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Aldafermin - NGM Biopharmaceuticals

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Drug Profile

Aldafermin - NGM Biopharmaceuticals

Alternative Names: M 52; NGM 282

Latest Information Update: 20 May 2025

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At a glance

  • Originator NGM Biopharmaceuticals
  • Class Anti-inflammatories; Antifibrotics; Antihyperglycaemics; Hepatoprotectants; Laxatives; Recombinant proteins
  • Mechanism of Action FGF19 protein replacements
  • Orphan Drug Status

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

    Yes - Primary sclerosing cholangitis; Primary biliary cirrhosis
  • New Molecular Entity No
  • Available For Licensing Yes - Non-alcoholic steatohepatitis

Highest Development Phases

  • Phase II/III Primary sclerosing cholangitis
  • Phase II Diarrhoea; Non-alcoholic steatohepatitis; Primary biliary cirrhosis
  • No development reported Constipation; Type 2 diabetes mellitus

Most Recent Events

  • 18 Mar 2025 NGM Biopharmaceuticals withdrawn a phase II/III trial in Primary Sclerosing Cholangitis due to the FDA advised a trial design change which made it infeasible to continue the study (NCT06654726)
  • 21 Oct 2024 Phase-II/III clinical trials in Primary sclerosing cholangitis in USA (SC) (NCT06654726)
  • 11 Mar 2024 NGM Biopharmaceuticals plans a registrational phase II/III trial for Primary Sclerosing Cholangitis in 2024 (NCT06654726)

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