Cholic acid - Asklepion

Drug Profile

Cholic acid - Asklepion

Alternative Names: Cholbam; Cholic acid FGK; Kolbam

Latest Information Update: 22 Aug 2016

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At a glance

  • Originator Asklepion Pharmaceuticals
  • Developer Asklepion Pharmaceuticals; FGK Representative Service; Retrophin
  • Class Choleretics; Cholic acids; Gallstone therapies; Small molecules
  • Mechanism of Action Cholesterol 7 alpha hydroxylase inhibitors
  • Orphan Drug Status

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

    Yes - Inborn genetic disorders
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Inborn genetic disorders; Infantile Refsum disease; Peroxisomal disorders; Zellweger syndrome

Most Recent Events

  • 01 Jul 2016 Asklepion completes Phase-III clinical trial in Inborn genetic disorders (In patients with inborn errors of bile acid synthesis) in USA, Canada, South America, Europe and Asia (NCT01438411)
  • 20 Nov 2015 The European Medicines Agency reinstates the marketing authorization for cholic acid for Inborn genetic disorders in the European Union (EU)
  • 24 Sep 2015 The EMA's CHMP recommends revised approval of cholic acid FGK for Inborn genetic disorders (In primary bile acid synthesis due to CTX, AMACR or CYP7a1 deficiencies) in European Union
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