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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: 31 Jul 2026

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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; Urologics
  • 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; Renal failure

Most Recent Events

  • 09 Jul 2026 Phase-II clinical trials in Renal failure in China (PO) (NCT07496177)
  • 09 Jul 2026 HighTide Biopharma initiates a phase II Negentropy trial in Type 2 diabetes mellitus in China (NCT07496177)
  • 27 Mar 2026 HighTide Biopharma plans phase-II Negentropy trial for Type 2 diabetes mellitus and Renal failure in China (PO), (NCT07496177)

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