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Last Updated: March 30, 2025

CLINICAL TRIALS PROFILE FOR XALATAN


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505(b)(2) Clinical Trials for XALATAN

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Showing 1 to 2 of 2 entries

All Clinical Trials for XALATAN

Trial IDTitleStatusSponsorPhaseStart DateSummary
NCT00140062 ↗ Efficacy And Safety Of Xalatan Compared To Usual Care In Patients With Open Angle Glaucoma Or Ocular Hypertension. Completed Pfizer Phase 4 2002-02-01 The primary purpose is to compare the intraocular pressure reducing effect of Xalatan with that of usual care over 36 months. Safety and health care utilization will be evaluated.
NCT00143429 ↗ Corneal Versus Conjunctival Delivery Using a Delivery Device Withdrawn Pfizer Phase 2 1969-12-31 Compare the antihypertensive efficacy of three methods for installing Xalatan
NCT00143429 ↗ Corneal Versus Conjunctival Delivery Using a Delivery Device Withdrawn Pfizer's Upjohn has merged with Mylan to form Viatris Inc. Phase 2 1969-12-31 Compare the antihypertensive efficacy of three methods for installing Xalatan
>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 3 of 3 entries

Clinical Trial Conditions for XALATAN

Condition Name

4427170051015202530354045Ocular HypertensionGlaucomaOpen-Angle Glaucoma[disabled in preview]
Condition Name for XALATAN
Intervention Trials
Ocular Hypertension 44
Glaucoma 27
Open-Angle Glaucoma 17
[disabled in preview] 0
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Condition MeSH

6751430010203040506070GlaucomaOcular HypertensionHypertension[disabled in preview]
Condition MeSH for XALATAN
Intervention Trials
Glaucoma 67
Ocular Hypertension 51
Hypertension 43
[disabled in preview] 0
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Clinical Trial Locations for XALATAN

Trials by Country

+
Trials by Country for XALATAN
Location Trials
United States 123
Canada 15
Japan 13
France 4
Finland 3
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Trials by US State

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Trials by US State for XALATAN
Location Trials
Florida 9
Texas 9
California 8
Tennessee 6
New York 6
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Clinical Trial Progress for XALATAN

Clinical Trial Phase

55.0%26.7%18.3%005101520253035Phase 4Phase 3Phase 2[disabled in preview]
Clinical Trial Phase for XALATAN
Clinical Trial Phase Trials
Phase 4 33
Phase 3 16
Phase 2 11
[disabled in preview] 0
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Clinical Trial Status

82.9%12.9%00102030405060CompletedUnknown statusTerminated[disabled in preview]
Clinical Trial Status for XALATAN
Clinical Trial Phase Trials
Completed 58
Unknown status 9
Terminated 3
[disabled in preview] 0
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Clinical Trial Sponsors for XALATAN

Sponsor Name

trials02468101214161820PfizerAlcon ResearchPfizer's Upjohn has merged with Mylan to form Viatris Inc.[disabled in preview]
Sponsor Name for XALATAN
Sponsor Trials
Pfizer 19
Alcon Research 15
Pfizer's Upjohn has merged with Mylan to form Viatris Inc. 10
[disabled in preview] 0
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Sponsor Type

63.6%35.5%0010203040506070IndustryOtherNIH[disabled in preview]
Sponsor Type for XALATAN
Sponsor Trials
Industry 68
Other 38
NIH 1
[disabled in preview] 0
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XALATAN (Latanoprost): Clinical Trials, Market Analysis, and Projections

Introduction to XALATAN (Latanoprost)

XALATAN, also known as latanoprost, is a prostaglandin analogue used primarily to treat elevated intraocular pressure (IOP) associated with conditions such as open-angle glaucoma and ocular hypertension. It works by increasing the outflow of aqueous humor, thereby reducing IOP and preventing optic nerve damage and vision loss.

Clinical Trials and Safety Studies

Efficacy in Reducing Intraocular Pressure

Clinical trials have demonstrated the efficacy of XALATAN in reducing IOP. In multi-center, randomized, controlled trials, patients with a mean baseline IOP of 24-25 mmHg showed a reduction of 6-8 mmHg after six months of treatment with XALATAN 0.005% once daily. This reduction was equivalent to the effect of timolol 0.5% dosed twice daily[1].

Long-Term Safety Studies

A 3-year open-label, prospective safety study with a 2-year extension phase was conducted to evaluate the progression of increased iris pigmentation with continuous use of XALATAN. The study involved 519 patients with open-angle glaucoma and showed that the onset of noticeable increased iris pigmentation occurred within the first year of treatment for the majority of patients. Patients continued to show signs of increasing iris pigmentation throughout the five years of the study[1].

Adverse Reactions and Side Effects

Common ocular adverse events reported in clinical trials include blurred vision, burning and stinging, conjunctival hyperemia, foreign body sensation, itching, increased pigmentation of the iris, and punctate epithelial keratopathy. Systemic adverse events, though less common, include upper respiratory tract infections, chest pain, muscle/joint/back pain, and rash/allergic skin reactions[1].

