Glenmark Pharmaceuticals Ltd. announced that the U.S. FDA has approved the expanded use of RYALTRIS (olopatadine hydrochloride and mometasone furoate) Nasal Spray, 665 mcg/25 mcg per spray, for treating symptoms of Seasonal Allergic Rhinitis (SAR) in pediatric patients aged 6 to less than 12 years. According to reports from CNBC TV18, this approval represents a significant expansion of the drug's therapeutic indication and patient population coverage. The approval extends the use of RYALTRIS, a fixed-dose combination of olopatadine hydrochloride and mometasone furoate, to a younger paediatric population who previously had limited therapeutic alternatives for seasonal allergic rhinitis symptoms. The USFDA decision allows the company to market the nasal spray to a younger population suffering from seasonal allergic rhinitis, a condition that affects millions of school-age children in the United States.
With this approval, RYALTRIS is now approved in the United States for adults and children aged 6 years and older, as reported by CNBC TV18. The expanded indication is supported by a Phase 3 randomised, double-blind, placebo-controlled study involving 446 children aged 6 to 11 years with seasonal allergic rhinitis. According to the company, the study showed that RYALTRIS improved nasal symptoms compared with placebo and was well tolerated over the 14-day treatment period. This regulatory decision extends the treatment option to a younger pediatric population who previously had limited therapeutic alternatives for seasonal allergic rhinitis symptoms. The therapy was first approved by the USFDA in 2022 for adults and adolescents aged 12 years and above, and with the latest approval, the drug can now be prescribed to patients aged six and above.
The approval comes at an important time for the drugmaker as seasonal allergies remain a significant public health issue among children. According to data from the U.S. Centers for Disease Control and Prevention, 25% of children aged 6 to 11 had a diagnosed seasonal allergy in 2024. Beyond sneezing and congestion, the condition can affect sleep quality, emotional well-being, school performance and physical activity, creating a broader burden on child health. The latest expansion strengthens the company's efforts to build a larger specialty respiratory franchise in its most important overseas market. The company's transition to direct commercialisation of RYALTRIS in the US effective April 1, 2026, gives Glenmark greater ownership of the brand and enables closer engagement with healthcare professionals and patients.
The FDA approval for expanded pediatric use of RYALTRIS represents a significant development for Glenmark in the U.S. market, according to CNBC TV18. Marc Kikuchi, President and Business Head, North America, stated that 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. The approval strengthens the role of RYALTRIS as a key innovative brand within Glenmark's growing US respiratory portfolio. The company's shift to direct commercialization gives Glenmark direct control over branding, pricing strategy, market access and physician engagement, which the company believes will help it deepen engagement with physicians and patients and accelerate growth of the brand.
The product is now approved across key markets including the European Union, the United Kingdom, Australia, South Korea, Russia and China, as reported by CNBC TV18. During FY26, RYALTRIS was launched in 11 additional markets, taking its global presence to 56 countries. RYALTRIS was initially approved by the USFDA in 2022 for treating symptoms of seasonal allergic rhinitis in adults and children aged 12 years and older. Following the latest approval announcement, shares of the company were trading 0.5% lower at ₹2,227.70 on Tuesday. The stock has gained about 15% over the last six months and just 2% in the last year.
