{"id":"mometasone","rwe":[],"tags":[],"phase":"discontinued","safety":{"boxedWarnings":[],"drugInteractions":["7 DRUG INTERACTIONS No formal drug-drug interaction studies have been conducted with mometasone furoate nasal spray. Inhibitors of Cytochrome P450 3A4: Studies have shown that mometasone furoate is primarily and extensively metabolized in the liver of all species investigated and undergoes extensive metabolism to multiple metabolites. In vitro studies have confirmed the primary role of cytochrome CYP3A4 in the metabolism of this compound. Concomitant administration of CYP3A4 inhibitors may inhibit the metabolism of, and increase the systemic exposure to, mometasone furoate and potentially increase the risk for systemic corticosteroid side effects. Caution should be exercised when considering the co-administration of mometasone furoate nasal spray with long-term ketoconazole and other known strong CYP3A4 inhibitors (e.g., ritonavir, cobicistat-containing products, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, telithromycin) [see Clinical Pharmacology (12.3) ] . Consider the benefit of co-administration versus the potential risk of systemic corticosteroid effects, in which case patients should be monitored for systemic corticosteroid side effects."],"commonSideEffects":["6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in labeling: Epistaxis, Ulcerations, Candida albicans Infection, Impaired Wound Healing [see Warnings and Precautions (5.1) ] Glaucoma and Cataracts [see Warnings and Precautions (5.2) ] Immunosuppression and Risk of Infections [see Warnings and Precautions (5.4) ] Hypercorticism and Adrenal Suppression, including Growth Reduction [see Warnings and Precautions (5.5, 5.6) , Use in Specific Populations (8.4) ] The most common adverse reactions (incidence ≥ 5%) included headache, viral infection, pharyngitis, epistaxis and cough. (6) To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Allergic Rhinitis Adults and pediatric patients 12 years of age and older In controlled U.S. and international clinical studies, a total of 3,210 adult and pediatric patients 12 years and older with allergic rhinitis received treatment with mometasone furoate nasal spray at doses of 50 mcg/day to 800 mcg/day. The majority of patients (n = 2,103) were treated with 200 mcg/day. A total of 350 adult and pediatric patients 12 years and older have been treated for one year or longer. Adverse reactions did not differ significantly based on age, sex, or race. Four percent or less of patients in clinical trials discontinued treatment because of adverse events and the discontinuation rate was similar for the vehicle and active comparators. All adverse reactions (regardless of relationship to treatment) reported by 5% or more of adult and pediatric patients ages 12 years and older who received mometasone furoate nasal spray, 200 mcg/day vs. placebo and that were more common with mometasone furoate nasal spray than placebo, are displayed in Table 1 below. Table 1: Adult and Pediatric Patients 12 Years and Older – Adverse Reactions from Controlled Clinical Trials in Seasonal Allergic and Perennial Allergic Rhinitis (Percent of Patients Reporting) MOMETASONE FUROATE 200 mcg (n=2103) % VEHICLE PLACEBO (n=1671) % Headache 26 22 Viral Infection 14 11 Pharyngitis 12 10 Epistaxis/Blood-Tinged Mucus 11 6 Coughing 7 6 Upper Respiratory Tract Infection 6 2 Dysmenorrhea 5 3 Musculoskeletal Pain 5 3 Sinusitis 5 3 Other adverse reactions which occurred in less than 5% but greater than or equal to 2% of adult and pediatric patients (ages 12 years and older) treated with mometasone furoate nasal spray, 200-mcg/day (regardless of relationship to treatment), and more frequently than in the placebo group included: arthralgia, asthma, bronchitis, chest pain, conjunctivitis, diarrhea, dyspepsia, earache, flu-like symptoms, myalgia, nausea, and rhinitis. Chronic Rhinosinusitis with Nasal Polyps Adults 18 years of age and