TRIFLURIDINE · Novartis
: Trifluridine Ophthalmic Solution is indicated for the treatment of primary keratoconjunctivitis and recurrent epithelial keratitis due to herpes simplex virus, types 1 and 2.
Details
- Status
- Prescription
- First Approved
- 1980-04-10
- Routes
- OPHTHALMIC
- Dosage Forms
- SOLUTION/DROPS
TRIFLURIDINE Approval History
What TRIFLURIDINE Treats
2 indicationsTRIFLURIDINE is approved for 2 conditions since its original approval in 1995. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Keratoconjunctivitis
- Epithelial Keratitis
Same approved indications as VIROPTIC (same active ingredient).
Novartis's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
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 |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
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.
TRIFLURIDINE FDA Label Details
Indications & Usage
: Trifluridine Ophthalmic Solution is indicated for the treatment of primary keratoconjunctivitis and recurrent epithelial keratitis due to herpes simplex virus, types 1 and 2.
Looking for the branded version?
VIROPTIC
Full clinical data, patents, trials, and competitive landscape for trifluridine.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.