NDAORALTABLET
Approved
Sep 2015
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
7
Data completeness
7/8 — Comprehensive
LONSURF (trifluridine and tipiracil) by Taiho Oncology is nucleic acid synthesis inhibitors [moa]. Approved for nucleoside analog antiviral [epc]. First approved in 2015.
Drug data last refreshed 19h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
LONSURF (trifluridine and tipiracil) is an oral nucleoside analog antiviral combination approved by the FDA in September 2015. The product works by inhibiting nucleic acid synthesis, disrupting viral replication mechanisms. It is indicated for treatment of nucleoside analog-responsive conditions and represents a fixed-dose combination approach to improving therapeutic efficacy and patient convenience.
$0.2BPart D
10.8 years to LOEMechanism of Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Class:
Nucleoside Analog Antiviral
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (7)
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 Assessing Adverse Events and Disease Activity When Comparing Intravenously (IV) Infused ABBV-400 to Trifluridine and Tipiracil (LONSURF) Oral Tablets Plus IV Infused Bevacizumab in Adult Participants With c-Met Protein Above Cutoff Level Above Refractory Metastatic Colorectal Cancer
Started Nov 2024
460 enrolled
Metastatic Colorectal Cancer
Study of Lonsurf in Combination With Gemcitabine and Nab-Paclitaxel in Patients With Advanced (PDAC)
Started Sep 2019
14 enrolled
Pancreatic CancerPancreatic Ductal Adenocarcinoma
Bioequivalence Study of Trifluridine and Tipiracil Tablets in Colorectal Cancer Patients
Started May 2019
64 enrolled
Colorectal Cancer
First-in-human Study of CA102N Monotherapy and CA102N Combined With Trifluridine/Tipiracil (LONSURF) in Subjects With Advanced Solid Tumors
Started Apr 2019
37 enrolled
Advanced or Metastatic Solid TumorsAdvanced or Metastatic Colorectal Cancer (mCRC)
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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.