{"id":"fexofenadine","rwe":[],"_fda":{"id":"46540fb6-3247-8ddd-e063-6394a90ae0cb","set_id":"00ef8467-30a0-7579-e063-6294a90a75af","openfda":{"unii":["2S068B75ZU"],"route":["ORAL"],"rxcui":["997420"],"spl_id":["46540fb6-3247-8ddd-e063-6394a90ae0cb"],"brand_name":["Fexofenadine HCL"],"spl_set_id":["00ef8467-30a0-7579-e063-6294a90a75af"],"package_ndc":["51316-767-03"],"product_ndc":["51316-767"],"generic_name":["FEXOFENADINE HCL"],"product_type":["HUMAN OTC DRUG"],"substance_name":["FEXOFENADINE HYDROCHLORIDE"],"manufacturer_name":["CVS"],"application_number":["ANDA211075"],"is_original_packager":[true]},"purpose":["Purpose Antihistamine"],"version":"5","stop_use":["Stop use and ask a doctor if  an allergic reaction to this product occurs. Seek medical help right away.  symptoms do not improve after 3 days of treatment  the hives have lasted more than 6 weeks"],"warnings":["Severe Allergy Warning: Get emergency help immediately if you have hives along with any of the following symptoms:  trouble swallowing  dizziness or loss of consciousness  swelling of tongue  swelling in or around mouth  trouble speaking  wheezing or problems breathing  drooling These symptoms may be signs of anaphylactic shock. This condition can be life threatening if not treated by a health professional immediately. Symptoms of anaphylactic shock may occur when hives first appear or up to a few hours later","Not a Substitute for Epinephrine. If your doctor has prescribed an epinephrine injector for “anaphylaxis” or severe allergy symptoms that could occur with your hives, never use this product as a substitute for the epinephrine injector. If you have been prescribed an epinephrine injector, you should carry it with you at all times."],"ask_doctor":["Ask a doctor before use if you have  kidney disease. Your doctor should determine if you need a different dose.  hives that are an unusual color, look bruised or blistered  hives that do not itch"],"do_not_use":["Do not use  to prevent hives from any known cause such as:  foods  insect stings  medicines  latex or rubber gloves because this product will not stop hives from occurring. Avoiding the cause of your hives is the only way to prevent them. Hives can sometimes be serious. If you do not know the cause of your hives, see your doctor for a medical exam. Your doctor may be able to help you find a cause.  if you have ever had an allergic reaction to this product or any of its ingredients"],"when_using":["When using this product  do not take more than directed  do not take at the same time as aluminum or magnesium antacids  do not take with fruit juices (see Directions)"],"effective_time":"20251219","active_ingredient":["Active ingredient (in each tablet) Fexofenadine HCl USP, 180 mg"],"inactive_ingredient":["Inactive ingredients colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, lactose monohydrate, macrogol, magnesium stearate, microcrystalline cellulose, pregelatinized starch, titanium dioxide."],"storage_and_handling":["Other information  safety sealed: do not use if foil printed with granules logo under bottle cap is opened or torn.  store between 20° and 25°C (68° and 77°F)  protect from excessive moisture"],"indications_and_usage":["Uses reduces hives and relieves itching due to hives (urticaria). This product will not prevent hives or an allergic skin reaction from occurring."],"dosage_and_administration":["Directions adults and children 12 years of age and over: take one 180 mg tablet with water every once a day; do not take more than 1 tablet in 24 hours children under 12 years of age: do not use adults 65 years of age and older: ask a doctor consumers with kidney disease: ask a doctor"],"spl_product_data_elements":["Fexofenadine HCL Fexofenadine HCL FERRIC OXIDE YELLOW CROSCARMELLOSE SODIUM FERROSOFERRIC OXIDE FERRIC OXIDE RED LACTOSE MONOHYDRATE MICROCRYSTALLINE CELLULOSE FEXOFENADINE HYDROCHLORIDE FEXOFENADINE HYPROMELLOSE 2910 (15 MPA.S) SILICON DIOXIDE TITANIUM DIOXIDE MAGNESIUM STEARATE STARCH, CORN POLYETHYLENE GLYCOL 6000 (peach) G6"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"keep_out_of_reach_of_children":["Keep out of reach of children In case of overdose, get medical help or contact a Poison Control Center right away."],"package_label_principal_display_panel":["Principal display panel 30ct"]},"tags":[],"phase":"marketed","safety":{"boxedWarnings":[],"safetySignals":[{"date":"","signal":"DRUG INEFFECTIVE","source":"FDA FAERS","actionTaken":"3947 reports"},{"date":"","signal":"FATIGUE","source":"FDA FAERS","actionTaken":"991 reports"},{"date":"","signal":"HEADACHE","source":"FDA FAERS","actionTaken":"991 reports"},{"date":"","signal":"NAUSEA","source":"FDA FAERS","actionTaken":"915 reports"},{"date":"","signal":"EXTRA DOSE ADMINISTERED","source":"FDA FAERS","actionTaken":"853 reports"},{"date":"","signal":"PRURITUS","source":"FDA FAERS","actionTaken":"843 reports"},{"date":"","signal":"NO ADVERSE EVENT","source":"FDA FAERS","actionTaken":"811 reports"},{"date":"","signal":"DIARRHOEA","source":"FDA FAERS","actionTaken":"805 reports"},{"date":"","signal":"DIZZINESS","source":"FDA FAERS","actionTaken":"767 reports"},{"date":"","signal":"DYSPNOEA","source":"FDA FAERS","actionTaken":"692 reports"}],"drugInteractions":[],"commonSideEffects":[],"contraindications":["Angle-closure glaucoma","Benign prostatic hyperplasia","Coronary arteriosclerosis","Diabetes mellitus","Hypertensive disorder","Hypertensive urgency","Hyperthyroidism","Kidney disease","Retention of urine"],"specialPopulations":{},"discontinuationRates":[],"seriousAdverseEvents":[]},"status":"approved","trials":["NCT00261079","NCT07487909","NCT00835276","NCT02966665","NCT01133483","NCT04534153","NCT06466421","NCT01469234","NCT00044824","NCT00647985","NCT00783146","NCT00783133","NCT00547768","NCT01033396","NCT01298505","NCT00636870","NCT00741897","NCT05932277","NCT04093531","NCT06548204","NCT01767272","NCT03078777","NCT01244230","NCT05131555","NCT02360644","NCT00435461","NCT03012763","NCT05804903","NCT00794248","NCT05263206","NCT04450134","NCT06785298","NCT03108274","NCT06284902","NCT00783211","NCT00044811","NCT00562120","NCT04527562","NCT00638118","NCT05820243","NCT00794768","NCT00637455","NCT01856348","NCT02908750","NCT03183297","NCT00637611","NCT00866788","NCT00649376","NCT03613246","NCT00637585"],"aliases":["Allegra","Telfast"],"patents":[],"pricing":[{"market":"United States","source":"CMS National Average Drug Acquisition Cost (NADAC)","asOfDate":"2024-01-03","unitCost":"$0.2392/EA","priceType":"NADAC","sourceUrl":"https://data.medicaid.gov/dataset/4j6z-xnwq","annualCost":"$87","description":"FEXOFENADINE HCL 180 MG TABLET","retrievedDate":"2026-04-07"}],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=fexofenadine","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T00:39:07.951850+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T00:39:13.546038+00:00"},"regulatory.us":{"url":"","method":"api_direct","source":"FDA Drugs@FDA","rawText":"","confidence":1,"sourceType":"fda_drugsfda","retrievedAt":"2026-04-20T00:39:07.050340+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=fexofenadine","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T00:39:13.796295+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:39:06.232475+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (no boxed