Efpeglenatide_Dosage, benefits & legal status
Also known as Eppe, Efe, Efpe, HM11260C, LAPSCA-Exendin-4
A drug Sanofi handed back, revived as a cheaper weekly option in one country.
Common vial size is what vendors typically sell, not a recommendation. Enter your own vial in the calculator.
What is Efpeglenatide?
Plain language first. The technical label stays, but it never stands alone.Overview
This is the first GLP-1 weight-loss drug developed in Korea, and it is the only one of its family on this site approved there and nowhere else. Two things are worth holding together. It is priced at roughly half of what Mounjaro costs there. Its own interim phase 3 result was about 9.75 percent weight loss over 40 weeks, against the 15 to 20 percent reported for Wegovy and Mounjaro in their own trials. Those trials enrolled different people under different designs, so the gap is not a clean head-to-head, and it is still a gap a reader should know about.
Efpeglenatide is a long-acting GLP-1 receptor agonist built on exendin-4 rather than on human GLP-1. Hanmi's own conference posters describe it as a conjugate of an exendin-4 analog, carrying a single amino acid change, joined through a flexible linker to a non-glycosylated human immunoglobulin Fc fragment at the 27th residue by site-specific conjugation. Korea's Ministry of Food and Drug Safety approved it on October 7, 2026 for chronic weight management in adults with obesity or overweight without diabetes, as a once-weekly subcutaneous auto-injector in 2, 4, 6, 8 and 10 mg strengths.
What it's used for
Chronic weight management in adults with obesity or overweight without diabetes, alongside diet and exercise, in South Korea only. It has no FDA approval and no approval outside Korea.
How does Efpeglenatide work?
What it does in the body, and where.Two things separate this from the GLP-1 drugs most readers know. It is built on exendin-4, the lizard peptide, rather than on human GLP-1. It is also made long-acting by bolting on a piece of an antibody rather than by attaching a fatty chain.
- 01The exendin family, not the human GLP-1 familyExenatide and lixisenatide come from exendin-4, a peptide first found in Gila monster venom that happens to activate the human GLP-1 receptor. Semaglutide, liraglutide and dulaglutide are built on human GLP-1 instead. Both families hit the same receptor, and they differ in sequence, in how the immune system sees them and in how they are made to last.
- 02An antibody fragment instead of a fatty chainSemaglutide lasts a week because a fatty side chain makes it cling to albumin. Efpeglenatide lasts a week because an exendin-4 analog is tied through a flexible linker to a non-glycosylated human antibody Fc fragment, attached at the 27th residue. Hanmi's posters say the Fc was left unglycosylated to help solubility and that the linker is there to limit the loss of activity that conjugation usually costs.
- 03What that buys, and what it does notA circulating half-life long enough for weekly dosing, reported by Hanmi at around 158 hours in a conference poster, and early work that explored monthly dosing at higher amounts. It does not buy more weight loss: the Korean phase 3 interim figure is below what the two incumbent drugs report in their own trials.
What else is it used for?
Each group carries its own evidence level.Approved means regulators have cleared it for that purpose. Investigational means it is in trials. Early research means it is being studied and is not established.
What the Korean approval rests on
Clinical use- Human trialAn interim phase 3 topline of about 9.75 percent average weight reduction over 40 weeks in 448 Korean adults with obesity. Hanmi has run phase 3 work in Korean patients since 2023.
- RegulatoryApproved October 7, 2026 by the Ministry of Food and Drug Safety for chronic weight management in adults with obesity or overweight without diabetes, as a once-weekly auto-injector at 2, 4, 6, 8 or 10 mg.
- No dataWegovy and Mounjaro report 15 to 20 percent in their own trials. The comparison is not head to head, and the honest summary is that this drug is cheaper in Korea and, on what has been published, less effective.
The trial most people have never heard of
peer-reviewed-human- Human trialAMPLITUDE-O randomized 4,076 people with type 2 diabetes and established heart or kidney disease to weekly efpeglenatide at 4 or 6 mg or placebo, with 1.8 years of follow-up. The composite of death, myocardial infarction or stroke fell from 9.2 to 7.0 percent, P of 0.007.
- Human trialA kidney outcome fell from 18.4 to 13.0 percent, P below 0.001. For a GLP-1 drug this was a substantial result.
- Human trialThe benefit was concentrated at 6 mg. The 6 mg hazard ratio was 0.65 with an interval of 0.50 to 0.86, while the 4 mg interval ran from 0.63 to 1.06 and so included no effect. Cardiovascular mortality showed the same split.
- No dataNo regulator approved it on the strength of that trial, and Sanofi, the company that ran it, did not bring the drug to market. What revived the molecule was a different indication in one country.
How it is built, and why that is unusual here
none- lab-analysisIt is an exendin-4 drug, not a human GLP-1 drug. On this site that puts it with exenatide and lixisenatide rather than with semaglutide, liraglutide and dulaglutide.
