Overview
Mometasone furoate is a corticosteroid drug that can be used for the treatment of asthma, rhinitis, and certain skin conditions. It has a glucocorticoid receptor binding affinity 22 times stronger than dexamethasone and higher than many other corticosteroids as well. Mometasone furoate is formulated as a dry powder inhaler, nasal spray, and ointment for its different indications.
Indication
Inhaled mometasone furoate is indicated for prophylaxis of asthma in patients ≥4 years. Applied topically as an ointment, mometasone furoate is indicated for symptomatic treatment of dermatitis and pruritis in patients ≥2 years. Mometasone furoate nasal spray is available both over-the-counter (OTC) and by prescription. The OTC nasal spray formulation of mometasone furoate is indicated for the treatment of upper respiratory allergic symptoms (e.g. rhinorrhea, sneezing) in patients ≥2 years of age. The prescription formulation is indicated for the treatment of chronic rhinosinusitis with nasal polyps in patients ≥18 year old and for the and prophylaxis of seasonal allergic rhinitis in patients ≥12 years old. It is also approved in combination with olopatadine for the symptomatic treatment of seasonal allergic rhinitis in patients ≥12 years.
Associated Conditions
- Asthma
- Chronic Rhinosinusitis Phenotype With Nasal Polyps (CRSwNP)
- Dermatitis
- Dermatitis, Eczematous caused by superficial Fungal skin infection
- Moderate to Severe Plaque Psoriasis
- Pruritus
- Psoriasis
- Psoriasis, Moderate to Severe
- Seasonal Allergic Rhinitis
- Seasonal Allergies
- Skin Diseases, Eczematous
- Skin Infections
- Moderate, severe Seasonal Allergic Rhinitis
- Ocular effects
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/06/12 | Early Phase 1 | Completed | Isola Tiberina - Gemelli Isola Hospital, Rome, Italy | ||
2025/04/07 | Phase 2 | Recruiting | |||
2025/02/19 | Phase 3 | Recruiting | |||
2025/02/19 | Phase 3 | Recruiting | |||
2025/01/30 | Phase 4 | Not yet recruiting | Beijing Tongren Hospital | ||
2024/11/15 | Phase 2 | Recruiting | |||
2024/05/31 | Not Applicable | Recruiting | Wuhan Union Hospital, China | ||
2024/05/06 | Phase 4 | Not yet recruiting | |||
2024/01/11 | Phase 3 | Recruiting | Zheng Liu ENT | ||
2023/08/28 | Phase 2 | Active, not recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Physicians Total Care, Inc. | 54868-3757 | TOPICAL | 1 mg in 1 mL | 9/1/2011 | |
| Padagis Israel Pharmaceuticals Ltd | 45802-118 | TOPICAL | 1 mg in 1 mL | 5/17/2017 | |
| Preferred Pharmaceuticals Inc. | 68788-8548 | TOPICAL | 1 mg in 1 g | 11/14/2023 | |
| Rebel Distributors Corp | 21695-786 | TOPICAL | 1 mg in 1 g | 12/16/2009 | |
| RPK Pharmaceuticals, Inc. | 53002-8321 | TOPICAL | 1 mg in 1 g | 2/9/2021 | |
| Physicians Total Care, Inc. | 54868-5547 | RESPIRATORY (INHALATION) | 220 ug in 1 1 | 11/19/2010 | |
| Bryant Ranch Prepack | 72162-1404 | TOPICAL | 1 mg in 1 g | 3/11/2024 | |
| Bryant Ranch Prepack | 63629-8683 | TOPICAL | 1 mg in 1 g | 1/20/2022 | |
