{"id":"ornidazole","rwe":[{"pmid":"41879414","year":"2026","title":"Development of an HPLC-QAMS method for simultaneous quantification of two morinidazole impurities, three ornidazole impurities and one levornidazole impurity in morinidazole sodium chloride injection.","finding":"","journal":"Pakistan journal of pharmaceutical sciences","studyType":"Clinical Study"},{"pmid":"41788167","year":"2026","title":"Qiangjing Tablets modulate oxidative stress and endoplasmic reticulum stress through the PI3K/Akt/NRF-2 signaling axis and regulate gut microbiota in ornidazole-induced asthenozoospermia rats.","finding":"","journal":"Journal of traditional and complementary medicine","studyType":"Clinical Study"},{"pmid":"41777726","year":"2026","title":"Characterization of Clostridium perfringens Causing Liver Abscess Using Whole-Genome Sequencing: A Case Report and Literature Review.","finding":"","journal":"Infection and drug resistance","studyType":"Clinical Study"},{"pmid":"41762605","year":"2026","title":"Microwave plasma torch mass spectrometry for rapid prediction of photo-thermal stability and degradation pathways of pharmaceuticals.","finding":"","journal":"Talanta","studyType":"Clinical Study"},{"pmid":"41761107","year":"2026","title":"Efficacy and safety of levornidazole disodium phosphate injection in patients with intra-abdominal infections caused by anaerobic bacteria: a multicenter, randomized, single-blind, phase IV, non-inferiority trial (ANAEROGUARD study).","finding":"","journal":"BMC infectious diseases","studyType":"Clinical Study"}],"tags":[{"label":"ornidazole","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"J01RA05","category":"atc"},{"label":"Active","category":"status"},{"label":"Amebicides","category":"pharmacology"},{"label":"Anti-Infective Agents","category":"pharmacology"},{"label":"Antiparasitic Agents","category":"pharmacology"},{"label":"Antiprotozoal Agents","category":"pharmacology"},{"label":"Antitrichomonal Agents","category":"pharmacology"},{"label":"Radiation-Sensitizing Agents","category":"pharmacology"}],"phase":"phase_3","safety":{"safetySignals":[{"llr":66.297,"date":"","count":17,"signal":"Premature baby","source":"DrugCentral FAERS","actionTaken":"Reported 17 times (LLR=66)"},{"llr":54.993,"date":"","count":10,"signal":"Oligohydramnios","source":"DrugCentral FAERS","actionTaken":"Reported 10 times (LLR=55)"}],"commonSideEffects":[{"effect":"Premature baby","drugRate":"LLR 66","severity":"common"},{"effect":"Oligohydramnios","drugRate":"LLR 55","severity":"common"}]},"trials":[],"aliases":[],"patents":[],"pricing":[],"allNames":"ornidal","offLabel":[],"synonyms":["ornidazole","ornidal","ornidone","ornilox","ornisid","ornitop"],"timeline":[],"approvals":[],"brandName":"Ornidal","ecosystem":[],"mechanism":{"modality":"Small Molecule","drugClass":"ornidazole","explanation":"Imagine your body is a garden, and bacteria are weeds. Ornidazole is like a weed killer that stops the weeds from growing and spreading, helping to keep your body healthy and free from infection.","oneSentence":"Ornidazole works by inhibiting the growth of bacteria and other microorganisms through its antimicrobial properties.","technicalDetail":"Ornidazole exerts its antimicrobial effects by interfering with the synthesis of nucleic acids and proteins in microorganisms, ultimately leading to their death or inhibition of growth."},"commercial":{},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/1997","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=ORNIDAZOLE","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=ORNIDAZOLE","fields":["publications"],"source":"PubMed/NCBI"}],"_enrichedAt":"2026-03-30T15:11:05.422106","_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T08:38:34.885177+00:00","fieldsConflicting":0,"overallConfidence":0.95},"biosimilars":[],"competitors":[{"drugName":"cefuroxime","drugSlug":"cefuroxime","fdaApproval":"1983-10-19","genericCount":10,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"metronidazole","drugSlug":"metronidazole","fdaApproval":"1963-07-18","patentExpiry":"Oct 4, 2039","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"levofloxacin","drugSlug":"levofloxacin","fdaApproval":"1996-12-20","genericCount":36,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"amikacin","drugSlug":"amikacin","fdaApproval":"1981-01-22","patentExpiry":"May 15, 