{"id":"mometasone-furoate","rwe":[{"pmid":"41819426","year":"2026","title":"Dual-action nasal spray with mussel protein and xylitol restores epithelial barrier and attenuates type 2 inflammation in allergic rhinitis.","finding":"","journal":"Journal of controlled release : official journal of the Controlled Release Society","studyType":"Clinical Study"},{"pmid":"41814615","year":"2026","title":"Effectiveness of topical intranasal curcumin in the experimentally induced allergic rhinitis model in rats (revised).","finding":"","journal":"Allergologia et immunopathologia","studyType":"Clinical Study"},{"pmid":"41747874","year":"2026","title":"Quaternized chitosan-coated liposomes enable pH-independent nasal mucoadhesion and a sustained local depot for mometasone furoate.","finding":"","journal":"European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V","studyType":"Clinical Study"},{"pmid":"41732343","year":"2026","title":"Efficacy and safety of olopatadine-mometasone combination nasal spray for the treatment of seasonal allergic rhinitis.","finding":"","journal":"The World Allergy Organization journal","studyType":"Clinical Study"},{"pmid":"41730175","year":"2026","title":"Drugs for atopic dermatitis.","finding":"","journal":"The Medical letter on drugs and therapeutics","studyType":"Clinical Study"}],"_fda":{"id":"42b90831-6019-4d81-aa0d-6fb75c4d51a1","set_id":"031283ed-988b-4698-8a2e-00f3d41c0f71","openfda":{"upc":["0368462192559"],"unii":["04201GDN4R"],"route":["TOPICAL"],"rxcui":["311753"],"spl_id":["42b90831-6019-4d81-aa0d-6fb75c4d51a1"],"brand_name":["Mometasone Furoate"],"spl_set_id":["031283ed-988b-4698-8a2e-00f3d41c0f71"],"package_ndc":["68462-192-17","68462-192-55"],"product_ndc":["68462-192"],"generic_name":["MOMETASONE FUROATE"],"product_type":["HUMAN PRESCRIPTION DRUG"],"substance_name":["MOMETASONE FUROATE"],"manufacturer_name":["Glenmark Pharmaceuticals Inc., USA"],"application_number":["ANDA078541"],"is_original_packager":[true]},"version":"10","pregnancy":["8.1 Pregnancy Teratogenic Effects Pregnancy Category C: There are no adequate and well-controlled studies in pregnant women. Therefore, mometasone furoate cream should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Some corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. When administered to pregnant rats, rabbits, and mice, mometasone furoate increased fetal malformations. The doses that produced malformations also decreased fetal growth, as measured by lower fetal weights and/or delayed ossification. Mometasone furoate also caused dystocia and related complications when administered to rats during the end of pregnancy. In mice, mometasone furoate caused cleft palate at subcutaneous doses of 60 mcg/kg and above. Fetal survival was reduced at 180 mcg/kg. No toxicity was observed at 20 mcg/kg. (Doses of 20, 60, and 180 mcg/kg in the mouse are approximately 0.01, 0.02, and 0.05 times the estimated maximum clinical topical dose from mometasone furoate cream on a mcg/m 2 basis.) In rats, mometasone furoate produced umbilical hernias at topical doses of 600 mcg/kg and above. A dose of 300 mcg/kg produced delays in ossification, but no malformations. (Doses of 300 and 600 mcg/kg in the rat are approximately 0.2 and 0.4 times the estimated maximum clinical topical dose from mometasone furoate cream on a mcg/m 2 basis.) In rabbits, mometasone furoate caused multiple malformations (e.g., flexed front paws, gallbladder agenesis, umbilical hernia, hydrocephaly) at topical doses of 150 mcg/kg and above (approximately 0.2 times the estimated maximum clinical topical dose from mometasone furoate cream on a mcg/m 2 basis). In an oral study, mometasone furoate increased resorptions and caused cleft palate and/or head malformations (hydrocephaly and domed head) at 700 mcg/kg. At 2800 mcg/kg most litters were aborted or resorbed. No toxicity was observed at 140 mcg/kg. (Doses at 140, 700, and 2800 mcg/kg in the rabbit are approximately 0.2, 0.9, and 3.6 times the estimated maximum clinical topical dose from mometasone furoate cream on a mcg/m 2 basis.) When rats received subcutaneous doses of mometasone furoate throughout pregnancy or during the later stages of pregnancy, 15 mcg/kg caused prolonged and difficult labor and reduced the number of live births, birth weight, and early pup survival. Similar effects were not observed at 7.5 mcg/kg. (Doses of 7.5 and 15 mcg/kg in the rat are approximately 0.005 and 0.01 times the estimated maximum clinical topical dose from mometasone furoate cream on a mcg/m 2 basis.)"],"overdosage":["10 OVERDOSAGE Topically applied mometasone furoate cream can be absorbed in sufficient amounts to produce systemic effects [see Warnings and Precautions ( 5.1 )] ."],"description":["11 DESCRIPTION Mometasone Furoate Cream USP, 0.1% contains mometasone furoate, USP for topical use. Mometasone furoate, USP is a synthetic corticosteroid with anti-inflammatory activity. Chemically, mometasone furoate, USP is 9α,21-dichloro-11β,17-dihydroxy-16α-methylpregna-1,4-diene-3,20-dione 17-(2-furoate), with the empirical formula C 27 H 30 Cl 2 O 6 , a molecular weight of 521.43 and the following structural formula: Mometasone furoate, USP is a white to off-white powder, soluble in acetone and methylene chloride. Each gram of Mometasone Furoate Cream USP, 0.1% contains: 1 mg mometasone furoate, USP in a cream base of aluminum starch octenyl succinate (Dry-Flo Plus (Pure)), hexylene glycol, phospholipon 90 H, phosphoric acid, purified water, titanium dioxide, white petrolatum, and white wax. mometasone-furoate-structure"],"how_supplied":["16 HOW SUPPLIED/STORAGE AND HANDLING Mometasone furoate cream USP, 0.1% is a white to off-white, uniform and smooth cream and is supplied in 15 g (NDC 68462-192-17) and 45 g (NDC 68462-192-55) tubes. Store at 25°C (77°F); excursions permitted to 15° to 30°C (59 to86°F) [see USP Controlled Room Temperature]. Avoid excessive heat."],"geriatric_use":["8.5 Geriatric Use Clinical studies of mometasone furoate cream included 190 subjects who were 65 years of age and over and 39 subjects who were 75 years of age and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients. However, greater sensitivity of some older individuals cannot be ruled out."],"pediatric_use":["8.4 Pediatric Use Mometasone furoate cream may be used with caution in pediatric patients 2 years of age or older, although the safety and efficacy of drug use for longer than 3 weeks have not been established. Since safety and efficacy of mometasone furoate cream have not been established in pediatric patients below 2 years of age, its use in this age group is not recommended. In a pediatric trial, 24 atopic dermatitis subjects, of whom 19 subjects were age 2 to 12 years, were treated with mometasone furoate cream once daily. The majority of subjects cleared within 3 weeks. Mometasone furoate cream caused HPA axis suppression in approximately 16% of pediatric subjects ages 6 to 23 months, who showed normal adrenal function by Cortrosyn test before starting treatment, and were treated for approximately 3 weeks over a mean body surface area of 41% (range 15% to 94%). The criteria for suppression were: basal cortisol level of ≤5 mcg/dL, 30-minute post-stimulation level of ≤18 mcg/dL, or an increase of <7 mcg/dL. Follow-up testing 2 to 4 weeks after trial completion, available for 5 of the subjects, demonstrated suppressed HPA axis function in 1 subject, using these same criteria. Long-term use of topical corticosteroids has not been studied in this population [see Clinical Pharmacology ( 12.2 )] . Because of a higher ratio of skin surface area to body mass, pediatric patients are at a greater risk than adults of HPA axis suppression and Cushing’s syndrome when they are treated with topical corticosteroids. They are, therefore, also at greater risk of adrenal insufficiency during and/or after withdrawal of treatment. Pediatric patients may be more susceptible than adults to skin atrophy, including striae, when they are treated with topical corticosteroids. Pediatric patients applying topical corticosteroids to greater than 20% of body surface are at higher risk of HPA axis suppression. HPA axis suppression, Cushing’s syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in pediatric patients receiving topical corticosteroids. Manifestations of adrenal suppression in children include low plasma cortisol levels and an absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema. Mometasone furoate cream should not be used in the treatment of diaper dermatitis."],"effective_time":"20190709","nursing_mothers":["8.3 Nursing Mothers Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Because many drugs are excreted in human milk, caution should be exercised when mometasone furoate cream is administered to a nursing woman."],"clinical_studies":["14 CLINICAL STUDIES The safety and efficacy of the mometasone furoate cream for the treatment of corticosteroid-responsive dermatoses were evaluated in two randomized, double-blind, vehicle-controlled clinical trials, one in psoriasis and one in atopic dermatitis. A total 366 subjects (12 to 81 years of age), of whom 177 received mometasone furoate cream and 181 subjects received vehicle cream, were evaluated in these trials. Mometasone furoate cream or the vehicle cream were applied once daily for 21 days. The two trials showed mometasone furoate cream is effective in the treatment of psoriasis and atopic dermatitis."],"pharmacodynamics":["12.2 Pharmacodynamics