Drugs / Brimonidine
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Brimonidine

Developed for
open-angle glaucoma · glaucoma · ocular hypertension · rosacea · presbyopia · ocular hyperemia · diabetic retinopathy · ptosis
+25 more · age-related macular degeneration · conjunctivitis · dry eye syndrome · hand-foot syndrome · angle-closure glaucoma · borderline glaucoma · capillary malformation · chemotherapy-induced neuropathy · conjunctival disorder · corneal edema · diffuse secondary choroid atrophy · ectropion · entropion · exfoliation syndrome · eye allergy · flushing of ears and somnolence · graft versus host disease · intraoperative floppy iris syndrome · low tension glaucoma · macular degeneration · myopia · retinitis pigmentosa · rhegmatogenous retinal detachment · telangiectasis · vascular disorder
Investigated by
Allergan · Galderma R&D · LENZ Therapeutics, Inc · Alcon Research · Bausch & Lomb Incorporated · ORA, Inc.
+56 more · Massachusetts Eye and Ear Infirmary · Ocugen · Tarian Pharma · University of Sao Paulo · Corxel Pharmaceuticals · Medical University of Vienna · Optall Vision · Padagis LLC · Uptown Eye Specialists · Wake Forest University Health Sciences · AbbVie · Actavis Inc. · Afyon Kocatepe University Hospital · BCN Peptides · Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma · Biogen · Canadian Glaucoma Clinical Research Council · Carmel Medical Center · Chicago Center for Vision Research · Chittagong Medical College · Credit Valley EyeCare · Denver Health and Hospital Authority · Derm Research, PLLC · Duke University · Eurotrials Brasil Consultores Cientificos Ltda · Eye Therapies, LLC · Fayoum University · Fundação de Apoio ao Ensino Pesquisa e Assitência do HCFMRPUSP · Galderma Brasil Ltda. · Heinrich-Heine University, Duesseldorf · Hermann Eye Center · Indiana University · Innovative Medical · Insight Eyecare Specialties, Inc. dba Vision Source Eyecare, · Istanbul Training and Research Hospital · Kukje Pharma · Laboratorios Sophia S.A de C.V. · Nanduri, Padma, M.D., FACS · Novartis Pharmaceuticals · Prairie Eye Center · Rabin Medical Center · Sengi · Sheba Medical Center · Sun Pharma Advanced Research Company Limited · Sun Yat-sen University · Tecnoquimicas · The Hospital for Sick Children · Tulane University · University Health Network, Toronto · University of California, Los Angeles · University of California, San Francisco · University of Louisville · University of Parma · Watson Laboratories, Inc. · Zagazig University · Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.

Regulatory milestones approvals, filings & regulatory actions · 3 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved EU (EMA) Mirvaso — 2014-02-20 europa.eu ↗
Label expansion US (FDA) ALPHAGAN — 2001-12-20 fda.gov ↗
Approved US (FDA) ALPHAGAN — 1996-09-06 fda.gov ↗