Market Analysis

Global Market Size and Growth

The global latanoprost market is projected to grow significantly over the next few years. As of 2024, the market size was estimated at USD 1.521 billion and is expected to expand at a compound annual growth rate (CAGR) of 2.50% from 2024 to 2031[2][5].

Regional Market Dynamics

  • Asia Pacific: This region holds around 23% of the global revenue, with a market size of USD 349.88 million in 2024. It is expected to grow at a CAGR of 4.5% from 2024 to 2031, driven by a large and diverse population and increasing prevalence of glaucoma and ocular hypertension[2].
  • Latin America: This region accounts for more than 5% of the global revenue, with a market size of USD 76.06 million in 2024. It is projected to grow at a CAGR of 1.9% from 2024 to 2031, driven by demographic shifts and increasing awareness of eye health[2].
  • Middle East and Africa: This region represents around 2% of the global revenue, with a market size of USD 30.42 million in 2024. It is expected to grow at a CAGR of 2.2% from 2024 to 2031, with a focus on tailored marketing strategies and collaborations with local stakeholders[2].
  • North America: This region leads the latanoprost market share, driven by the high prevalence of glaucoma and ocular hypertension and significant investments in R&D by pharmaceutical companies[5].

Market Drivers and Trends

Increasing Prevalence of Glaucoma and Ocular Hypertension

The rising incidence of glaucoma and ocular hypertension, particularly among the aging population, is a significant driver for the latanoprost market. Early diagnosis initiatives and increased awareness of eye health further boost the demand for effective treatments[2][5].

Technological Advancements

Advancements in drug formulations and the development of combination therapies enhance the effectiveness of latanoprost. Newer delivery systems, such as sustained-release formulations, ensure longer-lasting effects and better patient compliance, supporting market growth[5].

Government Initiatives and Healthcare Access

Government initiatives aimed at improving access to healthcare and making medications more affordable contribute to the expansion of the latanoprost market. Emerging markets, especially in the Asia-Pacific region, benefit from better access to healthcare services and growing healthcare expenditure[5].

Key Players in the Market

The latanoprost market is dominated by several key players, including:

  • Pfizer Inc.
  • Somerset Pharma LLC
  • Viatris Inc.
  • Alcon
  • Sun Pharmaceutical Industries Limited
  • Thea Pharma Inc.
  • Taj Pharmaceuticals Limited
  • Wellona Pharma
  • Apotex Inc.
  • Santen Pharmaceutical Co., Ltd.[5]

Future Projections

Market Size by 2033

The global latanoprost market is projected to reach USD 1.6 billion by 2033, growing at a CAGR of 2.1% from 2024 to 2033[5].

Regional Growth

The Asia-Pacific region, particularly India and China, is expected to be the fastest-growing market due to the rising prevalence of glaucoma, increased healthcare expenditure, and expanding pharmaceutical manufacturing capabilities[5].

Key Takeaways

  • XALATAN (latanoprost) is a highly effective medication for reducing intraocular pressure in patients with open-angle glaucoma and ocular hypertension.
  • Clinical trials have demonstrated its efficacy and safety over long-term use, although it can cause side effects such as increased iris pigmentation and ocular irritation.
  • The global latanoprost market is driven by the increasing prevalence of glaucoma and ocular hypertension, technological advancements, and government initiatives to improve healthcare access.
  • The market is expected to grow significantly, with the Asia-Pacific region showing the highest growth potential.

FAQs

What is the primary use of XALATAN (latanoprost)?

XALATAN (latanoprost) is primarily used to treat elevated intraocular pressure associated with open-angle glaucoma and ocular hypertension.

What are the common side effects of XALATAN?

Common side effects include blurred vision, burning and stinging, conjunctival hyperemia, foreign body sensation, itching, increased pigmentation of the iris, and punctate epithelial keratopathy.

What is the projected global market size of latanoprost by 2033?

The global latanoprost market is projected to reach USD 1.6 billion by 2033, growing at a CAGR of 2.1% from 2024 to 2033.

Which region is expected to show the highest growth in the latanoprost market?

The Asia-Pacific region, particularly India and China, is expected to be the fastest-growing market due to the rising prevalence of glaucoma and increased healthcare expenditure.

Who are the key players in the latanoprost market?

Key players include Pfizer Inc., Somerset Pharma LLC, Viatris Inc., Alcon, Sun Pharmaceutical Industries Limited, and others.

Sources

  1. Xalatan (latanoprost) Ophthalmic Solution, Labeling Revision. FDA.
  2. Latanoprost Market Report 2024. Cognitive Market Research.
  3. Comparison of clinical effects of two latanoprost 0.005% solutions (Arulatan® versus the reference drug Xalatan®) in primary open-angle glaucoma or ocular hypertensive patients: a randomized clinical trial. ResearchGate.
  4. EU Clinical Trials Register. European Union Clinical Trials Register.
  5. Latanoprost Market Size, Report | Industry Analysis, 2032. Allied Market Research.

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