Clinical Trials Pipeline & In-Development

HM15136

also known as: HM-15136, Efpegerglucagon

Hanmi's once-weekly glucagon analog being developed for congenital hyperinsulinism (CHI) — a rare paediatric indication in which chronic glucagon receptor agonism is used to counteract life-threatening hypoglycemia.

A long-acting glucagon analog on Hanmi's LAPSCOVERY Fc-conjugation platform, developed for congenital hyperinsulinism (CHI) — a rare genetic disorder of recurrent severe hypoglycemia — where weekly exogenous glucagon receptor agonism can prevent hypoglycemic events that neither diazoxide nor octreotide adequately control; orphan drug designation FDA and EMA.

Mechanism of action

Chronic weekly glucagon receptor agonism to counteract hyperinsulinemic hypoglycemia. In CHI, pancreatic β-cells oversecrete insulin despite hypoglycemia; sustained glucagon signaling restores hepatic glucose output and prevents neuroglycopenic events. A very different therapeutic use of glucagon from the acute rescue setting (Baqsimi, Gvoke).

Primary uses

Congenital hyperinsulinism (Phase 2, orphan)

Typical dosing

once weekly (subcutaneous)

Phase 2 dosing not publicly finalized.

Regulatory status

Not approved. FDA and EMA orphan drug designation for congenital hyperinsulinism. Phase 2 clinical development.

References

[manufacturer] Hanmi Pharmaceutical pipeline page — HM15136 efpegerglucagon for CHI.
[clinicaltrials] ClinicalTrials.gov — HM15136 congenital hyperinsulinism Phase 2.

Related peptides

Glucagon

The endogenous counter-regulatory hormone to insulin — FDA-approved for severe hypoglycemia (injectable GlucaGen, nasal Baqsimi, autoinjector Gvoke). Also the pharmacological template for GLP-1/glucagon dual agonists like Pemvidutide and Retatrutide.

Pramlintide

The FDA-approved amylin analog (Symlin, 2005) — taken at mealtimes alongside insulin in T1D and T2D. The pharmacological proof-of-concept for amylin agonism that petrelintide and cagrilintide are now building on.

Disclaimer

This entry is for educational purposes only and does not constitute medical advice. Dosing information reflects published regulatory or research data and is not a recommendation. Many compounds described here are not approved for human use in the United States. Consult a licensed medical professional before considering any peptide therapy.