TheraRadar
Data updated: May 26, 2026

NEPTAZANE (methazolamide)

Trial Activity: Mature
Ophthalmology Approved 1959-01-26
Jump to: Indications Approvals Trials Competitors Safety Patents

Development Insights

University of British Columbia conducting 2 trials (29%)
7 indications explored (Moderate)
→ mountain sickness (2 trials)
→ glaucoma (1 trials)
→ essential tremor (1 trials)
2
Indications
--
Phase 3 Trials
67
Years on Market

Details

Status
Discontinued
First Approved
1959-01-26
Routes
ORAL
Dosage Forms
TABLET

Companies

LEDERLE
Active Ingredient: METHAZOLAMIDE

NEPTAZANE Approval History

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Original
New Indication
New Form
Label Update
20 FDA actions from 1959 to 2009 · 1 indication expansions
Mar 2009 SUPPL
Label · Labeling
Jan 1999 SUPPL
Mfg · Manufacturing (CMC)
Nov 1992 SUPPL
Mfg · Manufacturing (CMC)

What NEPTAZANE Treats

2 FDA approvals

Originally approved for its first indication in 1959 . Covers 2 distinct patient populations.

  • Other (2)
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Clinical Trial Registry

7 trials
Trial Sponsor ID Phase Status Title
NCT02390284 STOP-RGCD results posted 20140587 R01EY014957 Ph 3 terminated Stop Retinal Ganglion Cell Dysfunction Study
NCT06312800 LeWitt02 Ph 2 withdrawn Acamprosate and Methazolamide for Essential Tremor
NCT02463357 results posted 15-0254 Ph 4 completed Three New Ideas to Protect Special Forces From the Stress of High Altitude
NCT02758470 H16-00896 Ph 4 completed Muscle Fatigue and Carbonic Anhydrase Inhibitors
NCT01587027 results posted GQ01 DARPA Ph 1 completed Safety Evaluation of Aminophylline and Methazolamide
NCT02760121 H16-00028 Ph 4 completed AZ, MZ, and the Pulmonary System Response to Hypoxia
NCT01702025 results posted N66001-10-C-2134 Ph 1, Ph 2 completed Rapid Acclimatization to Hypoxia at Altitude
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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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.

NEPTAZANE FDA Label Details

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Data Sources

FDA Approval: NDA011721 → Patents: FDA Orange Book → 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