TIMOLOL MALEATE
TIMOLOL MALEATE is indicated for the treatment of Hypertension; Myocardial Infarction; Migraine.
How TIMOLOL MALEATE Works
Timolol maleate is a non-selective beta-adrenergic receptor blocking agent. It competes with adrenergic neurotransmitters, such as catecholamines, for binding at both $\beta_1$-receptors (located primarily in cardiac muscle) and $\beta_2$-receptors (located in bronchial and vascular smooth muscle). It lacks significant intrinsic sympathomimetic, direct myocardial depressant, or membrane-stabilizing (local anesthetic) activity. The mechanism of its antihypertensive effect involves a reduction in cardiac output, decrease in sympathetic outflow from the central nervous system, and inhibition of renin release by the kidneys. In post-myocardial infarction management, timolol reduces myocardial oxygen demand by decreasing heart rate and contractility. The exact mechanism for migraine prophylaxis has not been fully established but is thought to involve the modulation of cerebral vascular tone or inhibition of beta-receptor-mediated vasodilation.
Details
- Status
- Discontinued
- First Approved
- 1989-04-13
- Routes
- ORAL, OPHTHALMIC
- Dosage Forms
- TABLET, SOLUTION/DROPS, SOLUTION, GEL FORMING/DROPS, SOLUTION
Companies
TIMOLOL MALEATE Approval History
What TIMOLOL MALEATE Treats
3 indicationsTIMOLOL MALEATE is approved for 3 conditions since its original approval in 1989. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Hypertension
- Myocardial Infarction
- Migraine
TIMOLOL MALEATE Target & Pathway
ProTarget
TIMOLOL MALEATE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
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 TIMOLOL MALEATE's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications TIMOLOL MALEATE treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to TIMOLOL MALEATE
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
5 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04830397 | QC-201 | Ph 2 | completed | Study to Evaluate QLS-101 Compared to Timolol Maleate Eye Drops in Subjects With High Eye Pressure (Glaucoma or Ocular Hypertension). |
| NCT03323164 results posted | 17-636E | Ph 4 | completed | Peripapillary Blood Flow After Use of Anti-glaucoma Medications: An OCT Angiography Study |
| NCT01707381 Constellation results posted | 803 | Ph 2 | completed | BOL-303259-X With Timolol 0.5% in Subjects With Open-Angle Glaucoma or Ocular Hypertension |
| NCT01607671 | NAION-001 | Ph 1 | withdrawn | Treatment Study for Ischemic Optic Neuropathy With Opthalmic Timolol Maleate 0.5% |
| NCT00879099 | 73654 Eudra CT 2008-007324-26 | Ph 1 | completed | Interaction Study of Timolol Eye Drops and Paroxetine Capsules |
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.
TIMOLOL MALEATE FDA Label Details
Indications & Usage
FDA Label (PDF)TIMOLOL MALEATE is indicated for the treatment of Hypertension; Myocardial Infarction; Migraine.
Looking for the branded version?
TIMOPTIC IN OCUDOSE
Full clinical data, patents, trials, and competitive landscape for timolol maleate.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.