Glenmark Secures U.S. FDA Approval to Expand RYALTRIS® Use for Pediatric Seasonal Allergic Rhinitis

Glenmark Secures U.S. FDA Approval to Expand RYALTRIS® Use for Pediatric Seasonal Allergic Rhinitis​

Glenmark Specialty S.A. (Glenmark) has announced that the U.S. Food and Drug Administration (FDA) has approved the expanded use of RYALTRIS® Nasal Spray (olopatadine hydrochloride and mometasone furoate, 665 mcg/25 mcg per spray). The approval extends the treatment option for Seasonal Allergic Rhinitis (SAR) to pediatric patients aged 6 years up to less than 12 years.

With this expanded indication, RYALTRIS® is now approved in the United States for adults and pediatric patients who are six years old or older. This advancement targets a younger segment of the pediatric population previously addressed by the medicine.

Clinical Basis and Market Impact​

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

This development strengthens Glenmark's innovative respiratory portfolio in the U.S. Following this approval, Glenmark Pharmaceuticals Inc., USA assumed end-to-end commercialization and distribution responsibility for RYALTRIS® in the United States starting April 1, 2026. The company plans to leverage direct commercialization to enhance brand ownership and engage closely with healthcare professionals and patients.

Seasonal allergies are a prevalent issue among school-age children in the U.S. Data from the U.S. Centers for Disease Control and Prevention indicates that 25% of children aged 6 to 11 years had a diagnosed seasonal allergy in 2024. SAR can significantly impact a child's emotional well-being, sleep, and physical activity, potentially leading to long-term consequences including obesity risk.

Product Details and Global Footprint​

RYALTRIS® is a fixed-dose combination nasal spray combining olopatadine hydrochloride (a histamine-1 receptor inhibitor) and mometasone furoate (a corticosteroid). It was initially approved by the U.S. FDA in 2022 for adults and pediatric patients aged 12 years and older.

The medication has established a broad international footprint, with approvals secured across markets including the European Union, United Kingdom, Australia, South Korea, Russia, and China. In fiscal year '26, RYALTRIS® was launched in 11 additional countries, expanding its global presence to 56 nations.

GLENMARK Stock Price Movement​

Shares of Glenmark Pharmaceuticals Limited edged higher on Monday, closing at ₹2239.5 after gaining 0.30%. The stock saw a total traded volume of 914,679 shares during the session.