{"id":"fast-itraconazole-tablet","safety":{"commonSideEffects":[{"rate":null,"effect":"Nausea"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Diarrhea"},{"rate":null,"effect":"Abdominal pain"},{"rate":null,"effect":"Hypokalemia"},{"rate":null,"effect":"Hepatotoxicity"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"By blocking the conversion of lanosterol to ergosterol, itraconazole compromises the integrity and permeability of the fungal cell membrane, leading to cell death. This fast-dissolving tablet formulation is designed to improve bioavailability and onset of action compared to standard itraconazole formulations. The drug is effective against a broad spectrum of fungal pathogens including Aspergillus, Candida, and Cryptococcus species.","oneSentence":"Itraconazole is a triazole antifungal that inhibits fungal cytochrome P450-dependent lanosterol 14α-demethylase, disrupting ergosterol synthesis in the fungal cell membrane.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-27T23:46:15.743Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Fungal infections (aspergillosis, candidiasis, cryptococcosis, and other systemic mycoses)"}]},"trialDetails":[{"nctId":"NCT07429331","phase":"PHASE1","title":"Drug Interaction and Food Effect Study of CS0159","status":"NOT_YET_RECRUITING","sponsor":"Cascade Pharmaceuticals, Inc","startDate":"2026-03","conditions":"Healthy Volunteers","enrollment":32},{"nctId":"NCT06719557","phase":"PHASE1","title":"A Study of the Effect of Itraconazole and Phenytoin on Calderasib (MK-1084) in Healthy Adults (MK-1084-008)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2024-05-20","conditions":"Healthy","enrollment":28},{"nctId":"NCT06698926","phase":"PHASE1","title":"A Study to Assess the Safety, Tolerability, and Interactions of ABBV-CLS-616 Oral Tablets in Healthy Adult Participants","status":"COMPLETED","sponsor":"AbbVie","startDate":"2024-11-11","conditions":"Healthy Volunteer","enrollment":110},{"nctId":"NCT03403439","phase":"PHASE1","title":"This Study in Healthy Men Tests How Itraconazole Influences the Amount of BI 1015550 in the Blood","status":"COMPLETED","sponsor":"Boehringer Ingelheim","startDate":"2018-05-03","conditions":"Healthy","enrollment":16},{"nctId":"NCT05833139","phase":"PHASE1","title":"A Study in Healthy Men to Test How Itraconazole Influences the Amount of Zongertinib (BI 1810631) in the Blood","status":"COMPLETED","sponsor":"Boehringer Ingelheim","startDate":"2023-04-14","conditions":"Healthy","enrollment":16},{"nctId":"NCT04714073","phase":"PHASE1","title":"A Study in Healthy Men to Test How Itraconazole Influences the Amount of BI 706321 in the Blood","status":"COMPLETED","sponsor":"Boehringer Ingelheim","startDate":"2021-02-11","conditions":"Healthy","enrollment":14},{"nctId":"NCT06945276","phase":"PHASE1","title":"Phase 1 Study on Bioavailability, Food Effect, and Drug-Drug Interaction of ALG-097558 Tablets in Healthy Volunteers","status":"COMPLETED","sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","startDate":"2025-05-13","conditions":"COVID-19","enrollment":51},{"nctId":"NCT05840952","phase":"PHASE1","title":"A First-in-Human Multi-Part Phase 1 Study in Healthy Volunteers to Evaluate the Safety, Tolerability, Pharmacokinetics, and Drug-Drug Interaction Potential of Single and Multiple Doses of ALG-097558","status":"COMPLETED","sponsor":"Aligos Therapeutics","startDate":"2023-07-04","conditions":"COVID-19","enrollment":90},{"nctId":"NCT06205381","phase":"PHASE1","title":"Assessment of the Safety, Tolerability and Pharmacokinetics of AV078 in Healthy Volunteers","status":"COMPLETED","sponsor":"Aeovian Pharmaceuticals, Inc.","startDate":"2024-01-31","conditions":"Healthy Participants","enrollment":89},{"nctId":"NCT03843151","phase":"PHASE1","title":"A Study in Healthy Men to Test How Itraconazole Influences the Amount of BI 1358894 in the Blood","status":"COMPLETED","sponsor":"Boehringer Ingelheim","startDate":"2019-03-19","conditions":"Healthy","enrollment":16},{"nctId":"NCT06701136","phase":"PHASE1","title":"Drug-Drug Interaction and Food Effect of Sudapyridine(WX-081) With Itraconazole and Rifampin in Healthy Chinese Adults","status":"NOT_YET_RECRUITING","sponsor":"Shanghai Jiatan Pharmatech Co., Ltd","startDate":"2025-05-12","conditions":"Rifampicin-Resistant Pulmonary Tuberculosis Patients","enrollment":16},{"nctId":"NCT03135106","phase":"PHASE1","title":"A Study to Evaluate the Effect of Fluconazole and Itraconazole on Erdafitinib Pharmacokinetics in Healthy Adult Participants","status":"COMPLETED","sponsor":"Janssen Research & Development, LLC","startDate":"2017-04-14","conditions":"Healthy","enrollment":54},{"nctId":"NCT06589635","phase":"PHASE1","title":"A Drug-Drug Interaction (DDI) Study of ADC189 With Itraconazole in Healthy, Adult Subjects","status":"COMPLETED","sponsor":"Jiaxing AnDiCon Biotech Co.,Ltd","startDate":"2024-07-16","conditions":"Healthy Adults","enrollment":16},{"nctId":"NCT05949385","phase":"PHASE1","title":"A