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Drug

Brinzolamide

Approved · EMA
Late-stage development

Also known as Azopt, Simbrinza, Brinzolamida.

RxNorm194881ChEMBLCHEMBL220491UNII9451Z89515
1
Regulatory events
Latest activity
beta

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

Stop Retinal Ganglion Cell Dysfunction Study

Clinical trial2024-10-04Terminated · ClinicalTrials.gov

Comparison of the Effects of Latanoprost(0.005%) and Brinzolamide(1.0%) on Intraocular Pressure in Primary Open-angle Glaucoma and Ocular Hypertension

Clinical trial2010-09-01Primary completion · ClinicalTrials.gov

Safety and Efficacy of Brinzolamide Dosed TID With Dorzolamide Dosed TID in Reducing Intraocular Pressure in Patients With Open Angle Glaucoma or Ocular Hypertension

Clinical trial2010-07-01Completed · ClinicalTrials.gov

Travoprost/Brinzolamide Fixed Combination Versus Travatan and Versus AZOPT

Clinical trial2009-02-01Terminated · ClinicalTrials.gov

IOP-Lowering Efficacy of Brinzolamide 1.0% Added to Travoprost 0.004%/Timolol 0.5% Fixed Combination as Adjunctive Therapy

Clinical trial2007-08-01Completed · ClinicalTrials.gov

Safety and Efficacy Study of BETAXON 0.5% and AZOPT 1.0% in Pediatric Patients With Glaucoma or Ocular Hypertension

Clinical trial2006-02-01Completed · ClinicalTrials.gov

A Comparison of the Additivity of Brinzolamide Ophthalmic Suspension, 1% (Azopt) and Brimonidine Tartrate Ophthalmic Solution, 0.15% (Alphagan P) to Travoprost Ophthalmic Solution, 0.004% (Travatan) in Patients With Elevated IOP on Travoprost. A Three Month Double-Masked, Multi-Center Trial in the United States

Clinical trial2005-10-01Completed · ClinicalTrials.gov

Approval: Azopt (EMA)

Regulatory2000-03-09EMA

Profile

Identifiers & mechanism

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

Canonical name
Brinzolamide
Aliases & brands
AzoptSimbrinzaBrinzolamida
RxNorm CUI
194881
ChEMBL ID
CHEMBL220491
UNII
9451Z89515
Regulatory jurisdictions
ema

Regulatory timeline

1 event

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.

Earliest approval
2000-03-09
Latest approval
2000-03-09
Authorities
EMA
Total events
1
emaEuropean Medicines Agency· 1 event
2000-03-09Approval
Approval: Azopt (EMA)
Indication: Azopt is indicated to decrease elevated intraocular pressure in: ocular hypertension; open-angle glaucomaas monotherapy in adult patients unresponsive to beta-blockers or in… Show full indication

Azopt is indicated to decrease elevated intraocular pressure in: ocular hypertension; open-angle glaucomaas monotherapy in adult patients unresponsive to beta-blockers or in adult patients in whom beta-blockers are contraindicated, or as adjunctive therapy to beta-blockers or prostaglandin analogues.

Evidence ↗

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

Clinical trials

7 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
7
registered trials across all phases
LATEST COMPLETION 2010
7
Late-stage (III+)
4
Completed
3
Discontinued
PHASE DISTRIBUTIONn = 7
Phase 33Phase 42Phase N / A2

Late-stage studies

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

Safety and Efficacy of Brinzolamide Dosed TID With Dorzolamide Dosed TID in Reducing Intraocular Pressure in Patients With Open Angle Glaucoma or Ocular Hypertension

CompletedPH IVAlcon Researchn=2002010

IOP-Lowering Efficacy of Brinzolamide 1.0% Added to Travoprost 0.004%/Timolol 0.5% Fixed Combination as Adjunctive Therapy

CompletedPH IVAlcon Researchn=1952007

Stop Retinal Ganglion Cell Dysfunction Study

TerminatedPH IIIUniversity of Miamin=282024

Travoprost/Brinzolamide Fixed Combination Versus Travatan and Versus AZOPT

TerminatedPH IIIAlcon Researchn=172009

Safety and Efficacy Study of BETAXON 0.5% and AZOPT 1.0% in Pediatric Patients With Glaucoma or Ocular Hypertension

CompletedPH IIIAlcon Researchn=782006

Recent completions

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

Safety and Efficacy of Brinzolamide Dosed TID With Dorzolamide Dosed TID in Reducing Intraocular Pressure in Patients With Open Angle Glaucoma or Ocular Hypertension

CompletedPH IVAlcon Researchn=2002010

IOP-Lowering Efficacy of Brinzolamide 1.0% Added to Travoprost 0.004%/Timolol 0.5% Fixed Combination as Adjunctive Therapy

CompletedPH IVAlcon Researchn=1952007

Safety and Efficacy Study of BETAXON 0.5% and AZOPT 1.0% in Pediatric Patients With Glaucoma or Ocular Hypertension

CompletedPH IIIAlcon Researchn=782006

A Comparison of the Additivity of Brinzolamide Ophthalmic Suspension, 1% (Azopt) and Brimonidine Tartrate Ophthalmic Solution, 0.15% (Alphagan P) to Travoprost Ophthalmic Solution, 0.004% (Travatan) in Patients With Elevated IOP on Travoprost. A Three Month Double-Masked, Multi-Center Trial in the United States

CompletedN/AHermann Eye Centern=2002005
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.