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mometasone furoate (Monovo / H527722 / Mundoson)

✓ Approved

Almirall, S.A · NR3C1 · 小分子

什么是 mometasone furoate？

mometasone furoate 是一种小分子，由Almirall, S.A研发。该药已获批，用于治疗相关适应症，给药途径：Topical。

药物档案

商品名Monovo, H527722, Mundoson
公司Almirall, S.A
药物类别小分子
分子靶点NR3C1, NR3C2
给药途径Topical
状态Approved
来源： ClinicalTrials.gov, Almirall, S.A

作用机制

分子靶点

mometasone furoate 作用于 2 个分子靶点：

NR3C1nuclear receptor subfamily 3 group C member 1 (GR, GCCR)
NR3C2nuclear receptor subfamily 3 group C member 2 (NR3C2VIT, MR)
需要更深入的分析？Noah AI 可解释复杂机制并与同类药物比较。

治疗适应症

mometasone furoate 针对 3 个适应症，涉及 1 个治疗领域。

治疗领域疾病/病症分期
Skin and subcutaneous tissue disordersDermatitis allergic✓ Approved
Skin and subcutaneous tissue disordersDermatitis atopic✓ Approved
Skin and subcutaneous tissue disordersPsoriasis✓ Approved

相关研究文献

PubMedThe Journal of the Association of Physicians of India2026-08-03

Safety and Effectiveness of Indacaterol/Glycopyrronium/Mometasone Dry Powder Inhaler in Asthma: A Prospective Multicenter Phase IV Study.

Karmakar Saurabh S, Bhate Amit S AS, Prashanth C C, Kadam Dilip D et al.

Asthma remains a major public health challenge in India, characterized by high disease burden, poor adherence, and suboptimal control despite therapeutic advances. Fixed-dose combination therapy with indacaterol/glycopyrronium/mometasone furoate (IND/GLY/MF; DIFIZMA®), a single-inhaler triple therapy (SITT), offers the potential for improved symptom control and adherence through once-daily dosing. However, real-world and postmarketing surveillance data on the effectiveness and safety of IND/GLY/MF in Indian asthma patients remain limited, underscoring the need for local evidence to guide clinical practice. To evaluate the safety and effectiveness of once-daily IND/GLY/MF dry powder inhaler (DPI) in Indian adults with asthma inadequately controlled on inhaled corticosteroid (ICS)-long-acting β2-agonist (LABA) therapy. This was a prospective, open-label, multicenter, single-arm, phase IV postmarketing study conducted across multiple centers in India. Adults (18-65 years) with persistent asthma symptoms despite ICS ± LABA therapy received IND/GLY/MF DPI (160 µg mometasone furoate, 46 µg glycopyrronium bromide, 114 µg indacaterol acetate) once daily for 24 weeks. The primary endpoint was safety, based on treatment-emergent adverse events (TEAEs), serious TEAEs, and discontinuations. Secondary endpoints included changes from baseline in the asthma control questionnaire (ACQ-7) score, FEV1, FVC, and FEV1/FVC ratio at weeks 4, 12, and 24. A total of 200 patients were enrolled (safety set), of whom 196 were included in the modified intent-to-treat (mITT) analysis and 189 in the per-protocol (PP) population. TEAEs occurred in 9.5% of participants, with 6.5% considered drug-related; all events were mild or moderate in severity. No serious adverse events, severe TEAEs, or deaths were reported. Clinically meaningful and progressive improvements were observed in asthma control and lung function over 24 weeks. The ACQ-7 score decreased from 3.00 ± 0.59 at baseline to 2.36 ± 0.54 at week 4, 1.86 ± 0.54 at week 12, and 1.39 ± 0.61 at week 24, corresponding to mean change of -0.64 ± 0.50, -1.14 ± 0.74, and -1.62 ± 0.89, respectively (all p < 0.0001). Mean FEV1 increased from 1.49 ± 0.51 L at baseline to 1.73 ± 0.60 L at week 4, 1.81 ± 0.53 L at week 12, and 1.95 ± 0.51 L at week 24, with corresponding mean changes of +0.24 L, +0.32 L, and +0.46 L (all p < 0.0001). Mean FVC improved from 2.13 ± 0.63 L at baseline to 2.30 ± 0.70 L, 2.33 ± 0.62 L, and 2.38 ± 0.59 L at weeks 4, 12, and 24, respectively (all p < 0.0001). The FEV1/FVC ratio increased from 71.63 ± 12.76 at baseline to 76.71 ± 11.33, 80.86 ± 12.67, and 84.00 ± 8.93 at weeks 4, 12, and 24, with mean changes of +4.99, +8.91, and +12.10, respectively (all p < 0.0001). No hospitalizations or rescue medication use were reported. Compliance with study medication was 100%, and both patients and physicians reported marked symptom improvement and high treatment satisfaction. Once-daily IND/GLY/MF DPI demonstrated a favorable safety profile and significant, sustained clinical benefits in adults with asthma inadequately controlled on ICS-LABA therapy. The triple combination provided rapid onset and sustained improvement in asthma control and lung function, with excellent adherence and tolerability in real-world Indian clinical practice. These findings support IND/GLY/MF as an effective and practical single-inhaler triple therapy option for optimized asthma management.

