Drugs / Brinzolamide

Regulatory milestones approvals, filings & regulatory actions · 3 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Label expansion US (FDA) AZOPT 2006-09-28 fda.gov
Approved EU (EMA) Azopt 2000-03-09 europa.eu
Approved US (FDA) AZOPT 1998-04-01 fda.gov

Trials 37 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 1/21 trial
Phase 1/2 NCT03896633 Feb → Nov 2018 open-angle glaucoma Bausch & Lomb Incorporated Completed No outcome recorded
Phase 23 trials
Phase 2 NCT03542006 Jun 2018 → Jan 2019 central serous chorioretinopathy Tel-Aviv Sourasky Medical Center Unknown No outcome recorded
Phase 2 NCT01426867 Sep → Nov 2011 ocular hypertension, open-angle glaucoma Alcon Research Completed No outcome recorded
Phase 2 NCT00527501 Aug → Dec 2007 ocular hypertension, open-angle glaucoma Alcon Research Completed No outcome recorded
Phase 310 trials
Phase 3 NCT05022004 Dec 2021 → Dec 2022 ocular hypertension, open-angle glaucoma Sun Pharmaceutical Industries, Inc. Completed No outcome recorded
Phase 3 NCT04944290 May 2021 → Mar 2022 ocular hypertension, open-angle glaucoma Padagis LLC Completed No outcome recorded
Phase 3 NCT02390284 Sep 2015 → Oct 2024 glaucoma University of Miami Terminated No outcome recorded
Phase 3 NCT01721707 Dec 2012 → Mar 2013 ocular hypertension, open-angle glaucoma Adapt Produtos Oftalmológicos Ltda. Withdrawn No outcome recorded
Phase 3 NCT01722604 Jan → Sep 2012 open-angle glaucoma Bausch & Lomb Incorporated Completed No outcome recorded
Phase 3 NCT01297920 Mar 2011 → Jun 2012 ocular hypertension, open-angle glaucoma Alcon Research Completed No outcome recorded
Phase 3 NCT00767481 Oct 2008 → Feb 2009 glaucoma, ocular hypertension Alcon Research Terminated No outcome recorded
Phase 3 NCT00314158 Nov 2005 → Jan 2007 ocular hypertension, open-angle glaucoma Alcon Research Completed No outcome recorded
Phase 3 NCT00314171 Oct 2005 → Aug 2007 ocular hypertension, open-angle glaucoma Alcon Research Completed No outcome recorded
Phase 3 NCT00061516 Jan 2003 → Feb 2006 glaucoma, ocular hypertension Alcon Research Completed No outcome recorded
Phase 421 trials
Phase 4 NCT06883123 May 2025 → Apr 2026 overdue open-angle glaucoma Prairie Eye Center Recruiting No outcome recorded
Phase 4 NCT03150160 Sep → Dec 2017 glaucoma Novartis Pharmaceuticals Completed No outcome recorded
Phase 4 NCT02730871 Jun 2016 → Jul 2018 ocular hypertension, open-angle glaucoma Alcon Research Terminated No outcome recorded
Phase 4 NCT02419508 Aug 2015 → Feb 2018 ocular hypertension, open-angle glaucoma Alcon Research Completed No outcome recorded
Phase 4 NCT02325518 Dec 2014 → Dec 2015 ocular hypertension, open-angle glaucoma Alcon, a Novartis Company Completed No outcome recorded
Phase 4 NCT03966560 Jan 2014 → Jan 2015 open-angle glaucoma Afyon Kocatepe University Hospital Completed No outcome recorded
Phase 4 NCT01514734 Mar → Aug 2012 glaucoma Alcon Research Terminated No outcome recorded
Phase 4 NCT01535768 Feb 2012 → Jun 2018 glaucoma Credit Valley EyeCare Unknown No outcome recorded
Phase 4 NCT01518244 Dec 2011 → Feb 2013 glaucoma Alcon Research Completed No outcome recorded
Phase 4 NCT01340014 Sep 2011 → Oct 2012 ocular hypertension, open-angle glaucoma Alcon Research Completed No outcome recorded
Phase not applicable2 trials
NCT04296916 Apr 2020 → Oct 2024 borderline glaucoma, myopia Sun Yat-sen University Unknown No outcome recorded
NCT00121147 Sep 2003 → Oct 2005 exfoliation syndrome, ocular hypertension, open-angle glaucoma Hermann Eye Center Completed No outcome recorded
Also used as a comparator or background therapy in 21 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 23 trials
Phase 2 NCT03763227 Comparator Jul 2015 → Aug 2019 inherited retinal dystrophy Sultan Qaboos University Completed No outcome recorded
Phase 2 NCT02140060 Comparator Jun → Nov 2014 ocular hypertension, open-angle glaucoma Alcon Research Completed No outcome recorded
Phase 2 NCT00961649 Comparator Oct 2009 → Feb 2010 ocular hypertension, open-angle glaucoma Alcon Research Terminated No outcome recorded
Phase 39 trials
Phase 3 NCT04024072 Comparator Jun 2019 → Feb 2020 ocular hypertension, open-angle glaucoma Padagis LLC Completed No outcome recorded
Phase 3 NCT02339584 Comparator Apr 2015 → Nov 2016 ocular hypertension, open-angle glaucoma Alcon Research Completed No outcome recorded
Phase 3 NCT01310777 Comparator May 2011 → Jan 2013 ocular hypertension, open-angle glaucoma Alcon Research Completed No outcome recorded
Phase 3 NCT01309204 Comparator May 2011 → Jan 2013 ocular hypertension, open-angle glaucoma Alcon Research Completed No outcome recorded
Phase 3 NCT01297517 Comparator Feb 2011 → Mar 2012 ocular hypertension, open-angle glaucoma Alcon Research Completed No outcome recorded
Phase 46 trials
Phase 4 NCT01312402 Comparator Jan 2011 → Mar 2014 pathologic nystagmus Akron Children's Hospital Completed No outcome recorded
Phase 4 NCT01471158 Comparator Sep 2010 → May 2011 glaucoma Alcon Research Completed No outcome recorded
Phase 4 NCT00761995 Comparator Feb 2009 → Jul 2010 ocular hypertension, open-angle glaucoma Alcon Research Completed No outcome recorded
Phase 4 NCT00471380 Comparator Mar 2007 → Oct 2008 glaucoma, ocular hypertension Alcon Research Completed No outcome recorded
Phase 4 NCT00440141 Comparator Jul 2006 → Mar 2007 glaucoma, ocular hypertension Allergan Completed No outcome recorded
Phase not applicable3 trials
NCT04523844 Comparator May → Jul 2020 ocular hypertension General Hospital of Athens Elpis Completed No outcome recorded
NCT03494257 Comparator Sep 2017 → Mar 2018 cataract University Hospital of Patras Completed No outcome recorded
NCT01084902 Comparator Feb → Sep 2010 ocular hypertension Peking University First Hospital Unknown No outcome recorded

