ASMANEX TWISTHALER (mometasone furoate)
Asmanex Twisthaler (mometasone furoate inhalation powder) is a corticosteroid indicated for the maintenance treatment of asthma as prophylactic therapy in patients 4 years of age and older. It is designed for long-term management to reduce airway inflammation, thereby preventing asthma symptoms such as wheezing and shortness of breath. It is not indicated for the relief of acute bronchospasm.
How ASMANEX TWISTHALER Works
Mometasone furoate is a corticosteroid with potent anti-inflammatory properties. It acts by inducing phospholipase $A_2$ inhibitory proteins, collectively known as lipocortins. These proteins are postulated to control the biosynthesis of potent mediators of inflammation, such as prostaglandins and leukotrienes, by inhibiting the release of their common precursor, arachidonic acid. In the context of asthma, mometasone furoate reduces the presence and activity of inflammatory cells (such as mast cells, eosinophils, and lymphocytes) and suppresses the release of cytokines and other mediators involved in the asthmatic response.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2005-03-30
- Routes
- INHALATION
- Dosage Forms
- POWDER
ASMANEX TWISTHALER Approval History
What ASMANEX TWISTHALER Treats
1 indicationsASMANEX TWISTHALER is approved for 1 conditions since its original approval in 2005. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Dermatoses
ASMANEX TWISTHALER Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to ASMANEX TWISTHALER
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
25 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04898764 Momestasone | AGO/2019/005 2019-003254-91 | Ph 4 | completed | Research on Underlying Causes of Long-term Use of Nasal Decongestants and the Structured Withdrawal of the Decongestant |
| NCT01135134 results posted | P06332 | Ph 3 | completed | Multicenter, Double-blind, Randomized, Placebo-controlled Study of Mometasone Furoate Nasal Spray in Pediatric Subjects With Perennial Allergic Rhinitis (Study P06332) |
| NCT01165424 results posted | P06333 | Ph 3 | completed | A Study of Long-term Administration of Mometasone Furoate Nasal Spray in Pediatric Subjects With Perennial Allergic Rhinitis (Study P06333AM1) |
| NCT06399783 | Sim vs Cs | Ph 4 | not yet recruiting | Topical Simvastatin Versus Topical Steroid in Treatment of Alopecia Areata |
| NCT04589663 results posted | CQMF149G2203 2020-002036-78 | Ph 2 | completed | Study to Compare the Pharmacokinetics of Mometasone Furoate Alone and in Combination With Indacaterol in Patients ≥ 6 to < 12 Years Old With Asthma |
| NCT04271007 LB2001 | EN19092501 | Ph 4 | completed | Comparative Study:Topison (Mometasone Furoate) Versus Two Others Mometasone Furoates |
| NCT05887843 | SAN-0791 2023-000362-34 | Ph 1 | terminated | Study to Compare the Pharmacokinetics of Fixed-Dose Combination of Mometasone + Azelastine Nasal Spray to Mometasone and Azelastine Nasal Sprays in Adolescents and Young Adults With Seasonal Allergic Rhinitis |
| NCT04499235 results posted | AKST4290-221 | Ph 2 | terminated | A Study to Assess the Therapeutic Effect and Safety of Adjunctive AKST4290 in Subjects With Bullous Pemphigoid |
| NCT04670653 | EMS0619 - MAGNÓLIA | Ph 3 | withdrawn | Efficacy and Safety of Magnólia Nasal Gel in the Treatment of Allergic Rhinitis |
| NCT01673659 | PRG-NY-12-008 | Ph 3 | completed | A Safety and Bioequivalence of a Mometasone Nasal Spray, 50 mcg/Actuation Compared With Nasonex® Nasal Spray 50 mcg/Actuation in the Relief of the Symptoms of Seasonal Allergic Rhinitis (SAR) |
| NCT03085797 results posted | 205687 2016-004255-70 | Ph 3 | completed | Effect of Mepolizumab in Severe Bilateral Nasal Polyps |
| NCT04532736 | 216S871 | Ph 2 | completed | Comparison of Methylprednisolone or Methotrexate in the Maintenance Treatment of Nasal Polyposis |
| NCT02554786 results posted | CQVM149B2301 2015-002529-21 | Ph 3 | completed | A Multicenter Randomized 52 Week Treatment Double-blind, Triple Dummy Parallel Group Study to Assess the Efficacy and Safety of QMF149 Compared to Mometasone Furoate in Participants With Asthma |
| NCT02061202 IMPROVE results posted | GCO 12-1565 K23HL119351 | Ph 2 | completed | Inhaled Mometasone to Reduce Painful Episodes in Patients With Sickle Cell Disease |
| NCT02113267 | VGFOUREG-226361 2012-005842-39 | Ph 2 | terminated | Mometasone-furoate for Treatment of Eosinophilic Esophagitis - a Randomized Placebo Controlled Study. |
| NCT01616160 MERK2 results posted | 2012P000387 | Ph 4 | terminated | An Open-label Study to Identify Molecular Markers of Steroid Resistance |
| NCT01372865 | EF 119 | Ph 3 | completed | A Clinical Trial About Treatment of Mild to Moderate Persistent Alergic Rhinnitis With Test or Reference Mometasone (PUMA) |
| NCT02498509 | 153PAR14017 | Ph 3 | completed | Clinical Trial to Evaluate the Efficacy and Safety of CKD-342 |
| NCT00784732 | CQAV680A2202 | Ph 2 | completed | A Study to Compare the Efficacy of QAV680 Against Placebo in Treating Seasonal Allergic Rhinitis in an Environmental Exposure Chamber |
| NCT02559440 | 81500772 | Ph 4 | completed | Mometasone Furoate and Oxymetazoline in the Treatment of Adenoid Hypertrophy |
| NCT01555151 results posted | CQMF149E2201 2011-005100-14 | Ph 2 | completed | Safety and Efficacy of Mometasone Furoate Delivered Via Concept1 Device or Twisthaler® Device in Adult and Adolescent Patients With Persistent Asthma |
| NCT01609478 results posted | CQMF149E2203 2012-000520-18 | Ph 2 | completed | Efficacy, Safety and Pharmacokinetics of Indacaterol Acetate in Patients With Persistent Asthma |
| NCT01470053 | HL_NSFX_301 | Ph 3 | completed | Efficacy and Safety of Mometasone Furoate Plus Azelastine HCl Combination Versus Mometasone Furoate Alone or Azelastine Alone in Patients With Perennial Allergic Rhinitis |
| NCT01523236 | 70936005 | Ph 1, Ph 2 | completed | Clinical Equivalence Study of Mometasone Nasal Spray, 50 Mcg/Actuation |
| NCT00721331 | CRx-197-001 EudraCT # 2008-000611-15 | Ph 1 | completed | A Phase I Study to Assess the Safety and Tolerability of Topical CRx-197 Formulations in Healthy Volunteers |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
ASMANEX TWISTHALER FDA Label Details
Indications & Usage
FDA Label (PDF)ASMANEX TWISTHALER is indicated for the treatment of Dermatoses.
Track ASMANEX TWISTHALER with TheraRadar Pro
Watchlist alerts, full database access, CSV exports across 14,000+ drugs.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment