XALATAN (latanoprost)
Xalatan helps patients manage elevated pressure within the eye, which is a significant risk factor for vision loss. It is used for individuals diagnosed with open-angle glaucoma or ocular hypertension. By lowering this internal pressure, the medication helps protect against damage to the optic nerve and subsequent visual field loss.
How XALATAN Works
This medication works by increasing the drainage of aqueous humor from the eye. As a prostaglandin F 2α analogue, it primarily enhances uveoscleral outflow to reduce internal eye pressure.
Development Insights
Details
- Status
- Prescription
- First Approved
- 1996-06-05
- Routes
- OPHTHALMIC
- Dosage Forms
- SOLUTION/DROPS
XALATAN Approval History
What XALATAN Treats
2 indicationsXALATAN is approved for 2 conditions since its original approval in 1996. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Glaucoma
- Ocular Hypertension
XALATAN Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in XALATAN's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications XALATAN treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to XALATAN
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
31 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 |
| NCT04957329 | WP3 2019-001642-18 | Ph 4 | recruiting | Effect of Benzalkonium Chloride Preserved and Preservative-free Latanoprost Eye Drops on Conjunctival Goblet Cells |
| NCT00934089 results posted | A0191002 | Ph 2 | completed | A Phase 2 Study Of The 24-Hour Intraocular Pressure Lowering And Systemic Exposure Of PF-04217329 |
| NCT04743622 | MIT 2019-02-020 | Ph 4 | completed | Comparison of Efficacy and Ocular Surface Disease Assessment Between Monoprost and BAK-preserved Latanoprost |
| 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 |
| NCT02059278 results posted | T-2345-001 | Ph 3 | completed | Safety and Efficacy of T-2345 Compared to Xalatan in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension |
| 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 |
| NCT00798694 results posted | 08-875 | Ph 4 | completed | How Similar Are Changes to the Surface of the Eye When Two Different Glaucoma Eye Drops Are Used? |
| 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 |
| NCT01155219 T1030 results posted | LTG1030-PIV-12/07 | Ph 4 | completed | Safety, Efficacy Assessment of Geltim LP® 1 mg/g in Ocular Hypertensive or Glaucomatous Patients. |
| 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 |
| NCT01037036 | PPL GLAU 08 | Ph 2 | completed | A Study of the L-PPDS With Adjunctive Xalatan® Eye Drops in Subjects With OH or OAG |
| 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 |
| NCT00799682 | GA6111ZH | Ph 4 | completed | Exploratory Study Comparing Signs and Symptoms in Patients With Ocular Hypertension or Glaucoma Using Xalatan R® or Travatan Z® |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
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.
XALATAN FDA Label Details
Indications & Usage
FDA Label (PDF)XALATAN is indicated for the treatment of Glaucoma; Ocular Hypertension.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment