Drug Profile


Alternative Names: BMS-247616; S-1; Tegafur/gimeracil/oteracil; Teysuno; TS-1; TS-ONE

Latest Information Update: 17 Oct 2017

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At a glance

  • Originator Taiho Pharmaceutical
  • Developer Nordic Group; Shandong New age Pharmaceutical; Taiho Pharmaceutical; TTY Biopharm
  • Class Antineoplastics; Pyridines; Pyrimidinones; Small molecules; Triazines
  • Mechanism of Action Thymidylate synthase inhibitors
  • Orphan Drug Status

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

    Yes - Gastric cancer
  • New Molecular Entity No

Highest Development Phases

  • Marketed Biliary cancer; Breast cancer; Colorectal cancer; Gastric cancer; Head and neck cancer; Non-small cell lung cancer; Pancreatic cancer
  • Phase III Cervical cancer; Hepatocellular carcinoma; Uterine cancer
  • Phase II Oesophageal cancer; Renal cancer
  • No development reported Prostate cancer

Most Recent Events

  • 08 Sep 2017 Efficacy data from the phase III TRICOLORE trial in Colorectal cancer presented at the 42nd European Society for Medical Oncology Congress (ESMO-2017)
  • 01 Sep 2017 Taiho completes the phase III TRICOLORE trial in Colorectal cancer (Metastatic disease, First-line therapy) in Japan before September 2017 (UMIN000007834)
  • 01 Sep 2017 Taiho Pharmaceutical terminated the phase III DIGEST trial due to slow patient accrual and the primary end point (overall survival) not met in Gastric cancer (Combination therapy, Metastatic disease, First-line therapy) in USA, Ukraine, South Africa, Russia, Mexico, Israel, Croatia, Colombia, Argentina, Brazil and European Union (PO) (NCT01285557) (EudraCT2009-016019-39)
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