Ursodeoxycholic acid

Drug Profile

Ursodeoxycholic acid

Alternative Names: Actigall; Delursan; LJDCA; UDCA; Urso; Urso 500; Urso DS; Urso Forte; Ursobilane; Ursochol; Ursodesoxycholic acid; Ursodiol; Ursolite; Ursosan

Latest Information Update: 12 Nov 2016

Price : $50

At a glance

  • Originator Alfa Farmaceutici; sanofi-aventis
  • Developer Adare Pharmaceuticals; Allergan; Axcan Pharma; Estedi; Mitsubishi Tanabe Pharma Corporation; Novartis; Procter & Gamble Pharmaceuticals Spain; sanofi-aventis; Zambon Company SpA
  • Class Cholic acids; Gallstone therapies; Hepatoprotectants
  • Mechanism of Action Apoptosis inhibitors; Cholesterol inhibitors; Immunomodulators; Immunosuppressants
  • Orphan Drug Status

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

    No
  • On Fast track

    Fast track status is assigned by the US FDA so therapies with the potential to address unmet needs can move faster through development.

    No
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Cholelithiasis; Liver disorders; Primary biliary cirrhosis; Primary sclerosing cholangitis
  • No development reported Colorectal cancer; Hypercholesterolaemia; Liver transplant rejection; Non-alcoholic steatohepatitis

Most Recent Events

  • 15 Mar 2016 Biomarkers information updated
  • 10 Jun 2015 No recent reports on development identified - Phase-II for Non-alcoholic steatohepatitis in USA (PO)
  • 10 Jun 2015 No recent reports on development identified - Phase-II/III for Colorectal cancer in USA (PO)
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