TIMOLOL MALEATE
Timolol maleate is indicated for the treatment of hypertension, where it may be used alone or in combination with other antihypertensive agents, particularly thiazide-type diuretics. It is also indicated for clinically stable survivors of the acute phase of a myocardial infarction to reduce cardiovascular mortality and the risk of reinfarction. Additionally, timolol maleate is indicated for the prophylaxis of migraine headache.
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
- Prescription
- 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 Competitors
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Competitors share the same molecular target (Beta-1 adrenergic receptor). Earlier expiry dates signal biosimilar/generic opportunities.
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Active Pipeline
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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
ProIndications & Usage
FDA Label (PDF)Hypertension Timolol maleate tablets are indicated for the treatment of hypertension. They may be used alone or in combination with other antihypertensive agents, especially thiazide-type diuretics. Myocardial Infarction Timolol is indicated in patients who have survived the acute phase of myocardial infarction, and are clinically stable, to reduce cardiovascular mortality and the risk of reinfarction. Migraine Timolol is indicated for the prophylaxis of migraine headache.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.