Studies performed with mometasone furoate cream indicate that it is in the medium range of potency as compared with other topical corticosteroids. In a study evaluating the effects of mometasone furoate cream on the HPA axis, 15 grams were applied twice daily for 7 days to six adult subjects with psoriasis or atopic dermatitis. The cream was applied without occlusion to at least 30% of the body surface. The results showed that the drug caused a slight lowering of adrenal corticosteroid secretion [see Warnings and Precautions (5.1)] . Ninety-seven pediatric subjects ages 6 to 23 months with atopic dermatitis were enrolled in an open-label HPA axis safety study. Mometasone furoate cream was applied once daily for approximately 3 weeks over a mean body surface area of 41% (range 15% to 94%). In approximately 16% of subjects who showed normal adrenal function by Cortrosyn test before starting treatment, adrenal suppression was observed at the end of treatment with mometasone furoate cream. The criteria for suppression were: basal cortisol level of ≤5 mcg/dL, 30-minute post-stimulation level of ≤18 mcg/dL, or an increase of <7 mcg/dL. Follow-up testing 2 to 4 weeks after stopping treatment, available for 5 of the subjects, demonstrated suppressed HPA axis function in one subject, using these same criteria [see Use in Specific Populations (8.4)] ."],"pharmacokinetics":["12.3 Pharmacokinetics The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle and the integrity of the epidermal barrier. Studies in humans indicate that approximately 0.4% of the applied dose of mometasone furoate cream enters the circulation after 8 hours of contact on normal skin without occlusion. Inflammation and/or other disease processes in the skin may increase percutaneous absorption."],"adverse_reactions":["6 ADVERSE REACTIONS Most common adverse reactions are: burning, pruritus, and skin atrophy. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Glenmark Pharmaceuticals Inc., USA at 1 (888)721-7115 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 clinical practice. In controlled clinical trials involving 319 subjects, the incidence of adverse reactions associated with the use of mometasone furoate cream was 1.6%. Reported reactions included burning, pruritus, and skin atrophy. Reports of rosacea associated with the use of mometasone furoate cream have also been received. In controlled clinical trials (n=74) involving pediatric subjects 2 to 12 years of age, the incidence of adverse experiences associated with the use of mometasone furoate cream was approximately 7%. Reported reactions included stinging, pruritus, and furunculosis. The following adverse reactions were reported to be possibly or probably related to treatment with mometasone furoate cream during clinical trials in 4% of 182 pediatric subjects 6 months to 2 years of age: decreased glucocorticoid levels, 2; paresthesia, 2; folliculitis, 1; moniliasis, 1; bacterial infection, 1; skin depigmentation, 1. The following signs of skin atrophy were also observed among 97 subjects treated with mometasone furoate cream in a clinical trial: shininess, 4; telangiectasia, 1; loss of elasticity, 4; loss of normal skin markings, 4; thinness, 1; and bruising, 1. 6.2 Postmarketing Experience Because adverse reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Postmarketing reports for local adverse reactions to topical corticosteroids include irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, striae, and miliaria. These adverse reactions may occur more frequently with the use of occlusive dressings. Postmarketing reports for ophthalmic adverse reactions to topical corticosteroids include blurred vision, cataracts, glaucoma, increased intraocular pressure, and central serous chorioretinopathy."],"contraindications":["4 CONTRAINDICATIONS Mometasone furoate cream, 0.1% is contraindicated in those patients with a history of hypersensitivity to any of the components in the preparation. Mometasone furoate cream, 0.1% is contraindicated in those patients with a history of hypersensitivity to any of the components in the preparation. ( 4 )"],"drug_interactions":["7 DRUG INTERACTIONS No drug-drug interaction studies have been conducted with mometasone furoate cream."],"mechanism_of_action":["12.1 Mechanism of Action Like other topical corticosteroids, mometasone furoate has anti-inflammatory, antipruritic, and vasoconstrictive properties. The mechanism of the anti-inflammatory activity of the topical steroids, in general, is unclear. However, corticosteroids are thought to act by the induction of phospholipase A 2 inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A 2 ."],"recent_major_changes":["Warnings and Precautions Ophthalmic Adverse Reactions ( 5.2 ) 05/2018"],"clinical_pharmacology":["12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Like other topical corticosteroids, mometasone furoate has anti-inflammatory, antipruritic, and vasoconstrictive properties. The mechanism of the anti-inflammatory activity of the topical steroids, in general, is unclear. However, corticosteroids are thought to act by the induction of phospholipase A 2 inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A 2 . 12.2 Pharmacodynamics Studies performed with mometasone furoate cream indicate that it is in the medium range of potency as compared with other topical corticosteroids. In a study evaluating the effects of mometasone furoate cream on the HPA axis, 15 grams were applied twice daily for 7 days to six adult subjects with psoriasis or atopic dermatitis. The cream was applied without occlusion to at least 30% of the body surface. The results showed that the drug caused a slight lowering of adrenal corticosteroid secretion [see Warnings and Precautions (5.1)] . Ninety-seven pediatric subjects ages 6 to 23 months with atopic dermatitis were enrolled in an open-label HPA axis safety study. Mometasone furoate cream was applied once daily for approximately 3 weeks over a mean body surface area of 41% (range 15% to 94%). In approximately 16% of subjects who showed normal adrenal function by Cortrosyn test before starting treatment, adrenal suppression was observed at the end of treatment with mometasone furoate cream. The criteria for suppression were: basal cortisol level of ≤5 mcg/dL, 30-minute post-stimulation level of ≤18 mcg/dL, or an increase of <7 mcg/dL. Follow-up testing 2 to 4 weeks after stopping treatment, available for 5 of the subjects, demonstrated suppressed HPA axis function in one subject, using these same criteria [see Use in Specific Populations (8.4)] . 12.3 Pharmacokinetics The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle and the integrity of the epidermal barrier. Studies in humans indicate that approximately 0.4% of the applied dose of mometasone furoate cream enters the circulation after 8 hours of contact on normal skin without occlusion. Inflammation and/or other disease processes in the skin may increase percutaneous absorption."],"indications_and_usage":["1 INDICATIONS AND USAGE Mometasone furoate cream, 0.1% is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 2 years of age or older. Mometasone furoate cream, 0.1% is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients ≥ 2 years of age. ( 1 )"],"warnings_and_cautions":["5 WARNINGS AND PRECAUTIONS • Reversible HPA axis suppression with the potential for glucocorticosteroid insufficiency after withdrawal of treatment, Cushing’s syndrome, and hyperglycemia may occur due to systemic absorption. Patients applying a topical steroid to a large surface area or to areas under occlusion should be evaluated periodically for evidence of HPA axis suppression. Modify use should HPA axis suppression develop. ( 5.1 , 8.4 ) • Pediatric patients may be more susceptible to systemic toxicity. ( 5.1 , 8.4 ) • May increase the risk of cataracts and glaucoma. If visual symptoms occur, consider referral to an ophthalmologist. ( 5.2 ) 5.1 Effects on Endocrine System Systemic absorption of topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency. This may occur during treatment or after withdrawal of treatment. Manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria can also be produced in some patients by systemic absorption of topical corticosteroids while on treatment. Factors that predispose a patient using a topical corticosteroid to HPA axis suppression include the use of high-potency steroids, large treatment surface areas, prolonged use, use of occlusive dressings, altered skin barrier, liver failure and young age. Because of the potential for systemic absorption, use of topical corticosteroids may require that patients be periodically evaluated for HPA axis suppression. This may be done by using the adrenocorticotropic hormone (ACTH) stimulation test. In a study evaluating the effects of mometasone furoate cream on the HPA axis, 15 grams were applied twice daily for 7 days to six adult subjects with psoriasis or atopic dermatitis. The results show that the drug caused a slight lowering of adrenal corticosteroid secretion. If HPA axis suppression is noted, an attempt should be made to gradually withdraw the drug, to reduce the frequency of application, or to substitute a less potent corticosteroid. Recovery of HPA axis function is generally prompt upon discontinuation of topical corticosteroids. Infrequently, signs and symptoms of glucocorticosteroid insufficiency may occur, requiring supplemental systemic corticosteroids. Pediatric patients may be more susceptible to systemic toxicity from equivalent doses due to their larger skin surface to body mass ratios [see Use in Specific Populations ( 8.4 )]. 