Drugs / Dorzolamide
Dorzolamide
also known as
Trusopt · Dorzolamide Hydrochloride · Cosopt pf · Dorzant · Dorzolamida · Dorzolamide (as hydrochloride) · dorzolamide HCl · Dorzolamide hydrochloride component of cosopt · +3 more
Small molecule targets CA2 via inhibition
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | TRUSOPT | — | 2004-04-15 | fda.gov ↗ |
| Approved | US (FDA) | TRUSOPT | — | 1994-12-09 | fda.gov ↗ |
Trials 37
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT02852057 | Jan 2018 → Aug 2021 | glaucoma | University of Florida | Completed | No outcome recorded |
| Phase 1 | NCT02967614 | Dec 2016 → Dec 2017 | glaucoma, ocular hypertension | Kukje Pharma | Completed | No outcome recorded |
| Phase 24 trials · 1 met primary | ||||||
| Phase 2 | NCT04448223 | Jun 2020 → Dec 2022 | ocular hypertension, open-angle glaucoma | Chong Kun Dang Pharmaceutical | Unknown | No outcome recorded |
| Phase 2 | NCT01527682 | Jul 2009 → Nov 2016 | congenital glaucoma | Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia | Completed | No outcome recorded |
| Phase 2 | NCT00832377 | Apr 2009 → Mar 2010 | glaucoma | Merck Sharp & Dohme LLC | Completed | Met primary |
| Phase 2 | NCT00572936 | Mar 2006 → Nov 2009 | glaucoma | University of Nebraska | Completed | No outcome recorded |
| Phase 37 trials · 1 met primary | ||||||
| Phase 3 | NCT05973305 | Apr 2017 | open-angle glaucoma | Jadran Galenski laboratorij d.d. | Completed | No outcome recorded |
| Phase 3 | NCT02390284 | Sep 2015 → Oct 2024 | glaucoma | University of Miami | Terminated | No outcome recorded |
| Phase 3 | NCT01284166 | Jul 2013 → May 2014 | glaucoma, ocular hypertension | Allergan | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT00878917 | Apr 2009 → Feb 2010 | ocular hypertension, open-angle glaucoma | Alfred E. Tiefenbacher (GmbH & Co. KG) | Completed | Met primary |
| Phase 3 | NCT00576342 | Dec 2007 → Jan 2008 | glaucoma, ocular hypertension | Alcon Research | Completed | No outcome recorded |
| Phase 3 | NCT00546286 | May 2006 → Aug 2007 | ocular hypertension, open-angle glaucoma | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT00108017 | Apr 2005 → Jul 2006 | glaucoma, ocular hypertension | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 418 trials · 1 missed | ||||||
| Phase 4 | NCT07690397 | Jun 2026 → Jul 2027 expected | ocular hypertension, open-angle glaucoma | Tecnoquimicas | Active not recruiting | No outcome recorded |
| Phase 4 | NCT05857267 | Mar 2023 → Nov 2024 | ocular hypertension, open-angle glaucoma | Laboratorios Poen | Completed | No outcome recorded |
| Phase 4 | NCT04702789 | Oct 2021 → Nov 2023 | ocular hypertension, open-angle glaucoma | Laboratorios Sophia S.A de C.V. | Terminated | No outcome recorded |
| Phase 4 | NCT04676126 | May 2021 → May 2022 | open-angle glaucoma | University of the Incarnate Word | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT02053298 | Jan 2014 → Dec 2015 | open-angle glaucoma | Universitaire Ziekenhuizen KU Leuven | Completed | No outcome recorded |
| Phase 4 | NCT03966560 | Jan 2014 → Jan 2015 | open-angle glaucoma | Afyon Kocatepe University Hospital | Completed | No outcome recorded |
| Phase 4 | NCT01535768 | Feb 2012 → Jun 2018 | glaucoma | Credit Valley EyeCare | Unknown | No outcome recorded |
| Phase 4 | NCT01340014 | Sep 2011 → Oct 2012 | ocular hypertension, open-angle glaucoma | Alcon Research | Completed | No outcome recorded |
| Phase 4 | NCT00906087 | Aug 2009 → Jul 2012 | glaucoma | University of Michigan | Completed | No outcome recorded |
| Phase 4 | NCT00957190 | May 2009 → Sep 2011 | eye disorder | Maisonneuve-Rosemont Hospital | Completed | No outcome recorded |
| Phase 4 | NCT00869141 | Mar 2009 → Mar 2013 | glaucoma | University of California, Los Angeles | Completed | No outcome recorded |
| Phase 4 | NCT00545064 | May 2007 → Sep 2008 | ocular hypertension, open-angle glaucoma | Merck Sharp & Dohme LLC | Completed | Missed primary |
| Phase 4 | NCT00273455 | Jan 2006 → May 2007 | open-angle glaucoma | Pharmaceutical Research Network | Completed | No outcome recorded |
| Phase 4 | NCT00273442 | Nov 2005 → Apr 2007 | exfoliation syndrome, ocular hypertension, open-angle glaucoma | Pharmaceutical Research Network | Completed | No outcome recorded |
