CER 001

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: 25 Nov 2016

Price : $50

At a glance

  • Originator Cerenis Therapeutics
  • Developer Academic Medical Center; Cerenis Therapeutics
  • Class Antihyperlipidaemics; Apolipoprotein therapeutics; Phospholipids; Recombinant proteins
  • Mechanism of Action Apolipoprotein A I stimulants
  • Orphan Drug Status

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

    Yes - Hypoalphalipoproteinaemia
  • 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.

  • New Molecular Entity Yes

Highest Development Phases

  • Phase II/III Hypoalphalipoproteinaemia
  • Phase II Acute coronary syndromes; Atherosclerosis
  • Phase I Lipid metabolism disorders

Most Recent Events

  • 27 Aug 2016 Safety data from the clinical development programmes for CER 001 presented by Cerenis Therapeutics at the Annual Congress of the European Society of Cardiology (ACS-2016)
  • 01 Aug 2016 Cerenis Therapeutics completes enrolment in the phase II CARAT trial for Acute Coronary Syndrome in USA, Australia, Hungary and the Netherlands
  • 01 Mar 2016 Cerenis Therapeutics completes a phase II trial in Atherosclerosis in Netherlands (IV) (EudraCT2014-001666-10)
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