warning)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:39:06.232501+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":"2026-04-20T00:39:15.269939+00:00"},"mechanism.target_chembl":{"url":"","method":"api_direct","source":"ChEMBL mechanism: Histamine H1 receptor antagonist","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T00:39:14.826498+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL1200618/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T00:39:14.495038+00:00"},"regulatory.fda_application":{"url":"","method":"deterministic","source":"FDA Label","rawText":"ANDA211075","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:39:06.232505+00:00"}},"allNames":"allegra","offLabel":[],"timeline":[],"aiSummary":"Fexofenadine (Allegra) is the least sedating antihistamine available, approved in 1996 as the safe successor to terfenadine. Available OTC and generically worldwide.","brandName":"Allegra","companyId":"unknown","ecosystem":[],"mechanism":{"target":"Solute carrier organic anion transporter family member 1A2, Multidrug resistance protein 1, Histamine H1 receptor","novelty":"","modality":"Small molecule","drugClass":"Second-generation antihistamine","explanation":"","oneSentence":"","technicalDetail":""},"commercial":null,"references":[],"_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T00:39:16.556324+00:00","fieldsConflicting":1,"overallConfidence":0.8},"biosimilars":[],"companyName":"Generic (originally Hoechst Marion Roussel/Sanofi)","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":"fexofenadine","indications":{"approved":[{"name":"Allergic conjunctivitis","diseaseId":"allergic-conjunctivitis","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Allergic rhinitis","diseaseId":"allergic-rhinitis","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Chronic idiopathic urticaria","diseaseId":"chronic-idiopathic-urticaria","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Seasonal allergic rhinitis","diseaseId":"seasonal-allergic-rhinitis","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Sneezing","diseaseId":"sneezing","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"}],"offLabel":[],"pipeline":[]},"labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT00261079","phase":"Phase 4","title":"The Evaluation of Efficacy and Safety of Fexofenadine 180mg Tablets for 7 Days in the Treatment of Pruritic Skin Disease","status":"COMPLETED","sponsor":"Handok Inc.","isPivotal":false,"enrollment":435,"indication":"Pruritus","completionDate":"2006-10"},{"nctId":"NCT07487909","phase":"Phase 1","title":"A Double-Blind, Placebo-Controlled, 4-Way Crossover Study to Evaluate the Pharmacokinetics and Pharmacodynamics at Two Dose Levels of SJP-001 in Comparison With Fexofenadine and Naproxen Administered ","status":"COMPLETED","sponsor":"Sen-Jam Pharmaceutical","isPivotal":false,"enrollment":47,"indication":"Healthy","completionDate":"2025-11-21"},{"nctId":"NCT00835276","phase":"Phase 1","title":"A Relative Bioavailability Study of 180 mg Fexofenadine Hydrochloride Tablets Under Fasting Conditions.","status":"COMPLETED","sponsor":"Teva Pharmaceuticals USA","isPivotal":false,"enrollment":60,"indication":"Healthy","completionDate":"2002-03"},{"nctId":"NCT02966665","phase":"Phase 1","title":"Vascular Function in Health & Disease: Rehabilitation for Hypertension; Exercise and Skeletal Muscle Afferent Feedback","status":"RECRUITING","sponsor":"Russell Richardson","isPivotal":false,"enrollment":420,"indication":"Chronic Obstructive Pulmonary Disease, Pulmonary Artery Hypertension","completionDate":"2026-08"},{"nctId":"NCT01133483","phase":"Phase 1","title":"An Open Label, Balanced, Randomized, Two-way, Single Dose, Crossover