Evidence & citations 14 cited values

Every value below carries the sentence it was read from. 60 sources stand behind the page.

FieldValueCited text
Known as brinzolamide “a topical carbonic anhydrase inhibitor eye drop. (brinzolamide 1% 1 gtts in study eye TID OR dorzolamide 2% 1 gtts in study eye TID)” NCT01535768
51

Brinzolamide Ophthalmic Suspension, 1% (Azopt), a carbonic anhydrase inhibitor” NCT00121147

“alphagan (or alphagan-P) will be switched to brinzolamide 1% eye drops.” NCT04296916

“oral acetazolamide 500mg/day or topical brinzolamide twice daily” NCT03763227

brinzolamide and brimonidine tartrate” NCT06883123

“AZOPT (brinzolamide)” NCT00061516

NCT01722604

NCT00800540

NCT00527501

NCT01084902

NCT01721707

NCT03542006

NCT01309204

NCT00758342

NCT02325518

NCT00300079

NCT00314171

NCT04944290

NCT00675207

NCT01357616

NCT00759941

NCT01484951

NCT04523844

NCT01297920

NCT03896633

NCT00314158

NCT00869141

NCT00471380

NCT01518244

NCT02730871

NCT05022004

NCT01297517

NCT00440141

NCT03494257

NCT01310777

NCT01312402

NCT02390284

NCT02140060

NCT04024072

NCT00767481

NCT00372827

NCT01055366

NCT02339584

NCT01263444

NCT01426867

NCT00961649

NCT01340014

NCT03150160

NCT00767494

NCT01111890

NCT02419508

NCT03966560

Known as AL-4862 ChEMBL registry synonym — accepted as the source's own label CHEMBL220491
Known as Azopt “This is a multiple-dose study of the IOP-lowering efficacy of Azopt (brinzolamide) 1.0% compared to timolol 0.5% when added to a prostaglandin analogue (PGA) as adjunctive...” NCT00300079
12

“Generic Brinzolamide 1% Ophthalmic Suspension Compared to Reference Listed Drug Azopt® (Brinzolamide) Ophthalmic Suspension 1%” NCT05022004

Azopt (Brinzolamide 1.0%) Plus Travatan (Travoprost 0.004%) in Treating Patients With Chronic Angle-Closure Glaucoma (CACG)” NCT00758342

“Brinzolamide Ophthalmic Suspension, 1% (Azopt), a carbonic anhydrase inhibitor” NCT00121147

“Brinzolamide 1% ophthalmic solution (Azopt)” NCT00759941

“Topical brinzolamide (Azopt) versus placebo” PMID 25336575 Oct 2014

NCT00382226

NCT00767494

NCT00980473

NCT00761995

NCT04024072

NCT01004900

NCT00061516

Known as AzoptTM AzoptTM (brinzolamide ophthalmic suspension 1%)” NCT01722604
Known as Brinzolamida ChEMBL registry synonym — accepted as the source's own label CHEMBL220491
Known as Brinzolamide component of azarga ChEMBL registry synonym — accepted as the source's own label CHEMBL220491
Known as Brinzolamide component of simbrinza ChEMBL registry synonym — accepted as the source's own label CHEMBL220491
Known as Brinzolamide Ophthalmic Suspension Brinzolamide Ophthalmic Suspension, 1% (Azopt), a carbonic anhydrase inhibitor” NCT00121147
Known as Brinzolamide/timolol maleate fixed combination ClinicalTrials.gov intervention name — accepted as the source's own label NCT01514734
1

NCT01471158

Known as NSC-760050 ChEMBL registry synonym — accepted as the source's own label CHEMBL220491
Action Inhibit “Brinzolamide Ophthalmic Suspension, 1% (Azopt), a carbonic anhydrase inhibitor” NCT00121147
1

“Carbonic anhydrase II inhibitor” CHEMBL220491

Modality Small molecule CHEMBL220491
Route Topical Topical carbonic anhydrase inhibitors (Brinzolamide)” NCT00121147
Target CA2 “Carbonic anhydrase II inhibitor” CHEMBL220491