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Dasiglucagon - Zealand Pharma/Novo Nordisk

Drug Profile

Dasiglucagon - Zealand Pharma/Novo Nordisk

Alternative Names: HypoPal rescue pen; ZEGALOGUE; Zegalogue®; ZP 4207; ZP-GA-1

Latest Information Update: 05 Jun 2024

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At a glance

  • Originator Zealand Pharma
  • Developer Beta Bionics; Zealand Pharma
  • Class Antihyperglycaemics; Antihypoglycaemics; Peptides
  • Mechanism of Action Glucagon receptor agonists
  • Orphan Drug Status

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

    Yes - Congenital hyperinsulinism
  • New Molecular Entity Yes
  • Available For Licensing Yes - Congenital hyperinsulinism

Highest Development Phases

  • Marketed Hypoglycaemia
  • Preregistration Congenital hyperinsulinism
  • Phase II/III Type 1 diabetes mellitus

Most Recent Events

  • 31 May 2024 Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issues a positive opinion and recommends marketing authorization approval for dasiglucagon for Hypoglycaemia (In adolescents, In adults, In children)
  • 31 May 2024 Zealand Pharma expects a final decision from the European Commission (EC) regarding approval of marketing authorization of dasiglucagon for Hypoglycaemia (In adolescents, In adults, In children), by August 2024
  • 16 May 2024 The US FDA assigns PDUFA action date of 08/10/2024 for dasiglucagon for Congenital-hyperinsulinism
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