| Phase 4 | NCT00716586 | Oct 2005 → Aug 2015 | retinal degeneration | University of Illinois at Chicago | Completed | No outcome recorded |
| Phase 4 | NCT00273481 | Sep 2005 → Apr 2007 | ocular hypertension, open-angle glaucoma | Pharmaceutical Research Network | Completed | No outcome recorded |
| Phase 4 | NCT00140049 | Jul 2005 → Jul 2006 | ocular hypertension, open-angle glaucoma | Viatris Inc. | Completed | No outcome recorded |
| Phase 4 | NCT00348400 | — | glaucoma | Innovative Medical | Completed | No outcome recorded |
| Phase not applicable6 trials | ||||||
| — | NCT02522039 | May → Nov 2014 | glaucoma | Glostrup University Hospital, Copenhagen | Completed | No outcome recorded |
| — | NCT01843920 | Jun 2011 → Apr 2013 | — | Jason Hsu, MD | Completed | No outcome recorded |
| — | NCT00275756 | Sep 2008 → Nov 2014 | glaucoma | Medical University of Vienna | Withdrawn | No outcome recorded |
| — | NCT00619034 | Sep 2007 → Dec 2010 | diabetic retinopathy | University of Aarhus | Completed | No outcome recorded |
| — | NCT00440336 | Oct 2006 → ? | open-angle glaucoma | Advanced Glaucoma Specialists | Unknown | No outcome recorded |
| — | NCT00152932 | May 2005 → Jun 2006 | glaucoma | University Health Network, Toronto | Unknown | No outcome recorded |
| Comparator or background therapy21 trials | ||||||
| Phase 2 | NCT01887223 Comparator | May 2010 → Jun 2011 | open-angle glaucoma | University of Sao Paulo General Hospital | Completed | No outcome recorded |
| Phase 2 | NCT01062971 Comparator | Feb 2006 → Aug 2007 | ocular hypertension, open-angle glaucoma | Laboratorios Sophia S.A de C.V. | Completed | No outcome recorded |
| Phase 2/3 | NCT05083689 Comparator | Oct 2021 → Mar 2022 | diabetic macular edema | Shahid Beheshti University of Medical Sciences | Unknown | No outcome recorded |
| Phase 2/3 | NCT00991822 Comparator | May 1999 → Dec 2001 | open-angle glaucoma | Medical University of Vienna | Completed | No outcome recorded |
| Phase 3 | NCT00449956 Comparator | Mar 2007 → Feb 2008 | glaucoma | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT00333125 Comparator | Apr 2006 → Feb 2007 | glaucoma, ocular hypertension | Alcon Research | Completed | No outcome recorded |
| Phase 3 | NCT00314171 Comparator | Oct 2005 → Aug 2007 | ocular hypertension, open-angle glaucoma | Alcon Research | Completed | Met primary |
| Phase 4 | NCT06883123 Comparator | May 2025 → Apr 2026 overdue | open-angle glaucoma | Prairie Eye Center | Recruiting | No outcome recorded |
| Phase 4 | NCT06369077 Comparator | Apr → Jul 2024 | open-angle glaucoma | CT Glaucoma Associates | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT02802137 Comparator | Mar → Dec 2015 | eye adnexa disorder, open-angle glaucoma | Aristotle University Of Thessaloniki | Completed | No outcome recorded |
| Phase 4 | NCT02325518 Comparator | Dec 2014 → Dec 2015 | ocular hypertension, open-angle glaucoma | Alcon, a Novartis Company | Completed | No outcome recorded |
| Phase 4 | NCT01471158 Comparator | Sep 2010 → May 2011 | glaucoma | Alcon Research | Completed | No outcome recorded |
| Phase 4 | NCT01111890 Comparator | Apr 2010 → Jul 2011 | glaucoma, ocular hypertension | Alcon Research | Completed | No outcome recorded |
| Phase 4 | NCT00972257 Comparator | Jan → Sep 2009 | open-angle glaucoma | Aristotle University Of Thessaloniki | Completed | No outcome recorded |
| Phase 4 | NCT00811850 Comparator | Dec 2008 → Dec 2009 | glaucoma | Allergan | Completed | No outcome recorded |
| Phase 4 | NCT00471380 Comparator | Mar 2007 → Oct 2008 | glaucoma, ocular hypertension | Alcon Research | Completed | No outcome recorded |
| Phase 4 | NCT00471068 Comparator | Mar 2007 → Aug 2008 | ocular hypertension, open-angle glaucoma | Alcon Research | Terminated | No outcome recorded |
| Phase 4 | NCT00675207 Comparator | Jan 2006 → Jul 2007 | ocular hypertension, open-angle glaucoma | Northwestern Ophthalmic Institute S.C. | Completed | No outcome recorded |
| Phase 4 | NCT01655758 Comparator | Jan 2002 → Dec 2003 | ocular hypertension | University of Parma | Completed | No outcome recorded |
| — | NCT00824824 Comparator | Jan 2009 → Aug 2012 | glaucoma | Massachusetts Eye and Ear Infirmary | Completed | No outcome recorded |