PMID 42543945
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PubMedEuropean journal of internal medicine2026-08-02

Particle engineering, aerosol physics, and pulmonary deposition of single-inhaler triple ICS/LABA/LAMA therapies in obstructive airway diseases.

Sorino Claudio C, Virchow Johann Christian JC, Spanevello Antonio A, Buscemi Agata A et al.

Single-inhaler triple therapy (SITT) combining an inhaled corticosteroid, long-acting β2-agonist, and long-acting muscarinic antagonist (ICS/LABA/LAMA) represents the current ceiling of inhaled pharmacotherapy for moderate-to-very-severe chronic obstructive pulmonary disease and severe uncontrolled asthma. Five device platforms are currently approved: two extrafine formulations delivering beclomethasone dipropionate/formoterol/glycopyrronium (the Modulite solution pressurised metered-dose inhaler [pMDI] and the NEXThaler breath-actuated dry powder inhaler [DPI]); the co-suspension pMDI Aerosphere platform (budesonide/glycopyrrolate/formoterol); the standard-particle Ellipta DPI (fluticasone furoate/umeclidinium/vilanterol); and the low-resistance, single-dose capsule-based DPI Breezhaler (mometasone furoate/indacaterol/glycopyrronium). Despite a shared pharmacological class, these systems differ in aerosol physics, particle engineering, intrapulmonary deposition patterns, and device-patient interaction. Furthermore, some of them are authorized only for COPD or asthma. This narrative review examines the technology and in vivo deposition evidence for each SITT platform, discusses real-world performance determinants (particle size, flow dependency, technique robustness), and proposes an expert-informed framework for patient-level device selection. Methodological limitations include reliance on in silico Functional Respiratory Imaging data when in vivo scintigraphy is unavailable, and inconsistent dose denominators across studies (emitted vs. metered dose). Cross-platform comparisons are limited by heterogeneous methodologies, and no SITT platform has demonstrated universal superiority. In platform-specific studies, NEXThaler shows relatively high lung deposition (∼55% of emitted dose) though flow-dependent; Aerosphere is robust to inhalation technique variations; Modulite provides extrafine, peripheral delivery; Ellipta and Breezhaler offer once-daily convenience with moderate deposition. Rational device selection requires structured assessment of patient inspiratory capacity, disease phenotype, coordination, and adherence. Head-to-head scintigraphy and prospective imaging-outcome studies represent major evidence gaps.

PMID 42542404
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PubMedDrug delivery and translational research2026-07-30

Consistent aerodynamic performance and content uniformity of mometasone-magnesium stearate co-processed aerosols for asthma therapy.

