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Data updated: May 26, 2026

NASONEX 24HR ALLERGY (mometasone furoate)

Respiratory Approved 2022-03-17
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
4
Years on Market

Details

Status
Over-the-counter
First Approved
2022-03-17
Routes
NASAL
Dosage Forms
SPRAY, METERED

Companies

PERRIGO PHARMA INTL
Active Ingredient: MOMETASONE FUROATE

NASONEX 24HR ALLERGY Approval History

2023
2024
2025
2026
Original
New Indication
New Form
Label Update
9 FDA actions from 2022 to 2024
Jun 2024 SUPPL
Mfg · Manufacturing (CMC)
FDA Letter Label
May 2023 SUPPL
Label · Labeling
FDA Letter Label
Mar 2023 SUPPL
Label · Labeling
FDA Letter Label

What NASONEX 24HR ALLERGY Treats

1 FDA approvals

Originally approved for its first indication in 2022 .

  • Other (1)
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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
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

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 24HR ALLERGY FDA Label Details

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Data Sources

FDA Approval: NDA215712 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.