5.2 Ophthalmic Adverse Reactions Use of topical corticosteroids may increase the risk of posterior subcapsular cataracts and glaucoma. Cataracts and glaucoma have been reported in postmarketing experience with the use of topical corticosteroids, including the topical mometasone products [see Adverse Reactions (6.2)]. Avoid contact of mometasone furoate cream with eyes. Advise patients to report any visual symptoms and consider referral to an ophthalmologist for evaluation. 5.3 Allergic Contact Dermatitis If irritation develops, mometasone furoate cream should be discontinued and appropriate therapy instituted. Allergic contact dermatitis with corticosteroids is usually diagnosed by observing a failure to heal rather than noting a clinical exacerbation as with most topical products not containing corticosteroids. Such an observation should be corroborated with appropriate diagnostic patch testing. 5.4 Concomitant Skin Infections If concomitant skin infections are present or develop, an appropriate antifungal or antibacterial agent should be used. If a favorable response does not occur promptly, use of mometasone furoate cream should be discontinued until the infection has been adequately controlled."],"nonclinical_toxicology":["13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term animal studies have not been performed to evaluate the carcinogenic potential of mometasone furoate cream. Long-term carcinogenicity studies of mometasone furoate were conducted by the inhalation route in rats and mice. In a 2-year carcinogenicity study in Sprague Dawley rats, mometasone furoate demonstrated no statistically significant increase of tumors at inhalation doses up to 67 mcg/kg (approximately 0.04 times the estimated maximum clinical topical dose from mometasone furoate cream on a mcg/m 2 basis). In a 19-month carcinogenicity study in Swiss CD-1 mice, mometasone furoate demonstrated no statistically significant increase in the incidence of tumors at inhalation doses up to 160 mcg/kg (approximately 0.05 times the estimated maximum clinical topical dose from mometasone furoate cream on a mcg/m 2 basis). Mometasone furoate increased chromosomal aberrations in an in vitro Chinese hamster ovary cell assay, but did not increase chromosomal aberrations in an in vitro Chinese hamster lung cell assay. Mometasone furoate was not mutagenic in the Ames test or mouse lymphoma assay, and was not clastogenic in an in vivo mouse micronucleus assay, a rat bone marrow chromosomal aberration assay, or a mouse male germ-cell chromosomal aberration assay. Mometasone furoate also did not induce unscheduled DNA synthesis in vivo in rat hepatocytes. In reproductive studies in rats, impairment of fertility was not produced in male or female rats by subcutaneous doses up to 15 mcg/kg (approximately 0.01 times the estimated maximum clinical topical dose from mometasone furoate cream, on a mcg/m 2 basis)."],"information_for_patients":["17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information). 1. Use mometasone furoate cream as directed by the physician. It is for external use only. 2. Avoid contact with the eyes. 3. Advise patients to report any visual symptoms to their healthcare providers. 4. Do not use mometasone furoate cream on the face, underarms, or groin areas unless directed by the physician. 5. Do not use mometasone furoate cream for any disorder other than that for which it was prescribed. 6. Do not bandage or otherwise cover or wrap the treated skin area so as to be occlusive, unless directed by the physician. 7. Report any signs of local adverse reactions to the physician. 8. Advise patients not to use mometasone furoate cream in the treatment of diaper dermatitis. Do not apply mometasone furoate cream in the diaper area, as diapers or plastic pants may constitute occlusive dressing. 9. Discontinue therapy when control is achieved. If no improvement is seen within 2 weeks, contact the physician. 10. Do not use other corticosteroid-containing products with mometasone furoate cream without first consulting with the physician. Manufactured by: Glenmark Pharmaceuticals Ltd. Village Kishanpura, Baddi Nalagarh Road District : Solan, Himachal Pradesh - 173205, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 Questions? 1 (888) 721-7115 www.glenmarkpharma.com/usa July 2019 glenmark-logo"],"dosage_and_administration":["2 DOSAGE AND ADMINISTRATION Apply a thin film of mometasone furoate cream, 0.1% to the affected skin areas once daily. Mometasone furoate cream, 0.1% may be used in pediatric patients 2 years of age or older. Since safety and efficacy of mometasone furoate cream, 0.1% have not been established in pediatric patients below 2 years of age; use in this age group is not recommended [see Warnings and Precautions ( 5.1 ) and Use in Specific Populations ( 8.4 )]. Therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary [see Warnings and Precautions (5.1)]. Do not use mometasone furoate cream, 0.1% with occlusive dressings unless directed by a physician. Do not apply mometasone furoate cream, 0.1% in the diaper area if the patient still requires diapers or plastic pants, as these garments may constitute occlusive dressing. Avoid contact with eyes. Wash hands after each application. Avoid use on the face, groin, or axillae. Mometasone furoate cream, 0.1% is for topical use only. It is not for oral, ophthalmic, or intravaginal use. • Apply a thin film to the affected skin areas once daily. ( 2 ) • Discontinue therapy when control is achieved. ( 2 ) • If no improvement is seen within 2 weeks, reassess diagnosis. ( 2 ) • Do not use with occlusive dressings unless directed by a physician. ( 2 )"],"spl_product_data_elements":["Mometasone Furoate Mometasone Furoate MOMETASONE FUROATE MOMETASONE ALUMINUM STARCH OCTENYLSUCCINATE HEXYLENE GLYCOL HYDROGENATED SOYBEAN LECITHIN PHOSPHORIC ACID WATER TITANIUM DIOXIDE PETROLATUM WHITE WAX"],"dosage_forms_and_strengths":["3 DOSAGE FORMS AND STRENGTHS Cream, 0.1%. Each gram of Mometasone Furoate Cream USP, 0.1% contains 1 mg of mometasone furoate, USP in a white to off-white, uniform and smooth cream. • Cream, 0.1%. ( 3 )"],"spl_patient_package_insert":["Patient Information Mometasone Furoate (moe-MET-a-sone-FYOOR-oh-ate) Cream, 0.1% Important information: Mometasone furoate cream is for use on skin only. Do not use mometasone furoate cream in your eyes, mouth, or vagina. What is Mometasone furoate cream? • Mometasone furoate cream is a prescription medicine used on the skin (topical) for the relief of redness, swelling, heat, pain (inflammation) and itching, caused by certain skin problems in people 2 years of age and older. • It is not known if mometasone furoate cream is safe and effective for use in children under 2 years of age. • Mometasone furoate cream should not be used in children under 2 years of age. • It is not known if mometasone furoate cream is safe and effective for use in children longer than 3 weeks. Do not use mometasone furoate cream if you are allergic to mometasone furoate or any of the ingredients in mometasone furoate cream, 0.1%. See the end of this leaflet for a complete list of ingredients in mometasone furoate cream. Before using mometasone furoate cream, tell your healthcare provider about all your medical conditions, including if you: • have a skin infection at the site to be treated. You may also need medicine to treat the skin infection. • are pregnant or plan to become pregnant. It is not known if mometasone furoate cream will harm your unborn baby. • are breastfeeding or plan to breastfeed. It is not known if mometasone furoate cream passes into your breast milk. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you take other corticosteroid medicines by mouth or use other products on your skin or scalp that contain corticosteroids. How should I use mometasone furoate cream? • Use mometasone furoate cream exactly as your healthcare provider tells you to use it. • Apply a thin film of mometasone furoate cream to the affected skin area 1 time each day. • Tell your healthcare provider if the treated skin area does not get better after 2 weeks of treatment. • Do not bandage, cover, or wrap the treated skin area unless your healthcare provider tells you to. • Mometasone furoate cream should not be used to treat diaper rash or redness. Do not apply mometasone furoate cream in the diaper area if wearing diapers or plastic pants. • Avoid using mometasone furoate cream on the face, groin, or underarms (armpits). • Wash your hands after applying mometasone furoate cream. What are the possible side effects of mometasone furoate cream? Mometasone furoate cream may cause serious side effects, including: • Mometasone furoate cream can pass through your skin. Too much mometasone furoate cream passing through your skin can cause your adrenal glands to stop working properly. Your healthcare provider may do blood tests to check for adrenal gland problems. • Vision problems. Topical corticosteroids may increase your chance of developing vision problems such as cataract and glaucoma. Tell your healthcare provider if you develop blurred vision or other vision problems during treatment with mometasone furoate cream. • Skin problems. Skin problems may happen during treatment with mometasone furoate cream, including allergic reactions (contact dermatitis) and skin infections at the treatment site. Stop using mometasone furoate cream and tell your healthcare provider if you develop any skin reactions such as pain, tenderness, swelling, or problems healing during treatment with mometasone furoate cream. The most common side effects of mometasone furoate cream include burning, itching, and thinning of the skin (atrophy). These are not all the possible side effects of mometasone furoate cream. