Timolol Maleate

(timolol)

ApprovedSmall molecule

CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Timolol Maleate is a small molecule that works as a Beta-1 Adrenergic Receptor Antagonist; Beta-2 Adrenergic Receptor Antagonist; Beta-1 Adrenergic Receptor Antagonist; Beta-2 Adrenergic Receptor Antagonist.[2] It is being used across 14 indications, with its most advanced program in Approved.[1]

Timolol Maleate is one of 312 small molecule programs targeting Cardiovascular Disease. It is currently in Approved.

Indications

Total Trials

Active Trials

311

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

Cardiovascular DiseaseActive, not recruiting

Open-Angle GlaucomaActive, not recruiting

GlaucomaActive, not recruiting

HypertensionActive, not recruiting

Capillary HemangiomaApproved

Migraine DisorderApproved

Varicose UlcerApproved

Exfoliation SyndromeApproved

MelanomaApproved

Carcinoma, Non-Small-Cell LungActive, not recruiting

Cardiovascular DiseaseApproved

Active, not recruiting

Open-Angle GlaucomaApproved

Active, not recruiting

GlaucomaApproved

Active, not recruiting

HypertensionApproved

Active, not recruiting

Capillary HemangiomaApproved

Approved

Migraine DisorderApproved

Approved

Varicose UlcerApproved

Approved

Exfoliation SyndromeApproved

Approved

MelanomaApproved

Approved

Carcinoma, Non-Small-Cell LungPhase 2

Active, not recruiting

Showing 10 of 13 indications

Competition

Competitive Landscape

191 competitors in Melanoma

#DrugCompanyPhaseTrials

Timolol Maleate

CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Approved

38 2

Mekinist

Novartis

Phase 3

45 3

Cotellic

Roche

Phase 3

21 4

Zelboraf

CConrado Roberto Hoffmann Filho

Phase 3

39 5

Taxol

Teva

Phase 3

13 6

Tecentriq

Roche

Phase 3

11 7

Proleukin

IIovance Biotherapeutics, Inc.

Phase 3

28 8

Lenvima

Eisai

Phase 3

9 9

Fabhalta

Regeneron

Phase 3

3 10

Tuoyi

SSun Yat-sen University

Phase 3

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

Timeline

Expected Milestones

Q2 2030

Phase 2Active, not recruiting

Carcinoma, Non-Small-Cell Lung

NCT06120140

Clinical

Trials by Indication[1]

Ocular Hypertension9 trials

A Study of Open Angle Glaucoma or Ocular Hypertension in Patients Within the United Kingdom

Completed·PPfizer's Upjohn has merged with Mylan to form Viatris Inc.·Phase 3·NCT00751049·294 enrolled

Comparing the Safety and Efficacy of BOL-303259-X Ophthalmic Solution With Timolol Maleate Ophthalmic Solution in Subjects With Open-Angle Glaucoma or Ocular Hypertension

Completed·BBausch & Lomb Incorporated·Phase 3·NCT01749930·420 enrolled

Phase 2b Study Evaluating Safety and Efficacy of OTX-TP Compared to Timolol Drops in the Treatment of Subjects With Open Angle Glaucoma or Ocular Hypertension

Completed·OOcular Therapeutix, Inc.·Phase 2·NCT02312544·72 enrolled

Show 6 more trials

A 6 Month Study Comparing Latanoprost With Timolol in Patients With Open Angle Glaucoma or Ocular Hypertension

Completed· Pfizer logo

Pfizer·Phase 3·NCT00751127·268 enrolled

Safety and Efficacy of Brimonidine Tartrate/Timolol Fixed Combination in Patients With Glaucoma or Ocular Hypertension

Completed· AbbVie logo

AbbVie·N/A·NCT01229462·238 enrolled

A Study of Open Angle Glaucoma or Ocular Hypertension in Patients Within Scandinavia

Completed·PPfizer's Upjohn has merged with Mylan to form Viatris Inc.·Phase 3·NCT00751062·267 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