older In controlled clinical studies, the types of adverse reactions observed in patients with chronic rhinosinusitis with nasal polyps were similar to those observed in patients with allergic rhinitis. A total of 594 adult patients (ages 18 to 86 years) received mometasone furoate nasal spray at doses of 200 mcg once or twice daily for up to 4 months for treatment of chronic rhinosinusitis with nasal polyps. The overall incidence of adverse reactions for patients treated with mometasone furoate nasal spray was comparable to patients with the placebo except for epistaxis, which was 9% for 200 mcg once daily, 13% for 200 mcg twice daily, and 5% for the placebo. Nasal ulcers and nasal and oral candidiasis were also reported in patients treated with mometasone furoate nasal spray primarily in patients treated for longer than 4 weeks. 6.2 Post-Marketing Experience The following adverse reactions "],"contraindications":["Acute tuberculosis","Adrenal cortical hypofunction","Asthenia","Atrophoderma","Bacterial infectious disease","Bilateral cataracts","Chronic myocardial ischemia","Conduction disorder of the heart","Congenital long QT syndrome","Denuded skin","Diabetes mellitus","Disease caused by parasite","Disease of liver","Epistaxis","Exacerbation of asthma","Fissure in skin","Glaucoma","Hypertensive disorder","Hypokalemia","Hypopituitarism","Immunosuppression","Inactive tuberculosis","Measles","Mycosis","Nasal Candidiasis","Nasal Septal Ulcers","Nasal Trauma","Ocular hypertension","Operation on nose","Ophthalmic herpes simplex","Osteopenia","Osteoporosis","Perforation of nasal septum","Peripheral vascular disease","Prolonged QT interval","Seizure disorder","Skin irritation","Skin ulcer","Telangiectasia disorder","Thyrotoxicosis","Uncontrolled Bacterial Infections","Untreated Fungal Infection","Varicella","Varicella-zoster virus infection"]},"status":"discontinued","trials":["NCT06834360","NCT02228720","NCT01850823","NCT00817817","NCT01372865","NCT01720797","NCT02892344","NCT00378378","NCT04499235","NCT05040828","NCT00424008","NCT00779740","NCT02154334","NCT01253577","NCT03879772","NCT03652454","NCT00383240","NCT02973776","NCT04532736","NCT07286201","NCT02565212","NCT06483477","NCT05912192","NCT06068270","NCT04127578","NCT01347060","NCT01210170","NCT02953379","NCT04851964","NCT05293119","NCT00521599","NCT03036735","NCT04892758","NCT02061202","NCT06200766","NCT00687531","NCT02318303","NCT07174115","NCT05145010","NCT06636240","NCT06269523","NCT07016763","NCT03444506","NCT00805155","NCT02397915","NCT00576069","NCT04670653","NCT02953366","NCT02495064","NCT00941798"],"aliases":[],"patents":[],"pricing":[],"offLabel":[],"timeline":[],"aiSummary":"","brandName":"MOMETASONE","companyId":"unknown","ecosystem":[],"mechanism":{"target":"Multidrug resistance protein 1, Glucocorticoid receptor, Progesterone receptor","drugClass":"","explanation":"1 INDICATIONS AND USAGE Mometasone furoate nasal spray is a corticosteroid indicated for: Prophylaxis of Nasal Symptoms of Seasonal Allergic Rhinitis in adult and pediatric patients 12 years of age and older ( 1.1 ) Treatment of Chronic Rhinosinusitis with Nasal Polyps in adult patients 18 years of age and older ( 1.2 ) 1.1 Prophylaxis of Seasonal Allergic Rhinitis Mometasone furoate nasal spray 50 mcg is indicated for the prophylaxis of the nasal symptoms of seasonal allergic rhinitis in adult and pediatric patients 12 years and older. 