Glenmark Specialty S A has received approval from the US Food and Drug Administration (US FDA) to expand the use of its allergy treatment RYALTRIS nasal spray for pediatric patients aged 6 to less than 12 years suffering from Seasonal Allergic Rhinitis (SAR).
The approval broadens the eligible patient population for the drug in the United States, where it is now approved for adults and children aged six years and above.
Approval backed by Phase 3 study
The expanded indication is supported by a Phase 3, randomized, double-blind, placebo-controlled clinical study involving 446 children aged 6 to 11 years with Seasonal Allergic Rhinitis.
According to the company, the study demonstrated that RYALTRIS significantly improved nasal allergy symptoms compared with placebo and was well tolerated throughout the 14-day treatment period.
Seasonal allergies remain a significant health concern among children in the United States. Citing data from the US Centers for Disease Control and Prevention (CDC), Glenmark said around 25% of children aged 6 to 11 years were diagnosed with seasonal allergies in 2024. Beyond nasal symptoms, Seasonal Allergic Rhinitis can adversely affect sleep, emotional well-being, school performance and physical activity.
Strengthening US respiratory portfolio
Glenmark Specialty S.A. President & Business Head, North America Marc Kikuchi said the approval marks an important milestone in expanding access to RYALTRIS for younger children with Seasonal Allergic Rhinitis.
He said the approval also reinforces RYALTRIS as one of the key innovative brands within Glenmark’s expanding respiratory portfolio in the United States.
Kikuchi added that Glenmark’s transition to direct commercialisation of the product provides greater ownership of the brand while enabling closer engagement with healthcare professionals and patients.
The company plans to leverage the platform to expand patient access, strengthen the RYALTRIS franchise and reinforce its innovation-led presence in the US specialty pharmaceutical market.
Direct commercialisation strategy
Effective April 1, 2026, Glenmark Pharmaceuticals Inc., USA assumed full responsibility for the commercialisation and distribution of RYALTRIS in the United States.
The company now directly manages the product’s brand strategy, market access, distribution and customer engagement, allowing for more focused execution and improved alignment with the needs of physicians and patients.
Global footprint expands
RYALTRIS is a fixed-dose combination nasal spray containing olopatadine hydrochloride, an antihistamine, and mometasone furoate, a corticosteroid, in a single formulation.
The product was initially approved by the US FDA in 2022 for adults and children aged 12 years and above with Seasonal Allergic Rhinitis.
Since then, RYALTRIS has secured approvals across major global markets, including the European Union, the United Kingdom, Australia, South Korea, Russia and China.
During FY26, Glenmark launched the product in 11 additional markets, taking its global presence to 56 countries, further strengthening its international respiratory portfolio.