Glenmark Pharmaceuticals has announced a strategic shift to direct commercialization and distribution of RYALTRIS® nasal spray in the United States, effective April 1, 2026. This development marks a significant milestone as RYALTRIS® becomes the company's first innovative product introduced into the US market, representing a meaningful step in building a direct commercial presence in the region.

Strategic Shift to Direct Control

Glenmark Pharmaceuticals Inc., USA will now manage end-to-end commercialization and distribution for RYALTRIS® (Olopatadine Hydrochloride and Mometasone Furoate) Nasal Spray, 665 mcg/25 mcg per spray in the United States. This strategic move allows the company greater operational direction in market engagement and provides closer alignment with healthcare providers while ensuring greater responsiveness to market needs.

Product Profile and Market Positioning

RYALTRIS® was launched in the United States in 2022 and is approved by the US Food and Drug Administration for the treatment of symptoms associated with Seasonal Allergic Rhinitis (SAR) in adults and pediatric patients 12 years of age and older. The product represents a fixed-dose combination nasal spray that brings together olopatadine hydrochloride (an antihistamine) and mometasone furoate (a corticosteroid) in a single formulation.

The nasal spray is supplied as a 240-metered spray nasal suspension, targeting the millions of patients across the United States affected by Seasonal Allergic Rhinitis. By combining two established therapies in one formulation, RYALTRIS® offers a convenient treatment option aligned with evolving patient and physician preferences, particularly addressing symptom control and treatment adherence considerations.

Leadership Perspective and Strategic Vision

Marc Kikuchi, President & Business Head, North America, emphasized the significance of this development: "The commercialization by Glenmark for RYALTRIS® in the United States is an important step forward for the growth of our company. It allows us greater operational direction in how we engage the market and support healthcare providers and patients across the nation."

Kikuchi further highlighted that this announcement marks a significant moment in the company's broader effort to strengthen its innovative businesses in the US and build a more direct, sustainable commercial presence over time. The move enables Glenmark to directly lead brand strategy, market access, and customer engagement for RYALTRIS® in the US market.

Global Market Expansion

RYALTRIS® has established a strong international presence, with approvals in key markets including the United States, European Union, United Kingdom, Australia, South Korea, Russia, and China. The product's global footprint expanded significantly in FY26, when it was launched in 11 additional markets, bringing its total presence to 55 countries worldwide.

This strategic shift to direct commercialization represents Glenmark's commitment to building a sustainable approach to its US operations while expanding its innovative portfolio in one of the world's largest pharmaceutical markets.

Glenmark Pharmaceuticals Ltd has officially launched GLIPIQ® (semaglutide) in India for Type 2 Diabetes Mellitus (T2DM) management, setting a new benchmark in affordability for GLP-1 therapy. The launch represents a significant milestone in making advanced diabetes treatment more accessible to Indian patients through improved cost-effectiveness.

Product Specifications and Pricing

GLIPIQ® introduces a new standard in GLP-1 therapy affordability, addressing one of the primary barriers to advanced diabetes treatment in India. The product is available in two distinct formulations designed to meet different patient needs and treatment stages.

Regulatory Approval and Clinical Evidence

The Central Drugs Standard Control Organization (CDSCO) approved GLIPIQ® following comprehensive clinical evaluation. The approval was based on a multicentre, randomised, comparative, active-controlled, open-label Phase III clinical study conducted specifically in India, demonstrating favourable efficacy and safety outcomes in Indian patients with Type 2 diabetes.

The vial-based formulation features dose-specific syringes designed to enable accessible, flexible, and clinically manageable GLP-1 therapy. This format supports physician-guided dosing aligned to individual patient needs, particularly beneficial during early treatment stages.

Treatment Pathway and Patient Support

Glenmark designed GLIPIQ® to offer a structured treatment pathway combining both vial and pen formats. The vial formulation provides cost-effective treatment initiation, while the pre-filled pen format offers convenience for long-term self-dosing therapy. This dual approach supports treatment continuity, improved adherence, and sustained therapeutic outcomes.

The company launched 'Sankalp', a comprehensive patient support program designed to:

• Support therapy initiations
• Improve patient comfort with injectable treatment
• Enable long-term treatment adherence
• Achieve better health outcomes

Clinical Applications and Benefits

Semaglutide functions as a GLP-1 receptor agonist widely used in Type 2 Diabetes management, particularly for patients with specific comorbidities. The therapy demonstrates broad cardiometabolic benefits beyond glycemic control, making it suitable for patients with:

Management Commentary

Alok Malik, President and Business Head, India Formulations at Glenmark Pharmaceuticals Ltd., emphasized the significance of addressing affordability barriers in advanced diabetes therapy. He highlighted that the vial-based format enables more affordable treatment options while supporting clinically guided initiation and flexible dosing approaches.

The launch builds on Glenmark's existing experience in the GLP-1 category, including their Lirafit™ (Liraglutide) product, demonstrating the company's continued commitment to expanding access to advanced diabetes treatments in the Indian market.