Dasiglucagon - Zealand Pharma/Novo Nordisk
Alternative Names: HypoPal rescue pen; ZEGALOGUE; Zegalogue®; ZP 4207; ZP-GA-1Latest Information Update: 05 Jun 2024
At a glance
- Originator Zealand Pharma
- Developer Beta Bionics; Zealand Pharma
- Class Antihyperglycaemics; Antihypoglycaemics; Peptides
- Mechanism of Action Glucagon receptor agonists
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Orphan Drug Status
Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.
- 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