The U.S. FDA has expanded Glenmark’s RYALTRIS approval to children aged 6 to less than 12 years with Seasonal Allergic Rhinitis, supported by Phase III data.
Glenmark Specialty S.A. has received U.S. Food and Drug Administration approval to expand the indication for RYALTRIS® (olopatadine hydrochloride and mometasone furoate) Nasal Spray, 665 mcg/25 mcg per spray, for the treatment of symptoms associated with Seasonal Allergic Rhinitis (SAR) in pediatric patients aged 6 to less than 12 years. With this approval, RYALTRIS® is now approved in the United States for adults and pediatric patients aged 6 years and older, expanding access to the therapy for a younger patient population.
Clinical Evidence Supports Pediatric Label Expansion
The expanded indication is supported by results from a Phase III randomized, double-blind, placebo-controlled trial involving 446 children aged 6 to 11 years with Seasonal Allergic Rhinitis. The study showed significantly greater improvement in nasal symptoms with RYALTRIS® compared with placebo and found the therapy to be generally well tolerated during the 14-day treatment period.
Addressing the Burden of Seasonal Allergic Rhinitis in Children
Seasonal allergies remain a common health concern among school-aged children in the United States. According to U.S. Centers for Disease Control and Prevention data referenced by Glenmark, approximately 25% of children aged 6 to 11 years had a diagnosed seasonal allergy in 2024.
Beyond nasal congestion and sneezing, Seasonal Allergic Rhinitis can adversely affect children’s overall health, emotional well-being, sleep quality, and participation in physical activities. The condition may also have longer-term consequences for healthy development and increase the risk of obesity-related complications.
Company Perspective
Marc Kikuchi, President and Business Head, North America, said the expanded indication marks an important step in increasing access to RYALTRIS® for children with Seasonal Allergic Rhinitis in the United States. He added that the approval further strengthens RYALTRIS® as an important product within Glenmark’s expanding U.S. respiratory portfolio.
Kikuchi also noted that Glenmark’s transition to direct commercialization of RYALTRIS® provides greater ownership of the brand and enables closer engagement with healthcare professionals and patients. According to the company, this strategy will help expand patient access, strengthen the RYALTRIS® franchise, and reinforce Glenmark’s innovation-led presence in the U.S. specialty pharmaceutical market.
Direct Commercialization Strategy in the United States
Effective April 1, 2026, Glenmark Pharmaceuticals Inc., USA assumed full responsibility for the commercialization and distribution of RYALTRIS® in the United States. Through this model, the company now directly manages brand strategy, market access, distribution, and customer engagement, enabling more focused execution and closer alignment with the needs of healthcare professionals and patients.
About RYALTRIS®
RYALTRIS® is a fixed-dose combination nasal spray containing olopatadine hydrochloride, an antihistamine, and mometasone furoate, a corticosteroid. The therapy combines antihistamine and anti-inflammatory mechanisms to relieve symptoms associated with Seasonal Allergic Rhinitis.
The product was initially approved by the U.S. FDA in 2022 for adults and pediatric patients aged 12 years and older. It has since gained approvals across major international markets, including the European Union, United Kingdom, Australia, South Korea, Russia, and China. During FY26, RYALTRIS® launched in 11 additional markets, expanding its global availability to 56 countries.
Safety Information
RYALTRIS® is contraindicated in patients with known hypersensitivity to any of its ingredients, including mometasone furoate. Important warnings include epistaxis, nasal ulceration, nasal septal perforation, impaired wound healing, Candida albicans infection, somnolence, glaucoma, cataracts, hypersensitivity reactions, immunosuppression-related infections, hypercorticism, adrenal suppression, and reduced growth velocity in pediatric patients. Routine monitoring is recommended where clinically appropriate.
The most commonly reported adverse reactions occurring in at least 1% of patients include dysgeusia, epistaxis, and nasal discomfort. RYALTRIS® is indicated for the treatment of symptoms associated with Seasonal Allergic Rhinitis in adults and pediatric patients aged 6 years and older.
Expanding Access to Pediatric Respiratory Care
The FDA’s approval broadens access to RYALTRIS® for younger children living with Seasonal Allergic Rhinitis, providing an additional treatment option supported by Phase III clinical evidence. The expanded indication also strengthens Glenmark’s respiratory portfolio in the United States while supporting the company’s strategy to grow the RYALTRIS® franchise through direct commercialization and expanded patient access.
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About the Writer
Kalyani Boharapi (LinkedIn) is a pharmacy professional and healthcare writer currently pursuing an M.Pharm in Regulatory Affairs at Dr. D. Y. Patil College of Pharmacy, with interests in pharmaceutical regulations, drug development, and healthcare innovation. She has academic exposure to dossier preparation, scientific writing, and regulatory documentation. Kalyani has also completed certification courses in Generative AI, AI in Pharma, and Bioinformatics, and actively participates in pharmaceutical conferences to stay updated with emerging trends and advancements in the healthcare and pharmaceutical industry.