Trials 110 · started per year

today
US approved 1996
EU approved 2014
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PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 03 trials · 1 met primary
Phase 0 NCT06730516 Jun → Sep 2024 glaucoma Zagazig University Completed No outcome recorded
Phase 0 NCT03825081 Jan → Sep 2019 presbyopia Massachusetts Eye and Ear Infirmary Unknown No outcome recorded
Phase 0 NCT03497442 Jul 2018 → Mar 2019 alcohol-related disorders, flushing of ears and somnolence University of California, San Francisco Completed Met primary
Phase 18 trials
Phase 1 NCT06270030 Mar → Apr 2024 presbyopia Corxel Pharmaceuticals Completed No outcome recorded
Phase 1 NCT05936489 Jul → Oct 2023 presbyopia LENZ Therapeutics, Inc Completed No outcome recorded
Phase 1 NCT05006911 Aug → Sep 2021 presbyopia Optall Vision Unknown No outcome recorded
Phase 1 NCT05006898 Jun → Jul 2020 presbyopia Optall Vision Completed No outcome recorded
Phase 1 NCT02967614 Dec 2016 → Dec 2017 glaucoma, ocular hypertension Kukje Pharma Completed No outcome recorded
Phase 1 NCT03139708 Sep 2016 → Oct 2017 — Wake Forest University Health Sciences Completed No outcome recorded
Phase 1 NCT02039765 Feb → Mar 2014 ocular hyperemia Bausch & Lomb Incorporated Completed No outcome recorded
Phase 1 NCT01229410 Dec 2010 → May 2011 — Allergan Completed No outcome recorded
Phase 1/21 trial
Phase 1/2 NCT00661479 Jul 2008 → Dec 2009 retinitis pigmentosa Allergan Completed No outcome recorded
Phase 227 trials · 4 met primary · 1 missed
Phase 2 NCT07457671 Mar 2026 → Mar 2027 expected hand-foot syndrome Tarian Pharma Not yet recruiting No outcome recorded
Phase 2 NCT07082764 Sep 2025 → Sep 2026 overdue chemotherapy-induced neuropathy Tarian Pharma Not yet recruiting No outcome recorded
Phase 2 NCT06948357 Mar → Sep 2025 overdue presbyopia Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd. Recruiting No outcome recorded
Phase 2 NCT06818058 Jan 2025 → Sep 2026 overdue — Tarian Pharma Recruiting No outcome recorded
Phase 2 NCT06365853 Jul 2024 → Jun 2026 overdue ovarian cancer AbbVie Recruiting No outcome recorded
Phase 2 NCT05431543 Aug → Dec 2022 presbyopia LENZ Therapeutics, Inc Completed Met primary
Phase 2 NCT05294328 May → Aug 2022 presbyopia LENZ Therapeutics, Inc Completed Met primary
Phase 2 NCT03760185 Jan 2019 → Sep 2020 intraoperative floppy iris syndrome Denver Health and Hospital Authority Completed No outcome recorded
Phase 2 NCT04205201 Jun 2018 → Sep 2019 — Chittagong Medical College Completed No outcome recorded
Phase 2 NCT03418727 Sep 2017 → Mar 2018 dry eye syndrome Ocugen Completed No outcome recorded
Phase 2/31 trial
Phase 2/3 NCT01726075 Feb 2013 → Nov 2015 diabetic retinopathy BCN Peptides Completed No outcome recorded
Phase 329 trials · 9 met primary · 1 missed
Phase 3 NCT06045299 Sep 2023 → Aug 2024 presbyopia Corxel Pharmaceuticals Completed No outcome recorded
Phase 3 NCT05815758 Apr → Sep 2023 eye allergy Bausch & Lomb Incorporated Completed No outcome recorded
Phase 3 NCT05728944 Mar → Dec 2023 presbyopia LENZ Therapeutics, Inc Completed Met primary
Phase 3 NCT05753189 Feb 2023 → Feb 2024 presbyopia LENZ Therapeutics, Inc Completed No outcome recorded
Phase 3 NCT05656027 Dec 2022 → Dec 2023 presbyopia LENZ Therapeutics, Inc Completed Met primary
Phase 3 NCT05591755 Nov 2022 → Aug 2023 conjunctivitis Bausch & Lomb Incorporated Completed No outcome recorded
