Dasiglucagon (Zegalogue)

Safety Summary

In the two placebo-controlled adult Phase 3 trials (N=116 dasiglucagon, N=53 placebo), the most common adverse reactions within 12 hours of treatment were nausea (57% vs 4%), vomiting (25% vs 2%), headache (11% vs 4%), diarrhea (5% vs 0%), and injection site pain (2% vs 0%). Pediatric overall rates were nausea (65%), vomiting (50%), headache (10%), and injection site pain (5%). Other reported adverse reactions include hypertension, hypotension, bradycardia, presyncope, palpitations, and orthostatic intolerance. In the integrated safety analysis across 316 adults exposed to dasiglucagon, no serious adverse events, AEs leading to withdrawal, or deaths were reported. The safety profile was similar to that of reconstituted native glucagon PMID 36692230. The immunogenicity trial (N=112, three weekly doses) found zero treatment-induced or treatment-boosted antidrug antibody responses and no injection site reactions with dasiglucagon PMID 34252289. The QTc study showed no clinically relevant QTc prolongation at concentrations up to 5-fold higher than therapeutic levels PMID 35464292. One case report documented necrolytic migratory erythema during prolonged continuous subcutaneous dasiglucagon infusion in a neonate with CHI, along with malnutrition and zinc deficiency, which resolved after drug discontinuation PMID 40300042.