Bioequivalence Study of Fexofenadine HCl 180 mg + Pseudoephedrine HCl 240 mg ER Tabs of Dr. Reddy's and Allegra-D 24 hr ER Tabs of ","status":"COMPLETED","sponsor":"Dr. Reddy's Laboratories Limited","isPivotal":false,"enrollment":38,"indication":"Healthy","completionDate":"2007-05"},{"nctId":"NCT04534153","phase":"EARLY/Phase 1","title":"The Effect of Sodium Lauryl Sulfate on the Oral Absorption of Fexofenadine in Humans","status":"COMPLETED","sponsor":"University of California, San Francisco","isPivotal":false,"enrollment":12,"indication":"The Impact of Excipients on Drug Absorption","completionDate":"2025-08-18"},{"nctId":"NCT06466421","phase":"Phase 4","title":"Clinical Study to Compare The Safety and Possible Efficacy of Fexofenadine Versus Gabapentin for Uremic Pruritus in Patients on Regular Hemodialysis","status":"COMPLETED","sponsor":"Tanta University","isPivotal":false,"enrollment":60,"indication":"Uremic Pruritus, Chronic Kidney Disease-associated Pruritus","completionDate":"2024-12-20"},{"nctId":"NCT01469234","phase":"Phase 4","title":"A Double-Blind, Parallel, Randomized, Placebo Controlled Trial to Evaluate Onset of Action of Loratadine and Fexofenadine in Subjects With Seasonal Allergic Rhinitis in a Pollen Challenge Chamber","status":"COMPLETED","sponsor":"Bayer","isPivotal":false,"enrollment":255,"indication":"Rhinitis","completionDate":"2011-11"},{"nctId":"NCT00044824","phase":"Phase 3","title":"A Multicenter, Double-Blind, Randomized, Parallel Groups Placebo-Controlled Study to Assess the Efficacy and Safety of Fexofenadine 120mg BID in Subjects With Mild to Moderate Persistent Asthma","status":"COMPLETED","sponsor":"Sanofi","isPivotal":true,"enrollment":1000,"indication":"Asthma","completionDate":"2003-10"},{"nctId":"NCT00647985","phase":"Phase 1","title":"Single-Dose Food In Vivo Bioequivalence Study of Fexofenadine Tablets (180 mg; Mylan) and Allegra® Tablets (180 mg; Aventis) in Healthy Adult Volunteers","status":"COMPLETED","sponsor":"Mylan Pharmaceuticals Inc","isPivotal":false,"enrollment":28,"indication":"Healthy","completionDate":"2003-11"},{"nctId":"NCT00783146","phase":"Phase 4","title":"A Placebo Controlled Study of the Efficacy and Safety of Desloratadine vs. Fexofenadine 180 mg. in the Treatment of Subjects With Symptomatic Seasonal Allergic Rhinitis (SAR)","status":"COMPLETED","sponsor":"Organon and Co","isPivotal":false,"enrollment":728,"indication":"Seasonal Allergic Rhinitis","completionDate":"2004-10-01"},{"nctId":"NCT00783133","phase":"Phase 4","title":"Preference Evaluation of Clarinex Tablets vs. Allegra Tablets in Subjects With Symptomatic Seasonal Allergic Rhinitis","status":"COMPLETED","sponsor":"Organon and Co","isPivotal":false,"enrollment":131,"indication":"Seasonal Allergic Rhinitis","completionDate":"2003-06-01"},{"nctId":"NCT00547768","phase":"Phase 4","title":"","status":"COMPLETED","sponsor":"Sanofi","isPivotal":false,"enrollment":36,"indication":"Allergy","completionDate":"2002-12"},{"nctId":"NCT01033396","phase":"Phase 2","title":"A Randomized, Double Blind, Placebo Controlled, Four Way Crossover Study To Determine The Effects Of PF-03654764 +/- Allegra (Fexofenadine) On Symptoms Of Allergic Rhinitis In Subjects Exposed To Ragw","status":"COMPLETED","sponsor":"Pfizer","isPivotal":false,"enrollment":64,"indication":"Allergic Rhinitis","completionDate":"2010-05"},{"nctId":"NCT01298505","phase":"Phase 1","title":"A Phase 1 Double-blind (3rd Party Open), Randomized, Placebo-controlled Study To Investigate The Safety And Toleration Of Multiple Oral Doses Of Pf-03654764 In Combination With Fexofenadine In