Mesalazine - Dr Falk Pharma

Drug Profile

Mesalazine - Dr Falk Pharma

Alternative Names: AJG501; Apriso; Mesalamine 0.375g extended-release capsules (Apriso) - Salix Pharmaceuticals; Mesalamine granules - Salix Pharmaceuticals; Salofalk; Salofalk Granu-Stix

Latest Information Update: 06 Nov 2017

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At a glance

  • Originator Dr Falk Pharma
  • Developer Ajinomoto; Dr Falk Pharma; Salix Pharmaceuticals
  • Class Aminosalicylic acids; Anti-inflammatories; Irritable bowel syndrome therapies; Small molecules
  • Mechanism of Action Lipoxygenase-cyclooxygenase 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 Ulcerative colitis
  • Phase III Microscopic colitis
  • Phase II Colorectal cancer; Ulcerative proctitis
  • Discontinued Diverticulitis

Most Recent Events

  • 18 Aug 2017 Valeant Pharmaceuticals International completes a phase I trial for Ulcerative Colitis (In volunteers) in USA (NCT03327558)
  • 15 May 2017 Valeant Pharmaceuticals International initiates a phase I trial for Ulcerative Colitis (In volunteers) in USA (NCT03327558)
  • 16 Jan 2017 Dr Falk Pharma completes a phase III trial in Microscopic colitis in Netherlands, Spain, Lithuania, Czech Republic, Denmark, Belgium, Sweden, Hungary, Germany (EudraCT2008-005994-36)
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