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Cobitolimod - Flerie

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Drug Profile

Cobitolimod - Flerie

Alternative Names: AEL; Antisense NF-KB-p65 oligonucleotide; Antisense oligonucleotide NF-KB-p65; Cobitolimod sodium - Flerie; DIMS-0150; IDX0150; Kappaproct; NF-ĸB(p65)AS

Latest Information Update: 07 Jan 2025

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At a glance

  • Originator InDex Pharmaceuticals
  • Developer Flerie; InDex Pharmaceuticals
  • Class Anti-inflammatories; Antiulcers; Oligodeoxyribonucleotides
  • Mechanism of Action Toll-like receptor 9 agonists
  • Orphan Drug Status

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

    Yes - Ulcerative colitis
  • New Molecular Entity Yes

Highest Development Phases

  • Phase III Ulcerative colitis
  • Discontinued Brain oedema

Most Recent Events

  • 21 Nov 2023 InDex Pharmaceuticals terminates a phase III CONCLUDE trial in Ulcerative colitis (Treatment-experienced) in US, Australia, Austria, Belgium, Bosnia and Herzegovina, Brazil, Croatia, France, Georgia, Germany, Hungary, Israel, Italy, South Korea, Lithuania, Mexico, the Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Sweden, Turkey and may extends to Denmark, Canada and UK due to unlikely possibility to meet the primary endpoint (NCT04985968)
  • 20 Oct 2023 InDex Pharmaceuticals has patent protection for cobitolimod in in the treatment of inflammatory bowel disease in South Korea
  • 14 Oct 2023 Safety and pharmacokinetics data from a phase I/II trial in colonic inflammation presented at the (f31st United European Gastroenterology Week (UEG -2023)

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