Randomized, Double-blind, Cross-over Clinical Trial to Assess Onset of Action and Efficacy of Azelastine Hydrochloride 0.15% Nasal Spray in the Treatment of Allergen-Induced Allergic Rhinitis Symptoms in an Environmental Exposure Unit in Comparison to Placebo and Mometasone Furoate/Olopatadine Hydrochloride Nasal Spray

This study is to assess the Onset of Action and Efficacy of azelastine hydrochloride 0.15% in treating the nasal symptoms of seasonal allergic rhinitis (SAR) induced by an allergen challenge in an Environmental Exposure Unit (EEU) followed by a single dose and a 3-day treatment at home.

Start Date30 Oct 2023

Sponsor / Collaborator

Meda Pharma GmbH & Co. KG

CTR20213407

/ CompletedPhase 3

一项多中心、随机、双盲、双模拟、三臂、平行对照评估GSP301 NS与Patanase®NS和内舒拿®NS治疗中国成人和青少年季节性过敏性鼻炎（SAR）的有效性、安全性、耐受性及药代动力学的III期临床研究

[Translation] A multicenter, randomized, double-blind, double-dummy, three-arm, parallel controlled Phase III clinical study to evaluate the efficacy, safety, tolerability and pharmacokinetics of GSP301 NS compared with Patanase® NS and Nasonex® NS in the treatment of seasonal allergic rhinitis (SAR) in Chinese adults and adolescents

主要目的：旨在通过14天的研究治疗，比较GSP 301 NS相对于Patanase®NS和内舒拿®NS的有效性。次要目的：（1）评估每项治疗的安全性和耐受性。（2）研究糠酸莫米松和盐酸奥洛他定的药代动力学（PK）。

[Translation]

Primary Objective: To compare the efficacy of GSP 301 NS relative to Patanase® NS and Nasonex® NS through 14 days of study treatment. Secondary Objectives: (1) To evaluate the safety and tolerability of each treatment. (2) To study the pharmacokinetics (PK) of mometasone furoate and olopatadine hydrochloride.

Start Date06 Apr 2022

Sponsor / Collaborator

Grand Pharmaceutical (China) Co., Ltd.

[+1]

NCT03463031

/ CompletedPhase 3

A Double-Blind, Randomized, Parallel-Group Study to Evaluate the Efficacy, Safety and Tolerability of Fixed Dose Combination GSP 301 Nasal Spray Compared With Placebo Nasal Spray in Pediatric Subjects (Aged 6 to Under 12 Years) With Seasonal Allergic Rhinitis (SAR)

Study to evaluate the efficacy, safety and tolerability of GSP 301 nasal spray (NS) compared with placebo NS in pediatric subjects (aged 6 to under 12 years) with Seasonal Allergic Rhinitis (SAR).

Start Date16 Mar 2018

Sponsor / Collaborator

Glenmark Specialty SA

100 Clinical Results associated with Olopatadine Hydrochloride/Mometasone Furoate Monohydrate

100 Translational Medicine associated with Olopatadine Hydrochloride/Mometasone Furoate Monohydrate

100 Patents (Medical) associated with Olopatadine Hydrochloride/Mometasone Furoate Monohydrate

Literatures (Medical) associated with Olopatadine Hydrochloride/Mometasone Furoate Monohydrate

01 Jul 2026·Brazilian Journal of Otorhinolaryngology

Olopatadine plus mometasone for seasonal allergic rhinitis treatment: A pooled analysis of clinical trials

Article

Author: Anselmo-Lima, Wilma Terezinha ; Gordonsmith, Roger Hereward ; Carbone, Luis Felipe Barreiras ; Wu, Wen ; Aggarwal, Vineet ; Nakanishi, Marcio ; Barkate, Hanmant

OBJECTIVE:

This study was conducted to analyze the efficacy and safety of a fixed-dose combination of olopatadine HCl (antihistamine) and mometasone furoate (corticosteroid) (Olo/Mom, GSP301) for the treatment of Seasonal Allergic Rhinitis (SAR).