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. How should I store mometasone furoate cream? • Store mometasone furoate cream at room temperature between 68°F to 77°F (20°C to 25°C). • Keep mometasone furoate cream and all medicines out of the reach of children. General information about the safe and effective use of mometasone furoate cream. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use mometasone furoate cream for a condition for which it was not prescribed. Do not give mometasone furoate cream to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about mometasone furoate cream that is written for health professionals. What are the ingredients in mometasone furoate cream, 0.1%? Active ingredient: mometasone furoate Inactive ingredients: aluminum starch octenyl succinate (Dry-Flo Plus(Pure)), hexylene glycol, phospholipon 90 H, phosphoric acid, purified water, titanium dioxide, white petrolatum, and white wax. Manufactured by: Glenmark Pharmaceuticals Ltd. Village Kishanpura, Baddi Nalagarh Road District : Solan, Himachal Pradesh - 173205, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 Questions? 1 (888) 721-7115 www.glenmarkpharma.com/usa July 2019 This Patient Information has been approved by the U.S. Food and Drug Administration. logo"],"use_in_specific_populations":["8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Teratogenic Effects Pregnancy Category C: There are no adequate and well-controlled studies in pregnant women. Therefore, mometasone furoate cream should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Some corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. When administered to pregnant rats, rabbits, and mice, mometasone furoate increased fetal malformations. The doses that produced malformations also decreased fetal growth, as measured by lower fetal weights and/or delayed ossification. Mometasone furoate also caused dystocia and related complications when administered to rats during the end of pregnancy. In mice, mometasone furoate caused cleft palate at subcutaneous doses of 60 mcg/kg and above. Fetal survival was reduced at 180 mcg/kg. No toxicity was observed at 20 mcg/kg. (Doses of 20, 60, and 180 mcg/kg in the mouse are approximately 0.01, 0.02, and 0.05 times the estimated maximum clinical topical dose from mometasone furoate cream on a mcg/m 2 basis.) In rats, mometasone furoate produced umbilical hernias at topical doses of 600 mcg/kg and above. A dose of 300 mcg/kg produced delays in ossification, but no malformations. (Doses of 300 and 600 mcg/kg in the rat are approximately 0.2 and 0.4 times the estimated maximum clinical topical dose from mometasone furoate cream on a mcg/m 2 basis.) In rabbits, mometasone furoate caused multiple malformations (e.g., flexed front paws, gallbladder agenesis, umbilical hernia, hydrocephaly) at topical doses of 150 mcg/kg and above (approximately 0.2 times the estimated maximum clinical topical dose from mometasone furoate cream on a mcg/m 2 basis). In an oral study, mometasone furoate increased resorptions and caused cleft palate and/or head malformations (hydrocephaly and domed head) at 700 mcg/kg. At 2800 mcg/kg most litters were aborted or resorbed. No toxicity was observed at 140 mcg/kg. (Doses at 140, 700, and 2800 mcg/kg in the rabbit are approximately 0.2, 0.9, and 3.6 times the estimated maximum clinical topical dose from mometasone furoate cream on a mcg/m 2 basis.) When rats received subcutaneous doses of mometasone furoate throughout pregnancy or during the later stages of pregnancy, 15 mcg/kg caused prolonged and difficult labor and reduced the number of live births, birth weight, and early pup survival. Similar effects were not observed at 7.5 mcg/kg. (Doses of 7.5 and 15 mcg/kg in the rat are approximately 0.005 and 0.01 times the estimated maximum clinical topical dose from mometasone furoate cream on a mcg/m 2 basis.) 8.3 Nursing Mothers Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Because many drugs are excreted in human milk, caution should be exercised when mometasone furoate cream is administered to a nursing woman. 8.4 Pediatric Use Mometasone furoate cream may be used with caution in pediatric patients 2 years of age or older, although the safety and efficacy of drug use for longer than 3 weeks have not been established. Since safety and efficacy of mometasone furoate cream have not been established in pediatric patients below 2 years of age, its use in this age group is not recommended. In a pediatric trial, 24 atopic dermatitis subjects, of whom 19 subjects were age 2 to 12 years, were treated with mometasone furoate cream once daily. The majority of subjects cleared within 3 weeks. Mometasone furoate cream caused HPA axis suppression in approximately 16% of pediatric subjects ages 6 to 23 months, who showed normal adrenal function by Cortrosyn test before starting treatment, and were treated for approximately 3 weeks over a mean body surface area of 41% (range 15% to 94%). The criteria for suppression were: basal cortisol level of ≤5 mcg/dL, 30-minute post-stimulation level of ≤18 mcg/dL, or an increase of <7 mcg/dL. Follow-up testing 2 to 4 weeks after trial completion, available for 5 of the subjects, demonstrated suppressed HPA axis function in 1 subject, using these same criteria. Long-term use of topical corticosteroids has not been studied in this population [see Clinical Pharmacology ( 12.2 )] . Because of a higher ratio of skin surface area to body mass, pediatric patients are at a greater risk than adults of HPA axis suppression and Cushing’s syndrome when they are treated with topical corticosteroids. They are, therefore, also at greater risk of adrenal insufficiency during and/or after withdrawal of treatment. Pediatric patients may be more susceptible than adults to skin atrophy, including striae, when they are treated with topical corticosteroids. Pediatric patients applying topical corticosteroids to greater than 20% of body surface are at higher risk of HPA axis suppression. HPA axis suppression, Cushing’s syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in pediatric patients receiving topical corticosteroids. Manifestations of adrenal suppression in children include low plasma cortisol levels and an absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema. Mometasone furoate cream should not be used in the treatment of diaper dermatitis. 8.5 Geriatric Use Clinical studies of mometasone furoate cream included 190 subjects who were 65 years of age and over and 39 subjects who were 75 years of age and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients. However, greater sensitivity of some older individuals cannot be ruled out."],"package_label_principal_display_panel":["Package/Label Display Panel NDC 68462-192-55 Mometasone Furaoate Cream USP, 0.1% cream-carton"],"carcinogenesis_and_mutagenesis_and_impairment_of_fertility":["13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term animal studies have not been performed to evaluate the carcinogenic potential of mometasone furoate cream. Long-term carcinogenicity studies of mometasone furoate were conducted by the inhalation route in rats and mice. In a 2-year carcinogenicity study in Sprague Dawley rats, mometasone furoate demonstrated no statistically significant increase of tumors at inhalation doses up to 67 mcg/kg (approximately 0.04 times the estimated maximum clinical topical dose from mometasone furoate cream on a mcg/m 2 basis). In a 19-month carcinogenicity study in Swiss CD-1 mice, mometasone furoate demonstrated no statistically significant increase in the incidence of tumors at inhalation doses up to 160 mcg/kg (approximately 0.05 times the estimated maximum clinical topical dose from mometasone furoate cream on a mcg/m 2 basis). Mometasone furoate increased chromosomal aberrations in an in vitro Chinese hamster ovary cell assay, but did not increase chromosomal aberrations in an in vitro Chinese hamster lung cell assay. Mometasone furoate was not mutagenic in the Ames test or mouse lymphoma assay, and was not clastogenic in an in vivo mouse micronucleus assay, a rat bone marrow chromosomal aberration assay, or a mouse male germ-cell chromosomal aberration assay. Mometasone furoate also did not induce unscheduled DNA synthesis in vivo in rat hepatocytes. In reproductive studies in rats, impairment of fertility was not produced in male or female rats by subcutaneous doses up to 15 mcg/kg (approximately 0.01 times the estimated maximum clinical topical dose from mometasone furoate cream, on a mcg/m 2 basis)."]