{"id":"delamanid-obr","safety":{"commonSideEffects":[{"rate":null,"effect":"Peripheral neuropathy"},{"rate":null,"effect":"QT prolongation"},{"rate":null,"effect":"Gastrointestinal disturbances"},{"rate":null,"effect":"Hepatotoxicity"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Delamanid is a nitro-imidazole prodrug that is activated by mycobacterial enzymes to form reactive intermediates that inhibit the synthesis of mycolic acids, critical components of the Mycobacterium tuberculosis cell wall. When combined with an optimized background regimen of standard anti-TB drugs, this combination approach targets drug-resistant tuberculosis through multiple pathways, improving treatment efficacy and reducing the risk of resistance development.","oneSentence":"Delamanid inhibits mycobacterial cell wall synthesis by targeting mycolic acid production, while OBR (optimized background regimen) provides synergistic anti-tuberculous activity through multiple complementary mechanisms.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:08:57.095Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Drug-resistant tuberculosis (MDR-TB and XDR-TB) in combination with optimized background regimen"}]},"trialDetails":[{"nctId":"NCT03141060","phase":"PHASE1, PHASE2","title":"Evaluating the Pharmacokinetics, Safety, and Tolerability of Delamanid in Combination With Optimized Multidrug Background Regimen (OBR) for Multidrug-Resistant Tuberculosis (MDR-TB) in HIV-Infected and HIV-Uninfected Children With MDR-TB","status":"COMPLETED","sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","startDate":"2018-01-30","conditions":"Tuberculosis, HIV Infections","enrollment":37},{"nctId":"NCT00685360","phase":"PHASE2","title":"A Trial to Evaluate OPC 67683 in Participants With Pulmonary Sputum Culture-positive, Multidrug-resistant Tuberculosis (TB)","status":"COMPLETED","sponsor":"Otsuka Pharmaceutical Development & Commercialization, Inc.","startDate":"2008-05-08","conditions":"Tuberculosis, Pulmonary, Tuberculosis, Multidrug Resistant, Extensively Drug-Resistant Tuberculosis","enrollment":481},{"nctId":"NCT01131351","phase":"PHASE2","title":"Safety and Pharmacokinetics (PK) in Multidrug-Resistant (MDR) Refractive Tuberculosis","status":"TERMINATED","sponsor":"Otsuka Pharmaceutical Development & Commercialization, Inc.","startDate":"2010-02-19","conditions":"Tuberculosis","enrollment":10},{"nctId":"NCT02573350","phase":"PHASE2","title":"A Trial to Evaluate Safety, Tolerability, and Efficacy of Orally Administered OPC-67683","status":"COMPLETED","sponsor":"Otsuka Pharmaceutical Development & Commercialization, Inc.","startDate":"2009-03-26","conditions":"Tuberculosis, Multidrug-Resistant","enrollment":213},{"nctId":"NCT01859923","phase":"PHASE2","title":"A 6-Month Safety, Efficacy, and Pharmacokinetic (PK) Trial of Delamanid in Pediatric Participants With Multidrug Resistant Tuberculosis (MDR-TB)","status":"COMPLETED","sponsor":"Otsuka Pharmaceutical Development & Commercialization, Inc.","startDate":"2013-07-20","conditions":"Multidrug Resistant Tuberculosis","enrollment":37},{"nctId":"NCT01424670","phase":"PHASE3","title":"Safety and Efficacy Trial of Delamanid for 6 Months in Participants With Multidrug-resistant Tuberculosis","status":"COMPLETED","sponsor":"Otsuka Pharmaceutical Development & Commercialization, Inc.","startDate":"2011-09-02","conditions":"Multidrug-resistant Tuberculosis","enrollment":511},{"nctId":"NCT01856634","phase":"PHASE1","title":"Pharmacokinetic and Safety Trial to Determine the Appropriate Dose for Pediatric Patients With Multidrug Resistant Tuberculosis","status":"COMPLETED","sponsor":"Otsuka Pharmaceutical Development & Commercialization, Inc.","startDate":"2013-06-14","conditions":"Multidrug Resistant Tuberculosis, Pediatric","enrollment":37}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":5,"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":"Delamanid + OBR","genericName":"Delamanid + OBR","companyName":"Otsuka Pharmaceutical Development & Commercialization, Inc.","companyId":"otsuka-pharmaceutical-development-commercialization-inc","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Delamanid inhibits mycobacterial cell wall synthesis by targeting mycolic acid production, while OBR (optimized background regimen) provides synergistic anti-tuberculous activity through multiple complementary mechanisms. Used for Drug-resistant tuberculosis (MDR-TB and XDR-TB) in combination with optimized background regimen.","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}