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
Research Report
Comprehensive Report: Mometasone Furoate (DB14512)
Executive Summary
Mometasone Furoate (DrugBank ID: DB14512) is a potent, synthetic, small-molecule glucocorticoid that has become a cornerstone therapy for a range of inflammatory conditions affecting the skin, nasal passages, and airways. Its clinical utility and commercial success are predicated on a meticulously engineered molecular structure that provides a high therapeutic index, characterized by strong local anti-inflammatory activity coupled with deliberately low systemic bioavailability. This profile minimizes the risk of systemic adverse effects commonly associated with corticosteroid therapy.
The drug is formulated for three distinct routes of administration, each targeting a specific set of indications. As a topical agent (e.g., Elocon®), it is a medium-to-high potency treatment for corticosteroid-responsive dermatoses such as eczema and psoriasis. As a nasal spray (e.g., Nasonex®), it is a first-line therapy for the treatment and prophylaxis of allergic rhinitis and the management of nasal polyps. As an inhaled powder or aerosol (e.g., Asmanex®), it serves as a maintenance therapy for the prevention of asthma symptoms.
Pharmacologically, Mometasone Furoate functions as a high-affinity agonist of the glucocorticoid receptor, with a binding affinity approximately 22 times that of dexamethasone. Its mechanism involves the classic genomic pathways of steroid action: transactivation of anti-inflammatory genes and transrepression of pro-inflammatory transcription factors like NF-κB, leading to potent anti-inflammatory, antipruritic, and vasoconstrictive 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 |
---|---|---|---|---|---|
No NMPA approvals found for this drug. |
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
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
---|---|---|---|---|---|
NASAL ALLERGY AND CONGESTION RELIEF | 02451905 | Spray, Metered Dose - Nasal | 50 MCG / SPRAY | N/A | |
NASONEX ALLERGY AND CONGESTION | Merck Canada Inc | 02410524 | Spray, Metered Dose - Nasal | 50 MCG / ACT | N/A |
APO-MOMETASONE | 02403587 | Spray, Metered Dose - Nasal | 50 MCG / ACT | 3/25/2013 | |
ZENHALE | organon canada inc. | 02361744 | Aerosol, Metered Dose - Inhalation | 50 MCG / ACT | 6/20/2011 |
PMS-MOMETASONE | 02244769 | Ointment - Topical | 0.1 % | 11/25/2003 | |
ENERZAIR BREEZHALER | novartis pharmaceuticals canada inc | 02501244 | Capsule - Inhalation | 160 MCG | 11/5/2020 |
TEVA-MOMETASONE | teva canada limited | 02248130 | Ointment - Topical | 0.1 % | 11/4/2003 |
ZENHALE | organon canada inc. | 02361752 | Aerosol, Metered Dose - Inhalation | 100 MCG / ACT | 3/10/2011 |
PMS-MOMETASONE | 02244768 | Lotion - Topical | .1 % | N/A | |
ELOCOM | organon canada inc. | 00851736 | Ointment - Topical | 0.1 % | 12/31/1991 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
---|---|---|---|---|---|
No CIMA AEMPS (Spain) approvals found for this drug. |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Philippines FDA approvals found for this drug. |
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Saudi SFDA approvals found for this drug. |
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Malaysia NPRA approvals found for this drug. |
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
---|---|---|---|---|---|
No UK EMC drug information found for this drug. |
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