Healthy","status":"TERMINATED","sponsor":"Pfizer","isPivotal":false,"enrollment":36,"indication":"Healthy","completionDate":"2010-06-04"},{"nctId":"NCT00636870","phase":"Phase 4","title":"A Randomized, Double-blind, Repeat-dose, Crossover Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Desloratadine (Clarinex®) Compared to Fexofenadine (Allegra®) in Healthy Adults W","status":"COMPLETED","sponsor":"Sanofi","isPivotal":false,"enrollment":220,"indication":"Allergic Rhinitis","completionDate":"2004-01"},{"nctId":"NCT00741897","phase":"Phase 4","title":"A Monitored Release Study On The Efficacy And Safety of Fexofenadine (Telfast®) 30mg Pediatric Tablets On Filipino Children Aged 6 To 11 for The Relief of Perennial And Intermittent Allergic Rhinitis.","status":"COMPLETED","sponsor":"Sanofi","isPivotal":false,"enrollment":264,"indication":"Rhinitis, Allergic, Perennial","completionDate":""},{"nctId":"NCT05932277","phase":"Phase 1","title":"A Phase 1 Open-label Study to Assess the Effect of BMS-986419 on the Single Dose Pharmacokinetics of Probe Substrates (Caffeine, Bupropion, Flurbiprofen, Omeprazole, Midazolam, and Fexofenadine) in He","status":"COMPLETED","sponsor":"Bristol-Myers Squibb","isPivotal":false,"enrollment":22,"indication":"Healthy Volunteers","completionDate":"2023-09-13"},{"nctId":"NCT04093531","phase":"Phase 1","title":"Pilot Trial of Ustekinumab for Primary Sjögren's Syndrome","status":"COMPLETED","sponsor":"University of Rochester","isPivotal":false,"enrollment":12,"indication":"Primary Sjögren Syndrome","completionDate":"2022-05-11"},{"nctId":"NCT06548204","phase":"Phase 2","title":"Effect and Safety of Fexofenadine Hydrochloride vs Placebo in Patients With Acute Myocardial Infaction: A Randomized Clinical Trial","status":"NOT_YET_RECRUITING","sponsor":"Second Affiliated Hospital, School of Medicine, Zhejiang University","isPivotal":false,"enrollment":165,"indication":"ST-segment Elevation Myocardial Infarction (STEMI)","completionDate":"2026-09"},{"nctId":"NCT01767272","phase":"NA","title":"Dose Proportionality of Fexofenadine","status":"COMPLETED","sponsor":"Damanhour University","isPivotal":false,"enrollment":25,"indication":"Healthy","completionDate":"2013-01"},{"nctId":"NCT03078777","phase":"Phase 4","title":"The Effect Dialysis on the Pharmacokinetics of Fexofenadine","status":"UNKNOWN","sponsor":"London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's","isPivotal":false,"enrollment":30,"indication":"Hemodialysis","completionDate":"2020-08"},{"nctId":"NCT01244230","phase":"Phase 2","title":"An Open-label, Uncontrolled 4-week Study to Assess the Safety, Efficacy and Pharmacokinetics of Allegra® (Dry Syrup Formulation) 15 mg or 30 mg Twice Daily in Pediatric Patients With Atopic Dermatitis","status":"COMPLETED","sponsor":"Sanofi","isPivotal":true,"enrollment":100,"indication":"Atopic Dermatitis","completionDate":"2011-08"},{"nctId":"NCT05131555","phase":"NA","title":"Influence of Endurance Training and Histamine Receptor Antagonists on the Transcriptome Response in Human Muscle","status":"COMPLETED","sponsor":"University Ghent","isPivotal":false,"enrollment":14,"indication":"Exercise, Histamine","completionDate":"2021-12-31"},{"nctId":"NCT02360644","phase":"NA","title":"Drug Metabolizing Enzyme and Transporter Function in Chronic Kidney Disease","status":"COMPLETED","sponsor":"University of Colorado, Denver","isPivotal":false,"enrollment":23,"indication":"Chronic Kidney Diseases, Deficiency, Vitamin D","completionDate":"2019-02-01"},{"nctId":"NCT00435461","phase":"Phase 4","title":"A Comparison of Fluticasone Furoate Nasal Spray Versus Oral Fexofenadine in the Treatment of Seasonal Allergic