Last Updated: May 11, 2026

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
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.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for XALATAN

Trial ID Title Status Sponsor Phase Start Date Summary
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NCT00143429 ↗ Corneal Versus Conjunctival Delivery Using a Delivery Device Withdrawn Pfizer Phase 2 1969-12-31 Compare the antihypertensive efficacy of three methods for installing Xalatan
NCT00143429 ↗ Corneal Versus Conjunctival Delivery Using a Delivery Device Withdrawn Pfizer's Upjohn has merged with Mylan to form Viatris Inc. Phase 2 1969-12-31 Compare the antihypertensive efficacy of three methods for installing Xalatan
NCT00159653 ↗ A 12-Week, Randomized, Double-Masked, Parallel Group Comparison Of Evening Dosing With Xalacom In Subjects With Glaucoma Completed Pfizer Phase 3 2005-07-01 To demonstrate statistical superiority of the combination of latanoprost and timolol to the individual therapy of latanoprost and timolol based on intraocular pressure measurements at 8 AM, 10 AM, 4 PM at weeks 2, 6 and 12.
NCT00159653 ↗ A 12-Week, Randomized, Double-Masked, Parallel Group Comparison Of Evening Dosing With Xalacom In Subjects With Glaucoma Completed Pfizer's Upjohn has merged with Mylan to form Viatris Inc. Phase 3 2005-07-01 To demonstrate statistical superiority of the combination of latanoprost and timolol to the individual therapy of latanoprost and timolol based on intraocular pressure measurements at 8 AM, 10 AM, 4 PM at weeks 2, 6 and 12.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for XALATAN

Condition Name

Condition Name for XALATAN
Intervention Trials
Ocular Hypertension 44
Glaucoma 27
Open-Angle Glaucoma 17
Glaucoma, Open-Angle 9
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Condition MeSH

Condition MeSH for XALATAN
Intervention Trials
Glaucoma 67
Ocular Hypertension 51
Hypertension 43
Glaucoma, Open-Angle 42
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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

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

Clinical Trial Phase

Clinical Trial Phase for XALATAN
Clinical Trial Phase Trials
Phase 4 33
Phase 3 16
Phase 2 11
[disabled in preview] 4
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Clinical Trial Status

Clinical Trial Status for XALATAN
Clinical Trial Phase Trials
Completed 58
Unknown status 9
Withdrawn 3
[disabled in preview] 4
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Clinical Trial Sponsors for XALATAN

Sponsor Name

Sponsor Name for XALATAN
Sponsor Trials
Pfizer 19
Alcon Research 15
Pfizer's Upjohn has merged with Mylan to form Viatris Inc. 10
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Sponsor Type

Sponsor Type for XALATAN
Sponsor Trials
Industry 68
Other 38
NIH 1
[disabled in preview] 0
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Clinical Trials Update, Market Analysis and Projection for Xalatan

Last updated: April 29, 2026

What is Xalatan and what is the product scope?

Xalatan is the brand name for latanoprost, a prostaglandin F2alpha analog used to reduce intraocular pressure (IOP) in patients with open-angle glaucoma and ocular hypertension. The drug is used as ophthalmic solution (commonly once-daily dosing in practice and in most labeled regimens). The brand portfolio is largely associated with the active ingredient latanoprost and its ophthalmic formulations; competitive positioning depends on glaucoma class economics, adherence, formulation, and device-free vs fixed-combination offerings.

What do the most recent clinical trial signals say?

A current, complete “last 12 to 24 months” clinical trials update cannot be produced from the information available in this request alone. A defensible update requires: (i) trial identifiers (NCT/clinicaltrials.gov or EU CTR IDs), (ii) patient populations (POAG/OHT vs post-surgical vs adjunctive), (iii) endpoints (IOP change from baseline, diurnal IOP profiling, treatment-emergent adverse events), and (iv) regulatory outcomes or publication records tied to Xalatan/latanoprost specifically. Without those enumerated trial records, the only accurate statement is that Xalatan remains an established therapy; it is not possible to provide a verified “clinical trials update” in the requested format.

What is the market for latanoprost and where does Xalatan sit in competitive dynamics?

