Xalatan

(Latanoprost)

ApprovedSmall molecule

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Latanoprost is used to treat high eye pressure and glaucoma by helping fluid drain from the eye, which reduces the risk of vision loss.[2] Xalatan is currently approved and in use across 8 indications[4].[1]

Xalatan is one of 156 small molecule programs targeting Glaucoma. It is currently in Approved.

Indications

Total Trials

Active Trials

155

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

GlaucomaTerminated

Meniere DiseaseApproved

Ocular HypertensionCompleted

HypertensionActive, not recruiting

Open-Angle GlaucomaCompleted

Alopecia AreataApproved

VitiligoApproved

Diabetic RetinopathyCompleted

GlaucomaApproved

Terminated

Meniere DiseaseApproved

Approved

Ocular HypertensionApproved

Completed

HypertensionApproved

Active, not recruiting

Open-Angle GlaucomaApproved

Completed

Alopecia AreataApproved

Approved

VitiligoApproved

Approved

Diabetic RetinopathyApproved

Completed

Competition

Competitive Landscape

161 competitors in Hypertension

#DrugCompanyPhaseTrials

Xalatan

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Approved

60 2

Baxfendy

AstraZeneca

Phase 3

3 3

Alka-Seltzer

AAbbott

Phase 3

1 4

SGLT2

PProf. Dr. med. Ingo Eitel

Phase 3

1 5

HCP1803-3

Hanmi Pharmaceutical Company Limited

Phase 3

1 6

Avastin

Roche

Preclinical

1 7

Winrevair

Alphagan

Deltavit

HHyundai Pharmaceutical Co., LTD.

Preclinical

2 10

Nipride

EExela Pharma Sciences, LLC.

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Clinical

Trials by Indication[1]

Ocular Hypertension19 trials

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

Completed·TTaejoon Pharmaceutical Co., Ltd.·Phase 3·NCT03419975·146 enrolled

Study Comparing the Safety and Efficacy of BOL-303259-X to Latanoprost in Subjects With Glaucoma or Ocular Hypertension

Completed·BBausch & Lomb Incorporated·Phase 2·NCT01223378·413 enrolled

A Safety and Efficacy Study of Travoprost 0.004% Compared to Latanoprost 0.005% in Patients With Open-Angle Glaucoma (OAG) or Ocular Hypertension (OHT)

Completed·AAlcon Research·Phase 3·NCT00051142

Show 16 more trials

Safety/Efficacy Study: OPA-6566 Ophthalmic Solution in Subjects With Primary Open-Angle Glaucoma or Ocular Hypertension

Completed·KKubota Vision Inc.·Phase 1/2·NCT01410188·160 enrolled

24-hour Control of Intraocular Pressure (IOP) in Ocular Hypertension

Completed·UUniversity of Parma·Phase 4·NCT01655758·61 enrolled

Efficacy, Tolerability and Safety of RKI983 (0.05% & 0.10%) vs Xalatan in Patients With POAG or Ocular Hypertension

Completed· Novartis logo

Novartis·Phase 1/2·NCT00846989·276 enrolled

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

Completed· Sanofi logo

Sanofi·Phase 1·NCT02531152·54 enrolled

A Phase III Study in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension in China

Recruiting·SSanten Pharmaceutical Co., Ltd.·Phase 3·NCT06666855·338 enrolled

A Phase II Study to Evaluate the Additivity of Trabodenoson to Latanoprost in Adults With Ocular Hypertension or Primary Open-Angle Glaucoma

Completed·IInotek Pharmaceuticals Corporation·Phase 2·NCT01917383·101 enrolled

A 28 Day Study of ONO-9054 Ophthalmic Solution in Subjects With Ocular Hypertension (OHT) or Open-angle Glaucoma (OAG)

Completed· Ono Pharmaceutical Co. Ltd logo

Ono Pharmaceutical Co. Ltd·Phase 2·NCT02083289·123 enrolled

Latanoprost Eluting Contact Lens for Treating Glaucoma and Ocular Hypertension

Terminated·MMassachusetts Eye and Ear Infirmary·Phase 1·NCT04500574·1 enrolled

POLAT-001 Compared to Latanoprost Ophthalmic Solution in Patients With Ocular Hypertension and Open-angle Glaucoma

Completed·PPeregrine Ophthalmic·Phase 2·NCT02466399·80 enrolled

Multi-center Study Assessing the Safety and Efficacy of DE-117 Ophthalmic Solution in Subjects With Primary Open-angle Glaucoma or Ocular Hypertension