1.2 Treatment of Chronic Rhinosinusitis with Nasal Polyps Mometasone furoate nasal spray 50 mcg is indicated for the treatment of chronic rhinosinusitis with nasal polyps in adult patients 18 years of age and older.","oneSentence":"12.1 Mechanism of Action Mometasone furoate nasal spray is a corticosteroid demonstrating potent anti-inflammatory properties. The precise mechanism of corticosteroid action on allergic rhinitis is not known. Corticosteroids have been shown to have a wide range of effects on multiple cell types (e.g., mast cells, eosinophils, neutrophils, macrophages, and lymphocytes) and mediators (e.g., histamine, eicosanoids, leukotrienes, and cytokines) involved in inflammation. In two clinical studies utilizing nasal antigen challenge, mometasone furoate nasal spray decreased some markers of the early- and late-phase allergic response. These observations included decreases (vs. placebo) in histamine and eosinophil cationic protein levels, and reductions (vs. baseline) in eosinophils, neutrophils, and epithelial cell adhesion proteins. The clinical significance of these findings is not known. The effect of mometasone furoate nasal spray on nasal mucosa following 12 months of treatment was examined in 46 patients with allergic rhinitis. There was no evidence of atrophy and there was a marked reduction in intraepithelial eosinophilia and inflammatory cell infiltration (e.g., eosinophils, lymphocytes, monocytes, neutrophils, and plasma cells)."},"commercial":null,"references":[],"biosimilars":[],"companyName":"","competitors":[],"dataSources":[{"url":"https://clinicaltrials.gov","name":"ClinicalTrials.gov","fields":["trialDetails","trials"],"retrievedDate":"2026-04-07"},{"url":"https://drugcentral.org","name":"DrugCentral","fields":["indications","contraindications","safety","target","drugInteractions"],"retrievedDate":"2026-04-07"}],"genericName":"MOMETASONE","indications":{"approved":[{"name":"Allergic Rhinitis Prevention","diseaseId":"allergic-rhinitis-prevention","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Allergic asthma","diseaseId":"allergic-asthma","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Allergic rhinitis","diseaseId":"allergic-rhinitis","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Asthma","diseaseId":"asthma","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Asthma management","diseaseId":"asthma-management","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Atopic dermatitis","diseaseId":"atopic-dermatitis","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Chronic Non-Allergic Rhinitis","diseaseId":"chronic-non-allergic-rhinitis","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Contact dermatitis","diseaseId":"contact-dermatitis","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Discoid lupus erythematosus","diseaseId":"discoid-lupus-erythematosus","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Eruption of skin","diseaseId":"eruption-of-skin","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Granuloma annulare","diseaseId":"granuloma-annulare","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Lichen simplex chronicus","diseaseId":"lichen-simplex-chronicus","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Non-allergic asthma","diseaseId":"non-allergic-asthma","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Plaque psoriasis","diseaseId":"plaque-psoriasis","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Primary cutaneous T-cell lymphoma","diseaseId":"primary-cutaneous-t-cell-lymphoma","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Pruritus ani","diseaseId":"pruritus-ani","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Pruritus of genital organs","diseaseId":"pruritus-of-genital-organs","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Scalp psoriasis","diseaseId":"scalp-psoriasis","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Seborrheic dermatitis","diseaseId":"seborrheic-dermatitis","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"}],"offLabel":[],"pipeline":[]},"labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT06834360","phase":"Phase 3","title":"A Randomized, Double-blind, Placebo-controlled, Parallel-group, 52-week Phase 3 Trial to Investigate the Efficacy, Safety, and Tolerability of Itepekimab in Adult Participants With Inadequately-contro","status":"RECRUITING","sponsor":"Sanofi","isPivotal":true,"enrollment":210,"indication":"Chronic Rhinosinusitis With Nasal