Data updated: May 26, 2026
NASONEX (mometasone furoate)
Respiratory
Approved 1997-10-01
7
Indications
--
Phase 3 Trials
28
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1997-10-01
- Revenue
- $327M (Q4-2013)
- Routes
- NASAL
- Dosage Forms
- SPRAY, METERED
NASONEX Approval History
1998
1999
2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
26 FDA actions from 1997 to 2022 · 6 indication expansions
Mar 2015 SUPPL
Mfg
Oct 2014 SUPPL
Mfg
Apr 2014 SUPPL
Mfg
Nov 2012 SUPPL
Mfg
Sep 2002 SUPPL
Mfg
Jan 2002 SUPPL
Mfg
Feb 2001 SUPPL
Mfg
Dec 2000 SUPPL
Label
Oct 2000 SUPPL
Mfg
Dec 1999 SUPPL
Efficacy
Apr 1999 SUPPL
Mfg
Nov 1998 SUPPL
Mfg
Jun 1998 SUPPL
Mfg
Oct 1997 ORIGINAL
New Form
What NASONEX Treats
7 FDA approvalsOriginally approved for its first indication in 1997 . Covers 7 distinct patient populations.
- Other (7)
Other
(7 approvals) 📋
Clinical Trial Registry
26 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 |
| NCT01861145 | Pro00032936 | Ph 4 | withdrawn | Intranasal Steroids for the Treatment of Nocturnal Enuresis With Associated Obstructive Sleep Apnea |
| 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 |
🔬
Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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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.
NASONEX FDA Label Details
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Revenue Insights
- • Q4-2013: $327M
- • Historical trend analysis
Patent Timeline
- • Patent expiration dates
- • Generic/biosimilar risk
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • Competitor tracking
- • Same target/indication analysis
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.