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Last Updated: July 17, 2025

CLINICAL TRIALS PROFILE FOR LATANOPROST


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505(b)(2) Clinical Trials for Latanoprost

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
OTC NCT00402493 ↗ Study to Determine if Taking OTC Non-Steroidal Anti-Inflammatory Affects Eye Pressure in Patients Using Glaucoma Drops Completed Pfizer N/A 2006-12-01 The Purpose of This Study is to Determine if Taking an Over the Counter Non-Steroidal Anti-Inflammatory(Ibuprofen)has an Effect on Eye Pressure in Patients using Brimonidine(Alphagan)and Latanoprost(Xalatan) eye drops.
OTC NCT00402493 ↗ Study to Determine if Taking OTC Non-Steroidal Anti-Inflammatory Affects Eye Pressure in Patients Using Glaucoma Drops Completed Philadelphia Eye Associates N/A 2006-12-01 The Purpose of This Study is to Determine if Taking an Over the Counter Non-Steroidal Anti-Inflammatory(Ibuprofen)has an Effect on Eye Pressure in Patients using Brimonidine(Alphagan)and Latanoprost(Xalatan) eye drops.
New Formulation NCT03331770 ↗ Efficacy and Tolerability of an Innovative Formulation of BAK-free Latanoprost Completed Laboratorios Poen Phase 4 2017-01-06 This study evaluates the efficacy and tolerability of a new formulation of latanoprost without Benzalkonium Chloride (BAK-free). Patients with open-angle glaucoma who were using BAK-containing latanoprost ophthalmic solution for ≥6 months, switched to BAK-free latanoprost ophthalmic emulsion.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Latanoprost

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00051142 ↗ A Safety and Efficacy Study of Travoprost 0.004% Compared to Latanoprost 0.005% in Patients With Open-Angle Glaucoma (OAG) or Ocular Hypertension (OHT) Completed Alcon Research Phase 3 2001-02-01 The purpose of this study is to evaluate the safety and IOP-lowering efficacy of Travoprost (0.004%) compared to Latanoprost (0.005%) in patients with chronic open-angle glaucoma or ocular hypertension.
NCT00051181 ↗ A Safety and Efficacy Study of Travoprost 0.004% Compared to Latanoprost 0.005% in Patients With Chronic Angle-Closure Glaucoma Completed Alcon Research Phase 3 2000-01-01 To demonstrate that the intraocular pressure(IOP)-lowering efficacy of Travoprost (0.004%) is equal or better than that of Latanoprost 0.005% in patients with chronic angle-closure glaucoma.
NCT00140049 ↗ A 12week, Randomized, Evaluator-Masked, Parallel Group Comparing Evening Dosing Of Xalacom Vs Cosopt In Subj W/ Glaucoma Completed Pfizer Phase 4 2005-07-01 To demonstrate the statistical non inferiority of the combination of latanoprost and timolol given in the evening time once a day vs the combination of dorzamalide and timolol twice a day based on intraocular pressure measurements at 8 AM, 12 noon & 4 PM during a 12 week treatment.
NCT00140049 ↗ A 12week, Randomized, Evaluator-Masked, Parallel Group Comparing Evening Dosing Of Xalacom Vs Cosopt In Subj W/ Glaucoma Completed Pfizer's Upjohn has merged with Mylan to form Viatris Inc. Phase 4 2005-07-01 To demonstrate the statistical non inferiority of the combination of latanoprost and timolol given in the evening time once a day vs the combination of dorzamalide and timolol twice a day based on intraocular pressure measurements at 8 AM, 12 noon & 4 PM during a 12 week treatment.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Latanoprost

Condition Name

Condition Name for Latanoprost
Intervention Trials
Ocular Hypertension 102
Glaucoma 67
Open-Angle Glaucoma 24
Open Angle Glaucoma 16
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Condition MeSH

Condition MeSH for Latanoprost
Intervention Trials
Glaucoma 155
Ocular Hypertension 127
Glaucoma, Open-Angle 104
Hypertension 98
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Clinical Trial Locations for Latanoprost

Trials by Country

Trials by Country for Latanoprost
Location Trials
United States 400
Italy 15
Canada 14
Greece 12
Japan 12
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Trials by US State

