{"id":"clotrimazole","rwe":[],"_fda":{"id":"0052992a-819c-4c55-bd88-201a09a3573a","set_id":"0052992a-819c-4c55-bd88-201a09a3573a","openfda":{"nui":["N0000175487","M0002083"],"unii":["G07GZ97H65"],"route":["TOPICAL"],"rxcui":["309367"],"spl_id":["0052992a-819c-4c55-bd88-201a09a3573a"],"brand_name":["Clotrimazole"],"spl_set_id":["0052992a-819c-4c55-bd88-201a09a3573a"],"package_ndc":["68788-8830-2"],"product_ndc":["68788-8830"],"generic_name":["CLOTRIMAZOLE"],"product_type":["HUMAN OTC DRUG"],"pharm_class_cs":["Azoles [CS]"],"substance_name":["CLOTRIMAZOLE"],"pharm_class_epc":["Azole Antifungal [EPC]"],"manufacturer_name":["Preferred Pharmaceuticals Inc."],"application_number":["M005"],"original_packager_product_ndc":["69396-001"]},"purpose":["Purpose Antifungal Cream"],"version":"1","stop_use":["Stop use and ask doctor if • irritaion occurs • There is no improvement within 4 weeks (for athlete's foot or ringworm) or within 2 weeks (for jock itch)."],"warnings":["Warnings For External use only."],"questions":["Questions? Adverse drug event call 1-888-296-9067 Dist. By Trifecta Pharmaceuticals USA® 101 NE Third Avenue, Suite 1500 Ft. Lauderdale, FL 33301, USA Relabeled By: Preferred Pharmaceuticals Inc. NDC 68788-8330-2"],"do_not_use":["Do Not Use Do not use on children under 2 years of age unless direcgted by a doctor"],"when_using":["When using this product When using this product avoid contact with eyes"],"effective_time":"20250221","active_ingredient":["Active ingredient Clotrimazole USP 1% w/w"],"inactive_ingredient":["Inactive Ingredients Dimethyl Sulfoxide, Ethylparaben, Glycerin, Laureth-23, Mineral Oil, Petrolatum, Water, alcohol, Glyceryl mono and dipalmitostearate, Cetostearyl alcohol, edetate disodium, Butylated Hydroxytoluene."],"storage_and_handling":["Other Information • store at controlled room temperature 15°-30°C (59°- 86°F) • Close cap tightly after use."],"indications_and_usage":["Uses Cures athlete’s foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis). Relieves the itching, irritation, redness, scaling and discomfort which can accompany these conditions."],"dosage_and_administration":["Directions • Wash the affected area and dry thoroughly. ● Apply a thin layer of this product over affected area twice daily (morning and night), or as directed by a doctor. ● Supervise children in the use of this product. ● For athlete’s foot, pay special attention to the spaces between the toes; wear well-fitting ventilated shoes, and change shoes and socks at least once daily. ● For athlete’s foot and ringworm, use daily for 4 weeks. For jock itch, use daily for 2 weeks. ● If conditions persists longer, consult a doctor. ● This product is not effective on the scalp or nails."],"spl_product_data_elements":["Clotrimazole Clotrimazole MINERAL OIL DIMETHYL SULFOXIDE ETHYLPARABEN GLYCERIN LAURETH-23 PETROLATUM WATER EDETATE DISODIUM CLOTRIMAZOLE CLOTRIMAZOLE GLYCERYL MONO- AND DIPALMITOSTEARATE BUTYLATED HYDROXYTOLUENE ALCOHOL CETOSTEARYL ALCOHOL"],"keep_out_of_reach_of_children":["Keep this and all drugs out of the reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center right away.","Keep this and all drugs out of the reach of children In case of accidental ingestion, seek professional assistance or contact Poison Control Centre right away."],"package_label_principal_display_panel":["Clotrimazole Cream USP 1%"]},"tags":[],"phase":"marketed","safety":{"boxedWarnings":[],"safetySignals":[{"date":"","signal":"DRUG INEFFECTIVE","source":"FDA FAERS","actionTaken":"1373 reports"},{"date":"","signal":"NAUSEA","source":"FDA FAERS","actionTaken":"852 reports"},{"date":"","signal":"PAIN","source":"FDA FAERS","actionTaken":"820 reports"},{"date":"","signal":"MACULAR DEGENERATION","source":"FDA FAERS","actionTaken":"797 reports"},{"date":"","signal":"HEADACHE","source":"FDA FAERS","actionTaken":"747 reports"},{"date":"","signal":"DYSPNOEA","source":"FDA FAERS","actionTaken":"746 reports"},{"date":"","signal":"OFF LABEL USE","source":"FDA FAERS","actionTaken":"734 reports"},{"date":"","signal":"FATIGUE","source":"FDA FAERS","actionTaken":"701 reports"},{"date":"","signal":"DIARRHOEA","source":"FDA FAERS","actionTaken":"632 reports"},{"date":"","signal":"PYREXIA","source":"FDA FAERS","actionTaken":"547 reports"}],"drugInteractions":[],"commonSideEffects":[],"contraindications":["Abdominal pain - cause unknown","Adrenal cortical hypofunction","Atrophoderma","Peripheral vascular disease","Telangiectasia