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Tipiracil/trifluridine - Taiho Pharmaceutical

Drug Profile

Tipiracil/trifluridine - Taiho Pharmaceutical

Alternative Names: FTD/TPI; Lonsurf; Orcantas; S 95005; S 95005/TAS-102; T15, T20; T15/T20; TAS-102; TAS-102/S-95005; Tipiracil-hydrochloride/trifluridine; Trifluridine/tipiracil; Trifluridine/tipiracil hydrochloride

Latest Information Update: 13 Feb 2019

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At a glance

  • Originator Taiho Pharmaceutical
  • Developer 3SBio; Amgen; Emory University; Ipsen; Servier; Taiho Pharmaceutical; TTY Biopharm; University of Florida; University of Wisconsin-Madison
  • Class Antineoplastics; Nucleosides; Pyrimidines; Pyrrolidines; Small molecules
  • Mechanism of Action DNA synthesis inhibitors; Thymidine phosphorylase inhibitors
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

  • New Molecular Entity No

Highest Development Phases

  • Marketed Colorectal cancer
  • Preregistration Gastric cancer
  • Phase II Bladder cancer; Oesophageal cancer; Pancreatic cancer; Small cell lung cancer
  • Phase I/II Gastrointestinal cancer
  • Phase I Neuroendocrine tumours
  • No development reported Solid tumours

Most Recent Events

  • 03 Jan 2019 Phase-II clinical trials in Bladder cancer (Metastatic disease, Late-stage disease, Inoperable/Unresectable, Second-line therapy or greater) in USA (PO) (NCT03762161)
  • 25 Oct 2018 Preregistration for Gastric cancer (Adjunctive treatment, Metastatic disease, Second-line therapy or greater, Late-stage disease, Inoperable/Unresectable) in USA (PO)
  • 25 Oct 2018 FDA assigns PDUFA action date of 24/02/2019 for tipiracil/trifluridine for Gastric cancer
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