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Last Updated: April 14, 2025

CLINICAL TRIALS PROFILE FOR PATANASE


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All Clinical Trials for PATANASE

Trial IDTitleStatusSponsorPhaseStart DateSummary
NCT03444506 ↗ Efficacy and Safety of Fixed Dose Combination (FDC) of Olopatadine Hydrochloride and Mometasone Furoate Nasal Spray (Molo; Also Referred as GSP 301) in the Treatment of Seasonal Allergic Rhinitis (SAR) Completed Glenmark Pharmaceuticals Ltd. India Phase 2 2014-01-27 A single-center, double-blind, placebo-controlled study of FDC olopatadine hydrochloride and mometasone furoate nasal spray (Molo; also referred as GSP 301) was conducted in subjects with seasonal allergic rhinitis. In this study, the efficacy and safety of two regimens (BID and QD) of the FDC (i.e. Molo 1 and Molo 2) were evaluated compared to placebo nasal spray, DYMISTA® and PATANASE®.
NCT00979615 ↗ Safety and Efficacy of Olopatadine 0.6% and Azelastine 137 Mcg in Vasomotor Rhinitis Completed Alcon Research Phase 4 2009-09-01 The purpose of this study is to examine safety and efficacy of Patanase and Astelin in treating the symptoms of non-allergic vasomotor rhinitis (VMR).
NCT00789555 ↗ Safety of PATANASE Nasal Spray in Patients With Perennial Allergic Rhinitis Completed Alcon Research Phase 4 2008-11-01 The purpose of this study was to assess local nasal adverse effects, as well as systemic effects, of PATANASE nasal spray when compared with Patanase Vehicle, pH 3.7 and Patanase Vehicle, pH 7.0 in patients with perennial allergic rhinitis (PAR).
NCT00794144 ↗ Safety and Pharmacokinetics of Patanase in Pediatric Patients 2 to < 6 Years of Age Completed Alcon Research Phase 2 2008-10-01 The purpose of the study is to assess the safety of the study drug, Patanase (Olopatadine Hydrochloride Nasal Spray 0.6%) compared to placebo (inactive substance) in children ages 2 to less than 6 who have a history of nasal allergies, and to assess the pharmcokinetics (study of the action of a drug in the body) in these children
>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 4 of 4 entries

Clinical Trial Conditions for PATANASE

Condition Name

11110-0.100.10.20.30.40.50.60.70.80.911.1Vasomotor RhinitisAllergic RhinitisPerennial Allergic RhinitisSeasonal Allergic Rhinitis[disabled in preview]
Condition Name for PATANASE
Intervention Trials
Vasomotor Rhinitis 1
Allergic Rhinitis 1
Perennial Allergic Rhinitis 1
Seasonal Allergic Rhinitis 1
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Condition MeSH

4311000.511.522.533.54RhinitisRhinitis, AllergicRhinitis, Allergic, SeasonalRhinitis, Vasomotor[disabled in preview]
Condition MeSH for PATANASE
Intervention Trials
Rhinitis 4
Rhinitis, Allergic 3
Rhinitis, Allergic, Seasonal 1
Rhinitis, Vasomotor 1
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Clinical Trial Locations for PATANASE

Trials by Country

+
Trials by Country for PATANASE
Location Trials
United States 3
Canada 1
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Trials by US State

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Trials by US State for PATANASE
Location Trials
Texas 3
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Clinical Trial Progress for PATANASE

Clinical Trial Phase

50.0%50.0%0-0.200.20.40.60.811.21.41.61.822.2Phase 4Phase 2[disabled in preview]
Clinical Trial Phase for PATANASE
Clinical Trial Phase Trials
Phase 4 2
Phase 2 2
[disabled in preview] 0
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Clinical Trial Status

100.0%000.511.522.533.54Completed[disabled in preview]
Clinical Trial Status for PATANASE
Clinical Trial Phase Trials
Completed 4
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Clinical Trial Sponsors for PATANASE

Sponsor Name

trials0112233Alcon ResearchGlenmark Pharmaceuticals Ltd. India[disabled in preview]
Sponsor Name for PATANASE
Sponsor Trials
Alcon Research 3
Glenmark Pharmaceuticals Ltd. India 1
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Sponsor Type

100.0%000.511.522.533.54Industry[disabled in preview]
Sponsor Type for PATANASE
Sponsor Trials
Industry 4
[disabled in preview] 0
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PATANASE: Clinical Trials, Market Analysis, and Projections

Introduction

PATANASE, also known as olopatadine hydrochloride, is a nasal spray used to treat seasonal and perennial allergic rhinitis. This article will delve into the clinical trials, market analysis, and future projections for PATANASE, providing a comprehensive overview of its efficacy, safety, market position, and growth potential.

Clinical Trials and Efficacy

Seasonal and Perennial Allergic Rhinitis

PATANASE has been evaluated in several clinical trials to assess its efficacy and safety in treating seasonal and perennial allergic rhinitis. In placebo-controlled clinical trials lasting from 2 weeks to 12 months, PATANASE demonstrated significant improvements in nasal symptoms.

