FDA Approves Ryaltris for Children Aged 6 to 11 With Seasonal Allergic Rhinitis

The US Food and Drug Administration (FDA) has expanded the approved use of Ryaltris (olopatadine hydrochloride and mometasone furoate) nasal spray, 665 mcg/25 mcg per spray, to include the treatment of seasonal allergic rhinitis symptoms in children aged 6 to 11 years, Glenmark Pharmaceuticals announced July 21, 2026.¹

With the approval, Ryaltris is now indicated for adults and pediatric patients aged ≥ 6 years in the United States, broadening access to a younger population than the drug's original 2022 approval for patients aged ≥ 12 years.² Ryaltris combines olopatadine hydrochloride, an antihistamine, with mometasone furoate, a corticosteroid, in a single nasal spray formulation.

“This approval marks an important step in expanding access to Ryaltris in the United States,” said Marc Kikuchi, president & business head in North America, in a statement.

Phase 3 Trial Data Supporting Ryaltris Pediatric Approval

The expanded indication was supported by a phase 3, randomized, double-blind, placebo-controlled trial of 446 children aged 6 to 11 years with seasonal allergic rhinitis.¹ Investigators found that Ryaltris. delivered as 1 spray in each nostril twice daily, improved nasal symptoms compared with placebo and was well tolerated over the 14-day treatment period.³

Seasonal allergies remain common among school-age children in the US. According to the Centers for Disease Control and Prevention, 25% of children aged 6 to 11 years were more likely to have a diagnosed seasonal allergy than children aged 0 to 5 years in 2024.⁴

Ryaltris Safety Profile and Warnings for Pediatric Use

Ryaltris is contraindicated in patients with known hypersensitivity to its ingredients, including mometasone furoate. Warnings include risk of epistaxis, nasal ulcerations, septal perforation, and impaired wound healing.

The label also notes risks of hypersensitivity reactions, immunosuppression with worsening of existing infections, hypercorticism and adrenal suppression with misuse, and potential reduction in growth velocity in pediatric patients. The most common adverse reactions, occurring in at least 1% of patients, are dysgeusia, epistaxis, and nasal discomfort.

References

1. Glenmark Receives U.S. FDA Approval to Expand the Use of RYALTRIS® Nasal Spray for Children Aged 6 to Less Than 12 Years. Glenmark. Published July 21, 2026. Accessed July 21, 2026. https://innovacia.in/glenmark-receives-u-s-fda-approval-to-expand-ryaltris-use-for-children-aged-6-to-less-than-12-years/

2. Ryaltris FDA Approval History. Drugs.com. Published on January 20, 2022. Accessed on July 21, 2026. https://www.drugs.com/history/ryaltris.html

3. Prenner BM, Amar NJ, Hampel FC Jr, Caracta CF, Wu W. Efficacy and safety of GSP301 nasal spray in children aged 6 to 11 years with seasonal allergic rhinitis. Ann Allergy Asthma Immunol. 2022;129(5):618-626.e2. doi:10.1016/j.anai.2022.07.029

4. National Center for Health Statistics. Diagnosed Allergic Conditions in Children Ages 0–17: United States, 2024. NCHS Data Brief No. 546. January 2026. https://www.cdc.gov/nchs/products/databriefs/db546.htm