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

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 · 2 met primary
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 Withdrawn No outcome recorded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 Met primary
Phase 3 NCT00314171 Oct 2005 → Aug 2007 ocular hypertension, open-angle glaucoma Alcon Research Completed Met primary
Phase 3 NCT00061516 Jan 2003 → Feb 2006 glaucoma, ocular hypertension Alcon Research Completed No outcome recorded
Phase 421 trials · 2 met primary
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 Met primary Stop: Enrollment
Phase 4 NCT02419508 Aug 2015 → Feb 2018 ocular hypertension, open-angle glaucoma Alcon Research Completed Met primary
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 Stop: Enrollment
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
Comparator or background therapy21 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 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

News releases announcing trial results or a regulatory action · 1

DateIssuerRelease
2015-11-15 Novartis Pharmaceuticals Results Alcon introduces Contoura Vision as first personalized LASIK procedure at American Academy of Ophthalmology Annual Meeting novartis.com ↗
Findings show additive effect of BBFC therapy in patients with open-angle glaucoma or ocular hypertension who were inadequately controlled on PGA alone.

All press releases naming this drug 1 release

DateIssuerRelease

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 ↗

NCT00314171 ↗

NCT02339584 ↗

NCT00372827 ↗

NCT00471380 ↗

NCT03494257 ↗

Show 41 more sources

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

NCT01004900 ↗

NCT04024072 ↗

NCT00767494 ↗

NCT00382226 ↗

NCT00980473 ↗

Show 2 more sources

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 NCT01471158 ↗
1

NCT01514734 ↗

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 ↗