Recombinant alkaline phosphatase

Drug Profile

Recombinant alkaline phosphatase

Alternative Names: Human recombinant alkaline phosphatase; recAP; Recombinant optimised human alkaline phosphatase

Latest Information Update: 11 May 2016

Price : $50

At a glance

  • Originator AM-Pharma Holding
  • Developer AM-Pharma
  • Class Phosphoric monoester hydrolases
  • Mechanism of Action Endotoxin inhibitors; Enzyme replacements
  • Orphan Drug Status

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

    Yes - Hypophosphatasia
  • 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.

    Acute kidney injury
  • New Molecular Entity Yes
  • Available For Licensing Yes - Ulcerative colitis

Highest Development Phases

  • Phase II Acute kidney injury
  • Preclinical Hypophosphatasia; Ulcerative colitis
  • Discontinued Septic shock

Most Recent Events

  • 10 May 2016 Pharmacokinetics data from a phase I trial in Acute kidney injury released by AM-Pharma
  • 26 Apr 2016 Recombinant alkaline phosphatase receives Fast Track designation for Acute kidney injury [IV,Infusion] in USA
  • 13 May 2015 Recombinant alkaline phosphatase receives Orphan Drug status for Hypophosphatasia in USA
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