TheraRadar
Data updated: May 26, 2026

MYDRIACYL (tropicamide)

Cholinergic Antagonists Trial Activity: Mature
Ophthalmology Approved 1960-02-23

MYDRIACYL is indicated for the treatment of Mydriasis; Cycloplegia.

Source: FDA Label • Novartis

Development Insights

Wake Forest University Health Sciences conducting 2 trials (50%)
3 indications explored (Focused)
intraocular pressure (2 trials)
anisocoria (1 trials)
cycloplegia (1 trials)
2
Indications
--
Phase 3 Trials
66
Years on Market

Details

Status
Discontinued
First Approved
1960-02-23
Routes
OPHTHALMIC
Dosage Forms
SOLUTION/DROPS

Companies

Active Ingredient: TROPICAMIDE

MYDRIACYL Approval History

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Original
New Indication
New Form
Label Update
53 FDA actions from 1960 to 2021
Aug 2021 SUPPL
Label · Labeling
Oct 2003 SUPPL
Label · Labeling
Dec 2002 SUPPL
Mfg · Manufacturing (CMC)

What MYDRIACYL Treats

2 indications

MYDRIACYL is approved for 2 conditions since its original approval in 1960. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Mydriasis
  • Cycloplegia
Source: FDA Label

MYDRIACYL 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.

Drugs Similar to MYDRIACYL

3 of 6

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

AKPENTOLATE
CYCLOPENTOLATE HYDROCHLORIDE
2 shared
RISING
Shared indications:
MydriasisCycloplegia
CYCLOGYL
CYCLOPENTOLATE HYDROCHLORIDE
2 shared
Novartis
Shared indications:
MydriasisCycloplegia
ISOPTO ATROPINE
ATROPINE SULFATE
2 shared
Novartis
Shared indications:
MydriasisCycloplegia
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Clinical Trial Registry

4 trials
Trial Sponsor ID Phase Status Title
NCT03959176 results posted IRB00058366 Ph 4 completed The Effect of Brimonidine
NCT05238233 results posted 1864081 Ph 4 completed Wearing-Off Period of Pharmacological Dilation and Anisocoria
NCT05442801 Cycloplegic Refraction Ph 4 completed Cycloplegic Refraction Among Children
NCT03139708 IRB00039213 Ph 1 completed The Effect of Brimonidine on Intraocular Pressure When Dilating Routine Patients
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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.

MYDRIACYL FDA Label Details

Indications & Usage

MYDRIACYL is indicated for the treatment of Mydriasis; Cycloplegia.

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Data Sources

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