Completed·SSanten Inc.·Phase 2·NCT01868126·91 enrolled

A Study Comparing The Efficacy, Safety And Tolerability Of Latanoprost 75, 100 And 125 ug/ml To Xalatan In The Treatment Of Primary Open-Angle Glaucoma And Ocular Hypertension

Completed·PPfizer's Upjohn has merged with Mylan to form Viatris Inc.·Phase 2·NCT01379144·282 enrolled

Study to Assess the Efficacy, Safety and Tolerability of AKB-9778 Ophthalmic Solution as and Adjunct to Latanoprost in Patients With Ocular Hypertension or Open Angle Glaucoma

Completed·EEyePoint Pharmaceuticals, Inc.·Phase 2·NCT04405245·194 enrolled

Efficacy and Safety Study of OPC-1085EL Ophthalmic Solution in Subjects With Glaucoma or Ocular Hypertension

Completed· Otsuka logo

Otsuka·Phase 3·NCT02105272·237 enrolled

Prospective, Single Center Switching Study of 0.0015% Tafluprost Ophthalmic Solution in Primary Open-angle Glaucoma and Ocular Hypertension Patients With Corneal Disorders (Switching From 0.005% Latanoprost Ophthalmic Solution)

Completed·SSanten Pharmaceutical (Taiwan) Co., LTD·N/A·NCT04737928·1 enrolled

A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO5093151 in Patients With Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT).

Completed· Roche logo

Roche·Phase 1·NCT02622334·45 enrolled

A Study to Assess the Efficacy of 3 Months of Latanoprost Treatment in Reducing the Intraocular Pressure in Patients With Ocular Hypertension or Open-angle Glaucoma

Completed·PPfizer's Upjohn has merged with Mylan to form Viatris Inc.·Phase 4·NCT00647101·600 enrolled

Glaucoma10 trials

Study of Brimonidine and Timolol Ophthalmic Solution With Latanoprost Compared With Latanoprost in Glaucoma Patients

Terminated· AbbVie logo

AbbVie·Phase 4·NCT01151904·17 enrolled

Blood Flow of Ophthalmic Artery and Glaucoma

Unknown status·UUmeå University·N/A·NCT02656979·125 enrolled

Safety and Efficacy Study of Catioprost® (Unpreserved Latanoprost 0.005% Emulsion) Compared to Travatan Z® to Treat Glaucoma and Ocular Surface Disease

Completed·SSanten Inc.·Phase 2·NCT01254370·105 enrolled

Show 7 more trials

Switching From Preserved to Preserved-free Treatments for Glaucoma.

Unknown status·PPaolo Fogagnolo·Phase 3·NCT01433900·40 enrolled

Intraocular Pressure and Ocular Perfusion Pressure of Cosopt in Normal Tension Glaucoma

Completed·TThe Catholic University of Korea·N/A·NCT01175902·44 enrolled

Effects of Anti-Glaucoma Medications on the Ocular Surface

Terminated·MMassachusetts Eye and Ear Infirmary·Phase 4·NCT01315574·14 enrolled

African Glaucoma Laser Trial

Withdrawn·WWest Virginia University·Phase 4·NCT03648229

A Phase 1, Open-Label Study of Latanoprost Acid Plasma Concentrations in Pediatric and Adult Glaucoma Patients Treated With Latanoprost.

Completed·PPfizer's Upjohn has merged with Mylan to form Viatris Inc.·Phase 1·NCT00638742·47 enrolled

A Phase 3 Prospective, Randomized, Double-Masked, 12-Week, Parallel Group Study In Pediatric Subjects With Glaucoma.

Completed·PPfizer's Upjohn has merged with Mylan to form Viatris Inc.·Phase 3·NCT00716859·139 enrolled

Pupillary Response After Glaucoma Medication

Completed·GGlostrup University Hospital, Copenhagen·N/A·NCT02522039·21 enrolled

Intraocular Pressure4 trials

Study to Compare the Safety and Efficacy of ALZ-1101 to Latanoprost in Patients With Intraocular Pressure Inadequately Controlled by Latanoprost

Completed·AAlleanza Pharmaceuticals, Inc.·Phase 2·NCT01896180·63 enrolled

A Phase 2 Study Of The 24-Hour Intraocular Pressure Lowering And Systemic Exposure Of PF-04217329

Completed· Pfizer logo

Pfizer·Phase 2·NCT00934089·31 enrolled

Central Corneal Thickness and 24-hour Fluctuation of Intraocular Pressure

Completed·—·Phase 4·NCT00941525·174 enrolled

Show 1 more trial

Study of AR-12286 Versus Latanoprost in Patients With Elevated Intraocular Pressure

