Clinical Trials

Netarsudil (AR-13324) has been evaluated across numerous clinical trials ranging from Early Phase 1 to Phase 4, primarily targeting open-angle glaucoma and ocular hypertension, alongside secondary conditions such as normal tension glaucoma, proliferative vitreoretinopathy, and Fuchs' endothelial dystrophy. Conducted by both industry sponsors, such as Aerie Pharmaceuticals and Alcon Research, and academic institutions including the Mayo Clinic and Massachusetts Eye and Ear Infirmary, these studies reflect diverse recruitment statuses ranging from actively recruiting and completed to not yet recruiting, active not recruiting, or terminated.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07588152 RECRUITING
Glaucoma; Ocular Hypertension
Indiana University
2026-06-05 PHASE4
NCT07325240 RECRUITING
Open Angle Glaucoma; Ocular Hypertension
Mayo Clinic
2025-11-21 PHASE4
NCT07465913 RECRUITING
Glaucoma
Eye Centers of Southeast Texas
2026-05-14 PHASE4
NCT04401982 RECRUITING
Ocular Hypertension; Suspect Glaucoma
University of Maryland, Baltimore
2026-07-02 PHASE4
NCT07048886 NOT_YET_RECRUITING
Primary Open Angle Glaucoma
Center for Sight Las Vegas
2025-07-15 PHASE4
NCT07209410 RECRUITING
Glaucoma
Insight Eyecare Specialties, Inc. dba Vision Source Eyecare,
2025-11-01 PHASE4
NCT06033703 RECRUITING
Rhegmatogenous Retinal Detachment; Proliferative Vitreoretinopathy
Massachusetts Eye and Ear Infirmary
2025-01-14 PHASE1; PHASE2
NCT06865144 ACTIVE_NOT_RECRUITING
Primary Open Angle Glaucoma or Ocular Hypertension
East Coast Institute for Research
2025-06-27 PHASE4
NCT07082816 COMPLETED
Ocular Hypertension; Open Angle Glaucoma
Alcon Research
2025-09-02 PHASE3
NCT06960629 COMPLETED
Pseudophakic Bullous Keratopathy; Glaucoma
University Hospital Dubrava
2025-01-01 PHASE2; PHASE3
NCT06441643 COMPLETED
Open Angle Glaucoma; Ocular Hypertension
Alcon Research
2024-09-04 PHASE2
NCT06449352 COMPLETED
Normal Tension Glaucoma
Westlake Eye Specialists
2024-06-13 PHASE4
NCT05660447 UNKNOWN
Rhegmatogenous Retinal Detachment; Proliferative Vitreoretinopathy
Wills Eye
2023-02-06 PHASE2; PHASE3
NCT06394973 COMPLETED
Glaucoma; Ocular Hypertension
Laboratoires Thea
2024-08-05 PHASE2
NCT06033703 Not yet recruiting
Rhegmatogenous Retinal Detachment|Proliferative Vitreoretinopathy
Massachusetts Eye and Ear Infirmary
2024-02 Phase 1|Phase 2
NCT04752020 COMPLETED
Fuchs' Endothelial Dystrophy
Massachusetts Eye and Ear Infirmary
2021-03-28 EARLY_PHASE1
NCT05283395 COMPLETED
Glaucoma
Aerie Pharmaceuticals
2022-03-28 PHASE4
NCT04064918 WITHDRAWN
OAG - Open-Angle Glaucoma; OHT - Ocular Hypertension
University of California, San Diego
2021-12
NCT04981886 UNKNOWN
Normal Tension Glaucoma
Salus University
2021-08 PHASE4
NCT03971357 TERMINATED
Fuchs' Endothelial Dystrophy
Price Vision Group
2019-07-22 PHASE2; PHASE3
NCT04498169 COMPLETED
Corneal Edema
Aerie Pharmaceuticals
2020-09-17 PHASE2
