Glenmark Specialty S.A. has received approval from the U.S. Food and Drug Administration (FDA) to expand the use of RYALTRIS Nasal Spray for the treatment of Seasonal Allergic Rhinitis (SAR) in children aged 6 to less than 12 years. The latest approval extends the therapy’s indication to a younger pediatric population, making it available for both adults and children aged six years and above in the United States.

The approval is based on findings from a Phase 3, randomized, double-blind, placebo-controlled clinical trial involving 446 children between the ages of six and 11 years. The study demonstrated that RYALTRIS significantly improved nasal allergy symptoms compared to placebo while maintaining a favourable safety and tolerability profile throughout the 14-day treatment period.

Seasonal Allergic Rhinitis remains one of the most common allergic conditions among children in the United States. According to the U.S. Centers for Disease Control and Prevention (CDC), nearly one in four children aged six to 11 years were diagnosed with seasonal allergies in 2024. Beyond nasal congestion and sneezing, the condition can affect sleep quality, emotional well-being, school performance, and overall quality of life.

Commenting on the milestone, Marc Kikuchi, President & Business Head – North America, Glenmark, said the approval represents an important step in expanding patient access to RYALTRIS while strengthening the product’s position within Glenmark’s growing respiratory portfolio in the United States. He added that the company’s transition to direct commercialization will enable stronger engagement with healthcare professionals, improve market access, and accelerate the growth of the RYALTRIS franchise.

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Effective April 1, 2026, Glenmark Pharmaceuticals Inc., USA assumed full responsibility for the commercialization and distribution of RYALTRIS in the United States, taking charge of brand strategy, market access, customer engagement, and distribution. The company believes this direct commercial model will support more focused execution and enhance patient access to innovative respiratory therapies.

Originally approved by the U.S. FDA in 2022 for adults and children aged 12 years and above, RYALTRIS is a fixed-dose combination nasal spray containing olopatadine hydrochloride and mometasone furoate. The product has now been approved across 56 countries, with launches in 11 new international markets during FY26, reinforcing Glenmark’s expanding global respiratory portfolio.

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