Polyps","completionDate":"2027-12-13"},{"nctId":"NCT02228720","phase":"NA","title":"The EXCEED Study: A Clinical Evaluation of the Drug-Eluting Propel Nova Sinus Implant When Placed in Peripheral Sinus Ostia to Maintain Patency","status":"COMPLETED","sponsor":"Intersect ENT","isPivotal":false,"enrollment":15,"indication":"Chronic Sinusitis","completionDate":"2015-01"},{"nctId":"NCT01850823","phase":"Phase 3","title":"","status":"COMPLETED","sponsor":"Actavis Inc.","isPivotal":true,"enrollment":880,"indication":"Seasonal Allergic Rhinitis","completionDate":"2013-12"},{"nctId":"NCT00817817","phase":"Phase 3","title":"An Open-Label, Comparative, Randomized, Parallel, Multicenter Study to Determine the Efficacy and Safety of Two Dry Powder Inhalers (DPIs) Used for the Application of Mometasone in the Treatment of As","status":"COMPLETED","sponsor":"Organon and Co","isPivotal":true,"enrollment":93,"indication":"Asthma","completionDate":"2003-05-01"},{"nctId":"NCT01372865","phase":"Phase 3","title":"A Phase III, Non-inferiority, Open-label, Multicenter and Randomized Clinical Trial About the Treatment of Mild to Moderate Persistent Allergic Rhinitis With Eurofarma Mometasone or Reference Mometaso","status":"COMPLETED","sponsor":"Eurofarma Laboratorios S.A.","isPivotal":true,"enrollment":364,"indication":"Mild to Moderate Persistent Allergic Rhinitis","completionDate":"2013-03"},{"nctId":"NCT01720797","phase":"NA","title":"Alveolar Microperforation for Inflammation-Enhanced Tooth Movement During Orthodontic Treatment","status":"COMPLETED","sponsor":"University of Florida","isPivotal":false,"enrollment":21,"indication":"Malocclusion","completionDate":"2015-04"},{"nctId":"NCT02892344","phase":"Phase 3","title":"A Multi-center, Randomized, 12-week Treatment, Doubleblind Study to Assess the Efficacy and Safety of QMF149 (150/80 Microgram) Compared With MF Twisthaler® (200 Microgram) in Adult and Adolescent Pat","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","isPivotal":true,"enrollment":802,"indication":"Mild Asthma","completionDate":"2018-11-30"},{"nctId":"NCT00378378","phase":"Phase 3","title":"Study of Nasonex® for the Treatment of Nasal Polyps in Pediatric Subjects Between Ages of 6 and Less Than 18 Years Old","status":"COMPLETED","sponsor":"Organon and Co","isPivotal":true,"enrollment":127,"indication":"Nasal Polyps","completionDate":"2008-06"},{"nctId":"NCT04499235","phase":"Phase 2","title":"Double-Blind, Randomized, Placebo-Controlled Trial of AKST4290 for Adjunctive Treatment of Mild to Moderate Bullous Pemphigoid","status":"TERMINATED","sponsor":"Alkahest, Inc.","isPivotal":false,"enrollment":6,"indication":"Pemphigoid, Bullous","completionDate":"2021-04-14"},{"nctId":"NCT05040828","phase":"Phase 4","title":"Early Intervention With Leukotriene Receptor Antagonists in Patients With Grass Pollinosis: Effects on Clinical Symptoms and Allergic Inflammation","status":"COMPLETED","sponsor":"Beijing Tongren Hospital","isPivotal":false,"enrollment":59,"indication":"Allergic Rhinitis Due to Weed Pollen, Montelukast","completionDate":"2020-11-10"},{"nctId":"NCT00424008","phase":"Phase 3","title":"A 52-Week Efficacy and Safety Non-Inferiority Study of Fluticasone Propionate/Salmeterol 250/50mcg BID Delivered by Dry Powder Inhaler (Diskus) Versus Mometasone Furoate/Formoterol Fumarate 200/10mcg ","status":"COMPLETED","sponsor":"Organon and Co","isPivotal":true,"enrollment":722,"indication":"Asthma","completionDate":"2008-11"},{"nctId":"NCT00779740","phase":"Phase 3","title":"Clinical Equivalency Study of Two Formulations of Mometasone Furoate Nasal Spray","status":"COMPLETED","sponsor":"Organon and Co","isPivotal":true,"enrollment":102,"indication":"Rhinitis, Allergic, Perennial","completionDate":"2005-04-01"},{"nctId":"NCT02154334","phase":"Phase 1","title":"An Open-label Study to Assess the Effects of Allergic Rhinitis and Coadministration of Mometasone or Oxymetazoline on the Pharmacokinetics, Safety, and Tolerability of Intranasal