Alphagan

(Brimonidine)

ApprovedSmall molecule

Brimonidine is used to treat high eye pressure in glaucoma patients and to reduce redness and flushing in the face caused by rosacea.[2] Alphagan is currently approved and in use across 15 indications[4].[1]

Alphagan is one of 317 small molecule programs targeting Eye Allergy. It is currently in Approved.

Indications

Total Trials

Active Trials

316

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Eye AllergyActive, not recruiting

MyopiaApproved

Capillary MalformationApproved

GlaucomaActive, not recruiting

Peripheral NeuropathyActive, not recruiting

RosaceaApproved

Eye DiseaseActive, not recruiting

ErythemaActive, not recruiting

Ocular HypertensionActive, not recruiting

PresbyopiaActive, not recruiting

Eye AllergyApproved

Active, not recruiting

MyopiaApproved

Approved

Capillary MalformationApproved

Approved

GlaucomaApproved

Active, not recruiting

Peripheral NeuropathyPhase 2

Active, not recruiting

RosaceaApproved

Approved

Eye DiseasePhase 2

Active, not recruiting

ErythemaPhase 3

Active, not recruiting

Ocular HypertensionPhase 3

Active, not recruiting

PresbyopiaPhase 3

Active, not recruiting

Showing 10 of 15 indications

Competition

Competitive Landscape

237 competitors in Age-Related Macular Degeneration

#DrugCompanyPhaseTrials

Eylea

Regeneron

Phase 3

44 2

Lucentis

Roche

Phase 3

64 3

Vabysmo

Roche

Phase 3

13 4

Beovu

Novartis

Phase 3

10 5

Alphagan

Novartis

Approved

1 6

Macugen

Pfizer

Phase 3

6 7

Avastin

BBio-Thera Solutions

Phase 3

18 8

Retaane

AAlcon Research

Phase 3

5 9

Forzinity

SStealth BioTherapeutics Inc.

Phase 3

2 10

Kenalog

BBausch Health Americas, Inc.

Phase 3

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 2Not yet recruiting

Peripheral Neuropathy

NCT07082764

Clinical

Trials by Indication[1]

Intraocular Pressure3 trials

Intraocular Pressure (IOP) Lowering Efficacy of Transdermal Brimonidine Therapy

Unknown status·NNanduri, Padma, M.D., FACS·Phase 2·NCT01345448·22 enrolled

Effects of Topical Clonidine vs. Brimonidine on Choroidal Blood Flow and Intraocular Pressure During Isometric Exercise

Completed·MMedical University of Vienna·Phase 4·NCT00312416·18 enrolled

Effectiveness of Oral Acetazolamide, Brimonidine Tartarate, and Anterior Chamber Paracentesis in Intraocular Pressure (IOP) After Bevacizumab

Completed·UUniversity of Sao Paulo·Phase 2·NCT00804921

Glaucoma3 trials

Brimonidine vs ALTP in Progressing Human Glaucoma

Completed·UUniversity of Parma·Phase 4·NCT00466479·50 enrolled

Effects of Common Topical Glaucoma Therapy on Optic Nerve Head Blood Flow Autoregulation During Increased Arterial Blood Pressure and Artificially Elevated Intraocular Pressure in Healthy Humans

Withdrawn·MMedical University of Vienna·N/A·NCT00275756

Effect of Antiglaucoma Agents on Short Term Intraocular Pressure Fluctuations After Intravitreal Bevacizumab Injection

Completed·MMashhad University of Medical Sciences·N/A·NCT02140450·70 enrolled

Ocular Hypertension1 trial

Safety and Efficacy of Brimonidine in Patients With Glaucoma or Ocular Hypertension

Completed· AbbVie logo

AbbVie·Phase 3·NCT00168363·207 enrolled

Inflammation1 trial

Topical Brimonidine to Reduce Inflammation After IPL-treatment in Patients With Facial Telangiectasias

Completed·MMerete Haedersdal·Phase 4·NCT02761174·19 enrolled

Erythema1 trial

Randomized, Double-blind, Multiple-site, Placebo-controlled, Parallel-design Study in Patients With Moderate to Severe Facial Erythema Associated With Rosacea

Completed·AActavis Inc.·Phase 3·NCT02289352·462 enrolled

12 more indications

Diabetic Retinopathy1 trial

Trial to Assess the Efficacy of Neuroprotective Drugs Administered Topically to Prevent or Arrest Diabetic Retinopathy

Completed·BBCN Peptides·Phase 2/3·NCT01726075·450 enrolled

Open-Angle Glaucoma1 trial

PRO-122 Versus Concomitant Therapy in Subjects With Uncontrolled Primary Open-angle Glaucoma (PRO-122LATAM)