Phase 3 NCT05579730 Oct 2022 → Jul 2023 conjunctivitis Bausch & Lomb Incorporated Completed No outcome recorded
Phase 3 NCT05360784 May → Nov 2022 ocular hyperemia Bausch & Lomb Incorporated Completed Met primary
Phase 3 NCT04944290 May 2021 → Mar 2022 ocular hypertension, open-angle glaucoma Padagis LLC Completed No outcome recorded
Phase 3 NCT03591874 Dec 2018 → Apr 2020 eye adnexa disorder, graft versus host disease Ocugen Terminated No outcome recorded
Phase 431 trials · 2 met primary
Phase 4 NCT07390578 Dec 2026 → Aug 2027 expected ptosis Duke University Not yet recruiting No outcome recorded
Phase 4 NCT04007276 Nov 2026 → Jun 2031 expected open-angle glaucoma, ptosis Tulane University Not yet recruiting No outcome recorded
Phase 4 NCT07690397 Jun 2026 → Jul 2027 expected ocular hypertension, open-angle glaucoma Tecnoquimicas Active not recruiting No outcome recorded
Phase 4 NCT07209410 Nov 2025 → Dec 2026 expected glaucoma Insight Eyecare Specialties, Inc. dba Vision Source Eyecare, Recruiting No outcome recorded
Phase 4 NCT06883123 May 2025 → Apr 2026 overdue open-angle glaucoma Prairie Eye Center Recruiting No outcome recorded
Phase 4 NCT07431476 May → Aug 2025 rosacea Istanbul Training and Research Hospital Completed No outcome recorded
Phase 4 NCT05480098 May 2022 → May 2024 ectropion, entropion, ptosis University of Louisville Withdrawn No outcome recorded Stop: Enrollment
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 NCT05474716 May 2020 → Dec 2021 ocular vascular disorder, open-angle glaucoma Fayoum University Completed No outcome recorded
Phase 4 NCT03959176 Jul 2019 ocular hypertension Wake Forest University Health Sciences Completed No outcome recorded
Phase not applicable10 trials · 1 met primary
— NCT04683159 Feb → Jul 2021 pterygium Uptown Eye Specialists Unknown No outcome recorded
— NCT04296916 Apr 2020 → Oct 2024 borderline glaucoma, myopia Sun Yat-sen University Unknown No outcome recorded
— NCT04633954 Jun → Aug 2019 cataract, conjunctival disorder Uptown Eye Specialists Completed No outcome recorded
— NCT03220490 Nov 2017 → Nov 2022 glaucoma Sheba Medical Center Unknown No outcome recorded
— NCT01105065 Mar 2010 → Sep 2012 glaucoma Massachusetts Eye and Ear Infirmary Completed Met primary
— NCT00824824 Jan 2009 → Aug 2012 glaucoma Massachusetts Eye and Ear Infirmary Completed No outcome recorded
— NCT00275756 Sep 2008 → Nov 2014 glaucoma Medical University of Vienna Withdrawn No outcome recorded
— NCT00435058 Sep 2005 → Apr 2006 glaucoma University of Sao Paulo Completed No outcome recorded
— NCT00352807 Feb → Dec 2005 cataract Indiana University Completed 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 therapy52 trials
Phase 0 NCT01144494 Comparator Aug 2010 → Oct 2011 ocular hypertension University of Nebraska Completed No outcome recorded
Phase 1 NCT05001243 Comparator Aug 2021 presbyopia Optall Vision Unknown No outcome recorded
Phase 1 NCT01687426 Comparator Sep → Dec 2012 open-angle glaucoma Eye Therapies, LLC Completed No outcome recorded
Phase 1/2 NCT02975557 Comparator May 2016 → Apr 2017 dry eye syndrome, graft versus host disease Sandeep Jain, MD Terminated No outcome recorded Stop: Enrollment
Phase 2 NCT06996236 Comparator Jul 2025 → Jul 2026 overdue myopia Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal Not yet recruiting No outcome recorded