Comparing Safety and Efficacy of BOL-303259-X With Timolol Maleate in Subjects With Open-Angle Glaucoma or Ocular Hypertension

Completed·BBausch & Lomb Incorporated·Phase 3·NCT01749904·420 enrolled

A Study to Evaluate Efficacy and Safety of a Fixed Combination Ocular Insert in Participants With Open-angle Glaucoma or Ocular Hypertension

Completed·FForSight Vision5, Inc.·Phase 1/2·NCT02742649·55 enrolled

Glaucoma9 trials

Efficacy and Safety Study of Combigan and 0.5% Timoptic in Normal Tension Glaucoma

Unknown status·SSeoul National University Hospital·Phase 4·NCT01446497·22 enrolled

Effect of Antiglaucoma Agents on Short Term Intraocular Pressure Fluctuations After Intravitreal Bevacizumab Injection

Completed·MMashhad University of Medical Sciences·N/A·NCT02140450·70 enrolled

A 12-week, Randomized, Double-masked, Parallel Group Comparison of Evening Dosing With Xalacom in Subjects With Glaucoma

Completed·PPfizer's Upjohn has merged with Mylan to form Viatris Inc.·Phase 3·NCT00277498·528 enrolled

Show 6 more trials

A Study of the Safety and Efficacy of Bimatoprost Ophthalmic Solution in Paediatric Patients With Glaucoma

Terminated· AbbVie logo

AbbVie·Phase 3·NCT01426113·6 enrolled

Effects of Common Topical Glaucoma Therapy on Optic Nerve Head Blood Flow Autoregulation During Increased Arterial Blood Pressure and Artificially Elevated Intraocular Pressure in Healthy Humans

Withdrawn·MMedical University of Vienna·N/A·NCT00275756

African Glaucoma Laser Trial

Withdrawn·WWest Virginia University·Phase 4·NCT03648229

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

A 12-Week, Randomized, Double-Masked, Parallel Group Comparison Of Evening Dosing With Xalacom In Subjects With Glaucoma

Completed·PPfizer's Upjohn has merged with Mylan to form Viatris Inc.·Phase 3·NCT00159653·500 enrolled

Hereditary Hemorrhagic Telangiectasia2 trials

Timolol Gel for Epistaxis in Hereditary Hemorrhagic Telangiectasia

Completed·WWashington University School of Medicine·Phase 2·NCT04139018·27 enrolled

Efficacy of a Timolol Nasal Spray as a Treatment for Epistaxis in Hereditary Hemorrhagic Telangiectasia (HHT) - (TEMPO)

Completed·HHospices Civils de Lyon·Phase 2·NCT02484716·58 enrolled

Treatment2 trials

Topical Timolol for the Treatment of Benign Vascular Periocular Lesions

Withdrawn·LLoyola University·Phase 4·NCT01250457

The Effect of Topical Treatment With Combigan Compared to Timolol and Brimonidine on Pupil Diameter

Unknown status·—·Phase 2·NCT02214680·25 enrolled

Hemangioma2 trials

Assessing the Impact of Dosage Frequency of Propranolol on Sleep Patterns in Patients With Infantile Hemangiomas

Terminated·TThe University of Texas Health Science Center, Houston·Phase 4·NCT05479123·52 enrolled

Topical Timolol for Infantile Hemangioma in Early Proliferative Phase

Completed·FFundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau·Phase 2·NCT02731287·70 enrolled

14 more indications

Chronic1 trial

Beta Adrenergic Antagonist for the Healing of Chronic DFU

Completed·VVA Office of Research and Development·Phase 3·NCT03282981·48 enrolled

Intraocular Pressure1 trial

Interval Intraocular Pressure in Intravitreal Injection Study

Completed·TThe University of Hong Kong·N/A·NCT04868175·64 enrolled

Clinical Trial1 trial

Effect of Timolol on Refractive Outcomes in Eyes With Myopic Regression After LASIK: a Randomized Clinical Trial