Rhinitis","status":"COMPLETED","sponsor":"GlaxoSmithKline","isPivotal":false,"enrollment":1000,"indication":"Rhinitis, Allergic, Seasonal","completionDate":"2007-02-28"},{"nctId":"NCT03012763","phase":"Phase 1","title":"Pharmacokinetics of Sulfasalazine, Paracetamol, Fexofenadine and Valsartan After Oral Administration Using 240 ml Non-caloric Water, a Carbohydrate Enriched Drink and Grapefruit Juice in Correlation t","status":"COMPLETED","sponsor":"University Medicine Greifswald","isPivotal":false,"enrollment":9,"indication":"Pharmacokinetics, Magnetic Resonance Imaging","completionDate":""},{"nctId":"NCT05804903","phase":"NA","title":"InvEstigation of the Safety and Performance of the NVT ALLEGRA Plus THV SysteM in Patients With Severe aortIc Stenosis or Failed suRgical Aortic bioprosthEsis","status":"SUSPENDED","sponsor":"NVT GmbH","isPivotal":false,"enrollment":177,"indication":"Transcatheter Aortic Valve Implantation","completionDate":"2030-08-01"},{"nctId":"NCT00794248","phase":"Phase 4","title":"Preference Evaluation of Clarinex Tablets vs. Allegra Tablets in Subjects With Symptomatic Seasonal Allergic Rhinitis","status":"COMPLETED","sponsor":"Organon and Co","isPivotal":false,"enrollment":122,"indication":"Seasonal Allergic Rhinitis","completionDate":"2003-05"},{"nctId":"NCT05263206","phase":"Phase 3","title":"Master Protocol of Two Randomized, Double Blind, Placebo-controlled, Multi-center, Parallel Group Studies to Evaluate the Efficacy and Safety of Dupilumab in Adult Patients With Chronic Pruritus of Un","status":"RECRUITING","sponsor":"Sanofi","isPivotal":true,"enrollment":284,"indication":"Pruritus","completionDate":"2027-08-25"},{"nctId":"NCT04450134","phase":"NA","title":"Role of Histamine H1/H2 Receptors in the Health- and Performance-promoting Adaptations to High-intensity Interval Training","status":"COMPLETED","sponsor":"University Ghent","isPivotal":false,"enrollment":19,"indication":"Exercise Training, Physical Activity","completionDate":"2021-04-14"},{"nctId":"NCT06785298","phase":"Phase 2","title":"Clinical Study to Evaluate the Possible Efficacy and Safety of Fexofenadine in Patients With Parkinson's Disease Treated With Conventional Treatment","status":"RECRUITING","sponsor":"Tanta University","isPivotal":true,"enrollment":46,"indication":"Parkinson Disease","completionDate":"2026-12-20"},{"nctId":"NCT03108274","phase":"Phase 1","title":"A Three-Part Phase 1 Study to Determine the Potential Drug Interaction Between ACH-0144471 and Midazolam, Fexofenadine and Mycophenolate Mofetil in Healthy Subjects","status":"COMPLETED","sponsor":"Alexion Pharmaceuticals, Inc.","isPivotal":false,"enrollment":35,"indication":"Healthy","completionDate":"2017-06-16"},{"nctId":"NCT06284902","phase":"Phase 1","title":"Open-Label, Single-Dose, Randomized, 6-Treatment, 6-Sequence, 6-Period Crossover Relative Bioavailability Study Comparing Fexofenadine HCl New Formulation Tablets (Test Drug) With or Without Water to ","status":"COMPLETED","sponsor":"Opella Healthcare Group SAS, a Sanofi Company","isPivotal":false,"enrollment":25,"indication":"Healthy Volunteers","completionDate":"2024-05-23"},{"nctId":"NCT00783211","phase":"Phase 4","title":"A Placebo Controlled Study of the Efficacy and Safety of Desloratadine vs. Fexofenadine 180 mg. in the Treatment of Subjects With Symptomatic Seasonal Allergic Rhinitis (SAR)","status":"COMPLETED","sponsor":"Organon and Co","isPivotal":false,"enrollment":722,"indication":"Seasonal Allergic Rhinitis","completionDate":"2004-10-01"},{"nctId":"NCT00044811","phase":"Phase 3","title":"A Multicenter, Double-Blind, Randomized, Parallel Groups Placebo-Controlled Study to Assess the Efficacy and Safety of Fexofenadine 120mg BID in Subjects With Mild to Moderate Persistent