METHODS:

Efficacy data from one phase II (NCT02318303 [GSP301-201]) and two pivotal phase III double-blind, randomized, active, placebo-controlled (NCT02631551 [GSP301-301] and NCT02870205 [GSP301-304]) clinical trials were collated and analyzed. These studies investigated Olo/Mom (administered twice daily/BID) compared with placebo and its monotherapy constituents for the treatment of SAR in patients aged ≥12-years. In addition, safety data were analyzed from the aforementioned studies and a proof-of-concept study (NCT03444506 [GSP301-POC]). Primary and secondary endpoints were compared between Olo/Mom, its active mometasone and olopatadine constituents, and placebo.

RESULTS:

For the efficacy analyses (n = 2971), Olo/Mom significantly reduced rTNSS scores compared with placebo (Least Square Mean Difference [LSMD = -0.94]; 95% CI: -1.17, -0.70; p < 0.0001), olopatadine (LSMD = -0.37; 95% CI: -0.60, -0.14; p = 0.0019), and mometasone (LSMD = -0.42; 95% CI: -0.65, -0.18; p = 0.0005). Olo/Mom also significantly improved the RQLQ and iTNSS scores compared with placebo and its monotherapy constituents (p < 0.05, all). The onset of action of Olo/Mom was observed at 15-minutes and was sustained at subsequent timepoints. The incidence of treatment-emergent adverse events in the Olo/Mom, placebo, olopatadine, and mometasone groups was 13.9%, 9.5%, 13.2%, and 7.9%, respectively.

CONCLUSION:

This pooled analysis demonstrated the superiority of Olo/Mom compared to its monotherapy constituents or placebo in reducing SAR symptoms over 14-days. Moreover, this study showed that Olo/Mom has a rapid onset of action and significantly improves RQLQ scores compared to placebo. Administration of Olo/Mom BID is an effective and well-tolerated option for the treatment of SAR in patients aged 12-years or older.

LEVEL OF EVIDENCE:

I (Level I - randomized controlled trials).

04 Dec 2023·Polish Journal of Otolaryngology

Intranasal combo: fixed-dose combination of mometasone furoate and olopatadine hydrochloride in therapeutic strategies for rhinosinusitis

Article

Author: Samoliński, Krzysztof ; Lipiec, Agnieszka ; Krzych-Fałta, Edyta ; Walkiewicz, Artur ; Borowicz, Jacek ; Samoliński, Bolesław ; Wojas, Oksana

A novel strategy for the treatment of allergic rhinitis results from the innovative combination of antihistamine and intranasal corticosteroid drugs. By combining two preparations with different mechanism of action, this novel approach facilitates quick and effective controls of all upper respiratory tract allergy symptoms. The article presents the results of a study of olopatadine hydrochloride and mometasone furoate fixed-dose combination (GSP301) administered intranasally from a spray formulation, with an attempt at positioning the treatment within the ARIA and EPOS guidelines.

03 Jun 2023·Expert review of clinical immunology

Intranasal corticosteroid and antihistamine combinations in the treatment of allergic rhinitis: the role of the novel formulation olopatadine/mometasone furoate

Review

Author: Paoletti, Giovanni ; Heffler, Enrico ; Ridolo, Erminia ; Nicoletta, Francesca ; Canonica, Giorgio Walter ; Barone, Alessandro ; Malvezzi, Luca

INTRODUCTION:

Allergic rhinitis (AR) is a common disease with an important impact on the quality of life and very high management costs. In many patients, the poor control of rhinitis symptoms often requires the use of different drugs, and polytherapy tends to reduce therapeutic adherence. According to the latest version of ARIA guidelines, the currently recommended drugs for the treatment of moderate-to-severe AR are second-generation antihistamines, intranasal corticosteroids, and their combination, even in a single nasal spray device. A single medication with a rapid onset of action, acting on breakthrough symptoms too, would be advantageous, also in terms of patient compliance.

AREAS COVERED:

GSP301 (olopatadine 600 µg - mometasone furoate 25 µg) is a novel intranasal formulation, combining the second-generation antihistamine olopatadine hydrochloride with mometasone furoate. Here, we review the evidence for GSP301, especially concerning the efficacy and safety profile of this intranasal combination in the treatment of AR.

EXPERT OPINION:

The evidence provided in the current review clearly supports the use of GSP301 as a novel intranasal corticosteroid/antihistamine combination with a well-documented efficacy and safety profile in terms of rapid symptom relief and good tolerability.