News releases announcing trial results or a regulatory action · 15

DateIssuerRelease
2025-11-20 Sun Pharma Advanced Research Company Limited Regulatory SPARC announces Complete Response Letter Resubmission for PDP-716 NDA by Ocuvex sparc.life ↗
2024-08-27 Lupin Limited Regulatory Lupin Receives Approval from U.S. FDA for Brimonidine Tartrate Ophthalmic Solution, 0.1% lupin.com ↗
Lupin Limited (Lupin) today announced that it has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Brimonidine Tartrate Ophthalmic Solution, 0.1%, to market a generic equivalent of Alphagan® P Ophthalmic Solution, 0.1%, of AbbVie Inc.
2024-08-14 Lupin Limited Regulatory Lupin Receives Tentative Approval from U.S. FDA for Brimonidine Tartrate Ophthalmic Solution, 0.025% (OTC) lupin.com ↗
2023-10-01 Alembic Pharmaceuticals Ltd. Regulatory Press Release USFDA Products Approval for Qtr ended 30th September 2023 alembicpharmaceuticals.com ↗
Alembic Pharmaceuticals receives various US Food & Drug Administration (USFDA) product approvals during the quarter ended 30th September, 2023.
2023-03-01 Alembic Pharmaceuticals Ltd. Regulatory 30th March, 2023, Vadodara, India alembicpharmaceuticals.com ↗
Alembic Pharmaceuticals Limited (Alembic) today announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Brimonidine Tartrate Ophthalmic Solution, 0.15%.
2022-10-18 LENZ Therapeutics, Inc Results LENZ Therapeutics Announces Positive Topline Data from Phase 2 INSIGHT Trial of LNZ100 and LNZ101 to Treat Presbyopia lenz-tx.com ↗
Both LNZ100 and LNZ101 maintained statistical significance of three-line or greater improvement compared to vehicle for all timepoints including the last measured at 10 hours, 37% and 48% respectively.
2021-05-14 Sun Pharma Advanced Research Company Limited Results SPARC Announces Positive Top-line Results from Pivotal Phase 3 Clinical Trial of PDP-716 for the Treatment of Open Angle Glaucoma or Ocular Hypertension Met Pre-specified Primary Endpoint sparc.life ↗
Equivalence in intraocular pressure was demonstrated across all 9 required timepoints, showing that the 2 formulations of brimonidine are functionally equivalent.
2018-05-02 Ocugen Results Ocugen Presents Preclinical Efficacy Data of its Proprietary Nanoemulsion Technology at ARVO 2018 ocugen.com ↗
The results highlight superior (statistically significant) efficacy of OCU300 in a surrogate mouse model of ocular graft versus host disease (oGVHD), as compared to placebo, untreated control, and marketed brimonidine.
2018-03-20 Ocugen Results Ocugen Reports Positive Phase 2 Clinical Results Demonstrating Proof-of-Concept for its Novel Combination Therapy for Dry Eye Disease ocugen.com ↗
The randomized, multi-center, double-blinded, placebo-controlled study met its primary endpoint of tolerability over a 12-week period.
2017-09-25 Ocugen Regulatory Ocugen Announces FDA Acceptance of Investigational New Drug Application for OCU310 (brimonidine/steroid combination therapy) and Initiates Proof of Concept Study for Treatment of Dry Eye Disease ocugen.com ↗
the U.S. Food and Drug Administration (FDA) accepted its Investigational New Drug (IND) application for OCU310 (brimonidine/steroid combination therapy), a topical formulation for the treatment of dry eye disease (DED).
2017-08-09 Ocugen Regulatory Ocugen Receives FDA Orphan Drug Designation for OCU300 (brimonidine tartrate) for the Treatment of Ocular Graft Versus Host Disease ocugen.com ↗
We are very excited to receive the first ever orphan drug designation by the FDA for oGVHD, emphasizing the unmet medical need for patients with this disease.
2017-08-04 Perrigo Company Regulatory Perrigo Announces Tentative FDA Approval For Generic Version Of Mirvaso® Gel perrigo.com ↗
Perrigo Company plc (NYSE; TASE: PRGO) today announced it has received tentative approval from the U.S. Food and Drug Administration for the generic version of Mirvaso ® (brimonidine) topical gel 0.33%.

