TheraRadar
Data updated: May 26, 2026

RYALTRIS (mometasone furoate)

Respiratory Approved 2022-01-13

RYALTRIS is indicated for the treatment of Seasonal Allergic Rhinitis.

Source: FDA Label • GLENMARK SPECLT

How RYALTRIS Works

Ryaltris targets the allergic response through two distinct mechanisms. Olopatadine hydrochloride functions as a histamine-1 (H1) receptor inhibitor, blocking the action of histamine to reduce immediate allergic symptoms. Mometasone furoate is a corticosteroid with potent anti-inflammatory properties; it inhibits multiple cell types (such as mast cells and eosinophils) and mediators (including cytokines and leukotrienes) that drive the inflammatory process in allergic rhinitis.

1
Indication
--
Phase 3 Trials
4
Years on Market

Details

Status
Prescription
First Approved
2022-01-13
Patent Cliff
2039

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Routes
NASAL
Dosage Forms
SPRAY, METERED

RYALTRIS Approval History

2023
2024
2025
2026
Original
New Indication
New Form
Label Update
4 FDA actions from 2022 to 2023
Aug 2023 SUPPL
Label · Labeling
Jun 2023 SUPPL
Mfg · Manufacturing (CMC)
Sep 2022 SUPPL
Label · Labeling

What RYALTRIS Treats

1 indications

RYALTRIS is approved for 1 conditions since its original approval in 2022. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Seasonal Allergic Rhinitis
Source: FDA Label

RYALTRIS Competitive Set

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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 RYALTRIS

3 of 4

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE
AZELASTINE HYDROCHLORIDE
1 shared
Apotex
Shared indications:
Seasonal Allergic Rhinitis
CLARINEX-D 12 HOUR
DESLORATADINE
1 shared
Merck
Shared indications:
Seasonal Allergic Rhinitis
DESLORATADINE AND PSEUDOEPHEDRINE SULFATE 24 HOUR
DESLORATADINE
1 shared
Dr. Reddy's
Shared indications:
Seasonal Allergic Rhinitis
📋

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

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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

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.

RYALTRIS FDA Label Details

Indications & Usage

FDA Label (PDF)

RYALTRIS is indicated for the treatment of Seasonal Allergic Rhinitis.

View full patent landscape →
16 OB patents · 9 families · 92 international docs across 27 countries

RYALTRIS Patents & Exclusivity

Latest Patent: Apr 2039

Patents (16 active)

US12303635 Expires Apr 8, 2039
US11679210 Expires Sep 3, 2038
US10765686 Expires Sep 4, 2034
US10758550 Expires Sep 4, 2034
US10646500 Expires Sep 4, 2034
US10548907 Expires Sep 4, 2034
US11400101 Expires Sep 4, 2034
US12064442 Expires Sep 4, 2034
US10016443 Expires Sep 4, 2034
US10517880 Expires Sep 4, 2034
US9750754 Expires Sep 4, 2034
US9078923 Expires Sep 4, 2034
US10561672 Expires Sep 4, 2034
US9370483 Expires Sep 4, 2034
US10376526 Expires Sep 4, 2034
US9937189 Expires Sep 4, 2034
Source: FDA Orange Book

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Patent Timeline

  • Cliff: 2039
  • 16 active patents

Trial Analysis

  • Clinical trial tracking
  • Development stage analysis

Competitive Landscape

  • 4 similar drugs
  • 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.