Data updated: Jun 28, 2026
XELPROS (latanoprost) · Sun Pharma
Ophthalmology
Approved 2018-09-12
XELPROS is FDA-approved to treat 2 conditions (same as IYUZEH).
1
Indication
--
Phase 3 Trials
7
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2018-09-12
- Patent Cliff
- 2029
- Routes
- OPHTHALMIC
- Dosage Forms
- EMULSION
XELPROS Approval History
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
3 FDA actions from 2018 to 2024
What XELPROS Treats
2 indicationsXELPROS is approved for 2 conditions since its original approval in 2018. These indications span multiple therapeutic areas including oncology, immunology, and more.
Same approved indications as IYUZEH (same active ingredient).
Source: FDA Label
Sun Pharma's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
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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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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
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.
XELPROS FDA Label Details
Indications & Usage
FDA Label (PDF)XELPROS is FDA-approved to treat 2 conditions — same approved indications as IYUZEH.
View full patent landscape →
2 OB patents · 1 families ·
28 international docs across 18 countries
Pro Intelligence Preview
Deep insights for XELPROS
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2029
- • 2 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • Competitor tracking
- • Same target/indication analysis
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.