Asthma","status":"COMPLETED","sponsor":"Sanofi","isPivotal":true,"enrollment":1000,"indication":"Asthma","completionDate":"2003-10"},{"nctId":"NCT00562120","phase":"Phase 2","title":"A Randomized, Double Blind, Double Dummy, Placebo Controlled, Four Way Crossover Study To Determine The Effects Of An H3 Receptor Antagonist (PF-03654746) On Congestion Following A Nasal Allergen Chal","status":"COMPLETED","sponsor":"Pfizer","isPivotal":false,"enrollment":21,"indication":"Allergic Rhinitis","completionDate":"2008-08"},{"nctId":"NCT04527562","phase":"NA","title":"Colchicine in Moderate Symptomatic COVID-19 Patients: Double Blind, Randomized, Placebo Controlled Trial to Observe the Efficacy","status":"COMPLETED","sponsor":"Dhaka Medical College","isPivotal":false,"enrollment":299,"indication":"Covid19","completionDate":"2020-12-10"},{"nctId":"NCT00638118","phase":"Phase 4","title":"A Comparison of Fexofenadine HCl 180 mg, Montelukast Sodium 10 mg and Placebo in Suppression of Wheal and Flare Induced by Seasonal Allergen","status":"COMPLETED","sponsor":"Sanofi","isPivotal":false,"enrollment":48,"indication":"Allergic Rhinitis","completionDate":"2003-05"},{"nctId":"NCT05820243","phase":"NA","title":"Determinants of Changes in Arterial Load Following Exercise","status":"UNKNOWN","sponsor":"University of Delaware","isPivotal":false,"enrollment":25,"indication":"Post-Exercise Hypotension","completionDate":"2024-09"},{"nctId":"NCT00794768","phase":"Phase 4","title":"Preference Evaluation of Clarinex Tablets vs. Allegra Tablets in Subjects With Symptomatic Seasonal Allergic Rhinitis","status":"COMPLETED","sponsor":"Organon and Co","isPivotal":false,"enrollment":118,"indication":"Seasonal Allergic Rhinitis","completionDate":"2003-07"},{"nctId":"NCT00637455","phase":"Phase 4","title":"Single Center, Randomized,Double-Blind,Crossover Study Comparing the Effects of Single-Dose Fexofenadine HCl 180 mg, Cetirizine 10 mg, and Placebo on Cognitive Performance in Naval Flight Personnel","status":"COMPLETED","sponsor":"Sanofi","isPivotal":false,"enrollment":72,"indication":"Seasonal Allergic Rhinitis","completionDate":"2005-01"},{"nctId":"NCT01856348","phase":"Phase 1","title":"Effects of Vitamin D3 (1,25 Dihydroxyvitamin D3) on Pharmacokinetics and Absorption of Folic Acid and Fexofenadine in Healthy Volunteers","status":"COMPLETED","sponsor":"University of Zurich","isPivotal":false,"enrollment":10,"indication":"Physiological Effects of Vitamin D","completionDate":"2013-07"},{"nctId":"NCT02908750","phase":"Phase 1","title":"An Open-label, Non-randomised, Phase I Study to Assess the Effect of Single and Multiple Oral Doses of Osimertinib (TAGRISSO™) on the Pharmacokinetics of a P-glycoprotein Probe Drug (Fexofenadine) in ","status":"COMPLETED","sponsor":"AstraZeneca","isPivotal":false,"enrollment":24,"indication":"Non Small Cell Lung Cancer","completionDate":"2022-10-11"},{"nctId":"NCT03183297","phase":"Phase 1","title":"A Double-Blind, Placebo-Controlled, 4-Way Crossover Study to Evaluate the Pharmacokinetics and Pharmacodynamics at Two Dose Levels of JMI-001 in Comparison With Fexofenadine and Naproxen Administered ","status":"UNKNOWN","sponsor":"Sen-Jam Pharmaceutical","isPivotal":false,"enrollment":48,"indication":"Veisalgia","completionDate":"2017-12"},{"nctId":"NCT00637611","phase":"Phase 4","title":"Single-Center, Double-Blind, Randomized , Parallel Study Comparing Onset of Action, Efficacy & Safety of a Single-Dose of Fexofenadine HCl 180 mg vs Montelukast Na 10 mg & Placebo in Treating Seasonal","status":"COMPLETED","sponsor":"Sanofi","isPivotal":false,"enrollment":1010,"indication":"Seasonal Allergic Rhinitis","completionDate":"2003-04"},{"nctId":"NCT00866788","phase":"Phase 