2035","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"cefepime","drugSlug":"cefepime","fdaApproval":"1996-01-18","genericCount":8,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"azithromycin","drugSlug":"azithromycin","fdaApproval":"1991-11-01","genericCount":31,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"fluconazole","drugSlug":"fluconazole","fdaApproval":"1990-01-29","genericCount":31,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"secnidazole","drugSlug":"secnidazole","fdaApproval":"2017-09-15","patentExpiry":"Sep 4, 2035","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"tetracycline","drugSlug":"tetracycline","fdaApproval":"1953-11-19","genericCount":34,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"ofloxacin","drugSlug":"ofloxacin","fdaApproval":"1990-12-28","genericCount":20,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"ciprofloxacin","drugSlug":"ciprofloxacin","fdaApproval":"1987-10-22","patentExpiry":"Nov 27, 2038","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"tinidazole","drugSlug":"tinidazole","fdaApproval":"2004-05-17","genericCount":4,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"norfloxacin","drugSlug":"norfloxacin","fdaApproval":"1986-10-31","patentStatus":"Unknown","relationship":"same-class"}],"genericName":"ornidazole","indications":{"approved":[],"offLabel":[],"pipeline":[]},"drugCategory":"active","labelChanges":[],"relatedDrugs":[{"drugId":"cefuroxime","brandName":"cefuroxime","genericName":"cefuroxime","approvalYear":"1983","relationship":"same-class"},{"drugId":"metronidazole","brandName":"metronidazole","genericName":"metronidazole","approvalYear":"1963","relationship":"same-class"},{"drugId":"levofloxacin","brandName":"levofloxacin","genericName":"levofloxacin","approvalYear":"1996","relationship":"same-class"},{"drugId":"amikacin","brandName":"amikacin","genericName":"amikacin","approvalYear":"1981","relationship":"same-class"},{"drugId":"cefepime","brandName":"cefepime","genericName":"cefepime","approvalYear":"1996","relationship":"same-class"},{"drugId":"azithromycin","brandName":"azithromycin","genericName":"azithromycin","approvalYear":"1991","relationship":"same-class"},{"drugId":"fluconazole","brandName":"fluconazole","genericName":"fluconazole","approvalYear":"1990","relationship":"same-class"},{"drugId":"secnidazole","brandName":"secnidazole","genericName":"secnidazole","approvalYear":"2017","relationship":"same-class"},{"drugId":"tetracycline","brandName":"tetracycline","genericName":"tetracycline","approvalYear":"1953","relationship":"same-class"},{"drugId":"ofloxacin","brandName":"ofloxacin","genericName":"ofloxacin","approvalYear":"1990","relationship":"same-class"}],"trialDetails":[{"nctId":"NCT06821789","phase":"NA","title":"Effects of Lacticaseibacillus Rhamnosus LRa05 on Bacterial Vaginosis and Ovarian Function in Women","status":"NOT_YET_RECRUITING","sponsor":"Wecare Probiotics Co., Ltd.","startDate":"2025-03-15","conditions":["Patients With Bacterial Vaginosis"],"enrollment":60,"completionDate":"2026-05-30"},{"nctId":"NCT06828874","phase":"PHASE4","title":"A Study of Levornidazole Disodium Phosphate for Injection vs. Ornidazole in Treatment of Postoperative Intra-Abdominal Infections Caused by Anaerobic Bacteria","status":"COMPLETED","sponsor":"Yangtze River Pharmaceutical Group Jiangsu Zilong Pharmaceutical Co. Ltd","startDate":"2023-05-10","conditions":["Intraabdominal Infections"],"enrollment":696,"completionDate":"2024-10-14"},{"nctId":"NCT06830122","phase":"NA","title":"Effects of Lactobacillus Crispatus LCr86 on Bacterial Vaginosis and Ovarian Function in Women","status":"NOT_YET_RECRUITING","sponsor":"Wecare Probiotics Co., Ltd.","startDate":"2025-03-20","conditions":["Patients With Bacterial Vaginosis"],"enrollment":60,"completionDate":"2026-04-30"},{"nctId":"NCT06437041","phase":"NA","title":"Effect of Antibiotic Pretreatment on the Efficacy of WMT in the Treatment of Irritable Bowel Syndrome","status":"NOT_YET_RECRUITING","sponsor":"Faming Zhang","startDate":"2024-06","conditions":["Irritable Bowel Syndrome"],"enrollment":96,"completionDate":"2030-03-31"},{"nctId":"NCT06427863","phase":"NA","title":"Effect of Antibiotic Pretreatment on the Efficacy of WMT in the Treatment of Chronic Constipation","status":"NOT_YET_RECRUITING","sponsor":"Faming Zhang","startDate":"2024-06","conditions":["Chronic Constipation"],"enrollment":96,"completionDate":"2029-12-31"},{"nctId":"NCT03491540","phase":"PHASE3","title":"Mechanical