},"tags":[{"label":"Corticosteroid","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"Progesterone receptor","category":"target"},{"label":"PGR","category":"gene"},{"label":"NR3C1","category":"gene"},{"label":"ABCB1","category":"gene"},{"label":"D07AC13","category":"atc"},{"label":"Nasal","category":"route"},{"label":"Respiratory (Inhalation)","category":"route"},{"label":"Intrasinal","category":"route"},{"label":"Aerosol","category":"form"},{"label":"Cream","category":"form"},{"label":"Implant","category":"form"},{"label":"Inhalant","category":"form"},{"label":"Off-Patent","category":"patent"},{"label":"Generic Available","category":"availability"},{"label":"Established","category":"status"},{"label":"Allergic Rhinitis Prevention","category":"indication"},{"label":"Allergic asthma","category":"indication"},{"label":"Allergic rhinitis","category":"indication"},{"label":"Asthma","category":"indication"},{"label":"Asthma management","category":"indication"},{"label":"Atopic dermatitis","category":"indication"},{"label":"Organon","category":"company"},{"label":"Approved 1980s","category":"decade"},{"label":"Anti-Allergic Agents","category":"pharmacology"},{"label":"Anti-Inflammatory Agents","category":"pharmacology"},{"label":"Dermatologic Agents","category":"pharmacology"}],"phase":"marketed","safety":{"boxedWarnings":[],"safetySignals":[{"llr":11304.307,"date":"","count":3723,"signal":"Product quality issue","source":"DrugCentral FAERS","actionTaken":"Reported 3,723 times (LLR=11304)"},{"llr":8485.299,"date":"","count":3299,"signal":"No adverse event","source":"DrugCentral FAERS","actionTaken":"Reported 3,299 times (LLR=8485)"},{"llr":5187.672,"date":"","count":1115,"signal":"Poor quality device used","source":"DrugCentral FAERS","actionTaken":"Reported 1,115 times (LLR=5188)"},{"llr":4498.71,"date":"","count":3588,"signal":"Product dose omission issue","source":"DrugCentral FAERS","actionTaken":"Reported 3,588 times (LLR=4499)"},{"llr":1434.532,"date":"","count":392,"signal":"Product container issue","source":"DrugCentral FAERS","actionTaken":"Reported 392 times (LLR=1435)"},{"llr":1272.612,"date":"","count":1301,"signal":"Asthma","source":"DrugCentral FAERS","actionTaken":"Reported 1,301 times (LLR=1273)"},{"llr":1143.752,"date":"","count":615,"signal":"Device malfunction","source":"DrugCentral FAERS","actionTaken":"Reported 615 times (LLR=1144)"},{"llr":934.218,"date":"","count":1005,"signal":"Wheezing","source":"DrugCentral FAERS","actionTaken":"Reported 1,005 times (LLR=934)"},{"llr":817.393,"date":"","count":333,"signal":"Circumstance or information capable of leading to medication error","source":"DrugCentral FAERS","actionTaken":"Reported 333 times (LLR=817)"},{"llr":654.68,"date":"","count":820,"signal":"Gastrooesophageal reflux disease","source":"DrugCentral FAERS","actionTaken":"Reported 820 times (LLR=655)"},{"llr":493.285,"date":"","count":306,"signal":"Sleep disorder due to a general medical condition","source":"DrugCentral FAERS","actionTaken":"Reported 306 times (LLR=493)"},{"llr":474.58,"date":"","count":1425,"signal":"Cough","source":"DrugCentral FAERS","actionTaken":"Reported 1,425 times (LLR=475)"},{"llr":447.085,"date":"","count":258,"signal":"Rhinitis allergic","source":"DrugCentral FAERS","actionTaken":"Reported 258 times (LLR=447)"},{"llr":407.587,"date":"","count":203,"signal":"Nasal polyps","source":"DrugCentral FAERS","actionTaken":"Reported 203 times (LLR=408)"},{"llr":367.988,"date":"","count":328,"signal":"Obstructive airways disorder","source":"DrugCentral FAERS","actionTaken":"Reported 328 times (LLR=368)"}],"commonSideEffects":[{"effect":"Skin atrophy","drugRate":"5%","severity":"mild","_validated":true},{"effect":"Decreased glucocorticoid levels","drugRate":"5%","severity":"mild","_validated":true},{"effect":"Unspecified skin disorder","drugRate":"reported","severity":"unknown"},{"effect":"Bacterial skin infection","drugRate":"reported","severity":"unknown"},{"effect":"Irritation","drugRate":"reported","severity":"unknown"},{"effect":"Dryness","drugRate":"reported","severity":"unknown"},{"effect":"Folliculitis","drugRate":"reported","severity":"unknown"},{"effect":"Hypertrichosis","drugRate":"reported","severity":"unknown"},{"effect":"Acneiform eruptions","drugRate":"reported","severity":"unknown"},{"effect":"Hypopigmentation","drugRate":"reported","severity":"unknown"},{"effect":"Perioral dermatitis","drugRate":"reported","severity":"unknown"},{"effect":"Allergic contact dermatitis","drugRate":"reported","severity":"unknown"},{"effect":"Secondary infection","drugRate":"reported","severity":"unknown"},{"effect":"Striae","drugRate":"reported","severity":"unknown"},{"effect":"Miliaria","drugRate":"reported","severity":"unknown"},{"effect":"Shininess","drugRate":"reported","severity":"unknown"},{"effect":"Telangiectasia","drugRate":"reported","severity":"unknown"},{"effect":"Loss of elasticity","drugRate":"reported","severity":"unknown"},{"effect":"Loss of normal skin markings","drugRate":"reported","severity":"unknown"},{"effect":"Thinness","drugRate":"reported","severity":"unknown"}],"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"],"specialPopulations":{"Lactation":"There are no available data on the presence of SINUVA Sinus Implant in human milk, the effects on the breastfed child or the effects on milk production. Systemic absorption of single inhaled 400 mcg mometasone dose was less than 1%. It is not known if mometasone furoate is excreted in human milk. Other inhaled corticosteroids, similar to mometasone furoate, are present in human milk.","Pregnancy":"Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Some corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. When administered to pregnant rats, rabbits, and mice, mometasone furoate increased fetal malformations. The doses that produced malformations also decreased fetal growth, as measured by lower fetal weights and/or delayed ossification.","Geriatric use":"Clinical studies of mometasone furoate cream USP 0.1% included 190 subjects who were 65 years of age and over and 39 subjects who were 75 years of age and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients.","Paediatric use":"Mometasone furoate cream USP 0.1% may be used with caution in pediatric patients years of age or older, although the safety and efficacy of drug use for longer than weeks have not been established. Use of mometasone furoate cream USP 0.1% is supported by results from adequate and well-controlled studies in pediatric patients with corticosteroid-responsive dermatoses."}},"trials":[],"aliases":[],"company":"Merck & Co.","patents":[{"type":"Formulation","number":"8025635","applicant":"INTERSECT ENT INC","territory":"US","tradeName":"SINUVA","expiryDate":"2027-06-12"},{"type":"Formulation","number":"10232152","applicant":"INTERSECT ENT INC","territory":"US","tradeName":"SINUVA","expiryDate":"2034-11-24"},{"type":"Method of Use","number":"10357640","applicant":"INTERSECT ENT INC","territory":"US","tradeName":"SINUVA","expiryDate":"2031-10-03"},{"type":"Method of Use","number":"9585681","applicant":"INTERSECT ENT INC","territory":"US","tradeName":"SINUVA","expiryDate":"2026-04-04"},{"type":"Method of Use","number":"7544192","applicant":"INTERSECT ENT INC","territory":"US","tradeName":"SINUVA","expiryDate":"2026-11-29"},{"type":"Formulation","number":"10406332","applicant":"INTERSECT ENT INC","territory":"US","tradeName":"SINUVA","expiryDate":"2034-03-13"},{"type":"Formulation","number":"8763222","applicant":"INTERSECT ENT INC","territory":"US","tradeName":"SINUVA","expiryDate":"2032-02-08"}],"pricing":[{"market":"United States","source":"CMS National Average Drug Acquisition Cost (NADAC)","asOfDate":"2024-01-03","unitCost":"$0.2857/GM","priceType":"NADAC","sourceUrl":"https://data.medicaid.gov/dataset/4j6z-xnwq","annualCost":"$104","description":"MOMETASONE FUROATE 0.1% CREAM","retrievedDate":"2026-04-07"}],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=MOMETASONE FUROATE","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T03:35:10.044791+00:00"},"patents":{"url":"","method":"deterministic","source":"FDA Orange Book","rawText":"","confidence":1,"sourceType":"fda_orange_book","retrievedAt":"2026-04-20T03:35:10.044709+00:00"},"timeline":{"url":"https://en.wikipedia.org/wiki/Mometasone Furoate","method":"deterministic","source":"Wikipedia","rawText":"","confidence":0.8,"sourceType":"wikipedia","retrievedAt":"2026-04-20T03:35:16.861798+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T03:35:15.441413+00:00"},"regulatory.eu":{"url":"","method":"api_direct","source":"European Medicines Agency","rawText":"","confidence":1,"sourceType":"ema_api","retrievedAt":"2026-04-20T03:35:10.114210+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=MOMETASONE FUROATE","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T03:35:15.804650+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T03:35:08.765026+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (no boxed warning)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T03:35:08.765053+00:00"},"mechanism.target_chembl":{"url":"","method":"api_direct","source":"ChEMBL mechanism: Glucocorticoid receptor agonist","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T03:35:16.861722+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL1161/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T03:35:16.518270+00:00"},"regulatory.fda_application":{"url":"","method":"deterministic","source":"FDA Label","rawText":"ANDA078541","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T03:35:08.765056+00:00"}},"allNames":"elocon","offLabel":[],"synonyms":["mometasone furoate hydrate","mometasone furoate","asmanex","ecural","elomet","nasonex","mometasone furoate monohydrate"],"timeline":[{"date":"1987-01-01","type":"neutral","source":"FDA Orange Book","milestone":"Rights transferred from MERCK SHARP DOHME to Organon"},{"date":"1987-04-30","type":"positive","source":"DrugCentral","milestone":"FDA approval (Merck Sharp Dohme)"},{"date":"1989-03-30","type":"positive","source":"FDA Orange Book","milestone":"Elocon approved — 0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**"},{"date":"1997-10-01","type":"positive","source":"FDA Orange Book","milestone":"Nasonex approved — 0.05MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**"},{"date":"2007-04-18","type":"neutral","source":"FDA Orange Book","milestone":"Generic entry — 7 manufacturers approved"},{"date":"2008-02-01","type":"positive","source":"FDA Orange Book","milestone":"Asmanex Twisthaler approved — 0.11MG/INH"},{"date":"2014-04-25","type":"positive","source":"FDA Orange Book","milestone":"Asmanex Hfa approved — 0.10MG/INH"},{"date":"2017-12-08","type":"positive","source":"FDA Orange Book","milestone":"Sinuva approved — 1.35MG"},{"date":"2020-05-30","type":"positive","source":"DrugCentral","milestone":"EMA approval (Novartis Europharm Limited)"},{"date":"2020-06-29","type":"positive","source":"DrugCentral","milestone":"PMDA approval (Novartis Pharma K.K.)"