Glenmark receives US FDA approval to expand the use of RYALTRIS nasal spray for children aged 6 to less than 12 years

Glenmark Specialty S.A. (Glenmark) announced that US FDA has approved the expanded use of RYALTRIS (olopatadine hydrochloride and mometasone furoate) Nasal Spray, 665 mcg/25 mcg per spray, for the treatment of symptoms of 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, extending this treatment option to a younger pediatric population.

The approval was supported by a Phase 3, randomized, double-blind, placebo-controlled study involving 446 children aged 6 to 11 years with Seasonal Allergic Rhinitis. The study demonstrated that RYALTRIS improved nasal symptoms compared with placebo and was well tolerated over the 14-day treatment period.

Seasonal allergies are common among school-age children in the United States. According to the US Centers for Disease Control and Prevention, 25% of children aged 6 to 11 years had a diagnosed seasonal allergy in 2024. Seasonal Allergic Rhinitis (SAR) affects far more than nasal symptoms, significantly impacting children’s overall health, emotional well-being, sleep, and participation in physical activity, with potential long-term consequences for healthy development and obesity risk.

Commenting on the development, Marc Kikuchi, President & Business Head, North America said, “This approval marks an important step in expanding access to RYALTRIS in the United States by extending its use to children aged 6 to less than 12 years with Seasonal Allergic Rhinitis. It also strengthens the role of RYALTRIS as a key innovative brand within Glenmark’s growing US respiratory portfolio.”

“Our transition to direct commercialization gives us greater ownership of the brand and enables closer engagement with healthcare professionals and patients. We intend to use this platform to expand access, build the RYALTRIS franchise and further strengthen Glenmark’s innovation-led presence in the U.S. specialty market,” he added.

Effective April 1, 2026, Glenmark Pharmaceuticals Inc., USA assumed responsibility for the end-to-end commercialization and distribution of RYALTRIS in the United States. Glenmark now directly leads the product’s brand strategy, market access, distribution and customer engagement, enabling more focused execution and closer alignment with the needs of healthcare professionals and patients.

RYALTRIS is a fixed-dose combination nasal spray that combines olopatadine hydrochloride (an antihistamine) and mometasone furoate (a corticosteroid) in a single formulation. It was initially approved by the US FDA in 2022 for the treatment of symptoms of Seasonal Allergic Rhinitis (SAR) in adults and pediatric patients 12 years of age and older.

RYALTRIS has established a broad international footprint, with approvals across key markets including the European Union, United Kingdom, Australia, South Korea, Russia, and China. In FY26, RYALTRIS was launched in 11 additional markets, further expanding its global presence to 56 countries.

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