Drug Profile


Alternative Names: CPP-1X/sul; CPP-1X/sulindac; CPP1-x/sulindac; Sulindac/CPP-1X; Sulindac/eflornithine; TP 09

Latest Information Update: 21 Feb 2018

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At a glance

  • Originator sanofi-aventis; University of Arizona
  • Developer Cancer Prevention Pharmaceuticals; Genzyme Corporation; National Cancer Institute (USA); World Health Organization
  • Class Antineoplastics; Basic amino acids; Diamino amino acids; Indenes; Nonsteroidal anti-inflammatories; Small molecules
  • Mechanism of Action Cyclooxygenase inhibitors; Ornithine decarboxylase inhibitors
  • Orphan Drug Status

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

    Yes - Familial adenomatous polyposis
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Trypanosomiasis
  • Phase III Colorectal cancer; Familial adenomatous polyposis
  • Discontinued Basal cell cancer; Bladder cancer; Prostate cancer; Sporadic adenomas; Squamous cell cancer

Most Recent Events

  • 13 Feb 2018 Sucampo Pharmaceuticals has been acquired and merged into Mallinckrodt plc
  • 26 Dec 2017 Sucampo Pharmaceuticals announces intention to submit NDA for Familial adenomatous polyposis in 2019
  • 18 Sep 2017 Eflornithine/sulindac receives Fast Track designation for Familial adenomatous polyposis [PO,Tablet] (Combination therapy) in USA
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