News (Medical) associated with Olopatadine Hydrochloride/Mometasone Furoate Monohydrate

05 May 2026

·www.businesswire.com

BlinkRx Announces Availability of RYALTRIS ® for Convenient Home Delivery Following Glenmark’s Commercial Transition

NEW YORK--(BUSINESS WIRE)--BlinkRx, the digital pharmacy platform designed to make prescription medications more accessible and affordable, today announced that RYALTRIS® (Olopatadine Hydrochloride and Mometasone Furoate) Nasal Spray, 665 mcg/25 mcg* per spray, is now available for fulfillment through the BlinkRx platform. This follows Glenmark Pharmaceuticals Inc., USA’s transition to direct commercialization and distribution of the product. Patients can now access RYALTRIS® through BlinkRx’s streamlined digital platform as allergy season peaks nationwide. As seasonal allergies reach peak levels in many parts of the country, BlinkRx is helping ensure that patients across the United States can access RYALTRIS® quickly and conveniently. While RYALTRIS® is not available through traditional retail pharmacy channels, patients can benefit from a seamless, end-to-end experience through BlinkRx that includes the best available price and free home delivery. “At BlinkRx, our mission is to ensure that essential medications are easily within reach for everyone. We’re excited to be expanding availability of RYALTRIS® on our platform during the worst seasonal allergies in many parts of the country,” said Geoff Chaiken, co-founder and CEO of BlinkRx. “We are pleased to expand access to RYALTRIS® through BlinkRx, which offers a convenient option for patients,” said Marc Kikuchi, President & Business Head, North America at Glenmark Pharmaceuticals Inc., USA. “As we continue to advance our direct commercialization efforts in the U.S., partnerships like these play a key role in improving how patients access and experience care.” RYALTRIS® is indicated for the treatment of symptoms associated with seasonal allergic rhinitis in adult and pediatric patients 12 years of age and older.1 It is a fixed-dose combination nasal spray that brings together olopatadine hydrochloride (an antihistamine) and mometasone furoate (a corticosteroid) in a single formulation. With demand for allergy relief increasing during the spring season, ensuring reliable and convenient access to effective therapies remains a priority for both providers and patients. Patients interested in finding out if RYALTRIS® is right for them should speak with their healthcare provider to learn more. Patients with existing RYALTRIS® prescriptions can ask their pharmacist to transfer the prescription to BlinkRx. About BlinkRx BlinkRx is redefining the pharmacy experience with integrated data-driven technology that improves patient access to branded medications. Its prescription journey management platform streamlines every step of the process, improving the prescription journey across all stakeholders. Patients enjoy the lowest network price, free home delivery, and personalized support. Healthcare providers benefit from dedicated access teams and enhanced prior authorization support for their patients. Pharmacies are able to access technologies that improve their ability to serve patients. And pharmaceutical manufacturers gain greater transparency from prescription to fulfillment. Learn more at www.blinkrx.com. About Glenmark Pharmaceuticals Limited Glenmark Pharmaceuticals Ltd. (BSE: 532296 | NSE: GLENMARK) is a global, research‐led, pharmaceutical company with a unique focus on innovation and accessibility. We pioneer transformative breakthrough therapies that aim to redefine treatment while expanding access to high-quality and affordable medicines for patients around the world. With 11 world-class manufacturing facilities across four continents, supported by six cutting-edge R&D centres, and a commercial footprint in 80+ countries, we deliver a diversified portfolio across branded, innovative, generics, and consumer health products, with a focus on respiratory, dermatology, and oncology. Scrip 100 positions Glenmark among the Top 100 biopharmaceutical companies globally by pharmaceutical sales for 2024. For more information, visit www.glenmarkpharma.com *Calculated on the anhydrous basis 1RYALTRIS® Nasal Spray approved prescribing information, Glenmark Specialty SA, Switzerland. Please click here to view full prescribing information, including Important Safety Information. For additional information about RYALTRIS® and how to access, please visit us.ryaltris.com. RYALTRIS is a registered trademark of Glenmark Specialty SA.

