Glenmark Pharma Expands RYALTRIS Market with USFDA Approval for Children Aged 6–12

Glenmark Pharmaceuticals has received USFDA approval to expand the use of its RYALTRIS nasal spray for the treatment of seasonal allergic rhinitis in children aged 6 to less than 12 years, broadening its eligible patient base in the US. RYALTRIS, a fixed-dose combination of olopatadine hydrochloride and mometasone furoate, is now approved for both adults and children aged 6 years and above. The approval is backed by a Phase 3 randomised, double-blind, placebo-controlled clinical study involving 446 children aged 6 to 11 years, where the treatment demonstrated improved relief from nasal allergy symptoms compared to placebo and was well tolerated over a 14-day treatment period. Glenmark also highlighted that, effective April 1, 2026, its US subsidiary assumed full responsibility for the commercialisation and distribution of RYALTRIS, providing greater control over the brand’s growth strategy. Originally approved by the USFDA in 2022 for adults and children aged 12 years and above, RYALTRIS is now approved across major markets including the European Union, the United Kingdom, Australia, South Korea, Russia and China. During FY26, the company launched the product in 11 additional markets, expanding its global presence to 56 countries. The latest approval further strengthens Glenmark’s respiratory portfolio and supports its strategy to expand access to innovative therapies across international markets. $GLENMARK Disclaimer: This post is for informational purposes only and not a recommendation to buy or sell any securities. I, or my family, associates, or relatives, may have a financial interest in the securities mentioned.