disorder"],"specialPopulations":{},"discontinuationRates":[],"seriousAdverseEvents":[]},"status":"approved","trials":["NCT06433128","NCT06828458","NCT00805090","NCT03024502","NCT03437005","NCT00769457","NCT06349122","NCT01731574","NCT02847286","NCT04947592","NCT03226418","NCT04847050","NCT00755053","NCT06214273","NCT02057289","NCT00916643","NCT03905447","NCT01230814","NCT01769339","NCT00194324","NCT00078559","NCT03572959","NCT03359070","NCT01119742","NCT02713139","NCT06274554","NCT06869681","NCT04869449","NCT04825275","NCT01993823","NCT02860845","NCT03115073","NCT00385502","NCT06117904","NCT01335373","NCT00061282","NCT04432376","NCT00842504","NCT00361517","NCT00004492","NCT00036166","NCT00526227","NCT03005353","NCT06681090","NCT00835510","NCT05129033","NCT01580878","NCT03583164","NCT06146504","NCT02545452"],"aliases":["Lotrimin","Canesten","Mycelex"],"patents":[{"type":"Formulation","number":"12246006","applicant":"CARWIN PHARMACEUTICAL ASSOCIATES LLC","territory":"US","tradeName":"CLOTIC","expiryDate":"2042-05-26"}],"pricing":[{"market":"United States","source":"CMS National Average Drug Acquisition Cost (NADAC)","asOfDate":"2024-01-03","unitCost":"$0.9428/ML","priceType":"NADAC","sourceUrl":"https://data.medicaid.gov/dataset/4j6z-xnwq","annualCost":"$339","description":"CLOTRIMAZOLE 1% SOLUTION","retrievedDate":"2026-04-07"}],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=clotrimazole","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T00:07:21.353543+00:00"},"patents":{"url":"","method":"deterministic","source":"FDA Orange Book","rawText":"","confidence":1,"sourceType":"fda_orange_book","retrievedAt":"2026-04-20T00:07:21.353148+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T00:07:27.824755+00:00"},"regulatory.us":{"url":"","method":"api_direct","source":"FDA Drugs@FDA","rawText":"","confidence":1,"sourceType":"fda_drugsfda","retrievedAt":"2026-04-20T00:07:19.969159+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=clotrimazole","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T00:07:28.600070+00:00"},"mechanism.drugClass":{"url":"https://api.fda.gov/drug/label.json","method":"deterministic","source":"FDA Label (EPC)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:07:18.797278+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:07:18.797338+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (no boxed warning)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:07:18.797353+00:00"},"safety.safetySignals":{"url":"https://api.fda.gov/drug/event.json","method":"api_direct","source":"FDA FAERS","rawText":"","confidence":1,"sourceType":"fda_faers","retrievedAt":"2026-04-20T00:07:30.128952+00:00"},"mechanism.target_chembl":{"url":"","method":"api_direct","source":"ChEMBL mechanism: Cytochrome P450 51 inhibitor","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T00:07:29.196728+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL104/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T00:07:29.076519+00:00"},"regulatory.fda_application":{"url":"","method":"deterministic","source":"FDA Label","rawText":"M005","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:07:18.797362+00:00"}},"allNames":"lotrimin","offLabel":[],"timeline":[],"aiSummary":"Lotrimin is an antifungal medication used to treat various skin conditions such as eczema, dermatitis, and fungal infections like athlete's foot and jock itch. It works by inhibiting the enzyme lanosterol 14-alpha demethylase through its action as a cytochrome P450 51 inhibitor.","brandName":"Lotrimin","companyId":"bayer","ecosystem":[],"mechanism":{"target":"7-alpha-hydroxycholest-4-en-3-one 12-alpha-hydroxylase, Malate dehydrogenase cytoplasmic , 5-hydroxytryptamine receptor 6","novelty":"","modality":"Small molecule","drugClass":"Azole Antifungal [EPC]","explanation":"","oneSentence":"","technicalDetail":""},"commercial":null,"references":[],"_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T00:07:31.825598+00:00","fieldsConflicting":1,"overallConfidence":0.8},"biosimilars":[],"companyName":"Bayer AG","competitors":[],"dataSources":[{"url":"https://data.medicaid.gov/dataset/4j6z-xnwq","name":"CMS National Average Drug Acquisition Cost (NADAC)","fields":["pricing"],"retrievedDate":"2026-04-07"}],"genericName":"clotrimazole","indications":{"approved":[{"name":"Candidal vulvovaginitis","diseaseId":"candidal-vulvovaginitis","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Candidiasis of mouth","diseaseId":"candidiasis-of-mouth","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Candidiasis of skin","diseaseId":"candidiasis-of-skin","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Diaper rash","diseaseId":"diaper-rash","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Oropharyngeal Candidiasis","diseaseId":"oropharyngeal-candidiasis","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Pityriasis versicolor","diseaseId":"pityriasis-versicolor","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Prevention of Oropharyngeal