Esketamine","status":"COMPLETED","sponsor":"Janssen Research & Development, LLC","isPivotal":false,"enrollment":47,"indication":"Allergic Rhinitis","completionDate":"2014-10"},{"nctId":"NCT01253577","phase":"Phase 3","title":"A Clinical Evaluation of a Steroid-Coated Sinus Stent When Used Following Functional Endoscopic Sinus Surgery in Patients With Chronic Sinusitis","status":"COMPLETED","sponsor":"Intersect ENT","isPivotal":true,"enrollment":105,"indication":"Chronic Sinusitis","completionDate":"2010-10"},{"nctId":"NCT03879772","phase":"Phase 3","title":"Dose-Ranging Study of Mometasone Furoate Nasal Spray (SCH 32088) in the Treatment of Children (Ages 6-11) With Seasonal Allergic Rhinitis (Protocol C95-161)","status":"COMPLETED","sponsor":"Organon and Co","isPivotal":true,"enrollment":679,"indication":"Rhinitis, Allergic, Seasonal","completionDate":"1996-07-01"},{"nctId":"NCT03652454","phase":"NA","title":"Efficiency Of Micro-osteoperforation During Alignment Stage","status":"COMPLETED","sponsor":"Izmir Katip Celebi University","isPivotal":false,"enrollment":28,"indication":"Crowding of Teeth","completionDate":"2019-06-24"},{"nctId":"NCT00383240","phase":"Phase 3","title":"A 26-Week Placebo-Controlled Efficacy and Safety Study of Mometasone Furoate/Formoterol Fumarate Combination Formulation Compared With Mometasone Furoate and Formoterol Monotherapy in Subjects With Pe","status":"COMPLETED","sponsor":"Organon and Co","isPivotal":true,"enrollment":781,"indication":"Asthma","completionDate":"2008-09"},{"nctId":"NCT02973776","phase":"Phase 1","title":"Vasoconstriction Trial Comparing LEO 90100 With Dermovate Cream, Diprosone Ointment, Elocon Cream, Locoid Ointment and LEO 90100 Vehicle","status":"COMPLETED","sponsor":"LEO Pharma","isPivotal":false,"enrollment":36,"indication":"Psoriasis Vulgaris","completionDate":"2017-02"},{"nctId":"NCT04532736","phase":"Phase 2","title":"Comparison of Methylprednisolone or Methotrexate With Standard Treatment in the Maintenance Treatment of Medically and Surgically Treated Chronic Rhinosinusitis With Nasal Polyposis","status":"COMPLETED","sponsor":"Dokuz Eylul University","isPivotal":false,"enrollment":41,"indication":"Nasal Polyposis","completionDate":"2019-05-05"},{"nctId":"NCT07286201","phase":"NA","title":"A Multicenter, Randomized, Controlled Study to Evaluate the Safety and Effectiveness of a Bioresorbable Nasal Dressing Containing Mometasone Furoate Compared to a Steroid-eluting Sinus Stent","status":"NOT_YET_RECRUITING","sponsor":"Polyganics BV","isPivotal":false,"enrollment":110,"indication":"Chronic Rhinosinusitis (CRS), Chronic Rhinosinusitis (CRS) With and Without Nasal Polyps","completionDate":"2027-01"},{"nctId":"NCT02565212","phase":"Phase 4","title":"Istanbul Gaziosmanpasa Taksim Research and Training Hospital,","status":"COMPLETED","sponsor":"Istanbul Training and Research Hospital","isPivotal":false,"enrollment":30,"indication":"Allergic Rhinitis","completionDate":"2014-10"},{"nctId":"NCT06483477","phase":"NA","title":"Dermatitis During Adjuvant Irradiation for BREAst Cancer: Grade ≥2 Radiation Dermatitis in Breast Cancer Patients with or Without a Mobile Application (Reminder-App)","status":"RECRUITING","sponsor":"University Hospital Schleswig-Holstein","isPivotal":false,"enrollment":268,"indication":"Breast Cancer Female","completionDate":"2026-09-30"},{"nctId":"NCT05912192","phase":"NA","title":"The Efficacy Of Elonide Nasal Corticosteroids In Managing Allergic Rhinitis","status":"COMPLETED","sponsor":"National University of Malaysia","isPivotal":false,"enrollment":163,"indication":"Allergic Rhinitis","completionDate":"2023-04-14"},{"nctId":"NCT06068270","phase":"NA","title":"Randomized Clinical Trial on the Effect of Micro-osteoperforations (MOPs) During Intrusion of Flared Upper Anterior Teeth in Stage IV Periodontitis Patients","status":"RECRUITING","sponsor":"Universidad Complutense de Madrid","isPivotal":false,"enrollment":28,"indication":"Stage IV