BRIMONIDINE TARTRATE
Brimonidine tartrate is an eye drop used to lower elevated pressure within the eye. It helps patients with open-angle glaucoma or ocular hypertension by managing intraocular pressure levels. Because the drug's effectiveness can decrease over time in some individuals, patients require regular monitoring to ensure the pressure remains controlled.
How BRIMONIDINE TARTRATE Works
This medication works as a selective alpha-2 adrenergic receptor agonist to lower eye pressure through two distinct methods. It reduces the amount of fluid the eye produces while simultaneously increasing the drainage of fluid through the uveoscleral pathway.
Details
- Status
- Prescription
- First Approved
- 2003-05-28
- Routes
- OPHTHALMIC, TOPICAL
- Dosage Forms
- SOLUTION/DROPS, GEL
Companies
BRIMONIDINE TARTRATE Approval History
What BRIMONIDINE TARTRATE Treats
2 indicationsBRIMONIDINE TARTRATE is approved for 2 conditions since its original approval in 2003. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Open-angle glaucoma
- Ocular hypertension
BRIMONIDINE TARTRATE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
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 BRIMONIDINE TARTRATE's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications BRIMONIDINE TARTRATE treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to BRIMONIDINE TARTRATE
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
12 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05270863 results posted | VT-002 | Ph 3 | completed | Safety and Efficacy Study BRIMOCHOL™ PF and Carbachol PF in Subjects With Emmetropic Phakic or Pseudophakic Presbyopia |
| NCT03785340 results posted | OCU-310-301 | Ph 3 | completed | Study of Brimonidine Tartrate Nanoemulsion Eye Drop Solution in the Treatment of Dry Eye Disease (DED) |
| NCT03591874 oGVHD results posted | OCU-300-301 | Ph 3 | terminated | Study of Brimonidine Tartrate Nanoemulsion Eye Drops in Patients With Ocular Graft-vs-Host Disease |
| NCT03760185 results posted | 18-1713 | Ph 2 | completed | Pupil Dilation for Treatment of IFIS |
| NCT03323164 results posted | 17-636E | Ph 4 | completed | Peripapillary Blood Flow After Use of Anti-glaucoma Medications: An OCT Angiography Study |
| NCT01959230 results posted | 861 | Ph 3 | completed | Efficacy and Safety of Brimonidine Tartrate Ophthalmic Solution in Adult and Geriatric Participants With Ocular Redness |
| NCT01959243 results posted | 862 | Ph 3 | completed | Safety of Brimonidine Tartrate Ophthalmic Solution in a Population of Pediatric, Adult, and Geriatric Participants |
| NCT03966560 | KAEK-2014/04-74 | Ph 4 | completed | Choroidal Thickness and Its Correlations With Ocular Parameters in Primary Open-angle Glaucoma |
| NCT03173365 BRIMOCAN | BRIMOCAN | Ph 2 | terminated | The Effect of Topical Brimonidine Tartrate on Hand-foot Syndrome (HFS) in Cancer Patients |
| NCT02039765 | 863/13-100-0007 | Ph 1 | completed | Pharmacokinetics and Safety of Topical Administration of Brimonidine Tartrate Ophthalmic Solution 0.025%. |
| NCT02856919 BR14004 | BR.14.004 | Ph 4 | completed | A Multicenter, Open-label Clinical Trial to Evaluate the Efficacy and Safety of Once Daily Mirvaso® Gel in Patients With Chronic Persistent Vascular Facial Erythema. |
| NCT02568111 BRITE | NLD-PEG-14-10784 2015-002159-89 | Ph 4 | withdrawn | Brimonidine Tartrate for the Treatment of Injection Related Erythema |
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.
BRIMONIDINE TARTRATE FDA Label Details
Indications & Usage
BRIMONIDINE TARTRATE is indicated for the treatment of Open-angle glaucoma; Ocular hypertension.
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BRIMONIDINE TARTRATE AND TIMOLOL MALEATE
Full clinical data, patents, trials, and competitive landscape for brimonidine tartrate.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.