2","title":"A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study of Xolair (Omalizumab) in Patients With Chronic Idiopathic Urticaria (CIU) Who Remain Symptomatic With Antihist","status":"COMPLETED","sponsor":"Genentech, Inc.","isPivotal":false,"enrollment":90,"indication":"Chronic Idiopathic Urticaria","completionDate":"2010-01"},{"nctId":"NCT00649376","phase":"Phase 1","title":"Single-Dose Fasting In Vivo Bioequivalence Study of Fexofenadine Tablets (180 mg; Mylan) and Allegra® Tablets (180 mg; Aventis) in Healthy Adult Volunteers","status":"COMPLETED","sponsor":"Mylan Pharmaceuticals Inc","isPivotal":false,"enrollment":68,"indication":"Healthy","completionDate":"2003-11"},{"nctId":"NCT03613246","phase":"N/A","title":"Clinical Outcomes of the NVT ALLEGRA TAVI System TF in Failing Calcified Aortic Heart Valves in a Real-world Patient Population With Elevated Surgical Risk","status":"ACTIVE_NOT_RECRUITING","sponsor":"NVT GmbH","isPivotal":false,"enrollment":346,"indication":"Transcatheter Aortic Valve Implantation","completionDate":"2029-01-26"},{"nctId":"NCT00637585","phase":"Phase 4","title":"A Comparison of Fexofenadine HCl 180 mg, Desloratadine 5 mg and Placebo in Suppression of Wheal and Flare Induced by Histamine","status":"COMPLETED","sponsor":"Sanofi","isPivotal":false,"enrollment":42,"indication":"Allergic Rhinitis","completionDate":"2003-07"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"administration":{"icon":"","route":"Oral","frequency":"Once or twice daily","formulation":"Tablet, Orally disintegrating tablet, Oral suspension"},"crossReferences":{"chemblId":"CHEMBL1200618"},"formularyStatus":[],"apiManufacturers":[],"developmentCodes":[],"ownershipHistory":[],"publicationCount":1121,"therapeuticAreas":["Metabolic"],"biosimilarFilings":[],"firstApprovalDate":"1996-07-25","companionDiagnostics":[],"firstApprovalCountry":"United States","genericManufacturerList":[],"modality":"Small molecule","enrichmentLevel":3,"visitCount":0,"regulatoryByCountry":[{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2015-09-16T00:00:00.000Z","mah":"SCIEGEN PHARMS","brand_name_local":null,"application_number":"ANDA204507"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2016-08-19T00:00:00.000Z","mah":"HETERO LABS LTD V","brand_name_local":null,"application_number":"ANDA204097"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2017-10-30T00:00:00.000Z","mah":"AUROBINDO PHARMA","brand_name_local":null,"application_number":"ANDA209116"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2018-08-13T00:00:00.000Z","mah":"UNIQUE","brand_name_local":null,"application_number":"ANDA210137"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2022-05-31T00:00:00.000Z","mah":"DR REDDYS","brand_name_local":null,"application_number":"ANDA215434"},{"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},{"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":"CA","regulator":"Health Canada","status":"approved","approval_date":null,"mah":"","brand_name_local":"","application_number":""},{"country_code":"GB","regulator":"MHRA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"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}],"pricingByCountry":[{"country_code":"Un","currency":"USD","price_amount":"87.00","price_per":"year","price_type":"NADAC","annual_cost_usd":null,"reimbursement_status":null}],"trialStats":{"total":12,"withResults":3},"validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T00:39:16.556324+00:00","fieldsConflicting":1,"overallConfidence":0.8},"verificationStatus":"partial","dataCompleteness":{"mechanism":false,"indications":true,"safety":false,"trials":true,"score":2}}