Periodontitis, Orthodontic Tooth Movement","completionDate":"2026-01"},{"nctId":"NCT04127578","phase":"Phase 1","title":"A Phase 1/2a Open-Label Ascending Dose Study to Evaluate the Safety and Effects of LY3884961 in Patients With Parkinson's Disease With at Least One GBA1 Mutation (PROPEL)","status":"ACTIVE_NOT_RECRUITING","sponsor":"Prevail Therapeutics","isPivotal":false,"enrollment":32,"indication":"Parkinson Disease","completionDate":"2030-12-31"},{"nctId":"NCT01347060","phase":"N/A","title":"Outcomes for Medicare Asthma Patients Taking Fluticasone Propionate/Salmeterol Xinafoate Combination Versus Inhaled Corticosteroids or Other Combination Therapy","status":"COMPLETED","sponsor":"GlaxoSmithKline","isPivotal":false,"enrollment":17448,"indication":"Asthma","completionDate":"2010-04"},{"nctId":"NCT01210170","phase":"NA","title":"Acute Effect of Mometasone Furoate DPI on Beta-adrenergic Airway and Airway Vascular Relaxation in Moderately Severe Asthma","status":"COMPLETED","sponsor":"University of Miami","isPivotal":false,"enrollment":22,"indication":"Asthma","completionDate":"2013-02"},{"nctId":"NCT02953379","phase":"Phase 3","title":"Phase III, National, Multicenter, Randomized, Single-blind, Non-inferiority to Compare the Efficacy of Mometasone Nasal Gel Compared to Mometasone Nasal Spray in the Treatment of Persistent or Intermi","status":"WITHDRAWN","sponsor":"EMS","isPivotal":true,"enrollment":0,"indication":"Allergic Rhinitis","completionDate":"2020-03"},{"nctId":"NCT04851964","phase":"Phase 3","title":"A Multicentre, Randomised, Double-Blind, Parallel-Group, Placebo-Controlled Phase 3 Efficacy and Safety Study of Tezepelumab in Participants With Severe Chronic Rhinosinusitis With Nasal Polyposis (WA","status":"COMPLETED","sponsor":"AstraZeneca","isPivotal":true,"enrollment":416,"indication":"Chronic Rhinosinusitis With Nasal Polyps","completionDate":"2024-12-11"},{"nctId":"NCT05293119","phase":"EARLY/Phase 1","title":"Efficacy of Tofacitinib in Vitiligo-a Randomized Controlled Trial in a Selected Tertiary Level Hospital in Dhaka","status":"UNKNOWN","sponsor":"Pi Research Consultancy Center, Bangladesh","isPivotal":false,"enrollment":80,"indication":"Vitiligo, Effect of Drug","completionDate":"2023-11-30"},{"nctId":"NCT00521599","phase":"Phase 4","title":"A Study of the Therapeutic Equivalency of MF DPI 100 mcg and 200 mcg Inhalers in Corticosteroid-Dependent Subjects With Moderate Asthma","status":"COMPLETED","sponsor":"Organon and Co","isPivotal":false,"enrollment":672,"indication":"Asthma","completionDate":"2009-03"},{"nctId":"NCT03036735","phase":"NA","title":"Rates of Middle Meatus (MM) Synechiae Formation Post Endoscopic Sinus Surgery (ESS)","status":"TERMINATED","sponsor":"Steward St. Elizabeth's Medical Center of Boston, Inc.","isPivotal":false,"enrollment":10,"indication":"Sinusitis","completionDate":"2016-12"},{"nctId":"NCT04892758","phase":"N/A","title":"Replication of the P04334 Asthma Trial in Healthcare Claims Data","status":"COMPLETED","sponsor":"Brigham and Women's Hospital","isPivotal":false,"enrollment":10288,"indication":"Asthma","completionDate":"2021-06-11"},{"nctId":"NCT02061202","phase":"Phase 2","title":"Inhaled Mometasone to Promote Reduction in Vasoocclusive Events","status":"COMPLETED","sponsor":"Jeffrey Glassberg","isPivotal":false,"enrollment":54,"indication":"Sickle Cell Disease","completionDate":"2017-11"},{"nctId":"NCT06200766","phase":"Phase 3","title":"A Multicenter, Randomized, Double-blind, Three-arm, Parallel Clinical Endpoint Bioequivalence Study of Monometasone Furoate Nasal Spray in Patients With Seasonal Allergic Rhinitis","status":"UNKNOWN","sponsor":"Zheng Liu ENT","isPivotal":true,"enrollment":640,"indication":"Seasonal Allergic Rhinitis","completionDate":"2024-06-30"},{"nctId":"NCT00687531","phase":"Phase 4","title":"Open Label, 12-week Clinical Trial to Assess Efficacy, Safety, Treatment Adherence and Quality of Life Impact of Mometasone Furoate Dry Powder 400 