conditions, including dapsone-resistant leprosy and erythema nodosum leprosum. Lamprene is off-patent, but currently owned by Novartis, with no generic manufacturers. Key safety considerations include its potential for skin discoloration and gastrointestinal side effects. It has a bioavailability of 57%.","approvals":[{"date":"1986-12-15","orphan":true,"company":"NOVARTIS","regulator":"FDA"}],"brandName":"Lamprene","ecosystem":[{"indication":"Dapsone resistant leprosy","otherDrugs":[],"globalPrevalence":null},{"indication":"Erythema nodosum leprosum","otherDrugs":[{"name":"thalidomide","slug":"thalidomide","company":"Celgene"}],"globalPrevalence":null},{"indication":"Leprosy","otherDrugs":[{"name":"dapsone","slug":"dapsone","company":"Jacobus"}],"globalPrevalence":null},{"indication":"Multibacillary leprosy","otherDrugs":[],"globalPrevalence":null},{"indication":"Pyoderma gangrenosum","otherDrugs":[{"name":"adalimumab","slug":"adalimumab","company":"Abbvie Inc"}],"globalPrevalence":null}],"mechanism":{"target":"ATP-binding cassette sub-family G member 2","novelty":"Follow-on","targets":[{"gene":"ABCG2","source":"DrugCentral","target":"ATP-binding cassette sub-family G member 2","protein":"ATP-binding cassette sub-family G member 2"}],"modality":"Small Molecule","drugClass":"Antimycobacterial","explanation":"","oneSentence":"","technicalDetail":"Lamprene targets the ATP-binding cassette sub-family G member 2 (ABCG2), a protein involved in the efflux of mycobacterial lipids, thereby inhibiting the growth of Mycobacterium leprae."},"_wikipedia":{"url":"https://en.wikipedia.org/wiki/Clofazimine","title":"Clofazimine","extract":"Clofazimine, sold under the brand name Lamprene, is a medication used together with rifampicin and dapsone to treat leprosy. It is specifically used for multibacillary (MB) leprosy and erythema nodosum leprosum, and its discovery greatly improved the overall efficiency of the treatment. Evidence is insufficient to support its use in other conditions, though a retrospective study found it 95% effective in the treatment of Mycobacterium avium complex (MAC) when administered together with a macrolide and ethambutol, as well as the drugs amikacin and clarithromycin. However, in the United States, clofazimine is currently considered an orphan drug, is unavailable in pharmacies, and its use in the treatment of MAC is overseen by the Food and Drug Administration. It is taken orally.","wiki_history":"==History==\nClofazimine, initially known as B663, was first synthesised in 1954 by a team of scientists at Trinity College, Dublin: Frank Winder, J.G. Belton, Stanley McElhinney, M.L. Conalty, Seán O'Sullivan, and Dermot Twomey, led by Vincent Barry. Clofazimine was originally intended as an anti-tuberculosis drug but proved ineffective. In 1959, a researcher named Y. T. Chang identified its effectiveness against leprosy. After clinical trials in Nigeria and elsewhere during the 1960s, Swiss pharmaceutical company Novartis launched the product in 1969 under the brand name Lamprene.\n\nNovartis was granted FDA approval of clofazimine in December 1986 as an orphan drug. The drug is currently no longer commercially available in the United States as Novartis has discontinued production of clofazimine for the US market and no generic or other brand names are marketed in the US although it retains FDA approval.","wiki_society_and_culture":"==Society and culture==\nClofazimine is marketed under the trade name Lamprene by Novartis although its discontinued in some countries like the US. Other brands are also available in many countries. Another producer of the clofazimine molecule is Sangrose Laboratories, located in Mavelikara, India."},"commercial":{"launchDate":"1986","_launchSource":"DrugCentral (FDA 1986-12-15, NOVARTIS)"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/692","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=clofazimine","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=clofazimine","fields":["publications"],"source":"PubMed/NCBI"},{"id":4,"url":"https://en.wikipedia.org/wiki/Clofazimine","fields":["history","overview"],"source":"Wikipedia"},{"id":5,"url":"https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files","fields":["patents","exclusivity","genericManufacturers"],"source":"FDA Orange Book"}],"_enrichedAt":"2026-03-30T10:10:26.000017","_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-19T23:40:54.429435+00:00","fieldsConflicting":2,"overallConfidence":0.8},"biosimilars":[],"competitors":[{"drugName":"dapsone","drugSlug":"dapsone","fdaApproval":"1979-07-03","patentExpiry":"Nov 18, 2033","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"aldesulfone","drugSlug":"aldesulfone","fdaApproval":"1974-05-24","relationship":"same-class"},{"drugName":"rifampicin","drugSlug":"rifampicin","fdaApproval":"1971-05-21","relationship":"same-class"}],"genericName":"clofazimine","indications":{"approved":[{"name":"Dapsone resistant leprosy","source":"DrugCentral","snomedId":416597004,"regulator":"FDA"},{"name":"Erythema nodosum leprosum","source":"DrugCentral","snomedId":240411003,"regulator":"FDA"},{"name":"Leprosy","source":"DrugCentral","snomedId":81004002,"regulator":"FDA"},{"name":"Multibacillary leprosy","source":"DrugCentral","snomedId":416257001,"regulator":"FDA"},{"name":"Pyoderma gangrenosum","source":"DrugCentral","snomedId":74578003,"regulator":"FDA"}],"offLabel":[{"name":"Mycobacteriosis","source":"DrugCentral","drugName":"clofazimine","evidenceCount":1504,"evidenceLevel":"strong"}],"pipeline":[]},"currentOwner":"Novartis","drugCategory":"active","labelChanges":[],"patentStatus":"Off-patent — no active Orange Book patents","relatedDrugs":[{"drugId":"dapsone","brandName":"dapsone","genericName":"dapsone","approvalYear":"1979","relationship":"same-class"},{"drugId":"aldesulfone","brandName":"aldesulfone","genericName":"aldesulfone","approvalYear":"1974","relationship":"same-class"},{"drugId":"rifampicin","brandName":"rifampicin","genericName":"rifampicin","approvalYear":"1971","relationship":"same-class"}],"trialDetails":[{"nctId":"NCT00018044","phase":"","title":"Study of Mycobacterial Infections","status":"RECRUITING","sponsor":"National Institute of Allergy and 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