{"id":"rifasutenizol-capsules","safety":{"commonSideEffects":[{"rate":null,"effect":"Hepatotoxicity"},{"rate":null,"effect":"Gastrointestinal disturbance"},{"rate":null,"effect":"Rash"},{"rate":null,"effect":"Drug interactions (CYP3A4 induction)"}]},"_chembl":{"chemblId":"CHEMBL5172403","moleculeType":"Small molecule","molecularWeight":"944.05"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"As a rifamycin derivative, rifasutenizol binds to the bacterial RNA polymerase β-subunit, blocking RNA synthesis in mycobacterial cells. This mechanism is similar to rifampicin but with potentially improved pharmacokinetic properties or activity against resistant strains. The drug is being developed for tuberculosis and other mycobacterial infections.","oneSentence":"Rifasutenizol is a rifamycin-class antibiotic that inhibits bacterial RNA polymerase to prevent transcription and translation in mycobacteria.","_ai_confidence":"low"},"_scrapedAt":"2026-03-28T00:52:23.467Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Tuberculosis (pulmonary and extrapulmonary)"},{"name":"Drug-resistant tuberculosis"}]},"trialDetails":[{"nctId":"NCT05857163","phase":"PHASE3","title":"Efficacy and Safety of Rifasutenizol (TNP 2198), Rabeprazole and Amoxicillin in Participants With H. Pylori Infection","status":"COMPLETED","sponsor":"TenNor Therapeutics (Suzhou) Limited","startDate":"2023-05-18","conditions":"H.Pylori Infection","enrollment":700},{"nctId":"NCT06076694","phase":"PHASE2","title":"Efficacy and Safety After Multiple Doses of TNP-2198 Capsules, Rabeprazole Sodium Enteric-coated Tablets and Amoxicillin Capsules in Helicobacter Pylori Infected-positive Participants","status":"COMPLETED","sponsor":"TenNor Therapeutics (Suzhou) Limited","startDate":"2022-06-26","conditions":"Helicobacter Pylori Infection","enrollment":80},{"nctId":"NCT06076681","phase":"PHASE1, PHASE2","title":"A Study to Evaluate Preliminary Helicobacter Pylori Eradication After Multiple Doses of TNP-2198 Capsules Combined With Rabeprazole Sodium Enteric-coated Tablets, or Rabeprazole Sodium Enteric-coated Tablets and Amoxicillin Capsules","status":"COMPLETED","sponsor":"TenNor Therapeutics (Suzhou) Limited","startDate":"2021-09-27","conditions":"Helicobacter Pylori Infection","enrollment":40},{"nctId":"NCT06081712","phase":"PHASE1","title":"A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of TNP-2198 Capsules in Asymptomatic Participants With Helicobacter Pylori Infection","status":"COMPLETED","sponsor":"TenNor Therapeutics (Suzhou) Limited","startDate":"2020-10-20","conditions":"Helicobacter Pylori Infection","enrollment":48},{"nctId":"NCT06081699","phase":"PHASE1","title":"A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Food Effect of TNP-2198 Capsules After Single Oral Dose in Healthy Participants","status":"COMPLETED","sponsor":"TenNor Therapeutics (Suzhou) Limited","startDate":"2019-05-09","conditions":"Helicobacter Pylori Infection","enrollment":78}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":2,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["TNP-2198 capsules","Rifasutenizol placebo"],"phase":"phase_3","status":"active","brandName":"Rifasutenizol capsules","genericName":"Rifasutenizol capsules","companyName":"TenNor Therapeutics (Suzhou) Limited","companyId":"tennor-therapeutics-suzhou-limited","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Rifasutenizol is a rifamycin-class antibiotic that inhibits bacterial RNA polymerase to prevent transcription and translation in mycobacteria. Used for Tuberculosis (pulmonary and extrapulmonary), Drug-resistant tuberculosis.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}