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Berberine ursodeoxycholate - HighTide Biopharma

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Drug Profile

Berberine ursodeoxycholate - HighTide Biopharma

Alternative Names: BUDCA - HighTide Biopharma; HTD-1801

Latest Information Update: 22 Sep 2025

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At a glance

  • Originator HighTide Biopharma
  • Class Anti-inflammatories; Antihyperglycaemics; Antihyperlipidaemics; Dioxolanes; Ethers; Hepatoprotectants; Heterocyclic compounds with 4 or more rings; Isoquinolines; Phenanthrenes; Small molecules
  • Mechanism of Action Lipid modulators
  • 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

Highest Development Phases

  • Phase III Type 2 diabetes mellitus
  • Phase II Hypercholesterolaemia; Non-alcoholic steatohepatitis; Primary biliary cirrhosis; Primary sclerosing cholangitis

Most Recent Events

  • 17 Sep 2025 Efficacy and adverse events data from a phase III trial in Type 2 diabetes mellitus released by HighTide Therapeutics
  • 20 Jun 2025 Efficacy and adverse events data from a phase III Symphony 1 trial in Type 2 diabetes mellitus presented at the 85th Annual Scientific Sessions of the American Diabetes Association (ADA-2025)
  • 30 Apr 2025 HighTide Biopharma completes the phase II CENTRICITY trial in Nonalcoholic steatohepatitis (In adults, In the elderly) in Hong Kong, Puerto Rico and USA (PO) (NCT05623189)

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