mcg Once-daily in Persistent Mild-moderate Asthmatic ","status":"TERMINATED","sponsor":"Organon and Co","isPivotal":false,"enrollment":385,"indication":"Asthma","completionDate":"2009-09"},{"nctId":"NCT02318303","phase":"Phase 2","title":"A Double-blind, Randomized, Parallel-group, Comparative Study to Evaluate the Efficacy, Safety and Tolerability of Two Different Strengths and Regimens of a Fixed Dose Combination GSP 301 Nasal Spray ","status":"COMPLETED","sponsor":"Glenmark Pharmaceuticals Ltd. India","isPivotal":false,"enrollment":1111,"indication":"Seasonal Allergic Rhinitis","completionDate":"2015-02"},{"nctId":"NCT07174115","phase":"Phase 2","title":"A Phase IIa Clinical Study to Evaluate the Efficacy and Safety of HTMC0658 Tablets in the Treatment of Chronic Rhinosinusitis Without Nasal Polyps","status":"RECRUITING","sponsor":"Shanghai Yidian Pharmaceutical Technology Development Co., Ltd.","isPivotal":false,"enrollment":30,"indication":"Chronic Sinusitis Without Nasal Polyps","completionDate":"2026-06"},{"nctId":"NCT05145010","phase":"Phase 2","title":"Phase 2, Open-Label, Long-Term, Extension (OLE) Study of Infigratinib, an FGFR 1-3-Selective Tyrosine Kinase Inhibitor, in Children With Achondroplasia: PROPEL OLE","status":"ENROLLING_BY_INVITATION","sponsor":"QED Therapeutics, a BridgeBio company","isPivotal":false,"enrollment":300,"indication":"Achondroplasia","completionDate":"2032-02-01"},{"nctId":"NCT06636240","phase":"NA","title":"Study on the Potential Prebiotic Effects and Gut Microbiota Changes of Glucoside-enriched Mulberry Fruit in Children and Adolescents With Atopic Dermatitis","status":"RECRUITING","sponsor":"Taipei Medical University Shuang Ho Hospital","isPivotal":false,"enrollment":120,"indication":"Atopic Dermatitis (Eczema), Atopic Dermatitis, Probiotics","completionDate":"2026-04-30"},{"nctId":"NCT06269523","phase":"NA","title":"Effects of Rehabilitation and Kinesio Taping to Prevent Axillary Web Syndrome After Breast Cancer Surgery","status":"COMPLETED","sponsor":"University of Palermo","isPivotal":false,"enrollment":18,"indication":"Axillary Web Syndrome","completionDate":"2024-01-31"},{"nctId":"NCT07016763","phase":"EARLY/Phase 1","title":"Combination of Oral Supplement With Fatty Acids, Vitamin B6, Perilla, and Liquorice With Nasal Steroids for the Treatment of Allergic Rhinitis: a Multicentre, Single-blinded, Randomized Controlled Tri","status":"COMPLETED","sponsor":"Isola Tiberina - Gemelli Isola Hospital, Rome, Italy","isPivotal":false,"enrollment":400,"indication":"Allergic Rhinitis","completionDate":"2025-03-01"},{"nctId":"NCT03444506","phase":"Phase 2","title":"A Single-Center, Double-Blind, Double-Dummy, Randomized, Parallel-Group, Comparative Environmental Exposure Chamber (EEC) Study to Evaluate Efficacy, Safety and Tolerability of Two Fixed Dose Combinat","status":"COMPLETED","sponsor":"Glenmark Pharmaceuticals Ltd. India","isPivotal":false,"enrollment":180,"indication":"Seasonal Allergic Rhinitis","completionDate":"2014-02-28"},{"nctId":"NCT00805155","phase":"N/A","title":"Bioequivalence of Three Mometasone Furoate 0.1% Topical Lotions","status":"COMPLETED","sponsor":"Padagis LLC","isPivotal":false,"enrollment":80,"indication":"Healthy","completionDate":"2004-03"},{"nctId":"NCT02397915","phase":"Phase 4","title":"A Patient Preference Evaluation Study of Fluticasone Furoate Nasal Spray and Mometasone Furoate Nasal Spray in Subjects With Allergic Rhinitis","status":"COMPLETED","sponsor":"GlaxoSmithKline","isPivotal":false,"enrollment":300,"indication":"Rhinitis, Allergic, Perennial and Seasonal","completionDate":"2015-06-08"},{"nctId":"NCT00576069","phase":"N/A","title":"Evaluation of Mechanism(s)Limiting Expiratory Airflow in Chronic, Stable Asthmatics Who Are Non-smokers","status":"RECRUITING","sponsor":"Gelb, Arthur F., M.D.","isPivotal":false,"enrollment":60,"indication":"Asthma","completionDate":"2027-06"},{"nctId":"NCT04670653","phase":"Phase 