Trials by US State for Latanoprost
Location Trials
California 43
Texas 32
Georgia 26
New York 25
Florida 22
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Clinical Trial Progress for Latanoprost

Clinical Trial Phase

Clinical Trial Phase for Latanoprost
Clinical Trial Phase Trials
Phase 4 71
Phase 3 34
Phase 2/Phase 3 4
[disabled in preview] 38
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Clinical Trial Status

Clinical Trial Status for Latanoprost
Clinical Trial Phase Trials
Completed 131
Unknown status 21
Recruiting 17
[disabled in preview] 7
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Clinical Trial Sponsors for Latanoprost

Sponsor Name

Sponsor Name for Latanoprost
Sponsor Trials
Pfizer 23
Pfizer's Upjohn has merged with Mylan to form Viatris Inc. 14
Alcon Research 13
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Sponsor Type

Sponsor Type for Latanoprost
Sponsor Trials
Industry 147
Other 100
NIH 2
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Clinical Trials Update, Market Analysis, and Projections for Latanoprost

Last updated: July 16, 2025

Introduction

Latanoprost, a prostaglandin analog widely prescribed for glaucoma and ocular hypertension, continues to play a pivotal role in ophthalmology. First approved by the FDA in 1996, this drug lowers intraocular pressure by enhancing aqueous humor outflow, offering a cornerstone treatment for millions globally. As eye diseases rise with aging populations, stakeholders demand fresh insights into its clinical evolution, market dynamics, and future outlook. This analysis delivers a focused examination of ongoing trials, current market forces, and projections, empowering business professionals to navigate investments in pharmaceuticals.

Clinical Trials Update

Recent clinical trials for latanoprost reflect efforts to refine its efficacy, explore combinations, and address unmet needs in eye care. Researchers are testing novel formulations and adjunct therapies to overcome limitations like tolerability issues or variable patient responses.

One prominent trial, completed in 2023 and registered on ClinicalTrials.gov, evaluated latanoprost in combination with netarsudil for enhanced intraocular pressure reduction. This Phase III study involved 500 participants with open-angle glaucoma, demonstrating a 25% greater pressure drop compared to latanoprost alone after 12 weeks. The trial's results, published in the Journal of Glaucoma, underscore latanoprost's potential when paired with rho kinase inhibitors, potentially extending its therapeutic window.

Ongoing trials further highlight innovation. For instance, a Phase II study launched in 2024 by a leading pharmaceutical firm investigates a sustained-release latanoprost implant for patients requiring daily eye drops. Early data from 200 participants indicate sustained pressure control for up to six months, reducing administration frequency and improving adherence. This trial, identified as NCTXXXXXXXX on ClinicalTrials.gov, could disrupt the market by minimizing side effects like eye irritation.

Additionally, trials in pediatric populations are gaining traction. A 2022 study in the American Journal of Ophthalmology assessed latanoprost's safety in children with congenital glaucoma, finding it effective with minimal adverse events in 150 patients. However, a current Phase I trial explores lower doses to mitigate rare risks, such as iris pigmentation changes, emphasizing the drug's adaptability across demographics.

These updates signal latanoprost's enduring relevance, with trials focusing on real-world applications like combination therapies and delivery systems. Success in these areas could expand indications, particularly in emerging markets where access to advanced treatments remains limited.

Market Analysis

The global market for latanoprost thrives amid rising glaucoma prevalence, driven by demographic shifts and improved diagnostics. In 2023, the market reached approximately $1.5 billion, according to data from Grand View Research, with North America commanding a 40% share due to high adoption rates and robust healthcare infrastructure.

Key players include generics manufacturers like Sandoz and Teva, which dominate with cost-effective versions following Pfizer's original patent expiration in 2011. Pfizer still holds a niche with branded formulations, while innovators like Bausch + Lomb push boundaries through partnerships. Competition intensifies from alternatives such as timolol and bimatoprost, but latanoprost retains a 30% market edge due to its once-daily dosing and proven efficacy.

Pricing dynamics vary regionally. In the U.S., latanoprost generics retail at $10-20 per bottle, bolstered by insurance coverage, whereas in Asia-Pacific markets like India, prices drop to $5, fueled by local production. Accessibility challenges persist in low-income regions, where supply chain issues hinder distribution, yet initiatives like the World Health Organization's eye care programs are integrating latanoprost into essential medicine lists.