| A-S Medication Solutions | 50090-2179 | TOPICAL | 1 mg in 1 g | 11/19/2015 | |
| Glenmark Pharmaceuticals Inc., USA | 68462-192 | TOPICAL | 1 mg in 1 g | 7/9/2019 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 5/30/2020 | ||
Authorised | 5/30/2020 | ||
Authorised | 7/3/2020 | ||
Authorised | 7/3/2020 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| MOMETASONE SANDOZ NASAL SPRAY 0.05% | SIN15328P | SPRAY, SUSPENSION | 50ug per actuation | 9/7/2017 | |
| ELOMET LOTION 0.1% | SIN07565P | LOTION | 0.1% | 12/6/1993 | |
| MOMETASONE NTC NASAL SPRAY SUSPENSION 50 MCG/ACTUATION | SIN15434P | SPRAY, SUSPENSION | 50mcg/actuation | 2/26/2018 | |
| ATECTURA BREEZHALER INHALATION POWDER, HARD CAPSULE 150 MCG /320 MCG | SIN16147P | POWDER, METERED | 320 mcg | 4/7/2021 | |
| ATECTURA BREEZHALER INHALATION POWDER, HARD CAPSULE 150 MCG /160 MCG | SIN16148P | POWDER, METERED | 160 mcg | 4/7/2021 | |
| Zenhale Pressurized Inhalation Aerosol 100/5mcg/actuation | SIN14190P | AEROSOL, METERED | 0.1210mg | 7/11/2012 | |
| ATECTURA BREEZHALER INHALATION POWDER, HARD CAPSULE 150 MCG /80 MCG | SIN16149P | POWDER, METERED | 80 mcg | 4/7/2021 | |
| RYALTRIS NASAL SPRAY 600/25MCG | SIN16523P | SPRAY, SUSPENSION | 25 MCG/SPRAY | 6/28/2022 | |
| ASMANEX TWISTHALER 200 mcg/inhalation | SIN11277P | POWDER, METERED | 200 mcg/inhalation | 2/8/2000 | |
| Exnise Nasal Spray 0.05% w/v | SIN16311P | SPRAY, SUSPENSION | 0.05% w/v | 8/30/2021 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Mometasone Furoate Gel | 国药准字H20080010 | 化学药品 | 凝胶剂 | 11/22/2022 | |
| Mometasone Furoate Gel | 国药准字H20090212 | 化学药品 | 凝胶剂 | 4/30/2020 | |
| Mometasone Furoate Gel | 国药准字H20080507 | 化学药品 | 凝胶剂 | 3/3/2023 | |
| Mometasone Furoate Nasal Spray | 国药准字HJ20140100 | 化学药品 | 鼻喷雾剂 | 9/27/2023 | |
| Mometasone Furoate Nasal Spray | 国药准字HJ20220084 | 化学药品 | 鼻用制剂 | 11/15/2022 | |
| Mometasone Furoate Nasal Spray | 国药准字H20113481 | 化学药品 | 喷雾剂 | 10/22/2021 | |
| Mometasone Furoate Nasal Spray | 国药准字HJ20220085 | 化学药品 | 鼻用制剂 | 11/15/2022 | |
| Mometasone Furoate Cream | 国药准字H20040853 | 化学药品 | 乳膏剂 | 4/7/2024 | |
| Mometasone Furoate Cream | 国药准字H20074090 | 化学药品 | 乳膏剂 | 7/11/2022 | |
| Mometasone Furoate Cream | 国药准字H20173401 | 化学药品 | 乳膏剂 | 11/15/2022 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| SYNLOMED CREAM 0.1% | N/A | N/A | N/A | 6/20/2008 | |
| RAVELIA CREAM 0.1% W/W | N/A | N/A | N/A | 3/9/2015 | |
| VIZOMET CREAM 0.1%W/W | N/A | N/A | N/A | 8/25/2011 | |
| METASPRAY NASAL SPRAY 0.05%W/V | N/A | N/A | N/A | 3/11/2014 | |
| ATECTURA BREEZHALER INHALATION POWDER HARD CAPSULES 150MCG/160MCG | N/A | N/A | N/A | 11/30/2023 | |
| BF-MOMETASONE CREAM 0.1% W/W | N/A | bright future pharmaceuticals factory o/b bright future pharmaceutical laboratories limited | N/A | N/A | 5/21/2025 |
| YEMOMET CREAM 0.1% | N/A | N/A | N/A | 10/13/2006 | |
| MOMETIX AQ NASAL SPRAY 0.05%W/W | N/A | N/A | N/A | 12/13/2011 |
TGA Drug Approvals
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