},{"date":"2022-03-17","type":"positive","source":"FDA Orange Book","milestone":"Nasonex 24Hr Allergy approved — 0.05MG/SPRAY"}],"aiSummary":"Elocon (MOMETASONE FUROATE) is a corticosteroid medication originally developed by Merck Sharp Dohme and currently owned by Organon. It targets the progesterone receptor and is a small molecule modality. Elocon is FDA-approved for various allergic and inflammatory conditions, including allergic rhinitis, asthma, and atopic dermatitis. The medication is off-patent, with 15 generic manufacturers available. Key safety considerations include its low bioavailability and short half-life.","approvals":[{"date":"1987-04-30","orphan":false,"company":"MERCK SHARP DOHME","regulator":"FDA"},{"date":"2020-05-30","orphan":false,"company":"Novartis Europharm Limited","regulator":"EMA"},{"date":"2020-06-29","orphan":false,"company":"Novartis Pharma K.K.","regulator":"PMDA"}],"brandName":"Elocon","ecosystem":[{"indication":"Allergic Rhinitis Prevention","otherDrugs":[{"name":"budesonide","slug":"budesonide","company":""},{"name":"desonide","slug":"desonide","company":"Perrigo New York"},{"name":"flunisolide","slug":"flunisolide","company":""},{"name":"triamcinolone","slug":"triamcinolone","company":""}],"globalPrevalence":null},{"indication":"Allergic asthma","otherDrugs":[{"name":"fluticasone propionate","slug":"fluticasone-propionate","company":"Fougera Pharms"},{"name":"formoterol","slug":"formoterol","company":"Novartis"},{"name":"montelukast","slug":"montelukast","company":"Merck"},{"name":"salmeterol","slug":"salmeterol","company":""}],"globalPrevalence":262000000},{"indication":"Allergic rhinitis","otherDrugs":[{"name":"acrivastine","slug":"acrivastine","company":"Auxilium Pharms Inc"},{"name":"alimemazine","slug":"alimemazine","company":"Allergan Herbert"},{"name":"antazoline","slug":"antazoline","company":"Novartis"},{"name":"astemizole","slug":"astemizole","company":""}],"globalPrevalence":null},{"indication":"Asthma","otherDrugs":[{"name":"beclometasone dipropionate","slug":"beclometasone-dipropionate","company":""},{"name":"betamethasone","slug":"betamethasone","company":""},{"name":"betamethasone acetate","slug":"betamethasone-acetate","company":""},{"name":"bitolterol","slug":"bitolterol","company":"Sanofi Aventis Us"}],"globalPrevalence":262000000},{"indication":"Asthma management","otherDrugs":[{"name":"beclometasone dipropionate","slug":"beclometasone-dipropionate","company":""},{"name":"bitolterol","slug":"bitolterol","company":"Sanofi Aventis Us"},{"name":"budesonide","slug":"budesonide","company":""},{"name":"ciclesonide","slug":"ciclesonide","company":"Takeda Gmbh"}],"globalPrevalence":262000000},{"indication":"Atopic dermatitis","otherDrugs":[{"name":"abrocitinib","slug":"abrocitinib","company":"PFIZER Inc"},{"name":"alclometasone dipropionate","slug":"alclometasone-dipropionate","company":""},{"name":"amcinonide","slug":"amcinonide","company":"Astellas"},{"name":"ammonium lactate","slug":"ammonium-lactate","company":"Ranbaxy"}],"globalPrevalence":204050000},{"indication":"Chronic Non-Allergic Rhinitis","otherDrugs":[{"name":"budesonide","slug":"budesonide","company":""},{"name":"desonide","slug":"desonide","company":"Perrigo New York"},{"name":"flunisolide","slug":"flunisolide","company":""},{"name":"fluticasone furoate","slug":"fluticasone-furoate","company":"Glaxosmithkline"}],"globalPrevalence":null},{"indication":"Contact dermatitis","otherDrugs":[{"name":"alclometasone dipropionate","slug":"alclometasone-dipropionate","company":""},{"name":"amcinonide","slug":"amcinonide","company":"Astellas"},{"name":"ammonium lactate","slug":"ammonium-lactate","company":"Ranbaxy"},{"name":"benzoyl peroxide","slug":"benzoyl-peroxide","company":"Valeant Intl"}],"globalPrevalence":324000000}],"mechanism":{"target":"Progesterone receptor","novelty":"Follow-on","targets":[{"gene":"PGR","source":"DrugCentral","target":"Progesterone receptor","protein":"Progesterone receptor"},{"gene":"NR3C1","source":"DrugCentral","target":"Glucocorticoid receptor","protein":"Glucocorticoid receptor"},{"gene":"ABCB1","source":"DrugCentral","target":"Multidrug resistance protein 1","protein":"Multidrug resistance protein 1"}],"moaClass":"Corticosteroid Hormone Receptor Agonists","modality":"Small Molecule","drugClass":"Corticosteroid","explanation":"NASONEX Nasal Spray 50 mcg is corticosteroid demonstrating potent anti-inflammatory properties. The precise mechanism of corticosteroid action on allergic rhinitis is not known. Corticosteroids have been shown to have 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, NASONEX Nasal Spray, 50 mcg 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 NASONEX Nasal Spray, 50 mcg on nasal mucosa following 12 months of treatment was examined in 46 patients w","oneSentence":"Elocon works by binding to the progesterone receptor, which reduces inflammation and immune response in the body.","technicalDetail":"Mometasone furoate is a synthetic corticosteroid that selectively binds to the glucocorticoid receptor, which then translocates to the nucleus and regulates the expression of anti-inflammatory genes, leading to a decrease in the production of pro-inflammatory cytokines and mediators.","_target_confidence":0.5},"_wikipedia":{"url":"https://en.wikipedia.org/wiki/Mometasone","title":"Mometasone","extract":"Mometasone and its derivate mometasone furoate are steroids, medications used to treat certain skin conditions, hay fever, and asthma. Specifically, they are used to prevent, rather than treat, asthma attacks. They can be applied to the skin, inhaled, or used in the nose. Currently only mometasone furoate is used in medical products.","wiki_society_and_culture":"==Society and culture==\n\n===Availability===\nAs of 2016, mometasone furoate is available worldwide in formulations for nasal, oral inhalation, and topical administration, for human and veterinary use, either as a single active agent or in combination with other medications, under many brand names.\n\n===Combinations===\nThe following combination medications are available as of 2022:\n{| class=\"wikitable\"\n|+\n!Combination\n!Commercial Name\n!Notes\n|-\n|azelastine\n|Nasaflex\n|\n|-\n|clotrimazole and gentamicin\n|Mometamax, Mometavet\n|Veterinary use\n|-\n|clotrimazole and mupirocin\n|Derma Q\n|\n|-\n|florfenicol and terbinafine\n|Claro\n|Veterinary use\n|-\n|formoterol\n|Dulera, Hexaler Bronquial Duo, Zenhale\n|\n|-\n|fusidic acid\n|Bactirest-M, Dermotil Fusid, Momate-F\n|\n|-\n|gentamicin and posaconazole\n|Mometamax Ultra\n|Veterinary use\n|-\n|hydroquinone and tretinoin\n|Acnezac-MH\n|\n|-\n|miconazole\n|Elica M, Elica-M, and Sensicort-F\n|\n|-\n|mupirocin\n|Sensicort-B\n|\n|-\n|orbifloxacin and posaconazole\n|Posatex, Posatex voor honden, Posatex für Hunde\n|Veterinary use\n|-\n|salicylic acid\n|Cortimax-S, Elicasal, Elocom Plus, Elosalic, Mezo-S, Momate-S, Momesalic, \nMomtas-S, Monsalic, Sensicort-S\n|\n|-\n|terbinafine\n|Cutizone-T, Mezo-T, MomelomTerbi-Humanity\n|\n|-\n|tiotropium\n|Tiomom\n|}"},"commercial":{"launchDate":"1987","_launchSource":"DrugCentral (FDA 1987-04-30, MERCK SHARP DOHME)"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/1832","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=MOMETASONE%20FUROATE","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=MOMETASONE FUROATE","fields":["publications"],"source":"PubMed/NCBI"},{"id":4,"url":"https://en.wikipedia.org/wiki/Mometasone","fields":["history","overview"],"source":"Wikipedia"},{"id":5,"url":"https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files","fields":["patents","exclusivity","genericManufacturers"],"source":"FDA Orange Book"}],"_emaChecked":true,"_enrichedAt":"2026-03-30T14:33:52.205103","_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T03:35:21.888367+00:00","fieldsConflicting":1,"overallConfidence":0.8},"biosimilars":[],"competitors":[{"drugName":"betamethasone","drugSlug":"betamethasone","fdaApproval":"1961-04-17","patentStatus":"Unknown","relationship":"same-class"},{"drugName":"desoximetasone","drugSlug":"desoximetasone","fdaApproval":"1977-02-28","patentExpiry":"Sep 1, 2028","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"fluocinolone acetonide","drugSlug":"fluocinolone-acetonide","fdaApproval":"1963-02-15","patentExpiry":"Nov 7, 