TheraRadar
Data updated: Jun 17, 2026

VIROPTIC (trifluridine)

Nucleic Acid Synthesis Inhibitors
Infectious Disease Approved 1980-04-10

VIROPTIC is indicated for the treatment of Keratoconjunctivitis; Epithelial Keratitis.

Source: FDA Label • MONARCH PHARMS
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
1
Priority Reviews
46
Years on Market

Details

Status
Prescription
First Approved
1980-04-10
Routes
OPHTHALMIC
Dosage Forms
SOLUTION/DROPS

Companies

MONARCH PHARMS
Active Ingredient: TRIFLURIDINE

VIROPTIC Approval History

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Original
New Indication
New Form
Label Update
15 FDA actions from 1980 to 2018
Mar 2018 SUPPL
Mfg · Manufacturing (CMC)
Feb 2002 SUPPL
Label · Labeling
FDA Letter
Oct 1997 SUPPL
Label · Labeling

What VIROPTIC Treats

2 indications

VIROPTIC is approved for 2 conditions since its original approval in 1980. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Keratoconjunctivitis
  • Epithelial Keratitis
Source: FDA Label
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Clinical Trial Registry

2 trials
Trial Sponsor ID Phase Status Title
NCT01867866 TPU-TAS-102-102 Ph 1 completed Study Comparing the Pharmacokinetics of FTD as a Component of TAS-102 With FTD Alone
NCT04854434 results posted XPORT-CRC-041 Ph 2 terminated A Study to Evaluate the Safety and Efficacy of Selinexor With or Without Pembrolizumab Versus Standard of Care in Previously Treated Metastatic Colorectal Cancer With RAS Mutations
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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.

VIROPTIC FDA Label Details

Indications & Usage

VIROPTIC is indicated for the treatment of Keratoconjunctivitis; Epithelial Keratitis.

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Data Sources

FDA Approval: NDA018299 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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