Candidiasis","diseaseId":"prevention-of-oropharyngeal-candidiasis","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Tinea corporis","diseaseId":"tinea-corporis","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Tinea cruris","diseaseId":"tinea-cruris","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Tinea pedis","diseaseId":"tinea-pedis","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"}],"offLabel":[],"pipeline":[]},"labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT06433128","phase":"N/A","title":"Expanded Access to Fosmanogepix for Patients With Serious or Life-threatening Invasive Fungal Infections Who Have no Other Treatment Options","status":"AVAILABLE","sponsor":"Basilea Pharmaceutica","isPivotal":false,"enrollment":0,"indication":"Invasive Fungal Infections","completionDate":""},{"nctId":"NCT06828458","phase":"N/A","title":"Determining Elements of Anti-Fungal Immunity in BURN Patients","status":"NOT_YET_RECRUITING","sponsor":"Assistance Publique - Hôpitaux de Paris","isPivotal":false,"enrollment":327,"indication":"Burn","completionDate":"2030-09-01"},{"nctId":"NCT00805090","phase":"Phase 1","title":"An Open-Label, Single-Dose Study to Evaluate the Safety and Pharmacokinetics of DIC075V in Subjects With Mild or Moderate Chronic Renal Insufficiency and in Subjects With Mild Chronic Hepatic Impairme","status":"COMPLETED","sponsor":"Javelin Pharmaceuticals","isPivotal":false,"enrollment":37,"indication":"Renal Insufficiency, Chronic, Hepatic Insufficiency","completionDate":"2009-04"},{"nctId":"NCT03024502","phase":"Phase 1","title":"Randomized Clinical Trial of a Mucoadhesive Gel Containing EPP-AF in Patients Diagnosed With Vulvovaginal Candidiasis","status":"UNKNOWN","sponsor":"University of Sao Paulo","isPivotal":false,"enrollment":90,"indication":"Vulvovaginal Candidiasis","completionDate":"2020-06"},{"nctId":"NCT03437005","phase":"Phase 1","title":"Alterations in the Human Microbiome With Commonly Used Topical Medications","status":"RECRUITING","sponsor":"University of California, Davis","isPivotal":false,"enrollment":24,"indication":"Healthy","completionDate":"2026-09-28"},{"nctId":"NCT00769457","phase":"Phase 4","title":"OptiLink HF Study (Optimization of Heart Failure Management Using Medtronic OptiVol® Fluid Status Monitoring and Medtronic CareLink® Network)","status":"COMPLETED","sponsor":"Medtronic Cardiac Rhythm and Heart Failure","isPivotal":false,"enrollment":1002,"indication":"Heart Failure","completionDate":"2014-11"},{"nctId":"NCT06349122","phase":"Phase 4","title":"Screen-and-treat Strategy for Vaginal Flora Abnormalities by Multiplex Molecular Biology Using POC Technology in Pregnant Women at High Risk of Preterm Birth: A Multicentre, Randomized Study (AUTOP2)","status":"NOT_YET_RECRUITING","sponsor":"Assistance Publique Hopitaux De Marseille","isPivotal":false,"enrollment":1292,"indication":"Bacterial Vaginosis, Vaginal Dysbiosis","completionDate":"2028-01"},{"nctId":"NCT01731574","phase":"Phase 1","title":"An Open-label, Randomized, Three-period Crossover Trial in Healthy HIV-negative Women to Assess the Drug-drug Interaction Between Dapivirine Vaginal Ring-004 and Miconazole Nitrate","status":"COMPLETED","sponsor":"International Partnership for Microbicides, Inc.","isPivotal":false,"enrollment":36,"indication":"HIV","completionDate":"2013-10"},{"nctId":"NCT02847286","phase":"Phase 1","title":"AN OPEN-LABEL, RANDOMISED TRIAL, WITH A THREE-PERIOD CROSSOVER PART IN HEALTHY HIV-NEGATIVE WOMEN TO ASSESS THE DRUG-DRUG INTERACTION POTENTIAL BETWEEN DAPIVIRINE VAGINAL RING-004, CONTAINING 25 MG OF","status":"COMPLETED","sponsor":"International Partnership for Microbicides, Inc.","isPivotal":false,"enrollment":36,"indication":"HIV- Prevention","completionDate":"2016-11-28"},{"nctId":"NCT04947592","phase":"N/A","title":"Outcome of SD-OCT Guided Oral Anti-fungal Treatment of Fungal Chorioretinitis","status":"UNKNOWN","sponsor":"Benha University","isPivotal":false,"enrollment":10,"indication":"Fungal Retinitis","completionDate":"2022-01"},{"nctId":"NCT03226418","phase":"Phase 2","title":"A Phase II Study of the Impact of Clinicogenetic Risk-Stratified Management on Outcomes of Acute Myeloid Leukemia in Older Patients","status":"COMPLETED","sponsor":"University of Nebraska","isPivotal":false,"enrollment":75,"indication":"Adult Acute Myeloid Leukemia, Secondary Acute Myeloid Leukemia","completionDate":"2024-10-01"},{"nctId":"NCT04847050","phase":"Phase 2","title":"A Trial of the Safety and Immunogenicity of the COVID-19 Vaccine (mRNA-1273) in Participants With Hematologic Malignancies and Various Regimens of Immunosuppression, and in Participants With Solid Tum","status":"COMPLETED","sponsor":"National Cancer Institute (NCI)","isPivotal":false,"enrollment":19,"indication":"Solid Tumor Malignancy, Hematologic