3","title":"National, Multicenter, Randomized, Simple-blind, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Magnólia Nasal Gel in the Treatment of Allergic Rhinitis in Participants With Age Great","status":"WITHDRAWN","sponsor":"EMS","isPivotal":true,"enrollment":0,"indication":"Allergic Rhinitis","completionDate":"2023-10"},{"nctId":"NCT02953366","phase":"Phase 3","title":"Phase III, National, Multicenter, Randomized, Single-blind, Non-inferiority to Compare the Efficacy of Mometasone Nasal Gel Compared to Mometasone Nasal Spray in the Treatment of Persistent or Intermi","status":"WITHDRAWN","sponsor":"EMS","isPivotal":true,"enrollment":0,"indication":"Allergic Rhinitis","completionDate":"2020-05"},{"nctId":"NCT02495064","phase":"Phase 4","title":"Mometasone Furoate Cream Reduces Acute Radiation Dermatitis in Head and Neck Squamous Cell Carcinomas' Patients Receiving Radiation Therapy","status":"UNKNOWN","sponsor":"Yao Liao","isPivotal":false,"enrollment":160,"indication":"Early Radiation Dermatitis","completionDate":"2016-12"},{"nctId":"NCT00941798","phase":"Phase 2","title":"A Randomized, Multi-center, Parallel Group, Double Blind, Study to Assess the Safety of QMF Twisthaler® (500/400 µg) and Mometasone Furoate Twisthaler® (400 µg) in Adolescent and Adult Patients With P","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","isPivotal":false,"enrollment":2283,"indication":"Asthma","completionDate":"2011-05"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"administration":{"route":"NASAL","dosage_text":"2 DOSAGE AND ADMINISTRATION For Nasal Use Only. Prophylaxis of Seasonal Allergic Rhinitis in Adult and Pediatric Patients 12 Years of Age and Older: 2 sprays in each nostril once daily ( 2.2 ) Treatment of Chronic Rhinosinusitis with Nasal Polyps in Adults (18 yrs. and older): 2 sprays in each nostril twice daily. 2 sprays in each nostril once daily may also be effective in some patients ( 2.3 ) 2.1 Preparation and Administration Administer mometasone furoate nasal spray by the nasal route only. Initial Priming Prior to initial use of mometasone furoate nasal spray, the pump must be primed by actuating ten times or until a fine spray appears. The pump may be stored unused for up to 1 week without repriming. Repriming (as needed) If unused for more than 1 week, reprime by actuating two times, or until a fine spray appears. 2.2 Recommended Dosage for Prophylaxis of Seasonal Allergic Rhinitis The recommended dosage for prophylaxis treatment of nasal symptoms of seasonal allergic rhinitis in adult and pediatric patients 12 years and older is mometasone furoate 2 sprays (2 sprays deliver a total of 100 mcg of mometasone furoate) in each nostril once daily (total daily dose of 200 mcg). In patients with a known seasonal allergen that precipitates nasal symptoms of seasonal allergic rhinitis, prophylaxis with 2 sprays (2 sprays deliver a total of 100 mcg of mometasone furoate) in each nostril once daily (total daily dose of 200 mcg) is recommended 2 to 4 weeks prior to the anticipated start of the pollen season. 2.3 Recommended Dosage for Treatment of Chronic Rhinosinusitis with Nasal Polyps The recommended dosage for the treatment of chronic rhinosinusitis with nasal polyps in adults 18 years and older is mometasone furoate 2 sprays (2 sprays deliver a total of 100 mcg of mometasone furoate) in each nostril twice daily (total daily dose of 400 mcg). A dose of 2 sprays (2 sprays deliver a total of 100 mcg of mometasone furoate) in each nostril once daily (total daily dose of 200 mcg) is also effective in some patients."},"formularyStatus":[],"apiManufacturers":[],"developmentCodes":[],"ownershipHistory":[],"therapeuticAreas":["Oncology"],"biosimilarFilings":[],"firstApprovalDate":"","companionDiagnostics":[],"firstApprovalCountry":null,"genericManufacturerList":[],"modality":"Small molecule","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":8,"withResults":1},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}