Efpegerglucagon
An investigational treatment for Congenital Hyperinsulinism.
The same compound appears under different names depending on the context. Here is how to identify Efpegerglucagon wherever you encounter it, plus the key facts at a glance.
- Generic name
- Efpegerglucagon
- Development code
- HM15136
- Drug class
- Glucagon analog
- Manufacturer
- Hanmi Pharmaceutical
- How it's taken
- Weekly injection under the skin (investigational)
Hanmi Pharmaceutical's once-weekly glucagon analog, tested as an add-on in children and adults with congenital hyperinsulinism whose lows persist on standard care. The Phase 2 study finished its main phase in June 2026; no results have been published.
We'll email you when the FDA acts on Efpegerglucagon and when new trials for Congenital Hyperinsulinism open. Unsubscribe anytime.
You'll get new recruiting trials, changes to trials, FDA decisions and condition news for Congenital Hyperinsulinism. Turn any of these off from the link in every email.
Where Efpegerglucagon fits
Being studied as an add-on for children and adults whose hypoglycemia continues despite diazoxide, somatostatin analogs, feeds or surgery. A weekly shot would be a different trade-off from the dasiglucagon pump if both reach approval.
How Efpegerglucagon works
Like dasiglucagon, efpegerglucagon copies the hormone glucagon, which tells the liver to release stored sugar. Hanmi built it to last much longer in the body so that 1 injection a week could hold up baseline glucose, instead of a pump running around the clock. The Phase 2 study tested multiple ascending doses to find the right exposure for different ages.
Mechanism: Long-acting glucagon analog designed for once-weekly injection, raising liver glucose output to counter excess insulin
Side effects and safety
No safety results from the hyperinsulinism study have been published. Glucagon-type medicines commonly cause nausea and vomiting, and the trial monitored for skin reactions and blood sugar swings. Treat any safety claim as unknown until Hanmi or the investigators report.
This is not a complete list of side effects. Talk to your doctor or pharmacist about what to expect and when to seek medical attention.
Taking Efpegerglucagon
Injection under the skin once a week, as an add-on to the child's existing treatment, in the Phase 2 study (NCT04732416). Dosing was set by cohort and is not public. Not available outside trials.
Availability and cost
Only available as the brand-name product.
Investigational; no price.
Clinical trial results
NCT04732416 is a Phase 2, open-label, multiple ascending dose study of 8 weeks of once-weekly HM15136 in people aged 2 years and older with CHI and persistent hypoglycemia on standard care. ClinicalTrials.gov lists 17 participants enrolled at Children's Hospital of Philadelphia, Otto von Guericke University Magdeburg, Hadassah Medical Center, 2 centers in South Korea, Great Ormond Street Hospital and Royal Manchester Children's Hospital.
The study began on May 5, 2022, its primary completion date was June 16, 2026, and overall completion is estimated for May 2027; the status is active, not recruiting, verified August 2026. No results are posted.
Development history
Hanmi first tested HM15136 in healthy volunteers (NCT04032782, completed 2019) and in people with obesity (NCT04167553, completed 2020) before opening the hyperinsulinism study in 2022. Hanmi's website could not be read for this page, and no company announcement of CHI results was found as of October 18, 2026.
Explore Congenital Hyperinsulinism trials
Other Congenital Hyperinsulinism treatments
Where to access Efpegerglucagon
Investigational: available only through clinical trial enrollment
Efpegerglucagon has not been approved by the FDA and is not available by prescription. The only way for a patient to receive Efpegerglucagon today is by enrolling in an active clinical trial and meeting that trial's eligibility criteria. Decisions about trial participation should be made with the specialist who manages the patient's condition and knows their current treatment.
Primary active trial
ClinicalTrials.gov record NCT04732416
View full trial record on ClinicalTrials.gov →Trial status, site list, and eligibility are pulled from ClinicalTrials.gov. Confirm current recruitment status and nearest site directly with the study team before traveling.
Common questions about Efpegerglucagon
▸What is Efpegerglucagon?
Hanmi Pharmaceutical's once-weekly glucagon analog, tested as an add-on in children and adults with congenital hyperinsulinism whose lows persist on standard care. The Phase 2 study finished its main phase in June 2026; no results have been published.
▸How does Efpegerglucagon work?
Like dasiglucagon, efpegerglucagon copies the hormone glucagon, which tells the liver to release stored sugar. Hanmi built it to last much longer in the body so that 1 injection a week could hold up baseline glucose, instead of a pump running around the clock. The Phase 2 study tested multiple ascending doses to find the right exposure for different ages.
▸What are the side effects of Efpegerglucagon?
No safety results from the hyperinsulinism study have been published. Glucagon-type medicines commonly cause nausea and vomiting, and the trial monitored for skin reactions and blood sugar swings. Treat any safety claim as unknown until Hanmi or the investigators report.
▸How is Efpegerglucagon taken?
Injection under the skin once a week, as an add-on to the child's existing treatment, in the Phase 2 study (NCT04732416). Dosing was set by cohort and is not public. Not available outside trials.
▸Is Efpegerglucagon FDA approved?
Efpegerglucagon is currently in phase 2 clinical trials for Congenital Hyperinsulinism. It has not yet received FDA approval.
Sources and references
Every factual claim on this page is drawn from the public sources listed below. Click any reference to open the original document.
- ClinicalTrials.gov · 2026-08-26. HM15136 (Efpegerglucagon) Treatment for 8 Weeks in Subjects Aged 2 Years and Older With Congenital Hyperinsulinism. https://clinicaltrials.gov/study/NCT04732416