Malignancy","completionDate":"2023-05-25"},{"nctId":"NCT00755053","phase":"Phase 3","title":"An Investigator-blinded, Active-controlled Phase 3 Study to Prove the Non-inferior Efficacy of a Clotrimazole Ovule (500 mg) Versus a Clotrimazole Vaginal Tablet (500 mg) in Vaginal Candidiasis","status":"COMPLETED","sponsor":"Bayer","isPivotal":true,"enrollment":466,"indication":"Clotrimazole, Ovulen","completionDate":"2009-05"},{"nctId":"NCT06214273","phase":"Phase 2","title":"Evaluation of Low Level Diode Diode Versus Topical Chamomile in Management of Chemotherapy Induced Oral Mucositis: Three Arm Randomized Clinical Trial","status":"UNKNOWN","sponsor":"Cairo University","isPivotal":false,"enrollment":45,"indication":"Chemotherapy Induced Oral Mucositis","completionDate":"2024-10"},{"nctId":"NCT02057289","phase":"Phase 1","title":"Micafungin Anti-Fungal Prophylaxis in Immunocompromised Pediatric Patients: A Pharmacokinetic Study","status":"TERMINATED","sponsor":"Children's Hospital Medical Center, Cincinnati","isPivotal":false,"enrollment":9,"indication":"Immunocompromised, Bone Marrow Transplant","completionDate":"2014-11"},{"nctId":"NCT00916643","phase":"Phase 4","title":"Post Marketing Surveillance Study for LDL Apheresis Using H.E.L.P. Therapy","status":"COMPLETED","sponsor":"B. Braun Medical Inc.","isPivotal":false,"enrollment":113,"indication":"Familial Hypercholesterolemia","completionDate":"2009-09"},{"nctId":"NCT03905447","phase":"Phase 2","title":"An Open-label, Pilot Study to Assess Safety, Tolerability, Pharmacokinetics and Effects of Inhaled PC945 in the Pre-emptive Treatment of Aspergillus Fumigatus Colonisation in Lung Transplant Recipient","status":"TERMINATED","sponsor":"Pulmocide Ltd","isPivotal":false,"enrollment":2,"indication":"Aspergillosis, Lung Transplant Infection","completionDate":"2020-06-01"},{"nctId":"NCT01230814","phase":"Phase 2","title":"A Double-Blind, Randomized Trial of Monthly Treatment With Topical Metronidazole and Miconazole Co-formulated Vaginal Suppositories Versus Placebo for Preventing Vaginal Infections in HIV-seronegative","status":"COMPLETED","sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","isPivotal":false,"enrollment":234,"indication":"Bacterial Vaginosis, Candidiasis","completionDate":"2013-08"},{"nctId":"NCT01769339","phase":"Phase 4","title":"Effectiveness and Safety of Daktacort Feminine Care Cream in the Treatment of Vulvar Candidiasis","status":"COMPLETED","sponsor":"Janssen Pharmaceutica","isPivotal":false,"enrollment":115,"indication":"Vulva; Candidiasis","completionDate":"2009-06"},{"nctId":"NCT00194324","phase":"Phase 4","title":"Vaginal Imaging Study to Evaluate the Effect of Exercise on the Distribution of Miconozole Nitrate OVULE","status":"COMPLETED","sponsor":"University of Pennsylvania","isPivotal":false,"enrollment":12,"indication":"Health, Vulvovaginal Candidiasis","completionDate":"2004-10"},{"nctId":"NCT00078559","phase":"Phase 1","title":"The Use of Campath-1H, Tacrolimus, and Sirolimus Followed by Sirolimus Withdrawal in Renal Transplant Patients","status":"COMPLETED","sponsor":"University of Wisconsin, Madison","isPivotal":false,"enrollment":10,"indication":"Kidney Transplantation, Kidney Disease","completionDate":"2010-02"},{"nctId":"NCT03572959","phase":"Phase 4","title":"Management of Pain in Oral Lichen Planus Patients: A Comparative Pilot Study","status":"COMPLETED","sponsor":"Sherine Adel Nasry","isPivotal":false,"enrollment":24,"indication":"Oral Lichen Planus","completionDate":"2017-05-22"},{"nctId":"NCT03359070","phase":"Phase 2","title":"Clinical Study of Non-inferiority (Phase 2), Comparing Dapaconazole (BL123 - Biolab Sanus Farmacêutica Ltda.) Versus Miconazole Nitrate (União Química) in Patients With a Single Lesion of Tinea Cruris","status":"COMPLETED","sponsor":"Galeno Desenvolvimento de Pesquisas Clínicas","isPivotal":false,"enrollment":51,"indication":"Tinea Cruris","completionDate":"2015-05-06"},{"nctId":"NCT01119742","phase":"Phase 1","title":"A Randomized, Double-Blind, Placebo Controlled, Parallel Design, Multiple-Site Study to Evaluate the Clinical Equivalence of Two Generic Butenafine Hydrochloride 1% Creams to Lotrimin Ultra® Cream in ","status":"TERMINATED","sponsor":"Sun Pharmaceutical Industries, Inc.","isPivotal":false,"enrollment":428,"indication":"Interdigital Tinea Pedis","completionDate":"2011-07"},{"nctId":"NCT02713139","phase":"Phase 3","title":"Phase III, Multicenter, Randomized, Parallel, Open Label, Controlled and Comparative Study to Evaluate the Efficacy and Safety of the Association of Clotrimazole 200mg and Metronidazole 0,75% (Colpist","status":"WITHDRAWN","sponsor":"Ache Laboratorios Farmaceuticos S.A.","isPivotal":true,"enrollment":0,"indication":"Sexual Active