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Latanoprost

Generic Name
Latanoprost
Brand Names
Iyuzeh, Rocklatan, Xalacom, Xalatan, Xelpros, Catiolanze, Roclanda
Drug Type
Small Molecule
Chemical Formula
C26H40O5
CAS Number
130209-82-4
Unique Ingredient Identifier
6Z5B6HVF6O

Overview

Latanoprost is a prodrug analog of prostaglandin F2 alpha that is used to treat elevated intraocular pressure (IOP). It was initially approved by the FDA in 1998. Latanoprost is the first topical prostaglandin F2 alpha analog used for glaucoma treatment. It has been found to be well-tolerated and its use does not normally result in systemic adverse effects like other drugs used to treat elevated intraocular pressure, such as Timolol. Another benefit latanoprost is that it can be administered once a day.

Indication

Latanoprost is indicated for the reduction of elevated intraocular pressure in patients who have been diagnosed with open-angle glaucoma or ocular hypertension. It is available as monotherapy or in a combination product with netarsudil or timolol. In Canada, latanoprost is also indicated to treat elevated intraocular pressure due to angle-closure glaucoma that has been treated with peripheral iridotomy or laser iridoplasty.

Associated Conditions

  • Increased Intra Ocular Pressure (IOP)
  • Ocular Hypertension
  • Open Angle Glaucoma (OAG)

Research Report

Published: Jul 21, 2025

A Comprehensive Monograph on Latanoprost: Pharmacology, Clinical Efficacy, and Therapeutic Landscape

Executive Summary

Latanoprost, a prostaglandin F2α analog, represents a cornerstone in the modern therapeutic management of glaucoma and ocular hypertension. Its introduction in 1996 revolutionized treatment paradigms due to its potent intraocular pressure (IOP)-lowering efficacy, convenient once-daily dosing regimen, and a favorable systemic safety profile that set it apart from previous standards of care. As an isopropyl ester prodrug, Latanoprost is designed for optimal corneal penetration, where it is hydrolyzed into its active acid form to exert its therapeutic effect. It acts locally by selectively targeting the prostanoid FP receptor, which initiates a cascade of cellular changes that increase aqueous humor outflow primarily through the uveoscleral pathway, an alternative drainage route to the conventional trabecular meshwork.

While highly effective, the clinical profile of Latanoprost is characterized by a well-defined and predictable set of ocular side effects. The most notable of these are conjunctival hyperemia (ocular redness), gradual and permanent changes in iris pigmentation, and reversible changes to eyelashes, including increased length, thickness, and darkness. The therapeutic landscape of Latanoprost has evolved significantly from its initial launch as a single blockbuster brand (Xalatan®). It has matured into a competitive market featuring multiple generic versions, value-added formulations designed to improve tolerability, and strategic fixed-dose combinations aimed at enhancing efficacy. This evolution reflects a growing clinical focus on mitigating long-term ocular surface toxicity, leading to the development of benzalkonium chloride (BAK)-free (Xelpros®) and entirely preservative-free (Iyuzeh™) formulations. Furthermore, fixed-dose combinations with agents like timolol and the novel Rho kinase inhibitor netarsudil (Rocklatan®)

Continue reading the full research report

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2025/05/09
Phase 2
Recruiting
2025/05/06
Phase 2
Not yet recruiting
VSPharmTech Co.,Ltd.
2025/03/19
Phase 4
Recruiting
Prairie Eye Center
2025/02/11
N/A
Recruiting
Colorado Ophthalmology Associates PC
2024/12/12
Early Phase 1
Completed
2024/10/31
Phase 3
Recruiting
2024/10/07
Phase 1
Completed
2024/06/04
Phase 2
Active, not recruiting
2024/05/09
Phase 4
Terminated
2024/02/02
Phase 1
Recruiting

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Somerset Therapeutics, LLC
70069-421
OPHTHALMIC
50 ug in 1 mL
3/9/2023
FDC Limited
55545-1010
OPHTHALMIC
50 ug in 1 mL
11/29/2019
NuCare Pharmaceuticals,Inc.
68071-4650
OPHTHALMIC
50 ug in 1 mL
2/17/2021
Aurobindo Pharma Limited
65862-872
OPHTHALMIC
50 ug in 1 mL
4/11/2023
ImprimisRx NJ
70261-515
OPHTHALMIC
0.05 mg in 1 mL
5/8/2018
NuCare Pharmaceuticals,Inc.
68071-2376
OPHTHALMIC
50 ug in 1 mL
3/26/2021
Alcon Laboratories, Inc.
70727-529
OPHTHALMIC, TOPICAL
0.05 mg in 1 mL
6/2/2020
PFIZER LABORATORIES DIV PFIZER INC
0013-8303
OPHTHALMIC
50 ug in 1 mL
12/27/2022
NuCare Pharmaceuticals,Inc.
68071-4893
OPHTHALMIC
50 ug in 1 mL
1/29/2021
Thea Pharma Inc.
82584-003
OPHTHALMIC
50 ug in 1 mL
10/26/2023

EMA Drug Approvals

Approved Product
Authorization Holder
Status
Issued Date
Authorised
11/15/2023
Authorised
1/7/2021