02 Apr 2026

·www.fiercepharma.com

Glenmark goes direct with new US Ryaltris marketing plan as it drops partner model

Glenmark will now directly lead brand strategy, market access, and customer engagement for the drug in the U.S. Six years after signing a U.S. marketing partnership with Hikma Pharma for its seasonal allergy spray Ryaltris, India’s Glenmark is now going it alone. Back in 2020, Glenmark penned a deal with Hikma as its U.S. distribution partner for Ryaltris while the drug was still in development.The FDA signed off on the spray in 2022 and since then, Hikma has been selling the product in the U.S.But in a marketing shift announced April 1, Glenmark’s U.S. division has dropped its partner model for the med and will “manage end-to-end commercialization and distribution for Ryaltris in the United States.” “This marks a meaningful step in Glenmark's continued expansion in the region with a sustainable approach to building a strong, direct commercial U.S. based presence,” the company said in a release.From April 1, Glenmark will directly lead brand strategy, market access, and customer engagement for the drug in the U.S. The spray generated nearly $100 million across all markets last year. "The commercialization by Glenmark for Ryaltris in the United States is an important step forward for the growth of our company,” Glenmark’s Marc Kikuchi, President & Business Head, North America, said in a statement. “It allows us greater operational direction in how we engage the market and support healthcare providers and patients across the nation,” Kikuchi added. “Today's announcement also marks a significant moment in our broader effort to strengthen our innovative businesses in the U.S. and build a more direct, sustainable commercial presence over time.”

Drug Approval

01 Apr 2026

·www.prnewswire.com

Glenmark Pharmaceuticals Announces Strategic Shift to Direct Commercialization and Distribution of RYALTRIS® in the U.S., Significantly Expanding Its Innovative Portfolio

RYALTRIS® is Glenmark's first innovative product introduced into the U.S. market ELMWOOD PARK, N.J., April 1, 2026 /PRNewswire/ -- Glenmark Pharmaceuticals Inc., USA (Glenmark) today announced that it will manage end-to-end commercialization and distribution for RYALTRIS® (Olopatadine Hydrochloride and Mometasone Furoate) Nasal Spray, 665 mcg/25 mcg* per spray in the United States, effective April 1, 2026. This marks a meaningful step in Glenmark's continued expansion in the region with a sustainable approach to building a strong, direct commercial U.S. based presence. RYALTRIS® was launched in the United States in 2022 and is approved by the U.S. Food and Drug Administration (U.S. FDA) for the treatment of symptoms associated with Seasonal Allergic Rhinitis (SAR) in adults and paediatric patients 12 years of age and older1. It is a fixed-dose combination nasal spray that brings together olopatadine hydrochloride (an antihistamine) and mometasone furoate (a corticosteroid) in a single formulation. The product is supplied as a 240-metered spray nasal suspension. Seasonal Allergic Rhinitis affects millions of patients across the United States and remains an area where symptom control and treatment adherence continue to be important considerations. By combining two established therapies in one formulation, RYALTRIS® offers a convenient treatment option1 aligned with evolving patient and physician preferences. Glenmark will directly lead brand strategy, market access, and customer engagement for RYALTRIS® in the U.S. This allows for more focused execution, closer alignment with healthcare providers and greater responsiveness to market needs. Commenting on the development, Marc Kikuchi, President & Business Head, North America said, "The commercialization by Glenmark for RYALTRIS® in the United States is an important step forward for the growth of our company. It allows us greater operational direction in how we engage the market and support healthcare providers and patients across the nation. Today's announcement also marks a significant moment in our broader effort to strengthen our innovative businesses in the U.S. and build a more direct, sustainable commercial presence over time." RYALTRIS® is already approved in key markets including the United States, European Union, United Kingdom, Australia, South Korea, Russia and China. In FY26, RYALTRIS® was launched in 11 additional markets, expanding its presence to 55 countries worldwide. *Calculated on the anhydrous basis 1RYALTRIS® Nasal Spray approved prescribing information, Glenmark Specialty SA, Switzerland. Please click here to view full prescribing information, including Important Safety Information. For additional information about RYALTRIS® and how to access, please visit us.ryaltris.com. RYALTRIS is a registered trademark of Glenmark Specialty SA. About Glenmark Pharmaceuticals Limited Glenmark Pharmaceuticals Ltd. (BSE: 532296) (NSE: GLENMARK) is a global, research‐led pharmaceutical company with a unique focus on innovation and accessibility. We pioneer transformative breakthrough therapies that aim to redefine treatment while expanding access to high-quality and affordable medicines for patients around the world. With 11 world-class manufacturing facilities across four continents, supported by six cutting-edge R&D centres, and a commercial footprint in 80+ countries, we deliver a diversified portfolio across branded, innovative, generics, and consumer health products, with a focus on respiratory, dermatology, and oncology. Scrip 100 positions Glenmark among the Top 100 biopharmaceutical companies globally by pharmaceutical sales for 2024. For more information, visit . Logo: SOURCE Glenmark Pharmaceuticals 21% more press release views with Request a Demo