NCT04620135 COMPLETED
Primary Open Angle Glaucoma; Ocular Hypertension
Aerie Pharmaceuticals
2020-11-30 PHASE3
NCT04234932 UNKNOWN
Glaucoma, Open-Angle
University of the Incarnate Word
2020-01-06 EARLY_PHASE1
NCT04057053 COMPLETED
Fuchs' Endothelial Dystrophy; Cataract
Massachusetts Eye and Ear Infirmary
2018-10-02 EARLY_PHASE1
NCT03284853 COMPLETED
Open Angle Glaucoma; Ocular Hypertension
Aerie Pharmaceuticals
2017-09-05 PHASE3
NCT04051463 COMPLETED
Fuchs Endothelial Dystrophy
Price Vision Group
2019-08-05 PHASE2; PHASE3
NCT03844945 COMPLETED
Open Angle Glaucoma; Ocular Hypertension
Aerie Pharmaceuticals
2019-03-19 PHASE2
NCT03808688 COMPLETED
Glaucoma, Open-Angle; Ocular Hypertension
Aerie Pharmaceuticals
2018-12-27 PHASE4
NCT03248037 COMPLETED
Fuchs' Endothelial Dystrophy; Bullous Keratopathy
Cornea Research Foundation of America
2017-09-05 PHASE3
NCT03310580 COMPLETED
Primary Open Angle Glaucoma or Ocular Hypertension
Aerie Pharmaceuticals
2017-11-15 PHASE2
NCT03233308 COMPLETED
Primary Open Angle Glaucoma or Ocular Hypertension
Aerie Pharmaceuticals
2017-10-20 PHASE2
NCT02558400 COMPLETED
Open-angle Glaucoma; Ocular Hypertension
Aerie Pharmaceuticals
2015-09-18 PHASE3
NCT02674854 COMPLETED
Open-angle Glaucoma; Ocular Hypertension
Aerie Pharmaceuticals
2016-02 PHASE3
NCT02246764 COMPLETED
Ocular Hypertension; Glaucoma
Aerie Pharmaceuticals
2014-09 PHASE3
NCT02558374 COMPLETED
Open-angle Glaucoma; Ocular Hypertension
Aerie Pharmaceuticals
2015-09 PHASE3
NCT02874846 COMPLETED
Ocular Hypertension; Open Angle Glaucoma
Aerie Pharmaceuticals
2016-07 PHASE2
NCT02406287 COMPLETED
Healthy Subjects
Aerie Pharmaceuticals
2015-04 PHASE1
NCT02207621 COMPLETED
Ocular Hypertension; Open-angle Glaucoma
Aerie Pharmaceuticals
2014-07 PHASE3
NCT02207491 COMPLETED
Ocular Hypertension; Open-angle Glaucoma
Aerie Pharmaceuticals
2014-07 PHASE3
NCT02057575 COMPLETED
Open Angle Glaucoma; Ocular Hypertension
Aerie Pharmaceuticals
2014-01 PHASE2
NCT01997879 COMPLETED
Healthy
Aerie Pharmaceuticals
2013-11 PHASE1
NCT01731002 COMPLETED
Ocular Hypertension; Open Angle Glaucoma
Aerie Pharmaceuticals
2012-11 PHASE2
NCT01528787 COMPLETED
Ocular Hypertension; Open Angle Glaucoma
Aerie Pharmaceuticals
2012-03 PHASE2

(data from https://clinicaltrials.gov, updated on 2026-06-11)

Check the Netarsudil (AR-13324) 2HCl product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Netarsudil functions as a potent Rho-associated protein kinase (ROCK) inhibitor that disrupts downstream phosphorylation pathways regulating actin cytoskeleton assembly in trabecular meshwork cells. This inhibition promotes cytoskeletal relaxation and enhances trabecular outflow facility, culminating in the reduction of elevated intraocular pressure associated with open-angle glaucoma and ocular hypertension.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

Note: Technical data last updated: Sep 1, 2026.