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CER 001

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Drug Profile

CER 001

Alternative Names: CER-001; Cerenis HDL; Recombinant Human Apolipoprotein A-I; Recombinant Human Apolipoprotein A-I/Phospholipids complex

Latest Information Update: 17 Jun 2024

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At a glance

  • Originator Cerenis Therapeutics
  • Developer ABIONYX Pharma; Academic Medical Center
  • Class Antihyperlipidaemics; Apolipoprotein therapeutics; Cardiovascular therapies; Eye disorder therapies; Phospholipids; Recombinant proteins; Vascular disorder therapies
  • Mechanism of Action Apolipoprotein A-I replacements
  • Orphan Drug Status

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

    Yes - Lecithin acyltransferase deficiency; Hypoalphalipoproteinaemia
  • New Molecular Entity Yes

Highest Development Phases

  • Phase III Hypoalphalipoproteinaemia
  • Phase II Acute coronary syndromes; Acute kidney injury; Atherosclerosis
  • Clinical Phase Unknown COVID 2019 infections; Lecithin acyltransferase deficiency
  • Preclinical Uveitis
  • No development reported Lipid metabolism disorders

Most Recent Events

  • 13 Jun 2024 ABIONYX Pharma completes a pre-IND meeting with the US FDA and receives feedback to support an IND filing of CER 001 for sepsis-induced Acute kidney injury
  • 13 Jun 2024 ABIONYX Pharma plans to file an IND application for sepsis-induced Acute kidney injury
  • 13 Jun 2024 ABIONYX Pharma plans a phase IIb/III trial for sepsis-induced Acute kidney injury

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