Glenmark Specialty S.A. announced today that the U.S. Food and Drug Administration has approved an expanded indication for RYALTRIS® nasal spray to treat symptoms of Seasonal Allergic Rhinitis in children aged 6 to less than 12 years. The approval extends the product’s U.S. indication to include adults and pediatric patients 6 years and older. It follows positive results from a Phase 3, randomized, double‑blind, placebo‑controlled study of 446 children aged 6- 11, which showed significant improvement in nasal symptoms and good tolerability over a 14‑day treatment period.
Seasonal allergies affect a large portion of school‑age children in the United States. Data from the U.S. Centers for Disease Control and Prevention indicate that 25% of children aged 6-11 had a diagnosed seasonal allergy in 2024. Beyond bothersome nasal symptoms, Seasonal Allergic Rhinitis can impair sleep, emotional well‑being, and participation in physical activity, with potential implications for long‑term development.
Marc Kikuchi, President & Business Head, North America, said the approval is an important milestone in expanding access to RYALTRIS® and strengthens the product’s role in Glenmark’s U.S. respiratory portfolio. He noted that Glenmark’s move to direct commercialization, effective April 1, 2026, gives the company greater ownership of the brand and closer engagement with healthcare professionals and patients, enabling more focused execution on market access, distribution and customer engagement.
RYALTRIS® combines an antihistamine (olopatadine hydrochloride) and a corticosteroid (mometasone furoate) in a fixed‑dose nasal spray. The product was first approved by the FDA in 2022 for adults and adolescents aged 12 and older. Globally, RYALTRIS® has been approved in major markets including the EU, UK, Australia, South Korea, Russia and China, and was launched in 11 additional markets in FY26, bringing its global availability to 56 countries.
The expanded pediatric approval reinforces Glenmark’s emphasis on innovation in respiratory care as the company scales its U.S. specialty presence.