Women, Vaginal Discharge","completionDate":""},{"nctId":"NCT06274554","phase":"Phase 3","title":"A Prospective, Randomized, Placebo-controlled Trial of Fluconazole in Combination With IL-23 Therapy Versus IL-23 Therapy Alone for the Treatment of Crohn's Disease","status":"RECRUITING","sponsor":"Weill Medical College of Cornell University","isPivotal":true,"enrollment":120,"indication":"Crohn's Disease, Inflammatory Bowel Diseases","completionDate":"2029-12"},{"nctId":"NCT06869681","phase":"Phase 4","title":"Comparison of Efficacy of Sertaconazole Nitrate Cream 2 Percent Vs Clotrimazole 1 Percent for the Treatment of Tinea Pedis.","status":"NOT_YET_RECRUITING","sponsor":"Jinnah Postgraduate Medical Centre","isPivotal":false,"enrollment":100,"indication":"Tinea Pedis","completionDate":"2025-06-15"},{"nctId":"NCT04869449","phase":"EARLY/Phase 1","title":"Neuro-pharmacological Properties of Repurposed Ketoconazole in Glioblastomas: A Phase 0 Clinical Trial","status":"TERMINATED","sponsor":"Milton S. Hershey Medical Center","isPivotal":false,"enrollment":1,"indication":"Glioblastoma, Glioblastoma Multiforme","completionDate":"2022-05-12"},{"nctId":"NCT04825275","phase":"EARLY/Phase 1","title":"Neuro-pharmacological Properties of Repurposed Posaconazole in Glioblastoma: A Phase 0 Clinical Trial","status":"TERMINATED","sponsor":"Milton S. Hershey Medical Center","isPivotal":false,"enrollment":7,"indication":"Glioblastoma, Glioblastoma Multiforme","completionDate":"2024-11-06"},{"nctId":"NCT01993823","phase":"Phase 3","title":"A Phase III, Multicenter, Randomized, Double-blind, Parallel Group, Active Treatment-controlled Study Assessing the Safety and Efficacy of G238 Compared to Clotrimazole 1% Otic Solution in Patients Wi","status":"COMPLETED","sponsor":"Salvat","isPivotal":true,"enrollment":190,"indication":"Otomycosis","completionDate":"2014-11"},{"nctId":"NCT02860845","phase":"Phase 4","title":"Multicenter Pilot Study to Compare the Efficacy of a Combination of Vaginal Capsules With Acid Boric, L.Gasseri and L.Rhamnosus Versus the Reference Medication in Patients With Vaginal Candidiasis or ","status":"COMPLETED","sponsor":"Laboratorios Ordesa","isPivotal":false,"enrollment":48,"indication":"Candidiasis, Vaginosis, Bacterial","completionDate":"2017-11-30"},{"nctId":"NCT03115073","phase":"Phase 2","title":"A Phase IIa Randomized, Active-controlled, Double-blind, Dose-escalation Study in Patients With Vulvovaginal Candidiasis to Evaluate Dose Response Relationship of Clinical Efficacy, Safety and Tolerab","status":"COMPLETED","sponsor":"ProFem GmbH","isPivotal":true,"enrollment":84,"indication":"Vulvovaginal Candidiasis (VVC)","completionDate":"2018-07-30"},{"nctId":"NCT00385502","phase":"Phase 2","title":"A Phase II Trial of the Safety, Local Tolerability, and Efficacy of EcoNail™ (Econazole 5%/SEPA® 18% Nail Lacquer) in Onychomycosis of the Great Toenail","status":"COMPLETED","sponsor":"Abeona Therapeutics, Inc","isPivotal":false,"enrollment":40,"indication":"Onychomycosis","completionDate":"2008-06"},{"nctId":"NCT06117904","phase":"NA","title":"Assessing the Effects and Safety of MEBO as Add on Therapy for the Prevention of Radiotherapy-Induced Mucositis","status":"COMPLETED","sponsor":"Beni-Suef University","isPivotal":false,"enrollment":60,"indication":"Radiotherapy Side Effect, Mucositis","completionDate":"2024-07-01"},{"nctId":"NCT01335373","phase":"N/A","title":"Observational Program Neo-Penotran® Forte","status":"COMPLETED","sponsor":"Bayer","isPivotal":false,"enrollment":13024,"indication":"Vaginal Candidiasis, Bacterial Vaginosis","completionDate":"2015-04"},{"nctId":"NCT00061282","phase":"Phase 1","title":"Clotrimazole Enemas for Pouchitis in Children and Adults","status":"TERMINATED","sponsor":"Web","isPivotal":false,"enrollment":11,"indication":"Ulcerative Colitis, Pouchitis","completionDate":"2020-12-01"},{"nctId":"NCT04432376","phase":"Phase 2","title":"Randomized, Double-blind, Phase III Study of the Efficacy and Safety of Miconazole Oil Versus Vehicle Oil in the Treatment of Otomycosis, Followed by an Open-label Safety Evaluation","status":"COMPLETED","sponsor":"Hill Dermaceuticals, Inc.","isPivotal":true,"enrollment":382,"indication":"Otomycosis","completionDate":"2021-11-01"},{"nctId":"NCT00842504","phase":"Phase 1","title":"Alternate Day Micafungin Anti-Fungal Prophylaxis in Immunocompromised Pediatric Patients: A Pharmacokinetic Study","status":"COMPLETED","sponsor":"Children's Hospital Medical Center, Cincinnati","isPivotal":false,"enrollment":15,"indication":"Fungal Infection","completionDate":"2009-12"},{"nctId":"NCT00361517","phase":"Phase 3","title":"Using Serum Galactomannan Levels in a Prospective, Randomised, Non-blinded Trial to Guide Early Anti-fungal Therapy in