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Mesalazine - Dr Falk Pharma

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Drug Profile

Mesalazine - Dr Falk Pharma

Alternative Names: 5-ASA; AJG501; Apriso; Mesalamine 0.375g extended-release capsules (Apriso) - Salix Pharmaceuticals; Mesalamine granules - Salix Pharmaceuticals; Salofalk; Salofalk Granu-Stix

Latest Information Update: 07 Oct 2025

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At a glance

  • Originator Dr Falk Pharma
  • Developer Ajinomoto; Dr Falk Pharma; Salix Pharmaceuticals
  • Class Aminosalicylic acids; Anti-inflammatories; Antineoplastics; 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.

    No
  • New Molecular Entity No

Highest Development Phases

  • Marketed Ulcerative colitis
  • Phase II Colorectal cancer; Ulcerative proctitis
  • Discontinued Diverticulitis; Eosinophilic oesophagitis; Microscopic colitis

Most Recent Events

  • 11 Jun 2025 Discontinued - Phase-II for Eosinophilic oesophagitis in Switzerland (PO)
  • 03 May 2025 Adverse events and efficacy data from a phase II trial in Eosinophilic esophagitis presented at the Digestive Disease Week 2025 (DDW 2025)
  • 20 Jul 2023 Dr. Falk Pharma completes a phase IIa trial in Eosinophilic oesophagitis in Switzerland (PO, Suspension) (NCT05488405)

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