{"id":"rifampin-isoniazid-pyrazinamide-ethambutol-fdc","safety":{"commonSideEffects":[{"rate":"1-5","effect":"Hepatotoxicity"},{"rate":"1-2","effect":"Peripheral neuropathy"},{"rate":"null","effect":"Hyperuricemia"},{"rate":"0.1-1","effect":"Optic neuritis (ethambutol-related)"},{"rate":"5-10","effect":"Gastrointestinal disturbance"},{"rate":"1-5","effect":"Rash"},{"rate":"null","effect":"Drug-induced lupus"}]},"_chembl":{"chemblId":"CHEMBL614","moleculeType":"Small molecule","molecularWeight":"123.11"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Rifampin inhibits bacterial RNA polymerase, isoniazid disrupts mycolic acid synthesis in the cell wall, pyrazinamide is converted to pyrazinoic acid which disrupts membrane potential and energy metabolism, and ethambutol inhibits arabinosyl transferases involved in cell wall synthesis. Together, these agents provide synergistic bactericidal and bacteriostatic activity against tuberculosis.","oneSentence":"This fixed-dose combination of four first-line anti-tuberculosis agents inhibits bacterial cell wall and protein synthesis to kill Mycobacterium tuberculosis.","_ai_confidence":"high"},"_scrapedAt":"2026-03-27T23:37:09.495Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Tuberculosis (drug-susceptible, pulmonary and extrapulmonary)"},{"name":"Tuberculosis treatment in HIV-coinfected patients"}]},"trialDetails":[{"nctId":"NCT04738812","phase":"PHASE3","title":"Determination of Adequate Tuberculosis Regimen in Patients Hospitalized With HIV-associated Severe Immune Suppression","status":"COMPLETED","sponsor":"ANRS, Emerging Infectious Diseases","startDate":"2022-04-21","conditions":"Tuberculosis, HIV-1-infection, Immuno-Deficiency","enrollment":1330},{"nctId":"NCT04260477","phase":"PHASE3","title":"Novel Triple-dose Tuberculosis Retreatment Regimen","status":"RECRUITING","sponsor":"Institute of Tropical Medicine, Belgium","startDate":"2021-03-01","conditions":"Multidrug-resistant Tuberculosis, Pulmonary Tuberculosis, Tuberculosis","enrollment":370},{"nctId":"NCT05971602","phase":"PHASE2","title":"Efficacy and Safety Evaluation of Two to Four Months of Treatment With the Combination Regimens of DBOS and PBOS in Adults With Pulmonary Tuberculosis","status":"TERMINATED","sponsor":"Gates Medical Research Institute","startDate":"2023-07-26","conditions":"Pulmonary Tuberculosis","enrollment":93},{"nctId":"NCT05005637","phase":"PHASE2","title":"The Effectivity of Anti Tuberculosis Therapy in Idiopathic Uveitis with Positive IGRA","status":"COMPLETED","sponsor":"Fakultas Kedokteran Universitas Indonesia","startDate":"2021-08-27","conditions":"Tuberculous Uveitis","enrollment":78},{"nctId":"NCT01380080","phase":"PHASE4","title":"REMEMBER: Reducing Early Mortality & Morbidity by Empiric Tuberculosis (TB) Treatment","status":"COMPLETED","sponsor":"Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections","startDate":"2011-10","conditions":"HIV Infection","enrollment":851},{"nctId":"NCT04088019","phase":"","title":"Proportion of Clinical Improvement & Type 1 Interferon (IFN) Score Changes in Idiopathic Uveitis Patients With Interferon Gamma Release Assay (IGRA) Positive","status":"UNKNOWN","sponsor":"Fakultas Kedokteran Universitas Indonesia","startDate":"2019-10-30","conditions":"Tuberculosis; Uveitis (Manifestation), Anti-Tuberculous Drug Reaction, Tuberculous Uveitis","enrollment":50},{"nctId":"NCT05047055","phase":"","title":"Four Months Moxifloxacin Containing Daily Regimen Study Among New Pulmonary Tuberculosis Patients","status":"UNKNOWN","sponsor":"Tuberculosis Research Centre, India","startDate":"2022-03-15","conditions":"Tuberculosis, Pulmonary","enrollment":550},{"nctId":"NCT03537495","phase":"PHASE2","title":"Pharmacokinetic Study of Linezolid for TB Meningitis","status":"COMPLETED","sponsor":"Universitas Padjadjaran","startDate":"2021-06-21","conditions":"Tuberculosis, Meningeal, Linezolid","enrollment":36},{"nctId":"NCT02457208","phase":"PHASE1","title":"PK Study of Anti-TB Drugs","status":"COMPLETED","sponsor":"University of Oxford","startDate":"2015-07-07","conditions":"Tuberculosis","enrollment":61},{"nctId":"NCT02953847","phase":"PHASE1","title":"The Bioavailability of Rifampicin in (FDCs) Widely Used in South Africa to Treat Drug-susceptible (TB)","status":"COMPLETED","sponsor":"University of Cape Town","startDate":"2016-11","conditions":"Tuberculosis","enrollment":21}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":1,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"marketed","status":"active","brandName":"Rifampin/isoniazid/pyrazinamide/ethambutol FDC","genericName":"Rifampin/isoniazid/pyrazinamide/ethambutol FDC","companyName":"Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections","companyId":"advancing-clinical-therapeutics-globally-for-hiv-aids-and-other-infections","modality":"Small molecule","firstApprovalDate":"","aiSummary":"This fixed-dose combination of four first-line anti-tuberculosis agents inhibits bacterial cell wall and protein synthesis to kill Mycobacterium tuberculosis. Used for Tuberculosis (drug-susceptible, pulmonary and extrapulmonary), Tuberculosis treatment in HIV-coinfected patients.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}