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
XALATAN EYE DROPS 0.005%
SIN09549P
SOLUTION
50 mcg/ml
11/21/1997
XALACOM EYE DROPS
SIN11922P
SOLUTION
50mcg/ml
5/11/2002
LATOCHEK STERILE EYE DROPS 0.005%
SIN14956P
SOLUTION, STERILE
0.05mg/ml
2/19/2016
LATANDROPS EYE DROPS SOLUTION 50mcg/ml
SIN14590P
SOLUTION
0.050 mg
8/15/2014
LANOTAN OPHTHALMIC SOLUTION 0.005% w/w
SIN14399P
SOLUTION
0.005% w/w
8/27/2013
ARISTO-LATA Latanoprost Eye Drops 0.005% w/v
SIN17024P
SOLUTION
0.005%w/v
6/11/2024
LATACHIMO COMBINATION OPHTHALMIC SOLUTION “NITTO”
SIN15974P
SOLUTION, STERILE
0.05 mg/ml
7/16/2020
PROSDROP EYE DROPS SOLUTION 0.05 MG/ML
SIN15135P
SOLUTION
0.050 mg/ ml
12/12/2016
LATACOM EYE DROPS
SIN16927P
SOLUTION, STERILE
0.05mg/mL
1/12/2024
LATANO SANTEN OPHTHALMIC SOLUTION, 0.005%w/v
SIN16849P
SOLUTION, STERILE
0.005%w/v
8/31/2023

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
TYGLACOM EYE DROPS SOLUTION 50MCG/ML+5MG/ML
N/A
N/A
N/A
10/14/2015
LATAMED EYE DROPS
N/A
N/A
N/A
11/18/2024
MONOPOST EYE DROPS 50MCG/ML
N/A
N/A
N/A
11/23/2018

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
LATANOPROST / TIMOLOL
02553848
Solution - Ophthalmic
50 MCG / ML
N/A
M-LATANOPROST-TIMOLOL
mantra pharma inc
02514516
Solution - Ophthalmic
50 MCG / ML
11/10/2021
LATANOPROST OPHTHALMIC SOLUTION
hikma canada limited
02489570
Solution - Ophthalmic
50 MCG / ML
6/26/2020
MINT-LATANOPROST/TIMOLOL
mint pharmaceuticals inc
02444666
Solution - Ophthalmic
50 MCG / ML
N/A
SANDOZ LATANOPROST/TIMOLOL
02394685
Solution - Ophthalmic
50 MCG / ML
3/4/2013
SANDOZ LATANOPROST
02367335
Solution - Ophthalmic
50 MCG / ML
12/6/2011
RIVA-LATANOPROST/TIMOLOL
laboratoire riva inc.
02459205
Solution - Ophthalmic
50 MCG / ML
1/3/2017
MYLAN-LATANOPROST/TIMOLOL
Mylan Pharmaceuticals ULC
02422492
Solution - Ophthalmic
50 MCG / ML
N/A
RIVA-LATANOPROST
laboratoire riva inc.
02341085
Solution - Ophthalmic
50 MCG / ML
5/11/2015
TEVA-LATANOPROST/TIMOLOL
teva canada limited
02393921
Solution - Ophthalmic
50 MCG / ML
N/A

CIMA AEMPS Drug Approvals

Approved Product
Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
XALACOM 50 microgramos/ml + 5 mg/ml COLIRIO EN SOLUCION
64187
COLIRIO EN SOLUCIÓN
Medicamento Sujeto A Prescripción Médica
Commercialized
LATANOPROST/TIMOLOL RAFARM 50 MICROGRAMOS/ML+ 5 MG/ML COLIRIO EN SOLUCION
78435
COLIRIO EN SOLUCIÓN
Medicamento Sujeto A Prescripción Médica
Not Commercialized
ARUCOM 50 MICROGRAMOS/ML+ 5 MG/ML COLIRIO EN SOLUCION
Dr. Gerhard Mann Chem.-Pharm. Fabrik Gmbh
76208
COLIRIO EN SOLUCIÓN
Medicamento Sujeto A Prescripción Médica
Not Commercialized
LATANOPROST QUALIGEN 50 MICROGRAMOS/ML COLIRIO EN SOLUCION
Neuraxpharm Spain S.L.
74843
COLIRIO EN SOLUCIÓN
Medicamento Sujeto A Prescripción Médica
Commercialized
LATANOPROST MEDICAL MIX 50 microgramos/ml COLIRIO EN SOLUCION
Farmamix Vision S.L.
73520
COLIRIO EN SOLUCIÓN
Medicamento Sujeto A Prescripción Médica
Not Commercialized
ROCLANDA 50 MICROGRAMOS/ML + 200 MICROGRAMOS/ML COLIRIO EN SOLUCION
1201502001
COLIRIO EN SOLUCIÓN
Diagnóstico Hospitalario
Commercialized
XALATAN 50 MICROGRAMOS/ML COLIRIO EN SOLUCION
BE183967
COLIRIO EN SOLUCIÓN
Medicamento Sujeto A Prescripción Médica
Not Commercialized
LATANOPROST/TIMOLOL FARMALIDER 50 MICROGRAMOS/ML + 5MG/ML COLIRIO EN SOLUCION
Farmalider S.A.
76571
COLIRIO EN SOLUCIÓN
Medicamento Sujeto A Prescripción Médica
Not Commercialized
LATANOPROST VIATRIS 50 MICROGRAMOS/ML COLIRIO EN SOLUCION
71102
COLIRIO EN SOLUCIÓN
Medicamento Sujeto A Prescripción Médica
Commercialized
MONOPROST 50 MICROGRAMOS/ML COLIRIO EN SOLUCION EN ENVASE UNIDOSIS
6400313C
COLIRIO EN SOLUCIÓN EN ENVASE UNIDOSIS
Medicamento Sujeto A Prescripción Médica
Commercialized

Philippines FDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product
Company
Registration Number
Dosage Form
Strength
Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name
MA Holder
MA Number
Pharmaceutical Form
Active Ingredient
Authorization Date
No UK EMC drug information found for this drug.

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