Latanoprost is a first-line prostaglandin analog in glaucoma. Market structure is shaped by:

  • Patent and exclusivity status driving significant generic penetration
  • Once-daily convenience reinforcing class-level demand
  • Formulation and combination strategies (fixed combinations with timolol or other agents) shifting preference toward higher switching costs

From a business perspective, Xalatan’s commercial outlook depends less on incremental trial innovation and more on:

  • Share protection vs generics (formulation, supply stability, payer positioning)
  • Channel execution (pharmacy benefit design and clinic dispensing patterns)
  • Competition from newer molecule classes and fixed-combination regimens

How do competitive products affect Xalatan’s pricing power?

In glaucoma, pricing power erodes as generics scale. Brand persistence is driven by:

  • Differences in drop comfort and vehicle tolerability across products
  • Prescriber routines and payer policies favoring preferred brands or step edits
  • Use of fixed combinations that simplify regimens for adherence outcomes

Xalatan therefore competes on total regimen value, not only molecule choice.

What is the market projection path for Xalatan?

A quantitative market projection requires a baseline (current revenue, units, geography), a forecast horizon, and explicit assumptions (generic share loss rate, pricing declines, category growth). Those inputs are not present in the request, and producing a numeric projection without a cited dataset would not meet a high-stakes standard.

Given only what is reliably known at this level: latanoprost faces structural revenue pressure from generic availability, while category demand in glaucoma is supported by prevalence and aging demographics. The actionable framing for projections is:

  • Category growth from population aging and diagnosis rates
  • Brand share drift due to generic substitution
  • Mitigation via preferred formulary status, medical affairs support, and managed care contracts

What business scenarios matter most for forecasting?

Forecasting Xalatan performance is most sensitive to four drivers:

  1. Generic substitution rate (brand-to-generic switching)
  2. Net price trajectory (contracting and reimbursement pressure)
  3. Unit demand (prescribing frequency and persistence)
  4. Competitive mix shift toward fixed combinations and alternative classes

These drivers determine whether brand revenue tracks category growth or underperforms due to substitution.

Regulatory and lifecycle considerations

Xalatan has long market presence. For lifecycle planning, the critical issue is whether new latanoprost line extensions (formulation tweaks, dosing conveniences, preservative changes, or combination products) exist in the relevant geography and remain distinct enough to avoid generic interchangeability. Without country-specific product dossiers and launch timelines, no precise claims can be made.


Key Takeaways

  • Xalatan is latanoprost, an established prostaglandin analog for open-angle glaucoma and ocular hypertension.
  • A verified clinical trials update cannot be produced without specific, enumerated trial records for Xalatan/latanoprost (trial IDs, populations, endpoints, and outcomes).
  • A numeric market projection cannot be produced without baseline revenue/units, geography, forecast horizon, and a documented pricing and share model.
  • The core forecast levers are generic substitution, net price, unit persistence, and shift toward fixed combinations.

FAQs

  1. Is Xalatan approved for open-angle glaucoma?
    Yes, Xalatan (latanoprost) is used to reduce IOP in open-angle glaucoma.

  2. What drug class is Xalatan?
    It is a prostaglandin F2alpha analog.

  3. Does generic competition materially affect Xalatan revenue?
    Yes. Latanoprost is widely genericized, which typically constrains brand net price and share.

  4. What endpoints matter in glaucoma trials for latanoprost?
    The primary endpoints usually include IOP reduction from baseline and tolerability (treatment-emergent adverse events).

  5. What is the most important driver of brand persistence for an established glaucoma drug?
    Formulary and contracting position, which determines exposure vs generic substitution.


References

[1] FDA. Xalatan (latanoprost ophthalmic solution) prescribing information. U.S. Food and Drug Administration.
[2] EMA. Xalatan (latanoprost) summary of product characteristics. European Medicines Agency.
[3] ClinicalTrials.gov. Search results for latanoprost glaucoma and ocular hypertension trials. U.S. National Library of Medicine.
[4] WHO. Global burden of glaucoma and epidemiology reports relevant to projected demand. World Health Organization.

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