Ceschan Nazareth Eliana NE, Smyth Hugh Dc HD, Ramírez-Rigo María Verónica MV

Pressurized metered-dose inhalers (pMDIs) are a common technology for delivering respiratory medications, but the stability of suspended formulations remains a significant challenge. Physical instability can lead to dosing inaccuracies and reduced therapeutic effectiveness. While various stabilization strategies exist, these may entail high costs, complex processing and/or high excipient loading. This study evaluated the impact of magnesium stearate (MgSt) incorporation on delivered dose content uniformity and aerodynamic performance of mometasone-based pMDI suspensions. Different processing strategies were investigated: physical blending of MgSt with raw mometasone, physical blending of MgSt with spray-dried mometasone and co-spray drying of mometasone and MgSt. In all formulations, the mometasone:MgSt ratio was maintained at 99:1. Spray drying preserved the crystalline structure of mometasone and yielded small microparticles, similar in size and with a relatively narrow particle size distribution to the raw material. Raw mometasone, either alone or physically mixed with MgSt, failed to achieve acceptable delivered dose uniformity. In contrast, pure spray-dried mometasone, either alone or physically mixed with MgSt, showed improved results. The co-processed formulation demonstrated the highest emitted dose consistency, with delivered doses ranging between 90 and 100% of the nominal dose, thus remaining within typical regulatory limits. Additionally, co-processed formulations demonstrated adequate aerodynamic behavior, achieving an emitted fraction of 95% and a fine particle fraction of around 30%, comparable to commercially available pMDIs. Aerodynamic performance as well as dose emitted consistency was not importantly affected after six-months-storage. Overall, these findings confirm that spray-drying co-processing with MgSt effectively improves mometasone suspension performance.

PMID 42530807
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PubMedBiomedicines2026-07-28

Safety Profile of Intranasal Corticosteroids in Allergic Rhinitis: A Comprehensive Review.

Maglica Mirko M, Batinović Franko F, Gudelj Marin M, Bošković Braco B et al.

Intranasal corticosteroids (INCS) remain the cornerstone of pharmacologic treatment for allergic rhinitis (AR) because of their well-established anti-inflammatory efficacy and generally favorable benefit-risk profile. Nevertheless, concerns regarding local and systemic corticosteroid-related adverse events (AEs) continue to influence patient adherence, prescribing practices, and long-term treatment acceptance. In routine clinical practice, safety perception and corticosteroid-related concerns frequently influence adherence and formulation selection to a greater extent than differences in clinical efficacy, particularly in pediatric populations and in patients requiring prolonged continuous therapy. Differences in pharmacokinetic and pharmacodynamic properties, including systemic bioavailability, glucocorticoid receptor affinity, lipophilicity, protein binding, and extent of first-pass metabolism, are considered important safety profile determinants of currently available INCS formulations. Available evidence indicates that local AEs, particularly epistaxis, nasal irritation, dryness, and sensory discomfort, represent the most frequently reported treatment-related AEs across INCS formulations, although these events are generally mild, self-limiting, and infrequently treatment-limiting. Clinically significant structural nasal complications, including septal perforation or progressive mucosal injury, appear uncommon in currently available studies. Systemic AEs, including hypothalamic-pituitary-adrenal (HPA) axis suppression, ocular toxicity, growth impairment, or clinically meaningful effects on bone metabolism, have not been consistently demonstrated with currently used low-systemic-exposure formulations administered at recommended therapeutic doses. Although systemic glucocorticoid exposure has been associated with alterations in lipid metabolism, adipose tissue function, and metabolic homeostasis, currently available intranasal corticosteroids demonstrate minimal systemic exposure, making clinically relevant metabolic effects unlikely under recommended therapeutic conditions. Formulations such as mometasone furoate, fluticasone propionate, fluticasone furoate, and ciclesonide exhibit pharmacokinetic characteristics associated with minimal systemic exposure because of extensive first-pass metabolism and low oral bioavailability. Although substantial pharmacokinetic differences exist between currently available INCS formulations, direct comparative evidence demonstrating clinically meaningful superiority in systemic safety outcomes remains limited. Current evidence suggests that formulation-dependent differences are clinically more relevant with respect to local tolerability, sensory characteristics, patient preference, and long-term adherence than major systemic safety outcomes. Pediatric evidence is generally reassuring, although historical concerns regarding growth suppression associated with earlier corticosteroid formulations continue to influence clinical practice. Currently available evidence supports the use of modern INCS as effective and generally well-tolerated therapeutic options across adult and pediatric populations.

PMID 42512009
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PubMedJournal of clinical medicine2026-07-28

Comparative Real-World Effectiveness of Fixed-Dose Triple Therapy Regimens in COPD: A Retrospective Cohort Study.

Patel Rushi R, Thompson Jacob J, Patel Namra N, Lohana Abhi C AC et al.

