{"id":"delamanid-in-oral-dosage-form","safety":{"commonSideEffects":[{"rate":null,"effect":"Nausea"},{"rate":null,"effect":"Vomiting"},{"rate":null,"effect":"Abdominal pain"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Peripheral neuropathy"},{"rate":null,"effect":"QT prolongation"}]},"_chembl":{"chemblId":"CHEMBL5285059","moleculeType":null,"molecularWeight":"534.49"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Delamanid is a nitro-aromatic prodrug that is activated by mycobacterial enzymes to form reactive intermediates that inhibit the enzyme DprE1, which is essential for the synthesis of decaprenylphosphoryl-arabinose—a critical precursor for mycolic acid biosynthesis in the mycobacterial cell wall. By disrupting cell wall integrity, delamanid leads to mycobacterial cell death and is particularly effective against drug-resistant tuberculosis strains.","oneSentence":"Delamanid inhibits mycobacterial cell wall synthesis by targeting mycolic acid production, thereby killing Mycobacterium tuberculosis.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T01:42:28.549Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Drug-resistant tuberculosis (MDR-TB and XDR-TB)"},{"name":"Pulmonary tuberculosis in combination with other anti-tuberculous agents"}]},"trialDetails":[{"nctId":"NCT00042289","phase":"","title":"Pharmacokinetic Study of Antiretroviral Drugs and Related Drugs During and After Pregnancy","status":"COMPLETED","sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","startDate":"2003-06-09","conditions":"HIV Infections","enrollment":1578},{"nctId":"NCT05382312","phase":"PHASE2","title":"Early Bactericidal Activity, Safety & 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Fluoroquinolone Resistance (endTB-Q)","status":"COMPLETED","sponsor":"Médecins Sans Frontières, France","startDate":"2020-04-06","conditions":"Tuberculosis, Multidrug-Resistant, Tuberculosis, Pulmonary Tuberculoses","enrollment":323},{"nctId":"NCT02619994","phase":"PHASE2","title":"Treatment Shortening of MDR-TB Using Existing and New Drugs","status":"COMPLETED","sponsor":"Seoul National University Hospital","startDate":"2016-01","conditions":"Tuberculosis, Multidrug-Resistant","enrollment":214},{"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":"NCT05926466","phase":"PHASE2","title":"BTZ-043 Dose Evaluation in Combination and Selection","status":"UNKNOWN","sponsor":"Michael Hoelscher","startDate":"2023-09-21","conditions":"Tuberculosis, Pulmonary, Other Specified Pulmonary Tuberculosis","enrollment":90},{"nctId":"NCT03678688","phase":"PHASE1, PHASE2","title":"A Phase 1/2 Trial of Multiple Oral Doses of OPC-167832 for Uncomplicated Pulmonary Tuberculosis","status":"COMPLETED","sponsor":"Otsuka Pharmaceutical Development & Commercialization, Inc.","startDate":"2018-10-18","conditions":"Pulmonary TB","enrollment":122},{"nctId":"NCT03959566","phase":"PHASE2","title":"PanACEA Sutezolid Dose-finding and Combination Evaluation","status":"COMPLETED","sponsor":"Michael Hoelscher","startDate":"2021-05-06","conditions":"Pulmonary Tuberculosis, Other Specified Pulmonary Tuberculosis","enrollment":75},{"nctId":"NCT00401271","phase":"PHASE2","title":"Safety, Efficacy and Pharmacokinetics of OPC-67683 in Patients With Pulmonary Tuberculosis","status":"COMPLETED","sponsor":"Otsuka Frankfurt Research Institute GmbH","startDate":"2006-11","conditions":"Pulmonary Tuberculosis","enrollment":54}],"_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":["Deltyba"],"phase":"phase_3","status":"active","brandName":"Delamanid in Oral Dosage Form","genericName":"Delamanid in Oral Dosage Form","companyName":"Wits Health Consortium (Pty) Ltd","companyId":"wits-health-consortium-pty-ltd","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Delamanid inhibits mycobacterial cell wall synthesis by targeting mycolic acid production, thereby killing Mycobacterium tuberculosis. Used for Drug-resistant tuberculosis (MDR-TB and XDR-TB), Pulmonary tuberculosis in combination with other anti-tuberculous agents.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}