All press releases naming this drug 17 releases

DateIssuerRelease

Evidence & citations 16 cited values

Every value below carries the sentence it was read from. 167 sources stand behind the page.

FieldValueCited text
Known as brimonidine “Mirvaso® (brimonidine) topical gel, 0.33% is an alpha adrenergic agonist indicated for the topical treatment of persistent facial erythema of rosacea in adults 18 years of age or older.” NCT03508869 ↗
136

“a topical alpha agonist eye drop. (brimonidine 0.1% 1 gtts in study eye TID OR brimonidine 0.15% 1 gtts in study eye TID)” NCT01535768 ↗

“Safety Extension Study to Evaluate the Biodegradation of the Brimonidine Tartrate Posterior Segment Drug Delivery System” NCT01080209 ↗

“Each patient will receive the active TAR-0520 gel containing 1.5% of Brimonidine tartrate.” NCT07457671 ↗

“Brimonidine tartrate ophthalmic solution 0.025% with sodium hyaluronate (BTOS-HA)” NCT06803654 ↗

“Brimonidine Tartrate Ophthalmic Solution, 0.15% (Alphagan-P), an alpha 2 agonist” NCT00121147 ↗

“Brimonidine tartrate 2.0mg, Timolol maleate 6.8mg(without preservative)” NCT06078592 ↗

“Compare also to timolol/brimonidine/dorzolamide/bimatoprost” NCT06369077 ↗

“Brimonidine was instilled in the other eye.” NCT05006898 ↗

“brinzolamide and brimonidine tartrate” NCT06883123 ↗

“Brimonidine , Timolol” NCT02967614 ↗

Show 126 more sources

Known as Alphagan “first "Brimonidine", "Alphagan®" (an alpha-agonist) followed by "Timolol", "Tiloptic®" (a beta-blocker).” NCT03220490 ↗
8

“In one group of 10 participants the left eyes will receive Alphagan prior to Tropicamide/phenylephrine.” NCT03139708 ↗

“Brimonidine 0.2 % (Alphagan, Irvine, CA, USA), dose: 1 drop per eye” NCT00712777 ↗

“Brimonidine (0.2%. alpha-2 adrenergic agonist, Alphagan®” NCT00275756 ↗

“Eyes receiving Brimonidine 0.1% (Alphagan) prior to SLT” NCT00567411 ↗

“Brimonidine(Alphagan)and Latanoprost(Xalatan) eye drops” NCT00402493 ↗

“alphagan 0.2% or alphagan-P 0.15% will be added.” NCT04296916 ↗

“Alphagan” NCT01887223 ↗

NCT00698945 ↗

Known as ALPHAGAN (brimonidine tartrate 0.2%) Allergan Pharm. Ltd “ALPHAGAN (brimonidine tartrate 0.2%) Allergan Pharm. Ltd” NCT03192826 ↗
Known as Alphagan P “OBJECTIVE: To compare the safety and intraocular pressure (IOP)-lowering effects of brimonidine-purite 0.1% with the marketed formulation of brimonidine-purite 0.15% (Alphagan...” PMID 18534052 ↗ Jun 2008
3

“Patients will be randomly assigned based on a pre-determined allocation sequence to receive topical brimonidine tartrate 0.15% (Alphagan® P; Allergan, Inc) during either the...” NCT03513172 ↗

“The purpose of this study is to test the use of a well-known eye medication (normally for treating glaucoma) called Brimonidine tartrate 0.15% (or Alphagan-P) in patients...” NCT04633954 ↗

“Brimonidine Tartrate Ophthalmic Solution, 0.15% (Alphagan-P), an alpha 2 agonist” NCT00121147 ↗

