NDAOPHTHALMICSOLUTION/DROPSPriority Review
Approved
Apr 1980
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
3/8 — Basic
Priority Review
VIROPTIC (trifluridine) by Monarch Therapeutics is nucleic acid synthesis inhibitors [moa]. First approved in 1980.
Drug data last refreshed 10h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
VIROPTIC (trifluridine) is a nucleic acid synthesis inhibitor administered as an ophthalmic solution for treating viral eye infections, particularly herpes simplex keratitis. It works by inhibiting viral DNA synthesis, preventing replication of herpes simplex virus in corneal tissue. This is a mature, legacy antiviral indicated for localized ocular viral disease.
LOE Approaching
As LOE approaches, the brand team is likely consolidating and focusing on patient retention; significant headcount reduction and transition to generic support expected within 2–3 years.
Mechanism of Action
Nucleic Acid Synthesis Inhibitors
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
A Study to Access Intravenous (IV) Telisotuzumab Adizutecan in Combination With IV Bevacizumab Compared to Standard of Care IV Bevacizumabin Combination With Oral Trifluridine and Tipiracil in Adult Participants With Refractory Metastatic Colorectal Cancer
Started May 2026
700 enrolled
Colorectal Cancer
A Study of Precemtabart Tocentecan With or Without Bevacizumab Compared to Trifluridine/Tipiracil Plus Bevacizumab in Participants With Previously Treated Metastatic Colorectal Cancer (PROCEADE-CRC-03)
Started May 2026
1,020 enrolled
Metastatic Colorectal Cancer
Trifluridine/Tipiracil + Fruquintinib Versus Trifluridine/Tipiracil Alone for Metastatic Oeso-gastric Adenocarcinoma
Started Dec 2025
324 enrolled
Metastatic Oesogastric Adenocarcinoma
BETWEEN: Biweekly Bevacizumab + Trifluridine/Tipiracil to Reduce Grade 3-4 Neutropenia in mCRC Patients
Started Sep 2025
162 enrolled
Metastatic Colorectal Cancer
Phase 2, Single-arm Trial of BMS-986340 in Association With Nivolumab, Trifluridine/Tipiracil and Bevacizumab for Patients Refractory to Standard of Care Treatment and With Microsatellite-stable Colorectal Cancer
Started Aug 2025
7 enrolled
Microsatellite-stable Colorectal CancerStandard of CareNivolumab+1 more
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.