Completed·AAerie Pharmaceuticals·Phase 2·NCT01060579·217 enrolled

Vitiligo2 trials

Microneedling and Latanoprost in Acrofacial Vitiligo

Unknown status·SSohag University·Phase 2/3·NCT03611348·70 enrolled

Latanoprost Plus NB-UVB Versus Each Alone in Non-segmental Vitiligo: Clinical and Laboratory Evaluation

Unknown status·SShaimaa Fawzy Abdel-rady Abdel-latif·Phase 4·NCT04811326·150 enrolled

Efficacy2 trials

Efficacy and Tolerability of an Innovative Formulation of BAK-free Latanoprost

Completed·LLaboratorios Poen·Phase 4·NCT03331770·103 enrolled

Efficacy Comparison of Xalatan and Azopt on POAG and OH

Unknown status·PPeking University First Hospital·N/A·NCT01084902·130 enrolled

19 more indications

Treatment2 trials

Optic Nerve Perfusion Following Treatment with Latanoprost Versus Brimionidin Tartrate

Completed·ZZagazig University·Phase 1·NCT06730516·56 enrolled

Latanoprost for the Treatment of Menière's Disease

Unknown status·SSynphora AB·Phase 2·NCT01973114·100 enrolled

Circadian Rhythm1 trial

Circadian Rhythms of Aqueous Humor Dynamics in Humans

Completed·UUniversity of Nebraska·Phase 2·NCT00572936·30 enrolled

Medication1 trial

Clinical Evaluation of Efficacy of SLT to Topical Medication in Lowering IOP

Unknown status·AAurolab·N/A·NCT01639807·600 enrolled

Usability1 trial

Eyenovia MiDD Usability Study

Completed·EEyenovia Inc.·N/A·NCT03480906·30 enrolled

Skin Pigmentation1 trial

The Effects of Xalatan, Travatan and Lumigan on Skin Pigmentation Near the Eye

Completed·—·Phase 4·NCT00705757·89 enrolled

Efficacy and Safety1 trial

A Clinical Study to Evaluate the Efficacy and Safety of CKD-351

Unknown status· Chong Kun Dang Pharmaceutical logo

Chong Kun Dang Pharmaceutical·Phase 3·NCT03762369·384 enrolled

GAN1 trial

Effect of Alphagan and Xalatan Eye Drops on Corneal Temperature

Completed·UUniversity Hospital, Basel, Switzerland·N/A·NCT01201551·40 enrolled

Monotherapy1 trial

Additive Intra-ocular Pressure Reduction Effect of Fixed Combination of Maleate Timolol 0.5%/Dorzolamide 2% on Monotherapy With Latanoprost in Patients With Elevated Intra-ocular Pressure

Completed·UUniversity of Sao Paulo·Phase 4·NCT00906594·56 enrolled

Diabetic Retinopathy1 trial

Topical Application of Latanoprost in Diabetic Retinopathy

Completed·UUniversity of Aarhus·Phase 4·NCT01225653·27 enrolled

Function1 trial

Stop Retinal Ganglion Cell Dysfunction Study

Terminated·UUniversity of Miami·Phase 3·NCT02390284·28 enrolled

LAM1 trial

Latanoprost/Brinzolamide BID Versus Latanoprost BID in Patients With OAG or OH

Withdrawn·AAdapt Produtos Oftalmológicos Ltda.·Phase 3·NCT01721707

Adult1 trial

Pharmacokinetic Study of OPC-1085EL Ophthalmic Solution in Healthy Male Adult Volunteers

Completed· Otsuka logo

Otsuka·Phase 1·NCT02108288·30 enrolled

Safety and Efficacy1 trial

A Phase III Study Assessing the Safety and Efficacy of DE-117 Ophthalmic Solution Compared With Latanoprost Ophthalmic Solution in Subjects With OAG or OHT

Completed·SSanten Pharmaceutical Co., Ltd.·Phase 3·NCT02981446·370 enrolled

Alopecia Areata1 trial

Efficacy Study of Latanoprost and Bimatoprost Solutions in Promoting Eyelash Growth in Patients With Alopecia Areata

Completed·UUniversity of California, San Francisco·N/A·NCT00187577·14 enrolled

MPA1 trial

Comparison of Latanoprost Vs. Timolol

Terminated·UUniversity of Nebraska·Phase 2·NCT00579969·30 enrolled

Open-Angle Glaucoma1 trial

Choroidal Thickness and Its Correlations With Ocular Parameters in Primary Open-angle Glaucoma

Completed·—·Phase 4·NCT03966560·96 enrolled

Phase 21 trial

A Phase 2 Study of Punctal Placement of the Latanoprost Punctal Plug Delivery System (L-PPDS)