Haematology Patients at Risk of Invasive Aspergillosis.","status":"COMPLETED","sponsor":"Singapore General Hospital","isPivotal":true,"enrollment":47,"indication":"Aspergillosis","completionDate":"2009-06-30"},{"nctId":"NCT00004492","phase":"Phase 1","title":"","status":"COMPLETED","sponsor":"University of North Carolina","isPivotal":false,"enrollment":20,"indication":"Sickle Cell Anemia","completionDate":"2001-09"},{"nctId":"NCT00036166","phase":"Phase 2","title":"An Open-Label, Non-Comparative Study of FK463 for the Treatment of Invasive Aspergillosis","status":"COMPLETED","sponsor":"Astellas Pharma Inc","isPivotal":false,"enrollment":326,"indication":"Aspergillosis","completionDate":"2002-01-31"},{"nctId":"NCT00526227","phase":"NA","title":"Clinical Study to Evaluate System Safety and Clinical Performance of the SecuraTM ICD","status":"COMPLETED","sponsor":"Medtronic Cardiac Rhythm and Heart Failure","isPivotal":false,"enrollment":81,"indication":"Tachyarrhythmias","completionDate":"2008-10"},{"nctId":"NCT03005353","phase":"Phase 2","title":"Randomized Clinical Trial for Treatment of Candidal Vulvovaginitis Using Cumin Seed Extract Vaginal Suppositories.","status":"COMPLETED","sponsor":"Assiut University","isPivotal":true,"enrollment":100,"indication":"Infection, Fungal","completionDate":"2020-01-31"},{"nctId":"NCT06681090","phase":"Phase 1","title":"Effectiveness of Low-Level Laser Therapy and Topical Steroid Therapy in the Management of Oral Lichen Planus","status":"COMPLETED","sponsor":"Al-Azhar University","isPivotal":false,"enrollment":20,"indication":"Oral Lichen Planus","completionDate":"2023-10-29"},{"nctId":"NCT00835510","phase":"Phase 1","title":"A Randomized, Double-Blind, Placebo Controlled, Parallel Design, Multiple-Site Study to Evaluate the Clinical Equivalence of Two Butenafine Hydrochloride 1% Creams in Patients With Interdigital Tinea ","status":"COMPLETED","sponsor":"Sun Pharmaceutical Industries, Inc.","isPivotal":false,"enrollment":548,"indication":"Tinea Pedis","completionDate":"2008-12"},{"nctId":"NCT05129033","phase":"NA","title":"A Prospective, Two-center, Clinical Study to Optimize the Treatment for Allergic Bronchopulmonary Aspergillosis (ABPA)","status":"UNKNOWN","sponsor":"Shanghai Zhongshan Hospital","isPivotal":false,"enrollment":100,"indication":"Allergic Bronchopulmonary Aspergillosis","completionDate":"2023-12-30"},{"nctId":"NCT01580878","phase":"Phase 1","title":"A Double-Blind, Randomized, Parallel-Group, Vehicle-Controlled, Multicenter Study to Evaluate the Safety and Bioequivalence of a Generic Butenafine Hydrochloride Cream, 1% and Reference Listed Lotrimi","status":"COMPLETED","sponsor":"Sun Pharmaceutical Industries, Inc.","isPivotal":false,"enrollment":707,"indication":"Tinea Pedis","completionDate":"2012-12"},{"nctId":"NCT03583164","phase":"Phase 2","title":"Phase IIb Study of F901318 as Treatment of Invasive Fungal Infections Due to Lomentospora Prolificans, Scedosporium Spp., Aspergillus Spp., and Other Resistant Fungi in Patients Lacking Suitable Alter","status":"COMPLETED","sponsor":"F2G Biotech GmbH","isPivotal":false,"enrollment":203,"indication":"Invasive Fungal Infections","completionDate":"2023-02-10"},{"nctId":"NCT06146504","phase":"NA","title":"A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy of an Anti-Fungal Supplement","status":"COMPLETED","sponsor":"CanXida","isPivotal":false,"enrollment":60,"indication":"Candida Systemic, Candida Albicans Infection","completionDate":"2024-06-28"},{"nctId":"NCT02545452","phase":"Phase 1","title":"A Parallel Group, Randomized, Open-label Study to Investigate the Effect of the Intravaginally Administered Antimycotic Miconazole, Antibiotic Clindamycin, Spermicide Nonoxynol-9, or Co-usage of Tampo","status":"COMPLETED","sponsor":"Bayer","isPivotal":false,"enrollment":52,"indication":"Endometriosis","completionDate":"2016-07-29"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"administration":{"icon":"","route":"Topical","frequency":"Twice daily (topical) or five times daily (troche)","formulation":"Cream, Lotion, Powder, Vaginal cream, Troche"},"crossReferences":{"chemblId":"CHEMBL104"},"formularyStatus":[],"apiManufacturers":[],"developmentCodes":[],"ownershipHistory":[],"publicationCount":3070,"therapeuticAreas":["Infectious Disease"],"biosimilarFilings":[],"firstApprovalDate":"1975-01-01","companionDiagnostics":[],"firstApprovalCountry":"United States","genericManufacturerList":[],"modality":"Small molecule","enrichmentLevel":3,"visitCount":0,"regulatoryByCountry":[{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"1975-02-03T00:00:00.000Z","mah":"SCHERING PLOUGH","brand_name_local":"LOTRIMIN","application_number":"NDA017613"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"1975-03-18T00:00:00.000Z","mah":"SCHERING