2028","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"fludroxycortide","drugSlug":"fludroxycortide","fdaApproval":"1963-03-19","relationship":"same-class"},{"drugName":"fluocinonide","drugSlug":"fluocinonide","fdaApproval":"1971-06-30","genericCount":23,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"budesonide","drugSlug":"budesonide","fdaApproval":"1994-02-14","patentExpiry":"Sep 9, 2036","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"diflorasone diacetate","drugSlug":"diflorasone-diacetate","fdaApproval":"1977-09-14","genericCount":6,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"amcinonide","drugSlug":"amcinonide","fdaApproval":"1979-10-18","genericCount":4,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"beclometasone dipropionate","drugSlug":"beclometasone-dipropionate","fdaApproval":"1976-05-12","relationship":"same-class"},{"drugName":"hydrocortisone aceponate","drugSlug":"hydrocortisone-aceponate","fdaApproval":"","relationship":"same-class"},{"drugName":"fluticasone furoate","drugSlug":"fluticasone-furoate","fdaApproval":"2007-04-27","patentExpiry":"Oct 15, 2028","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"fluticasone propionate","drugSlug":"fluticasone-propionate","fdaApproval":"1990-12-14","patentExpiry":"Sep 26, 2039","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"prednicarbate","drugSlug":"prednicarbate","fdaApproval":"1991-09-23","genericCount":1,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"difluprednate","drugSlug":"difluprednate","fdaApproval":"2008-06-23","genericCount":8,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"ulobetasol propionate","drugSlug":"ulobetasol-propionate","fdaApproval":"1990-12-17","relationship":"same-class"}],"dataSources":[{"url":"https://data.medicaid.gov/dataset/4j6z-xnwq","name":"CMS National Average Drug Acquisition Cost (NADAC)","fields":["pricing"],"retrievedDate":"2026-04-07"}],"genericName":"mometasone furoate","indications":{"approved":[{"name":"Allergic Rhinitis Prevention","source":"DrugCentral","snomedId":"","regulator":"FDA","eligibility":null},{"name":"Allergic asthma","source":"DrugCentral","snomedId":389145006,"regulator":"FDA","eligibility":null,"usPrevalence":25000000,"globalPrevalence":262000000,"prevalenceMethod":"curated","prevalenceSource":"WHO, 2023"},{"name":"Allergic rhinitis","source":"DrugCentral","snomedId":61582004,"regulator":"FDA","eligibility":null},{"name":"Asthma","source":"DrugCentral","snomedId":195967001,"regulator":"FDA","eligibility":null,"usPrevalence":25000000,"globalPrevalence":262000000,"prevalenceMethod":"curated","prevalenceSource":"WHO, 2023"},{"name":"Asthma management","source":"DrugCentral","snomedId":406162001,"regulator":"FDA","eligibility":null,"usPrevalence":25000000,"globalPrevalence":262000000,"prevalenceMethod":"curated","prevalenceSource":"WHO, 2023"},{"name":"Atopic dermatitis","source":"DrugCentral","snomedId":24079001,"regulator":"FDA","eligibility":null,"usPrevalence":null,"globalPrevalence":204050000,"prevalenceMethod":"curated","prevalenceSource":"Br J Dermatol, 2023 (PMID:37705227)"},{"name":"Chronic Non-Allergic Rhinitis","source":"DrugCentral","snomedId":"","regulator":"FDA","eligibility":null},{"name":"Contact dermatitis","source":"DrugCentral","snomedId":40275004,"regulator":"FDA","eligibility":null,"usPrevalence":null,"globalPrevalence":324000000,"prevalenceMethod":"curated","prevalenceSource":"Contact Dermatitis, 2025 (PMID:40107276)"},{"name":"Discoid lupus erythematosus","source":"DrugCentral","snomedId":200938002,"regulator":"FDA","eligibility":null,"usPrevalence":null,"globalPrevalence":2400000,"prevalenceMethod":"curated","prevalenceSource":"Orphanet (ORPHANET)"},{"name":"Eruption of skin","source":"DrugCentral","snomedId":271807003,"regulator":"FDA","eligibility":null},{"name":"Granuloma annulare","source":"DrugCentral","snomedId":65508009,"regulator":"FDA"},{"name":"Lichen simplex chronicus","source":"DrugCentral","snomedId":53891004,"regulator":"FDA"},{"name":"Non-allergic asthma","source":"DrugCentral","snomedId":266361008,"regulator":"FDA","usPrevalence":25000000,"globalPrevalence":262000000,"prevalenceMethod":"curated","prevalenceSource":"WHO, 2023"},{"name":"Plaque psoriasis","source":"DrugCentral","snomedId":200965009,"regulator":"FDA","usPrevalence":7500000,"globalPrevalence":125000000,"prevalenceMethod":"curated","prevalenceSource":"WHO, 2023"},{"name":"Primary cutaneous T-cell lymphoma","source":"DrugCentral","snomedId":400122007,"regulator":"FDA"},{"name":"Pruritus ani","source":"DrugCentral","snomedId":90446007,"regulator":"FDA"},{"name":"Pruritus of genital organs","source":"DrugCentral","snomedId":267802000,"regulator":"FDA"},{"name":"Scalp psoriasis","source":"DrugCentral","snomedId":238608008,"regulator":"FDA","usPrevalence":7500000,"globalPrevalence":125000000,"prevalenceMethod":"curated","prevalenceSource":"WHO, 2023"},{"name":"Seborrheic dermatitis","source":"DrugCentral","snomedId":50563003,"regulator":"FDA"}],"offLabel":[{"name":"Severe chronic obstructive pulmonary disease","source":"DrugCentral","drugName":"MOMETASONE FUROATE","evidenceCount":14,"evidenceLevel":"moderate"}],"pipeline":[]},"currentOwner":"Organon","drugCategory":"established","labelChanges":[],"patentStatus":"Off-patent — no active Orange Book patents","relatedDrugs":[{"drugId":"betamethasone","brandName":"betamethasone","genericName":"betamethasone","approvalYear":"1961","relationship":"same-class"},{"drugId":"desoximetasone","brandName":"desoximetasone","genericName":"desoximetasone","approvalYear":"1977","relationship":"same-class"},{"drugId":"fluocinolone-acetonide","brandName":"fluocinolone acetonide","genericName":"fluocinolone acetonide","approvalYear":"1963","relationship":"same-class"},{"drugId":"fludroxycortide","brandName":"fludroxycortide","genericName":"fludroxycortide","approvalYear":"1963","relationship":"same-class"},{"drugId":"fluocinonide","brandName":"fluocinonide","genericName":"fluocinonide","approvalYear":"1971","relationship":"same-class"},{"drugId":"budesonide","brandName":"budesonide","genericName":"budesonide","approvalYear":"1994","relationship":"same-class"},{"drugId":"diflorasone-diacetate","brandName":"diflorasone diacetate","genericName":"diflorasone diacetate","approvalYear":"1977","relationship":"same-class"},{"drugId":"amcinonide","brandName":"amcinonide","genericName":"amcinonide","approvalYear":"1979","relationship":"same-class"},{"drugId":"beclometasone-dipropionate","brandName":"beclometasone dipropionate","genericName":"beclometasone dipropionate","approvalYear":"1976","relationship":"same-class"},{"drugId":"hydrocortisone-aceponate","brandName":"hydrocortisone aceponate","genericName":"hydrocortisone aceponate","approvalYear":"","relationship":"same-class"}],"trialDetails":[{"nctId":"NCT06914908","phase":"PHASE2","title":"Long-term Safety and Efficacy Evaluation of Lunsekimig in Adult Participants With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP) Who Completed a Previous Lunsekimig CRSwNP Study","status":"RECRUITING","sponsor":"Sanofi","startDate":"2025-05-12","conditions":["Chronic Rhinosinusitis With Nasal Polyps"],"enrollment":64,"completionDate":"2031-01-29"},{"nctId":"NCT06834347","phase":"PHASE3","title":"A Phase 3 Study to Assess the Efficacy, Safety, and Tolerability of Itepekimab (Anti-IL-33 mAb) in Participants With Inadequately-controlled Chronic Rhinosinusitis With Nasal Polyps","status":"RECRUITING","sponsor":"Sanofi","startDate":"2025-02-12","conditions":["Chronic Rhinosinusitis With Nasal Polyps"],"enrollment":210,"completionDate":"2027-12-13"},{"nctId":"NCT06834360","phase":"PHASE3","title":"A Phase 3 Study to Assess the Efficacy, Safety, and Tolerability of Itepekimab (Anti-IL-33 mAb) in Participants With Inadequately-controlled Chronic Rhinosinusitis With Nasal Polyps","status":"RECRUITING","sponsor":"Sanofi","startDate":"2025-02-06","conditions":["Chronic Rhinosinusitis With Nasal Polyps"],"enrollment":210,"completionDate":"2027-12-13"},{"nctId":"NCT06439381","phase":"PHASE2","title":"Long-term Safety and Efficacy of TQH2722 Injection in the Treatment of Chronic Sinusitis With or Without Nasal Polyps","status":"RECRUITING","sponsor":"Chia Tai Tianqing Pharmaceutical Group Co., Ltd.","startDate":"2024-07-16","conditions":["Chronic Rhinosinusitis"],"enrollment":120,"completionDate":"2026-06"},{"nctId":"NCT05562466","phase":"PHASE3","title":"A Study to Evaluate the Efficacy and Safety of QMF149 (Indacaterol Acetate/Mometasone Furoate) Versus Budesonide in Children From 6 to Less Than 12 Years of Age With Asthma","status":"RECRUITING","sponsor":"Novartis Pharmaceuticals","startDate":"2023-05-11","conditions":["Asthma"],"enrollment":200,"completionDate":"2028-05-30"},{"nctId":"NCT05295459","phase":"PHASE3","title":"Efficacy and Safety of LYR-210 for the Treatment of Chronic Rhinosinusitis in Adults (ENLIGHTEN 2)","status":"COMPLETED","sponsor":"Lyra Therapeutics","startDate":"2022-05-13","conditions":["Chronic Sinusitis","Chronic Rhinosinusitis (Diagnosis)"],"enrollment":182,"completionDate":"2025-04-02"},{"nctId":"NCT06454240","phase":"PHASE2","title":"A Proof-of-concept Study of Lunsekimig Compared With Placebo in Adults With Chronic Rhinosinusitis With Nasal Polyps","status":"ACTIVE_NOT_RECRUITING","sponsor":"Sanofi","startDate":"2024-07-17","conditions":["Chronic Rhinosinusitis With Nasal Polyps"],"enrollment":79,"completionDate":"2026-04-23"},{"nctId":"NCT05776927","phase":"PHASE3","title":"A Study to Evaluate the Efficacy and Safety of QVM149 (Indacaterol Acetate / Glycopyrronium Bromide / Mometasone Furoate) Versus Salmeterol Xinafoate/Fluticasone Propionate in Children From 12 Years to Less Than 18 Years of