{"id":"nifurtimox-lampit-baya2502","safety":{"commonSideEffects":[{"rate":null,"effect":"Peripheral neuropathy"},{"rate":null,"effect":"Gastrointestinal disturbances"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Psychosis or psychiatric effects"}]},"_chembl":{"chemblId":"CHEMBL1486475","moleculeType":"Small molecule","molecularWeight":"287.30"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Nifurtimox undergoes metabolic activation to produce free radicals and reactive oxygen species that damage parasite DNA and proteins, leading to cell death. It has been used for decades against Chagas disease and is being investigated in Phase 3 trials for additional indications, potentially including other parasitic or infectious diseases where oxidative stress mechanisms are therapeutically beneficial.","oneSentence":"Nifurtimox is a nitrofuran compound that generates reactive oxygen species to kill parasites, particularly effective against Trypanosoma cruzi.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:23:02.290Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Chagas disease (Trypanosoma cruzi infection)"},{"name":"Phase 3 investigation for additional parasitic or infectious indications (specific indication not publicly detailed)"}]},"trialDetails":[{"nctId":"NCT05477953","phase":"","title":"An Observational Pregnancy Safety Study in Women Who Were Exposed to the Drug Nifurtimox During Pregnancy to Learn About the Risk of Pregnancy Complications and About the Mother's and Baby's Health","status":"NOT_YET_RECRUITING","sponsor":"Bayer","startDate":"2026-06-30","conditions":"Chagas Disease","enrollment":50},{"nctId":"NCT02625974","phase":"PHASE3","title":"A Study to Learn How Well Nifurtimox Works and How Safe it is in Children Aged 0 to 17 Years With Chagas' Disease, an Inflammatory, Infectious Disease Caused by the Parasite Trypanosoma Cruzi","status":"COMPLETED","sponsor":"Bayer","startDate":"2016-01-27","conditions":"Chagas Disease","enrollment":330},{"nctId":"NCT03784391","phase":"","title":"Study on Benefits of Therapy With Nifurtimox in Chagas Disease, a Parasitic Illness Mostly Transmitted to Humans by a Bug, Using Information From Patient Medical Records in Argentina","status":"COMPLETED","sponsor":"Bayer","startDate":"2018-12-14","conditions":"Chagas' Disease","enrollment":3000},{"nctId":"NCT03334838","phase":"PHASE1","title":"Study to Assess the Food Effect on the Pharmacokinetics of Nifurtimox Tablets in Chronic Chagas' Patients - Dietary Habits Study","status":"COMPLETED","sponsor":"Bayer","startDate":"2019-06-10","conditions":"Chagas' Disease","enrollment":36},{"nctId":"NCT03708133","phase":"PHASE1","title":"Study to Assess Bioequivalence of a New Nifurtimox Oral Tablet Formulation","status":"COMPLETED","sponsor":"Bayer","startDate":"2018-12-05","conditions":"Bioequivalence","enrollment":24},{"nctId":"NCT03350295","phase":"PHASE1","title":"Study Will Evaluate the Relative Bioavailability, Safety, and Tolerability of Single Doses of Nifurtimox 30 mg Tablets Exhibiting Different in Vitro Dissolution Characteristics, and to Evaluate the Relative Bioavailability of Nifurtimox 30 mg and 120 mg","status":"COMPLETED","sponsor":"Bayer","startDate":"2018-06-14","conditions":"Chagas Disease","enrollment":48},{"nctId":"NCT02606864","phase":"PHASE1","title":"Study to Assess the Food Effect on the Pharmacokinetics of Nifurtimox Tablets in Chronic Chagas' Patients","status":"COMPLETED","sponsor":"Bayer","startDate":"2015-12","conditions":"Chagas Disease","enrollment":36},{"nctId":"NCT01927224","phase":"PHASE1","title":"Study to Assess Bioequivalence of 30 and 120 mg Nifurtimox Tablets in Chronic Chagas' Patients","status":"COMPLETED","sponsor":"Bayer","startDate":"2013-11","conditions":"Chagas Disease","enrollment":37}],"_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":[],"phase":"phase_3","status":"active","brandName":"Nifurtimox (Lampit, BAYA2502)","genericName":"Nifurtimox (Lampit, BAYA2502)","companyName":"Bayer","companyId":"bayer","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Nifurtimox is a nitrofuran compound that generates reactive oxygen species to kill parasites, particularly effective against Trypanosoma cruzi. Used for Chagas disease (Trypanosoma cruzi infection), Phase 3 investigation for additional parasitic or infectious indications (specific indication not publicly detailed).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}