Dasiglucagon - Zealand Pharma/Novo Nordisk
Alternative Names: HypoPal rescue pen; ZEGALOGUE; Zegalogue®; ZP 4207; ZP-GA-1Latest Information Update: 11 Oct 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
- 09 Oct 2024 Zealand Pharma receives complete response letter from the US FDA for Dasiglucagon for Hypoglycemia
- 11 Sep 2024 Novo Nordisk plans a phase III trial for Hypoglycemia (in patients with Type 1 diabetes mellitus) (In children, In adolescents, In adults, In the elderly) in Japan (SC), in September 2024 (NCT06588504)
- 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)