FDA Approval Expands Access to Ryaltris Nasal Spray for Children Aged 6 to Under 12 Years
Glenmark Expands Ryaltris Nasal Spray Approval to Support Children With Seasonal Allergies
Seasonal allergies affect millions of children and can interfere with everyday activities, including school, sleep, exercise, and overall quality of life. In a significant development for pediatric allergy care, Glenmark Specialty S.A. has announced that the U.S. Food and Drug Administration (FDA) has approved the expanded use of Ryaltris® (olopatadine hydrochloride and mometasone furoate) Nasal Spray, 665 mcg/25 mcg per spray, for children aged 6 to less than 12 years with Seasonal Allergic Rhinitis (SAR).
The approval expands the availability of Ryaltris® to a younger pediatric population, offering another treatment option for managing symptoms associated with seasonal allergies. Previously approved in the United States for adults and children aged 12 years and older, Ryaltris® can now be used for patients aged 6 years and above.
This milestone represents an important step in Glenmark’s respiratory portfolio expansion and follows the company’s transition to direct commercialization of Ryaltris® in the United States.
Understanding Seasonal Allergic Rhinitis in Children
Seasonal Allergic Rhinitis, commonly known as seasonal allergies or hay fever, occurs when the immune system reacts to airborne allergens such as pollen from trees, grasses, or weeds. Common symptoms include sneezing, nasal congestion, runny nose, and itchy or watery eyes.
While seasonal allergies are often considered a minor health concern, they can have a meaningful impact on children’s daily lives. According to the U.S. Centers for Disease Control and Prevention (CDC), approximately 25% of children aged 6 to 11 years had a diagnosed seasonal allergy in 2024.
For children, uncontrolled allergy symptoms may affect concentration, sleep quality, participation in physical activities, and emotional well-being. Research has also explored associations between allergic conditions and broader effects on children’s health and development.
Clinical Study Supported FDA Approval
The FDA approval of Ryaltris® for children aged 6 to less than 12 years was supported by a Phase 3 clinical study evaluating the safety and effectiveness of the treatment in pediatric patients with Seasonal Allergic Rhinitis.
The randomized, double-blind, placebo-controlled study included 446 children between the ages of 6 and 11 years. Results showed that Ryaltris® improved nasal allergy symptoms compared with placebo during the 14-day treatment period. The treatment was also generally well tolerated among study participants.
Ryaltris® combines two active ingredients in a single nasal spray formulation:
- Olopatadine hydrochloride, an antihistamine that helps block histamine-related allergy symptoms.
- Mometasone furoate, a corticosteroid that helps reduce inflammation associated with allergic reactions.
By combining these two approaches in one formulation, Ryaltris® is designed to address multiple symptoms associated with Seasonal Allergic Rhinitis.
Glenmark Strengthens Its U.S. Respiratory Portfolio
The expanded approval comes as Glenmark continues to build its presence in the U.S. specialty pharmaceutical market. Effective April 1, 2026, Glenmark Pharmaceuticals Inc., USA assumed responsibility for the end-to-end commercialization and distribution of Ryaltris® in the United States.
Through direct commercialization, Glenmark now manages key areas including brand strategy, market access, distribution, and customer engagement. The company stated that this approach will help create closer connections with healthcare professionals and patients while supporting continued growth of the Ryaltris® brand.
Marc Kikuchi, President and Business Head, North America at Glenmark, highlighted the importance of the approval, noting that extending Ryaltris® use to children aged 6 to less than 12 years strengthens access to treatment options for pediatric patients with Seasonal Allergic Rhinitis.
The company also aims to further develop Ryaltris® as a key product within its growing respiratory portfolio.
Growing Global Presence of Ryaltris®
Since its initial U.S. FDA approval in 2022 for adults and pediatric patients aged 12 years and older, Ryaltris® has expanded across international markets. The product has received approvals in several regions, including the European Union, United Kingdom, Australia, South Korea, Russia, and China.
During fiscal year 2026, Ryaltris® was launched in 11 additional markets, increasing its global presence to 56 countries. This expansion reflects Glenmark’s broader focus on developing and delivering respiratory treatments for patients worldwide.
Safety Information and Considerations
Like all medicines, Ryaltris® has important safety considerations. Patients with known hypersensitivity to any ingredient of Ryaltris®, including mometasone furoate, should not use the medication.
Healthcare providers should monitor patients for potential nasal effects, including nosebleeds, nasal ulcers, nasal septal perforation, impaired wound healing, and fungal infections. Patients with changes in vision or a history of glaucoma or cataracts should also be monitored.
Additional warnings include possible hypersensitivity reactions, immune system effects, adrenal suppression with misuse or higher-than-recommended doses, and potential effects on growth velocity in children. Growth should be routinely monitored in pediatric patients receiving Ryaltris®.
The most common adverse reactions reported with Ryaltris® include dysgeusia (altered taste), epistaxis (nosebleed), and nasal discomfort.
Ryaltris® is indicated for the treatment of symptoms of Seasonal Allergic Rhinitis in adults and pediatric patients aged 6 years and older.
What This Approval Means for Families
The FDA’s expanded approval of Ryaltris® provides families and healthcare providers with an additional option for managing seasonal allergy symptoms in younger children. As seasonal allergies continue to affect many school-age children, access to well-studied treatment options can support better symptom management and help children maintain their daily routines.
The approval also highlights continued innovation in respiratory care, with pharmaceutical companies working to develop therapies that address the needs of different patient populations.
For more information about Ryaltris® and access details, visit the official product website: us.Ryaltris.com.
Sources
- Prenner BM, et al. “Efficacy and safety of GSP301 nasal spray in children aged 6–11 years with Seasonal Allergic Rhinitis.” Annals of Allergy, Asthma & Immunology. 2022;129(5):618–626.e2.
- National Center for Health Statistics. “Diagnosed Allergic Conditions in Children Ages 0–17: United States, 2024.” NCHS Data Brief No. 546. January 2026.
- Meltzer EO, Blaiss MS, Derebery MJ, et al. “Burden of allergic rhinitis: results from the Pediatric Allergies in America survey.” Journal of Allergy and Clinical Immunology. 2009;124(3 Suppl):S43–S70.
- Fereidouni M, et al. “A study of the association of cognitive abilities and emotional function with allergic disorders in young women.” BMC Women’s Health. 2021;21(1):205.
- Strom MA, Silverberg JI. “Associations of physical activity and sedentary behavior with atopic disease in United States children.” Journal of Pediatrics. 2016;174:247–253.e243.
Disclaimer
This article is intended for informational purposes only and does not constitute medical advice. Patients should consult qualified healthcare professionals for diagnosis, treatment decisions, and guidance regarding medication use. The safety information provided is a summary and does not replace the full prescribing information for Ryaltris®.
Source: Glenmark Pharmaceuticals Ltd.