TIMOLOL
This combination ophthalmic solution (dorzolamide and timolol) is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. It is specifically intended for individuals who have not achieved target IOP levels despite treatment with beta-blocker monotherapy. By lowering internal eye pressure, the medication helps mitigate the risk of progressive optic nerve damage and associated visual field loss.
How TIMOLOL Works
This medication reduces intraocular pressure by decreasing the secretion of aqueous humor through two distinct pharmacological pathways. Dorzolamide is a carbonic anhydrase II inhibitor that slows the formation of bicarbonate ions, thereby reducing sodium and fluid transport in the ciliary processes. Timolol is a non-selective beta-adrenergic receptor blocker. The combined administration of these two agents results in a greater reduction of IOP than either component used alone, although the fixed-dose combination administered twice daily may be slightly less effective than the individual components administered at their maximal separate dosing frequencies.
Details
- Status
- Prescription
- First Approved
- 2016-09-30
- Routes
- OPHTHALMIC
- Dosage Forms
- SOLUTION/DROPS
TIMOLOL Approval History
What TIMOLOL Treats
2 indicationsTIMOLOL is approved for 2 conditions since its original approval in 2016. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Glaucoma
- Ocular Hypertension
TIMOLOL 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.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
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's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications TIMOLOL treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to TIMOLOL
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
16 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06120140 COCOON | 61186372NSC2007 61186372NSC2007, 2023-505863-35-00 | Ph 2 | active not recruiting | Enhanced Dermatological Care to Reduce Rash and Paronychia in Epidermal Growth Factor Receptor (EGRF)-Mutated Non-Small Cell Lung Cancer (NSCLC) Treated First-line With Amivantamab Plus Lazertinib |
| NCT05479123 results posted | HSC-MS-22-0246 | Ph 4 | terminated | Assessing the Impact of Dosage Frequency of Propranolol on Sleep Patterns in Patients With Infantile Hemangiomas |
| NCT02422017 EETUV | PI2014_843_0022 2014-005046-22 | Ph 2 | completed | Topical Timolol Benefit in Venous Ulcers |
| NCT02390284 STOP-RGCD results posted | 20140587 R01EY014957 | Ph 3 | terminated | Stop Retinal Ganglion Cell Dysfunction Study |
| NCT03282981 BAART-DFU results posted | SURG-004-16F 17-08-00792 | Ph 3 | completed | Beta Adrenergic Antagonist for the Healing of Chronic DFU |
| NCT02774590 | IRB00074049 | Ph 1 | completed | Timolol for the Treatment of Acne and Rosacea |
| NCT00716859 results posted | A6111137 | Ph 3 | completed | A Phase 3 Prospective, Randomized, Double-Masked, 12-Week, Parallel Group Study In Pediatric Subjects With Glaucoma. |
| NCT03836664 results posted | STUDY00140465 | Ph 2 | completed | A Randomized Study Evaluating the Efficacy and Safety of Timolol Ophthalmic Solution as an Acute Treatment of Migraine |
| NCT01533376 | AVL-SWS-TT4PWM | Ph 1 | terminated | Treatment of Port-wine Mark in Sturge-Weber Syndrome Using Topical Timolol |
| NCT02742649 results posted | FSV5-FC-001 | Ph 1, Ph 2 | completed | A Study to Evaluate Efficacy and Safety of a Fixed Combination Ocular Insert in Participants With Open-angle Glaucoma or Ocular Hypertension |
| NCT01749930 LUNAR results posted | 770 | Ph 3 | completed | 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 |
| NCT02731287 | IIBSP-TIM-2013-156 | Ph 2 | completed | Topical Timolol for Infantile Hemangioma in Early Proliferative Phase |
| NCT01749904 APOLLO results posted | 769 | Ph 3 | completed | Comparing Safety and Efficacy of BOL-303259-X With Timolol Maleate in Subjects With Open-Angle Glaucoma or Ocular Hypertension |
| NCT01927406 | 26654 | Ph 4 | withdrawn | The Secondary Beneficial Effects of Prostaglandin Analog Treatment in Thyroid Eye Disease Patients. |
| NCT01917383 | IPC-01-2013 | Ph 2 | completed | A Phase II Study to Evaluate the Additivity of Trabodenoson to Latanoprost in Adults With Ocular Hypertension or Primary Open-Angle Glaucoma |
| NCT02312544 | OTX-13-004 | Ph 2 | completed | 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 |
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 FDA Label Details
Indications & Usage
TIMOLOL is indicated for the treatment of Glaucoma; Ocular Hypertension.
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BETIMOL
Full clinical data, patents, trials, and competitive landscape for timolol.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.