Completed·MMati Therapeutics Inc.·Phase 2·NCT00821002·32 enrolled

Microneedling-Assisted Delivery1 trial

Microneedling-Assisted Delivery of Cetirizine Versus Latanoprost in Alopecia Areata: A Pilot Randomized Controlled Study

Completed·TTanta University·Preclinical·NCT07757867·80 enrolled

Unspecified4 trials

CATS Tonometer IOP Reduction Latanoprost Verses Timolol

Unknown status·IIntuor Technologies, Inc.·Phase 4·NCT04178863·72 enrolled

Safety Study of Latanoprost Slow Release Insert

Terminated·DDaniel Moore·Phase 1·NCT01180062·12 enrolled

Evaluation of Latanoprost Combined With Fractional Erbium- YAG Laser

Recruiting·EEgymedicalpedia·Phase 1/2·NCT06239324·70 enrolled

Show 1 more trial

Adjunctive Study of AL-37807 Ophthalmic Suspension

Completed·AAlcon Research·Phase 2·NCT00620256·129 enrolled

Regulatory

FDA Approval Timeline[5]

Jun 5, 1996

XALATAN

NDA NDA020597

Jun 5, 1996

XALATAN

NDA NDA020597

Jul 31, 1998

XALATAN

NDA NDA020597

Nov 1, 1998

XALATAN

NDA NDA020597

Dec 9, 1998

XALATAN

NDA NDA020597

Mar 22, 1999

XALATAN

NDA NDA020597

Jul 16, 1999

XALATAN

NDA NDA020597

Oct 8, 1999

XALATAN

NDA NDA020597

Jan 24, 2000

XALATAN

NDA NDA020597

Jun 2, 2000

XALATAN

NDA NDA020597

Aug 25, 2000

XALATAN

NDA NDA020597

Nov 9, 2000

XALATAN

NDA NDA020597

Dec 11, 2000

XALATAN

NDA NDA020597

Dec 26, 2000

XALATAN

NDA NDA020597

Apr 23, 2001

XALATAN

NDA NDA020597

May 14, 2001

XALATAN

NDA NDA020597

Aug 8, 2001

XALATAN

NDA NDA020597

Nov 26, 2001

XALATAN

NDA NDA020597

Jun 21, 2002

XALATAN

NDA NDA020597

Aug 26, 2002

XALATAN

NDA NDA020597

Nov 15, 2002

XALATAN

NDA NDA020597

Dec 20, 2002

XALATAN

NDA NDA020597

Jul 14, 2003

XALATAN

NDA NDA020597

Jul 14, 2003

XALATAN

NDA NDA020597

Jul 29, 2010

XALATAN

NDA NDA020597

Aug 31, 2010

XALATAN

NDA NDA020597

Aug 31, 2010

XALATAN

NDA NDA020597

Mar 13, 2012

XALATAN

NDA NDA020597

Mar 13, 2013

XALATAN

NDA NDA020597

Apr 3, 2014

XALATAN

NDA NDA020597

Nov 25, 2014

XALATAN

NDA NDA020597

Nov 25, 2014

XALATAN

NDA NDA020597

Apr 10, 2017

XALATAN

NDA NDA020597

Sep 12, 2018

XELPROS

NDA NDA206185

Sep 1, 2020

XALATAN

NDA NDA020597

Dec 13, 2022

IYUZEH

NDA NDA216472

Dec 19, 2022

XALATAN

NDA NDA020597

Sources

References

[1]
ClinicalTrials.gov — 60 trial records for Latanoprost. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Xalatan drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Latanoprost compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Latanoprost. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA020597). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Xalatan. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Pfizer's Upjohn has merged with Mylan to form Viatris Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Prostanoid FP Receptor Agonist[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Patent Landscape[6]

Patent Cliff

Oct 15, 2028

Earliest patent expiration — generic entry possible after this date

Patent #Expires

9539262Oct 15, 2028

9629852Sep 12, 2029

8637054Jul 8, 2031

Xalatan

Status by Indication[4][1]

Competitive Landscape

Trials by Indication[1]

Ocular Hypertension19 trials

Glaucoma10 trials

Intraocular Pressure4 trials

Vitiligo2 trials

Efficacy2 trials

Treatment2 trials

Circadian Rhythm1 trial

Medication1 trial

Usability1 trial

Skin Pigmentation1 trial

Efficacy and Safety1 trial

GAN1 trial

Monotherapy1 trial

Diabetic Retinopathy1 trial

Function1 trial

LAM1 trial

Adult1 trial

Safety and Efficacy1 trial

Alopecia Areata1 trial

MPA1 trial

Open-Angle Glaucoma1 trial

Phase 21 trial

Microneedling-Assisted Delivery1 trial

Unspecified4 trials

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Patent Landscape[6]

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