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.

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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.