- lab-analysisIts weekly duration comes from conjugation to a non-glycosylated human antibody Fc fragment through a flexible linker, attached at the 27th residue of the exendin analog. Most of the weekly GLP-1 drugs on this site last instead because of a fatty side chain.
- No dataNo plain amino acid sequence describes the finished molecule, because it is a peptide joined to a protein fragment. Hanmi has not published which single residue of exendin-4 the CA analog changes.
Three things get mangled about this drug. First, the name: English-language coverage renders the Korean brand as Eppe, Efe and Efpe, and one outlet calls the product Efe Auto-Injector Injection, so a single confident spelling should be treated with suspicion. Second, the approval: it is Korean only, granted on October 7, 2026, and it carries no FDA or European approval, so anything offered as efpeglenatide elsewhere did not come from that supply chain. Third, and most often, the cardiovascular results. AMPLITUDE-O was a 4,076-patient trial in type 2 diabetes with established heart or kidney disease, at 4 and 6 mg, and nearly all of its benefit sat in the 6 mg arm. It is not evidence about weight management, and the approved Korean product reaches 10 mg, a dose that trial never tested. The 9.75 percent weight-loss figure also deserves care: it is an interim phase 3 topline over 40 weeks, and setting it beside the 15 to 20 percent quoted for Wegovy and Mounjaro compares different trials in different populations.
The published record
Papers and trials about Efpeglenatide
Searched: efpeglenatide, HM11260C, LAPSCA-Exendin-4, AMPLITUDE-O.
Left out: exendin-4 (the parent lizard peptide, with a large literature covering exenatide and lixisenatide rather than this conjugate); GLP-1 receptor agonist (a class term whose exemplars are semaglutide and tirzepatide, each with its own slug); Hanmi (a company name returning corporate and licensing coverage rather than science); Fc conjugate (a formulation technique shared with many unrelated biologics).
48 papers tagged human · 30 not reviews or lab · 12 clinical trial publications
5 registered trials · 5 with posted results
Furthest stage reached: Approved outside the US, South Korea
Counted from Europe PMC indexing, not read by a person; a human tag can land on reviews, commentary or lab papers; clinical trial publications is the narrower count.
At a glance
Four things to know about Efpeglenatide
Evidence
Clinical use
Category
Weight loss and metabolic
Common vial
Varies
Half-life
About 158 hours, from a conference poster
How much, and do you cycle it?
The range, and whether you take breaks.2 to 10 mg, once weekly. Continuous weekly dosing Clinical use
Chronic weight management is continuous treatment, as with the rest of this class. No cycling scheme applies.
How long does it stay in the body?
The half-life, and where the figure comes from.About 158 hours, from a conference posterNo figure
Hanmi's EASD 2015 material reports a half-life of roughly 158 hours, about 6.6 days, with a flat pharmacokinetic profile, in a companion poster on the phase 2 dose-finding study rather than in the poster we read directly. No hours figure is plotted here because the number is second-hand within a conference abstract. A week-long half-life is what the once-weekly dosing implies in any case, and early work explored monthly dosing at higher amounts.
You can compare this against the whole library to see where it sits.
How is it given?
Dosing context and source notes.Supplied as a pen or prefilled syringe, so there is nothing to mix.
Guideline range: 2 up to 10 mg per week.
The range is the set of approved Korean strengths as reported, 2, 4, 6, 8 and 10 mg once weekly, not a recommendation and not a titration schedule. The cardiovascular outcomes trial in type 2 diabetes used only 4 and 6 mg, so the top of this range has never been tested for heart or kidney outcomes.
How do you store it?
Before mixing, and after.Follow the storage on the product label.
Efpeglenatide is supplied as a finished product, so its label sets the storage. Pens, prefilled syringes, implants, tablets and ready-made solutions are used as supplied. Kits that include a powder are mixed just before the dose and usually used straight away, not kept for weeks. Many injectable products go in the fridge and must not be frozen, while others are kept at room temperature, so check the pack or ask the pharmacist.
What are the side effects and cautions?
Known cautions and warnings for this compound.Who should avoid it
- Anything sold as efpeglenatide outside Korea: the only approved product is a Korean auto-injector, and nothing with this name is approved anywhere else
- Reading the cardiovascular results as applying to weight management: that trial was in type 2 diabetes with established heart or kidney disease, at 4 and 6 mg
Stop and get help
- Severe or persistent abdominal pain, since that needs a pancreatitis assessment
- Signs of an allergic reaction to the injection
Common effects
- Nausea and other gut effects while the dose is escalating, as with the rest of the class
- Weight loss averaging about 9.75 percent over 40 weeks in the Korean phase 3 interim result
Where this page says nothing is established, that means nobody has studied it, not that a compound is safe.
Is Efpeglenatide approved?
