TheraRadar
Data updated: Jul 17, 2026

QOLIANA (brimonidine tartrate) · Novartis

Ophthalmology Approved 2006-05-22

Use relieves redness of the eye due to minor eye irritations

Source: FDA Label
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
20
Years on Market

Details

Status
Prescription
First Approved
2006-05-22
Routes
OPHTHALMIC
Dosage Forms
SOLUTION/DROPS

Companies

Novartis
Active Ingredient: BRIMONIDINE TARTRATE

QOLIANA Approval History

2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
7 FDA actions from 2006 to 2025
Nov 2025 SUPPL
Label · Labeling
FDA Letter Label
Jan 2016 SUPPL
Mfg · Manufacturing (CMC)
Nov 2015 SUPPL
Mfg · Manufacturing (CMC)

What QOLIANA Treats

2 indications

QOLIANA is approved for 2 conditions since its original approval in 2006. These indications span multiple therapeutic areas including oncology, immunology, and more.

Same approved indications as BRIMONIDINE TARTRATE (same active ingredient).

Source: FDA Label
📋

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

Pro

Ongoing clinical trials by development phase

Loading...
⭐

Key Completed Trials

Pro

Completed studies with published results, ranked by significance

Loading...
📊

Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

|
Loading...
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.

QOLIANA FDA Label Details

Indications & Usage

FDA Label (PDF)

Use relieves redness of the eye due to minor eye irritations

Track QOLIANA with TheraRadar Pro

Watchlist alerts, full database access, CSV exports across 14,000+ drugs.

Upgrade to Pro

Data Sources

FDA Approval: NDA021764 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.