{"id":"omadacycline-injection","safety":{"commonSideEffects":[{"rate":null,"effect":"Nausea"},{"rate":null,"effect":"Vomiting"},{"rate":null,"effect":"Photosensitivity"},{"rate":null,"effect":"Diarrhea"},{"rate":null,"effect":"Headache"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Omadacycline is a broad-spectrum tetracycline antibiotic that works by binding to the bacterial 30S ribosomal subunit, thereby inhibiting protein synthesis and preventing bacterial growth. It has enhanced activity against gram-positive and gram-negative bacteria, including some resistant strains. The drug is administered intravenously and is used to treat acute bacterial skin and skin structure infections (ABSSSI) and community-acquired bacterial pneumonia (CABP).","oneSentence":"Omadacycline is a tetracycline antibiotic that inhibits bacterial protein synthesis by binding to the ribosome.","_ai_confidence":"high"},"_scrapedAt":"2026-03-27T23:35:17.683Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Acute bacterial skin and skin structure infections (ABSSSI)"},{"name":"Community-acquired bacterial pneumonia (CABP)"}]},"trialDetails":[{"nctId":"NCT05217537","phase":"PHASE1","title":"Study to Evaluate the PK of IV and PO Omadacycline in Children and Adolescents With Suspected or Confirmed Bacterial Infections","status":"COMPLETED","sponsor":"Paratek Pharmaceuticals Inc","startDate":"2022-04-06","conditions":"Bacterial Infections","enrollment":23},{"nctId":"NCT04779242","phase":"PHASE3","title":"Omadacycline vs. Moxifloxacin for the Treatment of Community-Acquired Bacterial Pneumonia","status":"COMPLETED","sponsor":"Paratek Pharmaceuticals Inc","startDate":"2021-02-25","conditions":"Community-acquired Pneumonia, Bacterial Pneumonia","enrollment":670},{"nctId":"NCT05515562","phase":"PHASE4","title":"Effects of Intravenous (IV) Omadacycline on Gut Microbiome","status":"COMPLETED","sponsor":"Wake Forest University Health Sciences","startDate":"2023-03-20","conditions":"Microbial Colonization","enrollment":8},{"nctId":"NCT04460586","phase":"PHASE4","title":"Pharmacokinetics of Omadacycline in Cystic Fibrosis","status":"COMPLETED","sponsor":"Paul Beringer","startDate":"2021-07-01","conditions":"Cystic Fibrosis","enrollment":9},{"nctId":"NCT00865280","phase":"PHASE3","title":"Study the Safety and Efficacy of PTK 0796 in Patients With Complicated Skin and Skin Structure Infection (CSSSI)","status":"TERMINATED","sponsor":"Paratek Pharmaceuticals Inc","startDate":"2009-04-04","conditions":"Skin Diseases, Infectious","enrollment":143},{"nctId":"NCT03716024","phase":"PHASE2","title":"Study the Efficacy and Safety of PTK 0796 in Patients With Complicated Skin and Skin Structure Infection (CSSSI)","status":"COMPLETED","sponsor":"Paratek Pharmaceuticals Inc","startDate":"2007-07-18","conditions":"Infectious Skin Disease, Bacterial Skin Disease","enrollment":234},{"nctId":"NCT02378480","phase":"PHASE3","title":"Omadacycline Versus Linezolid for the Treatment of ABSSSI (EudraCT #2013-003644-23)","status":"COMPLETED","sponsor":"Paratek Pharmaceuticals Inc","startDate":"2015-06","conditions":"Bacterial Infections, Skin Structures and Soft Tissue Infections","enrollment":655},{"nctId":"NCT02531438","phase":"PHASE3","title":"Omadacycline vs Moxifloxacin for the Treatment of CABP (EudraCT #2013-004071-13)","status":"COMPLETED","sponsor":"Paratek Pharmaceuticals Inc","startDate":"2015-11","conditions":"Bacterial Pneumonia, Community-Acquired Infections","enrollment":774},{"nctId":"NCT00876850","phase":"PHASE3","title":"Phase 3 Study - Safety and Efficacy of PTK 0796 in Patients With Complicated Skin and Skin Structure Infection (CSSSI)","status":"WITHDRAWN","sponsor":"Paratek Pharmaceuticals Inc","startDate":"2009-07","conditions":"Skin Structures and Soft Tissue Infections","enrollment":""}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":3,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Omadacycline oral","NUZYRA","Nuzyra"],"phase":"marketed","status":"active","brandName":"Omadacycline Injection","genericName":"Omadacycline Injection","companyName":"Wake Forest University Health Sciences","companyId":"wake-forest-university-health-sciences","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Omadacycline is a tetracycline antibiotic that inhibits bacterial protein synthesis by binding to the ribosome. Used for Acute bacterial skin and skin structure infections (ABSSSI), Community-acquired bacterial pneumonia (CABP).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}