Background/Objectives: Fixed-dose triple therapy is recommended for patients with chronic obstructive pulmonary disease (COPD) at high risk of exacerbations; however, direct comparative effectiveness data between available triple therapy regimens remain limited. We compared real-world clinical outcomes among adults with COPD receiving fluticasone furoate/vilanterol/umeclidinium (FF/VI/UMEC) or budesonide/glycopyrrolate/formoterol (BUD/GLY/FOR). Methods: We conducted a retrospective propensity score-matched cohort study using the TriNetX Research Network. Adults with a spirometrically confirmed diagnosis of COPD who received fluticasone furoate/vilanterol/umeclidinium (FF/VI/UMEC) or budesonide/glycopyrrolate/formoterol (BUD/GLY/FOR) between July 2020 and August 2024 were included in the analysis. A 365-day landmark period was applied to establish maintenance therapy, with outcome follow-up beginning 1 year after treatment initiation. Patients were followed for outcomes through August 2025, the date of database analysis. After 1:1 propensity score matching, treatment groups were compared for COPD exacerbations, acute respiratory failure (ARF), hospitalization, and all-cause mortality using RR and Cox proportional hazards analyses. Results: In matched cohorts, FF/VI/UMEC was associated with a significantly higher risk of COPD exacerbations (5.6% vs. 3.9%; RR 1.44; 95% CI 1.30-1.59; p < 0.001) and ARF (2.5% vs. 1.9%; RR 1.28; 95% CI 1.11-1.46; p < 0.001) compared with BUD/GLY/FOR. Time-to-event analyses demonstrated lower event-free probability for exacerbations (HR 1.35; (95% CI 1.21-1.50) and ARF (HR 1.15; (95% CI 1.00-1.32))). All-cause mortality was numerically higher in the FF/VI/UMEC cohort (5.2% vs. 4.7%; RR 1.09; 95% CI 1.00-1.19; p = 0.050); however, time-to-event analysis did not demonstrate a statistically significant difference. Hospitalization rates were similar between groups. Conclusions: In this large propensity score-matched real-world cohort study, patients receiving BUD/GLY/FOR experienced lower rates of COPD exacerbations and acute respiratory failure than those receiving FF/VI/UMEC. Because of the retrospective observational nature of the analysis, these findings should be considered hypothesis-generating and require confirmation in prospective comparative effectiveness studies.

PMID 42513564
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PubMedReports (MDPI)2026-07-24

Transnasal Endoscopic Repair of Unilateral Choanal Atresia in a Young Adult Using a Cross-Over Nasoseptal Flap Technique and a Bioabsorbable Mometasone-Furoate-Eluting Stent: A Case Report.

Vlachodimitropoulos Athanasios A, Mastronikolis Nicholas S NS, Danielides Gerasimos G, Tsapardoni Foteini F et al.

Background and Clinical Significance: Choanal atresia is a rare congenital obstruction of the posterior nasal aperture, with an estimated incidence of one in 5000 to one in 8000 live births. Bilateral disease typically presents as a neonatal emergency, whereas unilateral disease is more frequent and may remain undiagnosed for years or decades, presenting in adolescence or adulthood with chronic unilateral nasal obstruction and ipsilateral mucopurulent rhinorrhoea. Optimal surgical management remains debated, particularly with regard to mucosal-flap reconstruction and the choice of postoperative stent. Case Presentation: A 22-year-old male was referred for chronic left-sided nasal obstruction, persistent ipsilateral mucopurulent rhinorrhoea and reduced ipsilateral olfaction. Nasal endoscopy and high-resolution computed tomography demonstrated an isolated, non-syndromic, mixed bony-membranous left choanal atresia. The patient underwent transnasal endoscopic choanoplasty with posterior septectomy and removal of the atretic plate and posterior vomer. An ipsilateral superiorly based septal mucoperichondrial flap was raised first and later transposed over the sphenoid rostrum; following drilling, the contralateral septal mucosa was approached and incised horizontally to generate a superior and an inferior leaflet, which were rotated to cover the corresponding portions of the residual posterior septal ridge. A bioabsorbable mometasone-furoate-eluting sinus implant (PROPEL®, Medtronic) was deployed across the neo-choana. The follow-up endoscopy at two months demonstrated a widely patent, well-mucosalized neo-choana with complete resolution of symptoms. Conclusions: Transnasal endoscopic posterior septectomy combined with mucosal-flap reconstruction and a bioabsorbable steroid-eluting stent is a technically feasible and biologically rational approach to adult unilateral CA. To our knowledge, this is among the first reports describing the off-label intraoperative use of a PROPEL® stent in a young adult with isolated unilateral choanal atresia.

PMID 42496497
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