Terminated·LLaboratorios Sophia S.A de C.V.·Phase 3·NCT03193333·51 enrolled

Peripheral Neuropathy1 trial

Safety and Efficacy Study of TAR-0520 Gel in Prevention of Taxane-induced Peripheral Neuropathy

Not yet recruiting·TTarian Pharma·Phase 2·NCT07082764·30 enrolled

Neuropathy1 trial

Safety and Effects of Brimonidine Intravitreal Implant in Patients With Glaucomatous Optic Neuropathy

Completed· AbbVie logo

AbbVie·Phase 2·NCT00693485·70 enrolled

Age-Related Macular Degeneration1 trial

A Safety and Efficacy Study of Brimonidine Intravitreal Implant in Geographic Atrophy Secondary to Age-related Macular Degeneration

Terminated· AbbVie logo

AbbVie·Phase 2·NCT02087085·310 enrolled

Intraoperative1 trial

Brimonidine for Intraoperative Hemostasis

Withdrawn·UUniversity of Louisville·Phase 4·NCT05480098

Safety and Efficacy1 trial

Safety and Efficacy of Brimonidine Tartrate Posterior Segment Drug Delivery System in Improving Visual Function

Completed· AbbVie logo

AbbVie·Phase 2·NCT00972374·44 enrolled

Eye Disease1 trial

Dry Eye Disease Study With Brimonidine

Completed·OOcugen·Phase 2·NCT03418727·84 enrolled

GAN1 trial

Effect of Alphagan and Xalatan Eye Drops on Corneal Temperature

Completed·UUniversity Hospital, Basel, Switzerland·N/A·NCT01201551·40 enrolled

Indomethacin1 trial

INFLUENCE OF TOPICAL INDOMETHACIN ON HYPOTHENSIVE EFFECT OF BRIMONIDINE

Terminated·FFederal University of São Paulo·Phase 4·NCT00347035

Presbyopia1 trial

Phase 3 Evaluation of the Safety and Efficacy of LNZ100 & LNZ101 for the Treatment of Presbyopia

Completed·LLENZ Therapeutics, Inc·Phase 3·NCT05656027·469 enrolled

Unspecified4 trials

Mirvaso in Use Study

Completed·GGalderma R&D·Phase 4·NCT02249065·205 enrolled

Effect of Netarsudil vs Brimonidine in NTG Patients on Latanoprost

Completed·WWestlake Eye Specialists·Phase 4·NCT06449352·100 enrolled

The Effect of Brimonidine

Completed·WWake Forest University Health Sciences·Phase 4·NCT03959176·13 enrolled

Show 1 more trial

Aqueous Humor Dynamics and Brimonidine

Completed·UUniversity of Nebraska·Phase 1·NCT01144494·35 enrolled

Regulatory

FDA Approval Timeline[5]

Sep 6, 1996

ALPHAGAN

NDA NDA020613

Mar 13, 1997

ALPHAGAN

NDA NDA020490

Mar 16, 2001

ALPHAGAN P

NDA NDA021262

Aug 19, 2005

ALPHAGAN P

NDA NDA021770

May 22, 2006

QOLIANA

NDA NDA021764

Aug 23, 2013

MIRVASO

NDA NDA204708

Dec 22, 2017

LUMIFY

NDA NDA208144

Apr 19, 2024

LUMIFY PRESERVATIVE FREE

NDA NDA218424

Sources

References

[1]
ClinicalTrials.gov — 24 trial records for Brimonidine. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Alphagan drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Brimonidine compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Brimonidine. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA218424). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Alphagan. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Novartis company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Adrenergic Receptor Alpha-2 Agonist[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: Novartis

Patent Landscape[6]

Patent Cliff

Jul 27, 2029

Earliest patent expiration — generic entry possible after this date

Patent #Expires

11596600Jul 27, 2029

11833245Jul 27, 2029

9259425Jul 14, 2030

8293742Jul 14, 2030

9861631Mar 25, 2031

6 more patents

9861632Mar 25, 2031

8513249Mar 25, 2031

8513247Mar 25, 2031

10201517Jun 13, 2031

8163725Jun 13, 2031

8053427Jun 13, 2031

Alphagan

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q4 2026

Trials by Indication[1]

Intraocular Pressure3 trials

Glaucoma3 trials

Ocular Hypertension1 trial

Inflammation1 trial

Erythema1 trial

Diabetic Retinopathy1 trial

Open-Angle Glaucoma1 trial

Peripheral Neuropathy1 trial

Neuropathy1 trial

Age-Related Macular Degeneration1 trial

Intraoperative1 trial

Safety and Efficacy1 trial

Eye Disease1 trial

GAN1 trial

Indomethacin1 trial

Presbyopia1 trial

Unspecified4 trials

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Patent Landscape[6]

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