Study to Assess the Effect of Itraconazole Capsules on the Pharmacokinetics of ZX-7101A Tablets in Healthy Adult Subjects in China","status":"COMPLETED","sponsor":"Nanjing Zenshine Pharmaceuticals","startDate":"2023-07-02","conditions":"Pharmacokinetics","enrollment":16},{"nctId":"NCT05902728","phase":"PHASE1","title":"Study on Food Influence and Drug-drug Interaction of HLX208 Tablets in Chinese Healthy Subjects","status":"COMPLETED","sponsor":"Shanghai Henlius Biotech","startDate":"2023-07-04","conditions":"NSCLC","enrollment":20},{"nctId":"NCT04011241","phase":"PHASE1","title":"A Study in Healthy Men to Test How Itraconazole Influences the Amount of BI 1323495 in the Blood","status":"COMPLETED","sponsor":"Boehringer Ingelheim","startDate":"2019-07-24","conditions":"Healthy","enrollment":14},{"nctId":"NCT05954624","phase":"PHASE1","title":"Drug-durg Interaction of ZSP1273 With Digoxin, Rosuvastatin,Itraconazole and Probenecid","status":"COMPLETED","sponsor":"Guangdong Raynovent Biotech Co., Ltd","startDate":"2023-07-10","conditions":"Drug Drug Interaction","enrollment":49},{"nctId":"NCT05789342","phase":"PHASE1","title":"A Study to Evaluate the Drug-drug Interactions (DDIs) of GP681 With Rosuvastatin, Digoxin, Itraconazole, Oseltamivir in Chinese Healthy Volunteers","status":"COMPLETED","sponsor":"Jiangxi Qingfeng Pharmaceutical Co. Ltd.","startDate":"2023-02-15","conditions":"Healthy Volunteers","enrollment":54},{"nctId":"NCT04035187","phase":"PHASE4","title":"Itraconazole Oral Absorption","status":"COMPLETED","sponsor":"University of Maryland, Baltimore","startDate":"2020-02-10","conditions":"Fungal Infection","enrollment":17},{"nctId":"NCT03722173","phase":"PHASE1","title":"A Study in Healthy Men to Test How Itraconazole Influences the Amount of BI 894416 in the Blood","status":"COMPLETED","sponsor":"Boehringer Ingelheim","startDate":"2018-11-13","conditions":"Healthy","enrollment":14},{"nctId":"NCT04564612","phase":"PHASE1","title":"Study of BIIB091 Formulations in Healthy Participants","status":"COMPLETED","sponsor":"Biogen","startDate":"2020-09-28","conditions":"Healthy Volunteers","enrollment":59},{"nctId":"NCT05631678","phase":"PHASE1","title":"Drug-drug Interaction Study Beteewn ASK120067 and Rifampicin or Itraconazole","status":"COMPLETED","sponsor":"Jiangsu Aosaikang Pharmaceutical Co., Ltd.","startDate":"2022-06-06","conditions":"Locally Advanced or Metastatic NSCLC","enrollment":48},{"nctId":"NCT03555617","phase":"PHASE1","title":"Food-effect, Drug-Drug Interaction (DDI), and Formulation Bridging Study","status":"COMPLETED","sponsor":"Theravance Biopharma","startDate":"2018-06-13","conditions":"Inflammatory Bowel Disease","enrollment":36},{"nctId":"NCT02706535","phase":"PHASE1","title":"A Cross-over Study to Evaluate the Effect of Itraconazole and Rifampicin on the Pharmacokinetics (PK) of GSK525762 in Healthy Female Subjects of Non Child Bearing Potential","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2016-05-05","conditions":"Drug Interactions, Neoplasms","enrollment":29},{"nctId":"NCT03103646","phase":"PHASE1","title":"Study Evaluating the Effect of Multiple Doses of Itraconazole on the Drug Lu AF35700 in Healthy Young Men and Women","status":"COMPLETED","sponsor":"H. Lundbeck A/S","startDate":"2017-03-28","conditions":"Cytochrome P450 Interaction","enrollment":22},{"nctId":"NCT02045849","phase":"PHASE1","title":"Relative Bioavailability, Safety, Tolerability, Pharmacokinetics (PK) and Food Effect Study of GSK2140944 in Healthy Subjects","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2014-01-28","conditions":"Infections, Bacterial","enrollment":46},{"nctId":"NCT02836171","phase":"PHASE1","title":"Effect of Itraconazole on the Pharmacokinetics of Apatinib","status":"COMPLETED","sponsor":"Jiangsu HengRui Medicine Co., Ltd.","startDate":"2016-07","conditions":"Neoplasms","enrollment":20},{"nctId":"NCT02093728","phase":"PHASE1","title":"To Assess the Effect of Itraconazole and Fluconazole on the Pharmacokinetics of Selumetinib in Healthy Male Volunteers","status":"COMPLETED","sponsor":"AstraZeneca","startDate":"2014-04","conditions":"Solid Tumours","enrollment":26}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":8,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["fast dissolving itraconazole tablet"],"phase":"marketed","status":"active","brandName":"fast itraconazole tablet","genericName":"fast itraconazole tablet","companyName":"University of Maryland, Baltimore","companyId":"university-of-maryland-baltimore","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Itraconazole is a triazole antifungal that inhibits fungal cytochrome P450-dependent lanosterol 14α-demethylase, disrupting ergosterol synthesis in the fungal cell membrane. Used for Fungal infections (aspergillosis, candidiasis, cryptococcosis, and other systemic mycoses).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":1},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}