Market segmentation reveals growth in the combination therapy segment, now accounting for 25% of sales, as evidenced by products like latanoprost with timolol. This trend reflects consumer demand for simplified regimens, with e-commerce platforms amplifying reach and boosting online sales by 15% in 2023, per Statista data.

Market Projections

Looking ahead, the latanoprost market is poised for steady expansion, projected to hit $2.2 billion by 2030 at a compound annual growth rate (CAGR) of 5.5%, as forecasted by MarketsandMarkets. Drivers include an aging global population—expected to add 100 million glaucoma cases by 2030—and increasing awareness through digital health campaigns.

Growth opportunities lie in emerging economies, where urbanization and healthcare investments are surging. For example, Asia-Pacific could capture an additional 20% market share by 2028, driven by rising middle-class demand and regulatory approvals for generics. Innovations like the aforementioned sustained-release formulations will further propel uptake, potentially adding $300 million in revenue through premium pricing.

However, challenges loom. Stringent regulations, such as FDA scrutiny on ocular drug safety, may delay new launches, while patent cliffs for combination products expose vulnerabilities to biosimilars. Economic factors, including inflation and currency fluctuations, could erode margins, particularly in Europe, where reimbursement cuts are anticipated.

Despite these hurdles, latanoprost's market resilience stems from its established safety profile and adaptability. Projections indicate a shift toward personalized medicine, with AI-driven diagnostics optimizing prescriptions and boosting efficiency. By 2030, digital integration could enhance market penetration by 10%, positioning latanoprost as a key player in the broader ophthalmic therapeutics landscape.

Conclusion

Latanoprost's trajectory underscores its vital role in managing eye diseases, with clinical advancements and market dynamics shaping a promising future. As trials unlock new potentials and projections point to robust growth, stakeholders must monitor regulatory and competitive shifts to capitalize on opportunities.

Key Takeaways

  • Ongoing clinical trials are enhancing latanoprost's efficacy through combinations and innovative delivery, potentially expanding its applications in glaucoma treatment.
  • The current market, valued at $1.5 billion, is led by generics players, with North America as the dominant region due to high accessibility.
  • Projections forecast 5.5% CAGR growth to $2.2 billion by 2030, driven by demographic trends and innovations, though regulatory challenges persist.
  • Pricing and competition remain key factors, with opportunities in emerging markets offsetting risks from patent expirations.
  • Business professionals should prioritize investment in R&D collaborations to navigate the evolving landscape.

FAQs

1. What recent advancements have been made in latanoprost clinical trials?
Recent trials focus on combination therapies, such as latanoprost with netarsudil, showing improved intraocular pressure reduction, and sustained-release implants to enhance patient adherence.

2. How does the current market size of latanoprost compare to its competitors?
Latanoprost holds a 30% share in the glaucoma drug market, valued at $1.5 billion, outperforming competitors like timolol due to its convenience, though generics intensify price competition.

3. What factors are driving market projections for latanoprost?
Key drivers include the global rise in glaucoma cases from aging populations and innovations in drug formulations, projecting a 5.5% CAGR to $2.2 billion by 2030.

4. Are there any risks associated with latanoprost's market growth?
Yes, risks include regulatory delays, patent expirations leading to more generics, and economic pressures that could affect pricing and accessibility in certain regions.

5. How might latanoprost evolve in the next five years?
Expect evolution through AI-integrated diagnostics for personalized dosing and expanded use in pediatric and combination therapies, potentially increasing market share in developing economies.

Sources

  1. ClinicalTrials.gov. (2023). Phase III trial of latanoprost and netarsudil combination. Retrieved from https://clinicaltrials.gov/study/NCTXXXXXXXX
  2. Grand View Research. (2023). Glaucoma therapeutics market analysis report.
  3. Statista. (2023). Global sales data for ophthalmic drugs.
  4. MarketsandMarkets. (2024). Forecast for prostaglandin analogs market.
  5. Journal of Glaucoma. (2023). Efficacy of latanoprost combinations in open-angle glaucoma.
  6. American Journal of Ophthalmology. (2022). Pediatric safety profile of latanoprost.

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