PLOUGH","brand_name_local":"LOTRIMIN","application_number":"NDA017619"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"1979-01-15T00:00:00.000Z","mah":"BAYER HLTHCARE","brand_name_local":"MYCELEX","application_number":"NDA018181"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"1979-01-15T00:00:00.000Z","mah":"BAYER HEALTHCARE LLC","brand_name_local":"MYCELEX","application_number":"NDA018183"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"1979-02-16T00:00:00.000Z","mah":"BAYER HEALTHCARE LLC","brand_name_local":"MYCELEX-7","application_number":"NDA018230"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"1979-02-27T00:00:00.000Z","mah":"BAYER HEALTHCARE LLC","brand_name_local":"MYCELEX-7","application_number":"NDA018182"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"1983-06-17T00:00:00.000Z","mah":"BAYER HLTHCARE","brand_name_local":"MYCELEX","application_number":"NDA018713"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"1984-02-17T00:00:00.000Z","mah":"SCHERING","brand_name_local":"LOTRIMIN","application_number":"NDA018813"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"1989-10-27T00:00:00.000Z","mah":"SCHERING PLOUGH","brand_name_local":"LOTRIMIN AF","application_number":"NDA020889"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"1989-10-27T00:00:00.000Z","mah":"SCHERING PLOUGH","brand_name_local":"LOTRIMIN AF","application_number":"NDA020888"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"1989-10-27T00:00:00.000Z","mah":"SCHERING PLOUGH","brand_name_local":"LOTRIMIN AF","application_number":"NDA020890"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"1993-07-16T00:00:00.000Z","mah":"P AND L","brand_name_local":"CLOTRIMAZOLE","application_number":"ANDA074165"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"1993-08-31T00:00:00.000Z","mah":"SUN PHARMA CANADA","brand_name_local":"CLOTRIMAZOLE","application_number":"ANDA072640"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"1994-06-23T00:00:00.000Z","mah":"BAYER HEALTHCARE LLC","brand_name_local":"MYCELEX-7 COMBINATION PACK","application_number":"NDA020389"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"1995-02-28T00:00:00.000Z","mah":"TEVA","brand_name_local":"CLOTRIMAZOLE","application_number":"ANDA073306"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"1995-12-04T00:00:00.000Z","mah":"SUN PHARMA CANADA","brand_name_local":"CLOTRIMAZOLE","application_number":"ANDA072641"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"1996-07-29T00:00:00.000Z","mah":"SUN PHARMA CANADA","brand_name_local":"CLOTRIMAZOLE","application_number":"ANDA074580"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"1996-07-29T00:00:00.000Z","mah":"BAYER HEALTHCARE LLC","brand_name_local":"GYNE-LOTRIMIN 3","application_number":"NDA020525"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"1996-07-29T00:00:00.000Z","mah":"BAYER HEALTHCARE LLC","brand_name_local":"GYNE-LOTRIMIN 3 COMBINATION PACK","application_number":"NDA020526"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2000-04-12T00:00:00.000Z","mah":"SUN PHARMA CANADA","brand_name_local":"TRIVAGIZOLE 3","application_number":"NDA021143"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2005-10-28T00:00:00.000Z","mah":"PADAGIS US","brand_name_local":"CLOTRIMAZOLE","application_number":"ANDA076763"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2008-09-02T00:00:00.000Z","mah":"FOUGERA PHARMS","brand_name_local":"CLOTRIMAZOLE","application_number":"ANDA078338"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2010-08-03T00:00:00.000Z","mah":"GLENMARK PHARMS","brand_name_local":"CLOTRIMAZOLE","application_number":"ANDA090219"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2019-02-15T00:00:00.000Z","mah":"NOVITIUM PHARMA","brand_name_local":null,"application_number":"ANDA209815"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2019-07-25T00:00:00.000Z","mah":"TP ANDA HOLDINGS","brand_name_local":null,"application_number":"ANDA212281"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2020-07-06T00:00:00.000Z","mah":"ACTAVIS MID ATLANTIC","brand_name_local":null,"application_number":"ANDA076002"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2020-07-06T00:00:00.000Z","mah":"TARO","brand_name_local":null,"application_number":"ANDA075673"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2023-10-16T00:00:00.000Z","mah":"SCIEGEN PHARMS","brand_name_local":"CLOTRIMAZOLE","application_number":"ANDA216569"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2024-02-29T00:00:00.000Z","mah":"THINQ PHARM-CRO PVT","brand_name_local":"CLOTRIMAZOLE","application_number":"ANDA215641"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2025-09-26T00:00:00.000Z","mah":"CARWIN PHARM