TheraRadar
Data updated: Nov 8, 2026

NETARSUDIL MESYLATE (netarsudil) · GLAND PHARMA LTD

Trial Activity: Declining
Ophthalmology
FDA label not available. This product's label is not in FDA's label database (openFDA, DailyMed). Search DailyMed → · Drugs@FDA approval documents →
Jump to: Indications Approvals Trials Competitors Safety Patents

Development Insights

Westlake Eye Specialists conducting 1 trials (33%)
3 indications explored (Focused)
→ fuchs' endothelial dystrophy (2 trials)
→ normal tension glaucoma (1 trials)
→ bullous keratopathy (1 trials)

Details

Status
Prescription
First Approved
N/A
Routes
DROPS
Dosage Forms
SOLUTION

Companies

GLAND PHARMA LTD
Active Ingredient: NETARSUDIL

NETARSUDIL MESYLATE Approval History

No approval records found

NETARSUDIL MESYLATE Competitive Set

Pro

Three rings of competition based on shared molecular targets and treated indications.

MoA expansion candidates

1

Same target(s), different indications — where else is this mechanism being explored?

RHOPRESSA
Novartis
2017 2 indic.

Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

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Clinical Trial Registry

3 trials
Trial Sponsor ID Phase Status Title
NCT06449352 ZV-24-01 Ph 4 completed Effect of Netarsudil vs Brimonidine in NTG Patients on Latanoprost
NCT03971357 results posted 2018-009 Ph 2, Ph 3 terminated Trial of Netarsudil for Acceleration of Corneal Endothelial Restoration
NCT03248037 results posted 2017-003 Ph 3 completed Trial of Netarsudil for Prevention of Corticosteroid-induced Intraocular Pressure Elevation
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Active Pipeline

Pro

Ongoing clinical trials by development phase

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Key Completed Trials

Pro

Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

NETARSUDIL MESYLATE FDA Label Details

FDA label not available. This product's label is not in FDA's label database (openFDA, DailyMed). Search DailyMed → · Drugs@FDA approval documents →

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Data Sources

FDA Approval: ANDA216855 → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.

How We Calculate These Metrics

Trial Activity Stage

Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.

Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.

  • Growth: High proportion of early-phase trials (Phase 1/2), active development
  • Expansion: Significant Phase 3 activity, approaching or pursuing approvals
  • Mature: Substantial Phase 4 post-marketing studies
  • Stable: Mixed phase distribution, steady development
  • Declining: Low active trial ratio, reduced R&D investment