Drug Approval

100 Deals associated with Olopatadine Hydrochloride/Mometasone Furoate Monohydrate

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	R01	-

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Rhinitis, Allergic, Seasonal	United States	Glenmark Specialty SA	13 Jan 2022
Rhinitis, Allergic	Australia	Seqirus Pty Ltd.	11 Dec 2019

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Rhinoconjunctivitis	Phase 3	China	Grand Pharmaceutical (China) Co., Ltd.	06 Apr 2022
Rhinoconjunctivitis	Phase 3	China	Glenmark Pharmaceuticals Ltd.	06 Apr 2022
Rhinitis, Allergic, Perennial	Phase 3	United States	Glenmark Specialty SA	01 Apr 2016

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03463031 (Pubmed \| Ann Allergy Asthma Immunol) Manual	Phase 3	Rhinitis, Allergic, Seasonal	446	GSP301	vbkxwxgjms(btdfajwhud): difference = -0.6 (95% CI, -0.9 to -0.2), P-Value = 0.001 View more	Positive	01 Aug 2022
				Placebo
NCT03463031 (GSP 301-305, CTgov)	Phase 3	Rhinitis, Allergic, Seasonal	446	GSP 301 NS	esjlnpjbkx(squtpdzsar) = hcvfltegds rkdmutsfzx (bcohvawtsq, 1.41) View more	-	08 Oct 2019
NCT02709538 (GSP 301-303 \| GSP301, CTgov)	Phase 3	Rhinitis, Allergic, Perennial	601	GSP 301 NS (GSP 301 NS)	wsvjdrukau = mbddfzamqc gveubbprpq (awirlmucwj, ssxiiudzwm - pkdhsxwrzl) View more	-	13 Sep 2018
				GSP 301 Placebo NS pH 3.7 (GSP 301 Placebo NS pH 3.7)	wsvjdrukau = xdpxkrjvht gveubbprpq (awirlmucwj, obkssyvkum - kylthulgam) View more
NCT02631551 (GSP 301-301, CTgov)	Phase 3	Rhinitis, Allergic, Seasonal	1,180	GSP 301 NS (GSP 301 NS)	enciykfxfg(bppfcelzjf) = rqbtofalws stdqrqwtaa (gkvnuybyyu, 1.2) View more	-	15 Aug 2018
				Olopatadine HCl NS (Olopatadine HCl NS)	enciykfxfg(bppfcelzjf) = himtuahpcb stdqrqwtaa (gkvnuybyyu, 1.3) View more
NCT02870205 (GSP 301-304, CTgov)	Phase 3	Rhinitis, Allergic, Seasonal	1,176	GSP 301 placebo NS (GSP 301 Placebo NS)	mzwaahjgea(gsgyvhqyua) = auocbxdgbz emcqdzdlga (opkqnwjoug, 1.2) View more	-	06 Apr 2018
				GSP 301 NS (GSP 301 NS)	mzwaahjgea(gsgyvhqyua) = rfsmhkafvj emcqdzdlga (opkqnwjoug, 1.2) View more
NCT02318303 (CTgov)	Phase 2	Rhinitis, Allergic, Seasonal	1,111	GSP 301-1 NS (QD) (GSP 301-1 NS (QD))	zjkvkjwjyd(xlrfplpxea) = xmyowuftay typtxcwlfw (yxusjsxknp, 1.24) View more	-	28 Jun 2017
				Mometasone Furoate (Mometasone Furoate-1 NS (QD))	zjkvkjwjyd(xlrfplpxea) = dwuymxmzbb typtxcwlfw (yxusjsxknp, 1.30) View more

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