TheraRadar
Data updated: Jul 17, 2026

TRUSOPT (dorzolamide hydrochloride) · Merck

Ophthalmology Approved 1994-12-09

TRUSOPT is FDA-approved to treat 2 conditions (same as DORZOLAMIDE HYDROCHLORIDE).

2
Indications
--
Phase 3 Trials
2
Priority Reviews
31
Years on Market

Details

Status
Discontinued
First Approved
1994-12-09
Routes
OPHTHALMIC
Dosage Forms
SOLUTION/DROPS

Companies

Active Ingredient: DORZOLAMIDE HYDROCHLORIDE

TRUSOPT Approval History

1995
1996
1997
1998
1999
2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
33 FDA actions from 1994 to 2020 · 1 indication expansions
Dec 2020 SUPPL
Label · Labeling
Feb 2014 SUPPL
Label · Labeling
Jun 2010 SUPPL
Label · Labeling

What TRUSOPT Treats

2 indications

TRUSOPT is approved for 2 conditions since its original approval in 1994. These indications span multiple therapeutic areas including oncology, immunology, and more.

Same approved indications as DORZOLAMIDE HYDROCHLORIDE (same active ingredient).

Source: FDA Label
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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

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.

TRUSOPT FDA Label Details

Indications & Usage

FDA Label (PDF)

TRUSOPT is FDA-approved to treat 2 conditions — same approved indications as DORZOLAMIDE HYDROCHLORIDE.

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Data Sources

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