TheraRadar
Data updated: Jun 17, 2026

LATANOPROST

Ophthalmology Approved 2011-03-22

Latanoprost ophthalmic solution is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.

Source: FDA Label • GLAND
Jump to: Indications Approvals Trials Competitors Safety Patents
8
Indications
--
Phase 3 Trials
15
Years on Market

Details

Status
Prescription
First Approved
2011-03-22
Routes
OPHTHALMIC
Dosage Forms
SOLUTION/DROPS, SOLUTION

Companies

GLAND CARNEGIE EUGIA PHARMA MICRO LABS Novartis EPIC PHARMA LLC SOMERSET Apotex MANKIND PHARMA PAR PHARM BAUSCH AND LOMB FDC LTD AMRING PHARMS
Active Ingredient: LATANOPROST

LATANOPROST Approval History

2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
41 FDA actions from 2011 to 2026
Jan 2026 SUPPL
Label · Labeling
Dec 2025 ORIGINAL
Update
Apr 2025 ORIGINAL
Update

What LATANOPROST Treats

8 FDA approvals

Originally approved for its first indication in 2011 . Covers 8 distinct patient populations.

  • Other (8)
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Clinical Trial Registry

24 trials
Trial Sponsor ID Phase Status Title
NCT02390284 STOP-RGCD results posted 20140587 R01EY014957 Ph 3 terminated Stop Retinal Ganglion Cell Dysfunction Study
NCT06666855 0117B02CN Ph 3 active not recruiting A Phase III Study in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension in China
NCT00934089 results posted A0191002 Ph 2 completed A Phase 2 Study Of The 24-Hour Intraocular Pressure Lowering And Systemic Exposure Of PF-04217329
NCT00716859 results posted A6111137 Ph 3 completed A Phase 3 Prospective, Randomized, Double-Masked, 12-Week, Parallel Group Study In Pediatric Subjects With Glaucoma.
NCT00638742 A6111139 Ph 1 completed A Phase 1, Open-Label Study of Latanoprost Acid Plasma Concentrations in Pediatric and Adult Glaucoma Patients Treated With Latanoprost.
NCT00846989 CRKI983A2201 Ph 1, Ph 2 completed Efficacy, Tolerability and Safety of RKI983 (0.05% & 0.10%) vs Xalatan in Patients With POAG or Ocular Hypertension
NCT03419975 TJO-002-301 Ph 3 completed A Multi-center, Randomized, Blinded Evaluator, Active Control, Parallel, Phase III Study to Evaluate the Efficacy and Safety of TJO-002 in POAG or Ocular Hypertension Patients
NCT03966560 KAEK-2014/04-74 Ph 4 completed Choroidal Thickness and Its Correlations With Ocular Parameters in Primary Open-angle Glaucoma
NCT01223378 Voyager results posted 659 Ph 2 completed Study Comparing the Safety and Efficacy of BOL-303259-X to Latanoprost in Subjects With Glaucoma or Ocular Hypertension
NCT02622334 BP30002 Ph 1 completed A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO5093151 in Patients With Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT).
NCT01917383 IPC-01-2013 Ph 2 completed A Phase II Study to Evaluate the Additivity of Trabodenoson to Latanoprost in Adults With Ocular Hypertension or Primary Open-Angle Glaucoma
NCT01315574 BAK results posted 11-007H Ph 4 terminated Effects of Anti-Glaucoma Medications on the Ocular Surface
NCT01254370 NVG10E118 Ph 2 completed Safety and Efficacy Study of Catioprost® (Unpreserved Latanoprost 0.005% Emulsion) Compared to Travatan Z® to Treat Glaucoma and Ocular Surface Disease
NCT02531152 TDR13459 U1111-1153-3544 Ph 1 completed 28-Day Repeated Topical Study to Evaluate the Safety and Activity of 5 Escalating Dose Levels of SAR366234 and One Dose of Latanoprost in Patients With Open Angle Glaucoma or Ocular Hypertension
NCT02083289 ONO-9054IOU003 Ph 2 completed A 28 Day Study of ONO-9054 Ophthalmic Solution in Subjects With Ocular Hypertension (OHT) or Open-angle Glaucoma (OAG)
NCT00705757 results posted Pfizer GA6111AX Ph 4 completed The Effects of Xalatan, Travatan and Lumigan on Skin Pigmentation Near the Eye
NCT00941525 CCT-IOP 83155 EudraCT: 2008-004629-41 Ph 4 completed Central Corneal Thickness and 24-hour Fluctuation of Intraocular Pressure
NCT01225653 Latano-2 Latano-2 2010-022433-29 Ph 4 completed Topical Application of Latanoprost in Diabetic Retinopathy
NCT01721707 BRINZLAT-12 08233812.4.0000.5505 Ph 3 withdrawn Latanoprost/Brinzolamide BID Versus Latanoprost BID in Patients With OAG or OH
NCT01180062 Latanoprost SR 10-0476-F1V IND# 109,182 Ph 1 terminated Safety Study of Latanoprost Slow Release Insert
NCT01896180 ALZ-1101-101 Ph 2 completed Study to Compare the Safety and Efficacy of ALZ-1101 to Latanoprost in Patients With Intraocular Pressure Inadequately Controlled by Latanoprost
NCT01410188 OPA-6566-101 Ph 1, Ph 2 completed Safety/Efficacy Study: OPA-6566 Ophthalmic Solution in Subjects With Primary Open-Angle Glaucoma or Ocular Hypertension
NCT00821002 PPL GLAU 05 Ph 2 completed A Phase 2 Study of Punctal Placement of the Latanoprost Punctal Plug Delivery System (L-PPDS)
NCT01151904 results posted MA-COM004 Ph 4 terminated Study of Brimonidine and Timolol Ophthalmic Solution With Latanoprost Compared With Latanoprost in Glaucoma Patients
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Active Pipeline

Pro

Ongoing clinical trials by development phase

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Key Completed Trials

Pro

Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

LATANOPROST FDA Label Details

Indications & Usage

Latanoprost ophthalmic solution is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. Latanoprost ophthalmic solution is a prostaglandin F 2α analogue indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.

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Data Sources

FDA Approval: ANDA218257 → Label: DailyMed → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.