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Drug

Brimonidine tartrate

Approved · FDA / EMA
Emerging researchLate-stage development
Also known as Alphagan, Brimonidine, Combigan, Lumify+5 more

Alphagan, Brimonidine, Combigan, Lumify, Mirvaso, Mirvaso Pump, Simbrinza, Yuvezzi, brimonidine (as tartrate).

RxNorm39171
1
Research papers
3
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Supplemental approval: BRIMONIDINE TARTRATE (ANDA091691)

Regulatory2026-06-22FDA

A Multi-Center, Double-Masked Phase 3 Evaluation of the Safety and Efficacy of LNZ101 for the Treatment of Presbyopia

Clinical trial2026-05-13Results posted · ClinicalTrials.gov

Effect of the Addition of Netarsudil 0.02% vs. Brimonidine 0.1% in Normal Tension Glaucoma Patients Currently on Latanoprost 0.005%

Clinical trial2025-09-22Completed · ClinicalTrials.gov

Multicenter, Double-Masked, Randomized, Safety and Efficacy Study of BRIMOCHOL™ PF and Carbachol PF Topical Ophthalmic Solution With Emmetropic Phakic and Pseudophakic Presbyopia

Clinical trial2024-10-15Results posted · ClinicalTrials.gov

The Effect of Brimonidine on Intraocular Pressure When Dilating Routine Patients, Pressure Control and Pupil Effects

Clinical trial2024-02-01Results posted · ClinicalTrials.gov

Circadian Rhythms of Aqueous Humor Dynamics in Subjects With Ocular Hypertension Using Brimonidine

Clinical trial2023-11-28Results posted · ClinicalTrials.gov

MIRVASO® In Use Study: Managing Rosacea Through Assessment and Control of Its Erythema (The MIRACLE Study)

Clinical trial2022-08-01Results posted · ClinicalTrials.gov

A Phase 3 Randomized, Placebo-Controlled, Double-Masked, Multicenter, Safety and Efficacy Study of Brimonidine Tartrate 0.2% Nanoemulsion Eye Drops in Patients With Dry Eye Disease (DED)

Clinical trial2022-07-18Results posted · ClinicalTrials.gov

A Randomized, Placebo-Controlled, Double-Blind, Multicenter, Proof-of-Concept Study of Brimonidine Eye Drops for the Treatment of Dry Eye Disease (DED)

Clinical trial2022-07-06Results posted · ClinicalTrials.gov

Approval: BRIMONIDINE TARTRATE (ANDA091691)

Regulatory2014-11-18FDA

Daytime and nighttime effects of brimonidine on IOP and aqueous humor dynamics in participants with ocular hypertension.

Research2014-06-01Journal of glaucoma

Approval: Mirvaso (EMA)

Regulatory2014-02-20EMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Brimonidine tartrate
Aliases & brands
AlphaganBrimonidineCombiganLumifyMirvasoMirvaso PumpSimbrinzaYuvezzibrimonidine (as tartrate)
RxNorm CUI
39171
Regulatory jurisdictions
emafda

Regulatory timeline

3 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Approval / market entry confirmed across FDA and EMA (2014-02-20 → 2014-11-18)
Earliest approval
2014-02-20
Latest approval
2026-06-22
Authorities
FDA · EMA
Total events
3
fdaU.S. Food and Drug Administration· 2 events
2026-06-22Supplemental approval
Supplemental approval: BRIMONIDINE TARTRATE (ANDA091691)
Evidence ↗
2014-11-18ApprovalMulti-authority
Approval: BRIMONIDINE TARTRATE (ANDA091691)
Evidence ↗
emaEuropean Medicines Agency· 1 event
2014-02-20ApprovalMulti-authority
Approval: Mirvaso (EMA)

Indication: Mirvaso is indicated for the symptomatic treatment of facial erythema of rosacea in adult patients.

Evidence ↗

Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

33 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
33
registered trials across all phases
LATEST COMPLETION 2025
24
Late-stage (III+)
25
Completed
8
Discontinued
PHASE DISTRIBUTIONn = 33
Early Phase 12Phase 12Phase 25Phase 2 / 31Phase 38Phase 412Phase N / A3

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Effect of the Addition of Netarsudil 0.02% vs. Brimonidine 0.1% in Normal Tension Glaucoma Patients Currently on Latanoprost 0.005%

CompletedPH IVWestlake Eye Specialistsn=1002025

Comparison of Efficacy and Ocular Surface Disease Assessment Between BRIDIN-T Eye Drops 0.15% and ALPHAGAN-P Eye Drops 0.15% in Glaucoma or Ocular Hypertensive Patients : Phase 4, Parallel Group Design, Investigator-blind, Active-control, Randomized, Multi-center Trial

Unknown statusPH IVCHA Universityn=612021

Changes in Peripapillary Blood Flow After Use of Anti-glaucoma Medications: A Prospective, Quantitative OCT Angiography Study

CompletedPH IVWills Eyen=352020

The Effect of Brimonidine on Intraocular Pressure When Dilating Routine Patients, Pressure Control and Pupil Effects

CompletedPH IVWake Forest University Health Sciencesn=132019

A Multicenter, Open-label Clinical Trial to Evaluate the Efficacy and Safety of Once Daily Mirvaso® Gel (5 mg/g Brimonidine Tartrate) in Patients With Chronic Persistent Vascular Facial Erythema.

CompletedPH IVGalderma Brasil Ltda.n=1012017

Recent completions

Trials that read out recently, adding to the completed evidence base.

Effect of the Addition of Netarsudil 0.02% vs. Brimonidine 0.1% in Normal Tension Glaucoma Patients Currently on Latanoprost 0.005%

CompletedPH IVWestlake Eye Specialistsn=1002025

A Multi-Center, Double-Masked Phase 3 Evaluation of the Safety and Efficacy of LNZ101 for the Treatment of Presbyopia

CompletedPH IIILENZ Therapeutics, Incn=4692024

Multicenter, Double-Masked, Randomized, Safety and Efficacy Study of BRIMOCHOL™ PF and Carbachol PF Topical Ophthalmic Solution With Emmetropic Phakic and Pseudophakic Presbyopia

CompletedPH IIIVisus Therapeuticsn=1822023

Enhanced Pupil Dilation in Patients Taking Alpha-Blockers for Potential Treatment of Intraoperative Floppy Iris Syndrome

CompletedPH IIDenver Health and Hospital Authorityn=132020

Changes in Peripapillary Blood Flow After Use of Anti-glaucoma Medications: A Prospective, Quantitative OCT Angiography Study

CompletedPH IVWills Eyen=352020

The Effect of Brimonidine on Intraocular Pressure When Dilating Routine Patients, Pressure Control and Pupil Effects

CompletedPH IVWake Forest University Health Sciencesn=132019

Research activity

1 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Journals, researchers & institutions
Top journals
  • Journal of glaucoma1
Leading researchers
  • Agrawal A1
  • Fan S1
  • Gulati V1
  • Neely DG1
  • Toris CB1
Leading institutions
free-text, unnormalised
  • University of Nebraska Medical Center1
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.