Completed·SShahid Beheshti University of Medical Sciences·N/A·NCT01506635·45 enrolled

Monotherapy1 trial

A Long-term Study of DE-117 Ophthalmic Solution Monotherapy and Concomitant Use of DE-117 Ophthalmic Solution With Timolol Ophthalmic Solution in Patients With OAG or OH: RENGE Study

Completed·SSanten Pharmaceutical Co., Ltd.·Phase 3·NCT02822729·125 enrolled

Paronychia1 trial

Efficacy and Safety of Timolol for TKI Induced Paronychia

Unknown status·QQueen Mary Hospital, Hong Kong·Phase 3·NCT06140186·40 enrolled

MPA1 trial

Comparison of Latanoprost Vs. Timolol

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

Sturge-Weber syndrome1 trial

Treatment of Port-wine Mark in Sturge-Weber Syndrome Using Topical Timolol

Terminated·WWills Eye·Phase 1·NCT01533376·3 enrolled

Rosacea1 trial

Timolol for the Treatment of Acne and Rosacea

Completed·JJohns Hopkins University·Phase 1·NCT02774590·8 enrolled

Migraine1 trial

A Randomized Study Evaluating the Efficacy and Safety of Timolol Ophthalmic Solution as an Acute Treatment of Migraine

Completed·UUniversity of Kansas Medical Center·Phase 2·NCT03836664·25 enrolled

Thyroid Eye Disease1 trial

The Secondary Beneficial Effects of Prostaglandin Analog Treatment in Thyroid Eye Disease Patients.

Withdrawn·SStanford University·Phase 4·NCT01927406

Function1 trial

Stop Retinal Ganglion Cell Dysfunction Study

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

Circadian Rhythm1 trial

Circadian Rhythms of Aqueous Humor Dynamics in Humans

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

Carcinoma, Non-Small-Cell Lung1 trial

A Phase 2, Open-Label, Randomized Trial Evaluating the Impact of Enhanced Versus Standard Dermatologic Management on Selected Dermatologic Adverse Events Among Patients With Locally Advanced or Metastatic EGFR-Mutated NSCLC Treated First-Line With Amivantamab + Lazertinib

Active, not recruiting· Johnson & Johnson logo

Johnson & Johnson·Phase 2·NCT06120140·305 enrolled

Unspecified1 trial

Topical Timolol Benefit in Venous Ulcers

Completed·—·Phase 2·NCT02422017·42 enrolled

Regulatory

FDA Approval Timeline[4]

Jan 1, 1982

TIMOPTIC

NDA NDA018086

Jan 1, 1982

BLOCADREN

NDA NDA018017

Nov 5, 1986

TIMOPTIC IN OCUDOSE

NDA NDA019463

Nov 4, 1993

TIMOPTIC-XE

NDA NDA020330

Mar 31, 1995

BETIMOL

NDA NDA020439

Oct 21, 1998

TIMOLOL MALEATE

NDA NDA020963

Jun 4, 2004

ISTALOL

NDA NDA021516

Sources

References

[1]
ClinicalTrials.gov — 38 trial records for timolol. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — timolol compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for timolol. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA021516). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Beta-1 Adrenergic Receptor Antagonist; Beta-2 Adrenergic Receptor Antagonist; Beta-1 Adrenergic Receptor Antagonist; Beta-2 Adrenergic Receptor Antagonist[2]
Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Timolol Maleate

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q2 2030

Trials by Indication[1]

Ocular Hypertension9 trials

Glaucoma9 trials

Hereditary Hemorrhagic Telangiectasia2 trials

Treatment2 trials

Hemangioma2 trials

Chronic1 trial

Intraocular Pressure1 trial

Clinical Trial1 trial

Monotherapy1 trial

Paronychia1 trial

MPA1 trial

Sturge-Weber syndrome1 trial

Rosacea1 trial

Migraine1 trial

Thyroid Eye Disease1 trial

Function1 trial

Circadian Rhythm1 trial

Carcinoma, Non-Small-Cell Lung1 trial

Unspecified1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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