TheraRadar
Data updated: May 26, 2026

DORZOLAMIDE HYDROCHLORIDE

Ophthalmology Approved 2008-10-28

Dorzolamide hydrochloride helps patients with open-angle glaucoma or ocular hypertension by lowering elevated pressure within the eye. It is used to manage this pressure, which is a significant risk factor for damage to the optic nerve and loss of the visual field. This medication provides a way to reduce intraocular pressure through topical application.

Source: FDA Label • ZAMBON SPA

How DORZOLAMIDE HYDROCHLORIDE Works

This medication works by inhibiting carbonic anhydrase II, an enzyme in the eye that helps produce aqueous humor. By blocking this enzyme, the drug slows the formation of bicarbonate ions and reduces fluid transport, which ultimately lowers the pressure inside the eye.

13
Indications
--
Phase 3 Trials
17
Years on Market

Details

Status
Discontinued
First Approved
2008-10-28
Routes
OPHTHALMIC
Dosage Forms
SOLUTION/DROPS

DORZOLAMIDE HYDROCHLORIDE Approval History

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2026
Original
New Indication
New Form
Label Update
32 FDA actions from 2008 to 2025
Oct 2025 SUPPL
Label · Labeling
May 2025 SUPPL
Label · Labeling
Feb 2025 ORIGINAL
Update

What DORZOLAMIDE HYDROCHLORIDE Treats

2 indications

DORZOLAMIDE HYDROCHLORIDE is approved for 2 conditions since its original approval in 2008. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Ocular hypertension
  • Open-angle glaucoma
Source: FDA Label

DORZOLAMIDE HYDROCHLORIDE Competitive Set

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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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Active Pipeline

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Key Completed Trials

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Trial Timeline

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.

DORZOLAMIDE HYDROCHLORIDE FDA Label Details

Indications & Usage

FDA Label (PDF)

DORZOLAMIDE HYDROCHLORIDE is indicated for the treatment of Ocular hypertension; Open-angle glaucoma.

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Data Sources

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