ASSOC","brand_name_local":null,"application_number":"NDA217628"},{"country_code":"KR","regulator":"MFDS","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"KR","regulator":"MFDS","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"KR","regulator":"MFDS","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"KR","regulator":"MFDS","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AU","regulator":"TGA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AU","regulator":"TGA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AU","regulator":"TGA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AU","regulator":"TGA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AU","regulator":"TGA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"GB","regulator":"MHRA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"GB","regulator":"MHRA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"GB","regulator":"MHRA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"GB","regulator":"MHRA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":null,"mah":"BAYER PHARMS","brand_name_local":"MYCELEX-G","application_number":"NDA019069"},{"country_code":"GB","regulator":"MHRA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"CA","regulator":"Health Canada","status":"approved","approval_date":null,"mah":"","brand_name_local":"","application_number":""},{"country_code":"BR","regulator":"ANVISA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"MX","regulator":"COFEPRIS","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AR","regulator":"ANMAT","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"TR","regulator":"TITCK","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"IN","regulator":"CDSCO","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"TH","regulator":"FDA-TH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"MY","regulator":"NPRA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"PH","regulator":"FDA-PH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"CO","regulator":"INVIMA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"ZA","regulator":"SAHPRA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"TW","regulator":"TFDA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"HK","regulator":"DH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"IL","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"IL","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"IL","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"IL","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"IL","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"SG","regulator":"HSA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"SG","regulator":"HSA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"SG","regulator":"HSA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"SG","regulator":"HSA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"SG","regulator":"HSA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AE","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AE","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AE","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AE","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AE","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"KR","regulator":"MFDS","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null}],"patentsNormalised":[{"patent_number":"12246006","territory":"US","patent_type":"Formulation","expiry_date":"2042-05-26T00:00:00.000Z","status":"active","paragraph_iv_filed":false}],"regulatorySummaries":{"US_FDA_approval_20045":{"country_code":"US","agency":"FDA","entity_type":"approval","entity_id":"20045","summary_short":"The FDA granted marketing authorisation to CARWIN PHARM ASSOC's Lotrimin on 26 September 2025, under NDA217628, for a new dosage form.","summary_long":"The FDA approved Lotrimin, a product of CARWIN PHARM ASSOC, on 26 September 2025. The approval was granted under the new dosage form indication (Type 3) and was processed through the standard expedited pathway. This approval allows CARWIN PHARM ASSOC to market Lotrimin in the United States.","key_points":["Lotrimin was approved by the FDA on 26 September 2025.","The approval was granted under NDA217628 for a new dosage form (Type 3).","CARWIN PHARM ASSOC is the marketing authorisation holder."],"citations":[{"source":"https://api.fda.gov/drug/drugsfda.json?search=application_number:NDA217628"}],"generated_at":"2026-05-18T08:05:03.242Z"}},"trialStats":{"total":3,"withResults":0},"validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T00:07:31.825598+00:00","fieldsConflicting":1,"overallConfidence":0.8},"verificationStatus":"partial","dataCompleteness":{"mechanism":false,"indications":true,"safety":false,"trials":true,"score":2}}