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Recombinant alkaline phosphatase - AM-Pharma Holding

Drug Profile

Recombinant alkaline phosphatase - AM-Pharma Holding

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

Latest Information Update: 02 Jul 2020

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At a glance

  • Originator AM-Pharma Holding
  • Developer AM-Pharma
  • Class Anti-inflammatories; Recombinant proteins
  • 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
  • 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

  • 29 Jun 2020 AM-Pharma plans the pivotal phase III REVIVAL trial for sepsis-associated Acute kidney injury (IV)
  • 18 Jul 2019 Recombinant alkaline phosphatase is still in preclinical development for Hypophosphatasia (SC) and Ulcerative colitis (PO) in Netherlands (AM-Pharma website, July 2019)
  • 17 Jul 2019 AM-Pharma plans to submit market authorisation applications for Acute kidney injury following the successful completion of the pivotal phase III trial
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