| — | NCT00815373 Comparator | Dec 2008 → Dec 2011 | ocular hypertension, open-angle glaucoma | Meir Medical Center | Withdrawn | No outcome recorded |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2019-08-01 | Alembic Pharmaceuticals Ltd. | Regulatory 13th August, 2019, Vadodara, India alembicpharmaceuticals.com ↗
Alembic Pharmaceuticals Limited today announced that the Company has received approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Dorzolamide Hydrochloride Ophthalmic Solution USP, 2%. |
All press releases naming this drug 3 releases
| Date | Issuer | Release |
|---|---|---|
| 2019-08-01 | Alembic Pharmaceuticals Ltd. | 13th August, 2019, Vadodara, India alembicpharmaceuticals.com ↗ |
| 2014-12-18 | Lannett Company, Inc. | Lannett Receives FDA Approval for Dorzolamide HCL with TimololPDF Version investorroom.com ↗ |
| 2008-10-28 | Prasco LLC | Prasco to Distribute Generic Forms of Dorzolamide Hydrochloride-Timolol Maleate and Dorzolamide Hydrochloride Ophthalmic Solutions (comparable to Merck’s COSOPT ® and TRUSOPT ® Ophthalmic Solutions) prasco.com ↗ |
Evidence & citations 16 cited values
Every value below carries the sentence it was read from. 60 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Dorzolamide | “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 ↗55“The Fixed Combination Of Latanoprost And Timolol (Xalacom) With The Fixed Combination Of Dorzolamide And Timolol (Cosopt)” NCT00140049 ↗ “Trade name: Dorzol Active ingredient: dorzolamide Pharmaceutical form: eye drops Dosage: 20 mg/mL” NCT05973305 ↗ “Cosopt (dorzolamide 20 mg/ml and timolol maleate 5 mg/ml eye drops, solution)” NCT00471068 ↗ “First Step: Alphagan (Brimonidine) Second Step: Dorzolamide (Trusopt)” NCT00440336 ↗ “Latanoprost (25ug/ml), Dorzolamide (20mg/ml), twice a day” NCT04448223 ↗ “dorzolamide hydrochloride and timolol maleate” NCT06883123 ↗ “Dorzolamide” NCT02967614 ↗ |
| Known as | Cosopt pf | ChEMBL registry synonym — accepted as the source's own label CHEMBL218490 ↗ |
| Known as | Dorzant | ChEMBL registry synonym — accepted as the source's own label CHEMBL218490 ↗ |
| Known as | Dorzolamida | ChEMBL registry synonym — accepted as the source's own label CHEMBL218490 ↗ |
| Known as | Dorzolamide (as hydrochloride) | ChEMBL registry synonym — accepted as the source's own label CHEMBL218490 ↗ |
| Known as | dorzolamide HCl | “Combination treatment of dorzolamide HCl (2%)/ timolol maleate (0.5%) BID for six weeks in patients with open-angle glaucoma or ocular hypertension.” NCT00546286 ↗ |
| Known as | Dorzolamide Hydrochloride | “Dorzolamide (as Dorzolamide Hydrochloride) 20 Mg/mL and Timolol (as Timolol Maleate) 5 Mg/mL Eye Drops” NCT03966560 ↗2“Dorzolamide hydrochloride 1%/Timolol maleate 0.5% ophthalmic solution” NCT02325518 ↗ “Cosopt (dorzolamide hydrochloride and timolol maleate)” NCT00440336 ↗ |
| Known as | Dorzolamide hydrochloride component of cosopt | ChEMBL registry synonym — accepted as the source's own label CHEMBL218490 ↗ |
| Known as | Dorzolamide, trans-(-)- | ChEMBL registry synonym — accepted as the source's own label CHEMBL218490 ↗ |
| Known as | Dorzolamide/timolol Maleate Fixed Combination | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01471158 ↗ |
| Known as | MK-507 | ChEMBL registry synonym — accepted as the source's own label CHEMBL218490 ↗ |
| Known as | Trusopt | “The topical carbonic anhydrase inhibitor, Dorzolamide (Trusopt\*), has recently been approved for chronic use in the treatment of glaucoma.” NCT00815373 ↗4“reference product (Trusopt®) or test product (dorzolamide 2% eye drops, Rompharm Company SRL)” PMID 35909461 ↗ Jul 2022 “First Step: Alphagan (Brimonidine) Second Step: Dorzolamide (Trusopt)” NCT00440336 ↗ “Dorzolamide (2%, carbonic anhydrase inhibitor, Trusopt®” NCT00275756 ↗ “Trusopt” NCT01887223 ↗ |
| Action | Inhibit | “carbonic anhydrase inhibitor which reduces intraocular pressure (IOP) by decreasing the production of aqueous humour” NCT00152932 ↗1“Carbonic anhydrase II inhibitor” CHEMBL218490 ↗ |
| Modality | Small molecule | — CHEMBL218490 ↗ |
| Route | Topical | “topically applied Dorzolamide” NCT00152932 ↗ |
| Target | CA2 | “Carbonic anhydrase II inhibitor” CHEMBL218490 ↗ |