Known as Brimo DDS “Brimonidine Drug Delivery System (Brimo DDS), a biodegradable intravitreal implant” PMID 32134802 ↗ Jan 2021
Known as Brimonidine Drug Delivery System “Brimonidine Drug Delivery System (Brimo DDS), a biodegradable intravitreal implant” PMID 32134802 ↗ Jan 2021
Known as brimonidine purite “To evaluate the efficacy and tolerability of brimonidine purite 0.1% in comparison to brinzolamide 1% when used as adjunctive therapy to latanoprost 0.005% in patients with...” PMID 18402717 ↗ Apr 2008
Known as Brimonidine tartarate “Drug: Brimonidine tartarate” NCT00864838 ↗
Known as Brimonidine Tartrate “The purpose of this study is to test the use of a well-known eye medication (normally for treating glaucoma) called Brimonidine tartrate 0.15% (or Alphagan-P) in patients...” NCT04633954 ↗
29

“The purpose of this study is to evaluate the safety and efficacy of brimonidine tartrate 0.025% ophthalmic solution used four times daily in a population of adult and geriatric subjects” NCT01675609 ↗

“the alpha2-adrenergic agonist brimonidine tartrate 0.2% to the beta-adrenergic antagonist timolol maleate 0.5% in preserving visual function in low-pressure glaucoma.” PMID 21257146 ↗ Jan 2011

“One drop of brimonidine tartrate ophthalmic solution (Alphagan®) administered to the affected eye(s) twice daily (morning and evening) for four weeks.” NCT01229462 ↗

“Brimonidine tartrate has a vasoconstrictive effect, which helps to reduce the amount of blood flow and hyperemia to the eye.” NCT04683159 ↗

“Safety Extension Study to Evaluate the Biodegradation of the Brimonidine Tartrate Posterior Segment Drug Delivery System” NCT01080209 ↗

“0.15% Brimonidine Tartrate (Alphagan® P) 1 drop in the affected eye 3 times daily for 3 months.” NCT02003534 ↗

“Brimonidine Tartrate Ophthalmic Solution, 0.15% (Alphagan-P), an alpha 2 agonist” NCT00121147 ↗

“Brimonidine tartrate 2mg/mL One drop/eye administered twice a day.” NCT01726075 ↗

“brimonidine tartrate ophthalmic solution 0.2% in each eye” NCT01863953 ↗

“Brimonidine tartrate ophthalmic solution 0.025%” NCT03782701 ↗

Show 19 more sources

Known as Brimonidine Tartrate PS DDS “Brimonidine Tartrate PS DDS®” NCT01229410 ↗
Known as BTOS-PF 0.025% “A BAK-free formulation of LUMIFY 0.025% (BTOS-PF 0.025%) could offer a solution for BAK-sensitive patients.” PMID 40711722 ↗ Jul 2025
Known as CD07805/47 ClinicalTrials.gov intervention name — accepted as the source's own label NCT01355471 ↗
8

NCT01355458 ↗

NCT01882712 ↗

NCT01174030 ↗

NCT02300129 ↗

NCT00989014 ↗

NCT01659853 ↗

NCT01789775 ↗

NCT01318733 ↗

Known as Lumify “Lumify® (brimonidine tartrate ophthalmic solution 0.025%). Participants will instill 1 drop of the assigned investigational drug in each eye 4 times a day approximately 4 hours...” NCT05360784 ↗
2

“Patients experiencing hyperemia greater than grade 2 on Efron scale will receive brimonidine tartrate (Lumify).” NCT07209410 ↗

“Brimonidine 0.025% (Lumify)” NCT07390578 ↗

Known as Mirvaso “Reference Product Mirvaso® (Brimonidine) Topical Gel, 0.33% (Galderma Laboratories, L.P., USA)” NCT02289352 ↗
1

NCT03508869 ↗

Action Activate “Brimonidine Tartrate Ophthalmic Solution, 0.15% (Alphagan-P), an alpha 2 agonist” NCT00121147 ↗
Route Topical “dose: 1 drop in one eye twice daily for two weeks” NCT00275756 ↗