Age With Asthma.","status":"NOT_YET_RECRUITING","sponsor":"Novartis Pharmaceuticals","startDate":"2026-05-29","conditions":["Asthma"],"enrollment":304,"completionDate":"2029-12-24"},{"nctId":"NCT04898764","phase":"PHASE4","title":"Research on Underlying Causes of Long-term Use of Nasal Decongestants and the Structured Withdrawal of the Decongestant","status":"COMPLETED","sponsor":"University Hospital, Ghent","startDate":"2020-10-21","conditions":["Rhinitis Medicamentosa"],"enrollment":72,"completionDate":"2025-04-30"},{"nctId":"NCT04851964","phase":"PHASE3","title":"Efficacy and Safety of Tezepelumab in Participants With Severe Chronic Rhinosinusitis With Nasal Polyposis","status":"COMPLETED","sponsor":"AstraZeneca","startDate":"2021-04-22","conditions":["Chronic Rhinosinusitis With Nasal Polyps"],"enrollment":416,"completionDate":"2024-12-11"},{"nctId":"NCT02892344","phase":"PHASE3","title":"Study of QMF149 (150/80 µg) Compared With MF Twisthaler® (200 µg) in Patients With Asthma","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2017-01-16","conditions":["Mild Asthma"],"enrollment":802,"completionDate":"2018-11-30"},{"nctId":"NCT07311759","phase":"PHASE3","title":"Safety and Efficacy of Intralesional 0.5% Triamcinolone Acetonide in 0.2% Fluconazole Solution vs 0.1% Topical Mometasone Furoate With 2% Miconazole Nitrate Cream in the Treatment of Chronic Paronychia: An Intraindividual Randomized Controlled Trial.","status":"ACTIVE_NOT_RECRUITING","sponsor":"Cairo University","startDate":"2024-08-17","conditions":["Chronic Paronychia"],"enrollment":21,"completionDate":"2026-05"},{"nctId":"NCT07286201","phase":"NA","title":"Evaluation of the Safety and Performance of a Bioresorbable Nasal Dressing Containing Mometasone Furoate (MF)","status":"NOT_YET_RECRUITING","sponsor":"Polyganics BV","startDate":"2026-01","conditions":["Chronic Rhinosinusitis (CRS)","Chronic Rhinosinusitis (CRS) With and Without Nasal Polyps"],"enrollment":110,"completionDate":"2027-01"},{"nctId":"NCT06451640","phase":"PHASE2","title":"A Extension Clinical Study of TQC2731 Injection in the Treatment of Chronic Sinusitis With Nasal Polyps","status":"COMPLETED","sponsor":"Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.","startDate":"2024-07-04","conditions":["Chronic Rhinosinusitis With Nasal Polyps"],"enrollment":59,"completionDate":"2025-10-17"},{"nctId":"NCT07240376","phase":"NA","title":"Efficacy and Safety of Stapokibart in Non-Allergic Rhinitis With Eosinophilia Syndrome","status":"NOT_YET_RECRUITING","sponsor":"Huazhong University of Science and Technology","startDate":"2025-11-25","conditions":["Non-Allergic Rhinitis With Eosinophilia Syndrome"],"enrollment":90,"completionDate":"2027-02-28"},{"nctId":"NCT06691113","phase":"PHASE2","title":"A Proof-of-Concept Study to Assess the Efficacy, Safety and Tolerability of Itepekimab (Anti--IL-33 mAb) in Participants With Chronic Rhinosinusitis Without Nasal Polyps","status":"ACTIVE_NOT_RECRUITING","sponsor":"Sanofi","startDate":"2024-12-16","conditions":["Chronic Rhinosinusitis Without Nasal Polyps"],"enrollment":60,"completionDate":"2027-02-09"},{"nctId":"NCT06013241","phase":"PHASE2","title":"A Study of the Efficacy and Safety of Brensocatib in Participants With Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP)","status":"COMPLETED","sponsor":"Insmed Incorporated","startDate":"2023-10-30","conditions":["Chronic Rhinosinusitis Without Nasal Polyps"],"enrollment":288,"completionDate":"2025-10-30"},{"nctId":"NCT07052942","phase":"PHASE4","title":"Individualizing Treatment for Asthma in Primary Care (Full Study)","status":"RECRUITING","sponsor":"DARTNet Institute","startDate":"2025-08-01","conditions":["Asthma","Asthma Attack","Asthma Exacerbations"],"enrollment":3200,"completionDate":"2029-11-15"},{"nctId":"NCT05382494","phase":"PHASE4","title":"Intranasal Steroid as Medical Therapy For Sleep-Disordered Breathing in Children","status":"COMPLETED","sponsor":"Murdoch Childrens Research Institute","startDate":"2022-12-05","conditions":["Sleep Disorder; Breathing-Related","Snoring","Obstructive Sleep Apnea of Child","Sleep Disorders in Children","Tonsillar Hypertrophy","Adenoidal Disorder"],"enrollment":130,"completionDate":"2025-07-17"},{"nctId":"NCT07174115","phase":"PHASE2","title":"A 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.","startDate":"2025-08-18","conditions":["Chronic Sinusitis Without Nasal Polyps"],"enrollment":30,"completionDate":"2026-06"},{"nctId":"NCT05217810","phase":"","title":"A 24-week Prospective, Open-label, Multicenter, Single-arm rPMS Study in Real-world Setting for Atectura®","status":"RECRUITING","sponsor":"Novartis Pharmaceuticals","startDate":"2022-05-09","conditions":["Asthma"],"enrollment":600,"completionDate":"2026-12-23"},{"nctId":"NCT07114107","phase":"NA","title":"Vibroacoustic Therapy With Oscillating Positive Expiratory Pressure in the Treatment of Nasal Congestion","status":"NOT_YET_RECRUITING","sponsor":"Second Affiliated Hospital, School of Medicine, Zhejiang University","startDate":"2025-08","conditions":["Atopic Rhinitis","Atopic Asthma"],"enrollment":200,"completionDate":"2026-05"},{"nctId":"NCT04480242","phase":"","title":"Asthma Research in Children and Adolescents","status":"ACTIVE_NOT_RECRUITING","sponsor":"Parc de Salut Mar","startDate":"2017-07-26","conditions":["Persistent Asthma","Asthma in Children","Asthma Exacerbation"],"enrollment":525,"completionDate":"2030-12-31"},{"nctId":"NCT06436534","phase":"NA","title":"Efficacy and Safety of Ganciclovir Capsules in the Treatment of Refractory Moderate-to-severe Allergic Rhinitis","status":"RECRUITING","sponsor":"Union Hospital, Tongji Medical College, Huazhong University of Science and Technology","startDate":"2024-05-24","conditions":["Rhinitis, Allergic"],"enrollment":50,"completionDate":"2026-05"},{"nctId":"NCT03705793","phase":"PHASE4","title":"Effectiveness of Mometasone Nasal Irrigation for Chronic Rhinosinusitis","status":"COMPLETED","sponsor":"Washington University School of Medicine","startDate":"2019-01-01","conditions":["Chronic Rhinosinusitis (Diagnosis)","Allergic Rhinosinusitis","Chronic Eosinophilic Rhinosinusitis"],"enrollment":53,"completionDate":"2020-03-15"},{"nctId":"NCT07016763","phase":"EARLY_PHASE1","title":"Combination of Oral Supplement With Fatty Acids, Vitamin B6, Perilla, and Liquorice With Nasal Steroids for the Treatment of Allergic Rhinitis","status":"COMPLETED","sponsor":"Isola Tiberina - Gemelli Isola Hospital, Rome, Italy","startDate":"2024-09-01","conditions":["Allergic Rhinitis"],"enrollment":400,"completionDate":"2025-03-01"},{"nctId":"NCT07016113","phase":"PHASE2","title":"0.005% Latanoprost Gel for Nonsegmental Vitiligo","status":"NOT_YET_RECRUITING","sponsor":"Universitas Padjadjaran","startDate":"2025-07-01","conditions":["Vitiligo - Macular Depigmentation"],"enrollment":10,"completionDate":"2025-11-30"},{"nctId":"NCT05756647","phase":"PHASE2","title":"Mandibular Advancement vs Home Treatment for Primary Snoring","status":"COMPLETED","sponsor":"Washington University School of Medicine","startDate":"2022-11-07","conditions":["Snoring"],"enrollment":100,"completionDate":"2023-07-03"},{"nctId":"NCT06636240","phase":"NA","title":"Prebiotic Effects of Mulberry Fruit in Children and Adolescents With Atopic Dermatitis","status":"RECRUITING","sponsor":"Taipei Medical University Shuang Ho Hospital","startDate":"2025-03-17","conditions":["Atopic Dermatitis (Eczema)","Atopic Dermatitis, Probiotics"],"enrollment":120,"completionDate":"2026-04-30"},{"nctId":"NCT05545072","phase":"PHASE3","title":"Add-on Dupilumab for AFRS as Postoperative Therapy (ADAPT)","status":"TERMINATED","sponsor":"Emory University","startDate":"2023-10-26","conditions":["Allergic Fungal Rhinosinusitis"],"enrollment":5,"completionDate":"2024-07-10"},{"nctId":"NCT05219968","phase":"PHASE3","title":"Efficacy and Safety of LYR-210 for the Treatment of Chronic Rhinosinusitis in Adults","status":"COMPLETED","sponsor":"Lyra Therapeutics","startDate":"2022-01-27","conditions":["Chronic Sinusitis","Chronic Rhinosinusitis (Diagnosis)"],"enrollment":196,"completionDate":"2024-09-16"},{"nctId":"NCT06272370","phase":"PHASE4","title":"Individualizing Treatment for Asthma in Primary Care","status":"COMPLETED","sponsor":"DARTNet Institute","startDate":"2024-02-01","conditions":["Asthma","Bronchial Diseases","Respiratory Tract Infections","Lung Diseases, Obstructive","Lung Diseases","Respiratory 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Polyps"],"enrollment":200,"completionDate":"2027-12-30"},{"nctId":"NCT03141424","phase":"PHASE4","title":"Periostin-guided Withdrawal of Inhaled Corticosteroids in Patients With Non-eosinophilic Asthma","status":"COMPLETED","sponsor":"Hvidovre University Hospital","startDate":"2022-06-01","conditions":["Asthma"],"enrollment":20,"completionDate":"2024-10-25"},{"nctId":"NCT05902325","phase":"PHASE4","title":"Identifying Predictors Of Response To Mepolizumab In CRSwNP","status":"RECRUITING","sponsor":"Centre hospitalier de l'Université de Montréal (CHUM)","startDate":"2023-10-03","conditions":["Chronic Rhinosinusitis With Nasal Polyps"],"enrollment":36,"completionDate":"2026-12-31"},{"nctId":"NCT04596189","phase":"PHASE4","title":"Dupilumab for Prevention of Recurrence of CRSwNP After ESS","status":"COMPLETED","sponsor":"Centre hospitalier de l'Université de Montréal (CHUM)","startDate":"2021-05-25","conditions":["Chronic Rhinosinusitis With Nasal 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