Timolol Maleate

(Timolol maleate)

ApprovedSmall molecule

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

Timolol Maleate is one of 45 small molecule programs targeting Glaucoma. It is currently in Approved.

Indications

Total Trials

Active Trials

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

GlaucomaActive, not recruiting

ExtremityRecruiting

GlaucomaApproved

Active, not recruiting

ExtremityPhase 1

Recruiting

Competition

Competitive Landscape

54 competitors in Glaucoma

#DrugCompanyPhaseTrials

Alphagan

Novartis

Approved

3 2

Zolymbus

AbbVie

Approved

3 3

Travatan

Novartis

Approved

3 4

Xalatan

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

Approved

10 5

Crestor

AstraZeneca

Approved

1 6

Timolol Maleate

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

Approved

9 7

Diamox

Teva

Approved

1 8

Neoral

Isopto Carpine

1 10

Tobrex

VViatris Specialty LLC

Approved

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

Timeline

Expected Milestones

Q4 2028

N/ARecruiting

Hemangioma

NCT01873131

Clinical

Trials by Indication[1]

Ocular Hypertension5 trials

Phase 1-2 Evaluation of OT-730 Eye Drops in Reducing the Intraocular Pressure in Patients With Ocular Hypertension or Open-Angle Glaucoma

Completed·OOthera Pharmaceuticals·Phase 1/2·NCT00753168·48 enrolled

Safety and Efficacy Trial to Treat Open-Angle Glaucoma or Ocular Hypertension

Completed·SSanten Inc.·Phase 1/2·NCT01279083·147 enrolled

BOL-303259-X With Timolol 0.5% in Subjects With Open-Angle Glaucoma or Ocular Hypertension

Completed·BBausch & Lomb Incorporated·Phase 2·NCT01707381·25 enrolled

Show 2 more trials

A Comfort Survey of Open-angle Glaucoma or Ocular Hypertension Patients Treated With 2 Drugs

Completed·VVistakon Pharmaceuticals··NCT00823043·103 enrolled

Study to Evaluate QLS-101 Compared to Timolol Maleate Eye Drops in Subjects With High Eye Pressure (Glaucoma or Ocular Hypertension).

Completed·QQlaris Bio, Inc.·Phase 2·NCT04830397·84 enrolled

Hemangioma2 trials

Timolol Maleate Gel for the Treatment of Infantile Hemangioma

Completed·AAuson Pharmaceuticals Inc.·Phase 2/3·NCT06677853·168 enrolled

A Clinical Trial of Pulsed-dye Laser Versus Timolol Topical Solution Versus Observation on the Growth of Hemangioma in Newborn

Recruiting·MMassachusetts General Hospital·N/A·NCT01873131·126 enrolled

Extremity1 trial

Topical 0.5% Timolol Solution for Healing Lower Extremity Wounds

Recruiting·IIcahn School of Medicine at Mount Sinai·Phase 1·NCT06941467·102 enrolled

Neuropathy1 trial

Treatment Study for Ischemic Optic Neuropathy With Opthalmic Timolol Maleate 0.5%

Withdrawn·FFraser Health·Phase 1·NCT01607671

Esophageal Varices1 trial

Prevention of Esophageal Varices by Beta-Adrenergic Blockers

Completed·NNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)·Phase 3·NCT00006398·213 enrolled

7 more indications

Anti-angiogenic Therapy1 trial

Topical Anti-angiogenic Therapy for Telangiectasia in HHT: Proof of Concept

Completed·UUnity Health Toronto·Phase 1/2·NCT01752049·5 enrolled

Tolerance1 trial

Evaluate the Safety, Tolerance, and Pharmacokinetic Profiles of Timolol Maleate Gel

Completed·AAuson Pharmaceuticals Inc.·Phase 1·NCT06824948·28 enrolled

Interaction1 trial

Interaction Study of Timolol Eye Drops and Paroxetine Capsules

Completed·SSanten Oy·Phase 1·NCT00879099·12 enrolled

Glaucoma1 trial

Peripapillary Blood Flow After Use of Anti-glaucoma Medications: An OCT Angiography Study

Completed·WWills Eye·Phase 4·NCT03323164·35 enrolled

Chronic Wounds1 trial

Absorption and Safety of Topical Timolol to Treat Chronic Wounds

Completed·VVA Northern California Health Care System··NCT04903366·40 enrolled

ESS1 trial

Assessing Cosopt Switch Patients

Completed·PPharmaceutical Research Network·Phase 4·NCT00273442·60 enrolled

Capsule Opacification1 trial

Prophylactic Use of Timolol Maleate to Prevent Intraocular Pressure Elevation After Nd:YAG Laser Posterior Capsulotomy

Completed·CCMH Multan Institute of Medical Sciences·Preclinical·NCT07729189·210 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 — 17 trial records for Timolol maleate. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Timolol maleate compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Timolol maleate. 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

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

Q4 2028

Trials by Indication[1]

Ocular Hypertension5 trials

Hemangioma2 trials

Extremity1 trial

Neuropathy1 trial

Esophageal Varices1 trial

Anti-angiogenic Therapy1 trial

Tolerance1 trial

Interaction1 trial

Glaucoma1 trial

Chronic Wounds1 trial

ESS1 trial

Capsule Opacification1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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