  • Seasonal Allergic Rhinitis: In studies involving adult and adolescent patients (12 years and older), PATANASE showed statistically significant reductions in Total Nasal Symptom Score (TNSS) compared to placebo and vehicle nasal spray. Common adverse reactions included bitter taste, headache, epistaxis, and pharyngolaryngeal pain[1].
  • Perennial Allergic Rhinitis: A 12-month placebo-controlled trial involving 1026 patients showed that PATANASE was effective in reducing nasal symptoms, with a discontinuation rate due to adverse reactions comparable to the vehicle nasal spray group[1].

Safety Profile

The safety profile of PATANASE has been extensively studied. The most common adverse reactions include epistaxis, nasal ulcerations, and bitter taste. However, the incidence of these reactions was generally low and comparable to or slightly higher than those in the vehicle nasal spray groups[1].

Market Analysis

Market Size and Growth

The allergic rhinitis drugs market, which includes intranasal antihistamines like PATANASE, is projected to grow significantly. The global market for allergic rhinitis drugs is expected to see increased demand due to rising prevalence, expanding healthcare coverage, and advancements in drug delivery technologies[2].

  • U.S. Nasal Spray Market: The U.S. nasal spray market, which includes PATANASE, was valued at $10.32 billion in 2022 and is expected to grow at a CAGR of 8.8% from 2023 to 2030. The prescription segment, where PATANASE is categorized, dominated the market in 2022 and is expected to continue growing due to R&D investments and the launch of new drugs[5].

Competitive Landscape

PATANASE competes in a market with several other intranasal antihistamines and corticosteroids. Key competitors include:

  • Intranasal Antihistamines: Azelastine (Astelin, Astepro)
  • Intranasal Corticosteroids: Nasonex, Omnaris
  • Leading Companies: UCB, Sanofi, GlaxoSmithKline, Merck & Co, and Johnson & Johnson[2].

Regional Market Prospects

The market for allergic rhinitis drugs is not limited to developed countries; emerging economies in South America and Asia are also expected to contribute significantly to the growth.

  • Key Markets: The U.S., China, Japan, India, Germany, France, UK, Italy, Spain, Brazil, Russia, and Mexico are identified as key markets with significant growth potential[2].

Market Projections

Revenue Forecasts

The allergic rhinitis drugs market, including PATANASE, is expected to see substantial revenue growth. Here are some key projections:

  • Global Sales: The market is forecasted to grow due to the increasing demand for allergic rhinitis treatments, driven by rising prevalence and advancements in drug delivery technologies[2].
  • Regional Growth: Emerging economies are expected to drive growth, with countries like China, India, and Brazil showing high revenue growth potential[2].

Product Category Forecasts

Intranasal antihistamines, the category to which PATANASE belongs, are expected to see significant growth.

  • Intranasal Antihistamines: This submarket is forecasted to grow as part of the broader allergic rhinitis drugs market, driven by the efficacy and convenience of intranasal formulations[2].

Distribution and Sales Channels

The distribution of PATANASE and other nasal sprays is primarily through:

  • Drug Stores & Retail Pharmacies: This segment dominated the market in 2022 due to the availability of diverse product choices and the presence of skilled pharmacists[5].
  • Online Pharmacies: The growth in online sales is expected to boost the segmental growth of over-the-counter (OTC) products, although PATANASE is primarily a prescription-based drug[5].

Key Takeaways

  • Efficacy and Safety: PATANASE has demonstrated efficacy in reducing nasal symptoms in seasonal and perennial allergic rhinitis, with a generally favorable safety profile.
  • Market Growth: The allergic rhinitis drugs market is expected to grow significantly, driven by increasing prevalence, healthcare coverage, and technological advancements.
  • Competitive Landscape: PATANASE competes in a market with other intranasal antihistamines and corticosteroids, with key players including UCB, Sanofi, and GlaxoSmithKline.
  • Regional Prospects: Emerging economies are expected to contribute significantly to market growth.

FAQs

What are the common adverse reactions associated with PATANASE?

Common adverse reactions include bitter taste, headache, epistaxis, and pharyngolaryngeal pain[1].

How does PATANASE compare to other intranasal antihistamines in the market?

PATANASE is comparable in efficacy to other intranasal antihistamines like azelastine (Astelin, Astepro) but has a distinct safety profile and patient preference[1][5].

What is the projected growth rate of the U.S. nasal spray market?

The U.S. nasal spray market is projected to grow at a CAGR of 8.8% from 2023 to 2030[5].

Which regions are expected to drive the growth of the allergic rhinitis drugs market?

Emerging economies in South America and Asia, along with developed countries like the U.S., China, and Japan, are expected to drive market growth[2].

What are the key distribution channels for PATANASE and other nasal sprays?

The primary distribution channels include drug stores & retail pharmacies, hospital pharmacies, and online pharmacies[5].

Sources

  1. Novartis - PATANASE® (olopatadine hydrochloride) nasal spray.
  2. PR Newswire - Allergic Rhinitis Drugs Market Forecast 2015-2025.
  3. Newron Pharmaceuticals - vL Report 25MAR24.pdf.
  4. PubMed - Efficacy and safety of twice-daily and once-daily olopatadine ...
  5. Fortune Business Insights - U.S. Nasal Spray Market Size, Share, Trends | Growth [2030].

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