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Norucholic acid - Dr Falk Pharma

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Drug Profile

Norucholic acid - Dr Falk Pharma

Alternative Names: EA-3355; NorUDCA; Norursodeoxycholic acid; NUC - Dr Falk Pharma; Ursodeoxycholic acid homologue

Latest Information Update: 15 May 2025

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At a glance

  • Originator Dr Falk Pharma
  • Developer Dr Falk Pharma; EA Pharma
  • Class Anti-inflammatories; Antifibrotics; Cholic acids; Gallstone therapies; Hepatoprotectants
  • Mechanism of Action Cholesterol inhibitors
  • Orphan Drug Status

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

    Yes - Primary sclerosing cholangitis
  • New Molecular Entity Yes
  • Available For Licensing Yes

Highest Development Phases

  • Phase III Primary sclerosing cholangitis
  • Phase II Non-alcoholic steatohepatitis; Primary biliary cirrhosis
  • Discontinued Liver disorders

Most Recent Events

  • 07 May 2025 Efficacy and adverse event data from phase III trial in Primary sclerosing cholangitis released by Dr Falk Pharma
  • 25 Mar 2025 Dr. Falk Pharma GmbH plans to initiate a phase III trial for Primary Sclerosing Cholangitis (PO) (NCT06886360)
  • 20 May 2022 Discontinued - Phase-I for Liver disorders (In volunteers) in Japan (PO), due to business priorities (EA Pharma, Eisai Co Ltd pipeline, May 2022)

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