Bowel Preparation and Oral Antibiotics Before Rectal Cancer Surgery","status":"COMPLETED","sponsor":"Assistance Publique - Hôpitaux de Paris","startDate":"2018-09-03","conditions":["Rectal Cancer Surgery"],"enrollment":414,"completionDate":"2023-12-12"},{"nctId":"NCT02618720","phase":"PHASE3","title":"Intravenous Versus Combined Oral and Intravenous Antimicrobial Prophylaxis for the Prevention of Surgical Site Infection in Elective Colorectal Surgery","status":"COMPLETED","sponsor":"University Hospital, Clermont-Ferrand","startDate":"2016-05-25","conditions":["Elective Colorectal Surgery"],"enrollment":920,"completionDate":"2020-06-30"},{"nctId":"NCT03475680","phase":"PHASE3","title":"Mechanical Bowel Preparation and Oral Antibiotics Before Colon Cancer Surgery","status":"TERMINATED","sponsor":"Assistance Publique - Hôpitaux de Paris","startDate":"2018-08-08","conditions":["Colon Cancer"],"enrollment":193,"completionDate":"2022-03-23"},{"nctId":"NCT05228093","phase":"NA","title":"A Randomized Controlled Clinical Trial of Surgery Versus Conservative Treatment for Mild and Moderate-grade Nasopharyngeal Necrosis","status":"UNKNOWN","sponsor":"Sun Yat-sen University","startDate":"2021-11-01","conditions":["Nasopharyngeal Carcinoma, Postradiation, Necrosis, Endoscopy Surgery, Conservative Treatment"],"enrollment":216,"completionDate":"2024-10-30"},{"nctId":"NCT01662765","phase":"NA","title":"Conservative Versus Surgical Treatment of Umbilical Pilonidal Disease","status":"COMPLETED","sponsor":"Medical Park Gaziantep Hospital","startDate":"2003-11","conditions":["Pilonidal Sinus","Sinus; Dermal, Pilonidal","Umbilical Granuloma"],"enrollment":84,"completionDate":"2012-05"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"crossReferences":{"NUI":"N0000167081","NDDF":"005696","UNII":"62XCK0G93T","CHEBI":"CHEBI:75176","INN_ID":"3319","RXNORM":"7701","UMLSCUI":"C0029274","ChEMBL_ID":"CHEMBL1449676","KEGG_DRUG":"D05274","DRUGBANK_ID":"DB13026","PUBCHEM_CID":"28061","SNOMEDCT_US":"442845007","MESH_DESCRIPTOR_UI":"D009950"},"formularyStatus":[],"_enricherVersion":"v2","developmentCodes":[],"ownershipHistory":[],"pharmacokinetics":{"source":"DrugCentral","halfLife":"12.0 hours","clearance":"1.08 mL/min/kg","fractionUnbound":"0.88%","volumeOfDistribution":"1.16 L/kg"},"publicationCount":689,"therapeuticAreas":["Infectious Disease"],"atcClassification":{"source":"DrugCentral","atcCode":"J01RA05","allCodes":["G01AF06","J01RA05","J01RA09","J01RA12","J01RA15","J01XD03","P01AB03"]},"biosimilarFilings":[],"recentPublications":[{"date":"2026 May","pmid":"41879414","title":"Development of an HPLC-QAMS method for simultaneous quantification of two morinidazole impurities, three ornidazole impurities and one levornidazole impurity in morinidazole sodium chloride injection.","journal":"Pakistan journal of pharmaceutical sciences"},{"date":"2026 Mar","pmid":"41788167","title":"Qiangjing Tablets modulate oxidative stress and endoplasmic reticulum stress through the PI3K/Akt/NRF-2 signaling axis and regulate gut microbiota in ornidazole-induced asthenozoospermia rats.","journal":"Journal of traditional and complementary medicine"},{"date":"2026","pmid":"41777726","title":"Characterization of Clostridium perfringens Causing Liver Abscess Using Whole-Genome Sequencing: A Case Report and Literature Review.","journal":"Infection and drug resistance"},{"date":"2026 Feb 24","pmid":"41762605","title":"Microwave plasma torch mass spectrometry for rapid prediction of photo-thermal stability and degradation pathways of pharmaceuticals.","journal":"Talanta"},{"date":"2026 Feb 28","pmid":"41761107","title":"Efficacy and safety of levornidazole disodium phosphate injection in patients with intra-abdominal infections caused by anaerobic bacteria: a multicenter, randomized, single-blind, phase IV, non-inferiority trial (ANAEROGUARD study).","journal":"BMC infectious diseases"}],"companionDiagnostics":[],"genericManufacturerList":[],"status":"active","companyName":"","companyId":"","modality":"Small molecule","firstApprovalDate":"","aiSummary":"","enrichmentLevel":5,"visitCount":0,"trialStats":{"total":3,"withResults":0},"validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T08:38:34.885177+00:00","fieldsConflicting":0,"overallConfidence":0.95},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":false,"safety":true,"trials":true,"score":3}}