And where the numbers on this page come from.Not in the United States. Efpeglenatide has no FDA approval. It is approved in South Korea.
- Approval statusClinical use
- RouteUnder the skin (subcutaneous)
- Checked26 October 2026
- Approved outside the USSouth Korea.This does not change the United States position above.
- DoseFrom product labeling and clinical guidelines.
- Vial sizeFrom what vendors typically list; not a recommendation.
- SourcesKorea Biomedical Review, Hanmi's first Korean-developed GLP-1 obesity drug set for launchSeoul Economic Daily, Hanmi wins approval for Korea's first homegrown obesity drugHanmi conference poster, EASD 2015, PS069-792Hanmi conference poster, ADA 2014, 1009-PGerstein and colleagues, New England Journal of Medicine, the AMPLITUDE-O trial
What has happened recently
Approved in South Korea and nowhere else. The Ministry of Food and Drug Safety approved it on October 7, 2026 for chronic weight management in adults with obesity or overweight without diabetes, alongside diet and exercise. It is a once-weekly subcutaneous auto-injector in 2, 4, 6, 8 and 10 mg strengths, and can be given at any time of day regardless of meals. Hanmi announced at a Seoul symposium that launch was expected at selected medical institutions around October 29, 2026, so this page was written three days before the drug reached patients. The reported first-month supply price is about 130,000 won, roughly 98 US dollars, against about 270,000 won for the lowest-dose four-week supply of Mounjaro and a little over 200,000 won for Wegovy; those are supply prices rather than what a patient pays. The English brand name is not settled: Korean outlets render it Eppe, Efe and Efpe, and one describes the product as Efe Auto-Injector Injection. There is no FDA approval and no European approval. The drug was previously partnered with Sanofi, and Sanofi ran the cardiovascular outcomes trial below without taking it to market.
You can compare this against the whole library, or read how to check a seller.
What else is like Efpeglenatide?
Others in GLP-1 agonists, side by side.If you're weighing Efpeglenatide, it's worth reading Exenatide (Byetta / Bydureon), GZC8072, and KAI-4729 in the same class.
A drug Sanofi handed back, revived as a cheaper weekly option in one country.
- Dose
- 2 to 10 mg
- How often
- Once weekly
The first GLP-1 drug, found in lizard venom, now mostly retired.
- Dose
- 2 mg per week (the weekly form)
- How often
- Weekly
An experimental weekly GLP-1 pill from China, made from a modified GLP-1 peptide, with no human results yet.
- Dose
- No dose disclosed
- How often
- Weekly (intended)
An experimental weekly GLP-1/GIP/glucagon triple agonist, not to be confused with retatrutide.
- Dose
- 1 up to 12 mg per week (trial doses)
- How often
- Weekly
Guides for this compound
- How to Reconstitute a Peptide
Mix peptide powder with bacteriostatic water, step by step.
- How to Read an Insulin Syringe
Read the units, convert to millilitres, and draw the exact dose.
- mcg vs mg: The Peptide Dosing Mistake to Avoid
Your vial says mg and your protocol says mcg. Here is the conversion and how to check it.
- Semaglutide vs Tirzepatide vs Retatrutide
One receptor, two, or three. Mechanism, trial weight loss, side effects, and real cost.
Sources
- Korea Biomedical Review, Hanmi's first Korean-developed GLP-1 obesity drug set for launch(2026)Gives the approval as October 7, 2026 from the Ministry of Food and Drug Safety, the indication as chronic weight management in adults with obesity or overweight without diabetes alongside diet and exercise, and the product as a once-weekly injection. Launch expected at selected Korean medical institutions around October 29, 2026, announced at a Seoul symposium. Reports the interim phase 3 topline as an average weight reduction of 9.75 percent over 40 weeks in 448 Korean adults with obesity. States that separate Wegovy and Mounjaro trials have reported average reductions of 15 to 20 percent while cautioning that differences in trial populations and designs limit direct comparisons. First-month supply price about 130,000 won, roughly 98 US dollars, against about 270,000 won for Mounjaro's lowest-dose four-week supply and a little over 200,000 won for Wegovy, all supply prices rather than patient costs.
- Seoul Economic Daily, Hanmi wins approval for Korea's first homegrown obesity drug(2026)Independently confirms the October 7 approval and the regulator. Names the product Efe Auto-Injector Injection and gives the presentation as an auto-injector with strengths of 2, 4, 6, 8 and 10 mg, dosed once weekly subcutaneously at any time of day regardless of meals. Notes Hanmi has run phase 3 trials in Korean patients since 2023 and planned to launch as early as October 2026. Reports no efficacy figures.
- Hanmi conference poster, EASD 2015, PS069-792(2015)Titled LAPSCA-Exendin-4 (efpeglenatide) Enhances Insulin Secretion and Beta Cell Responsiveness in Subjects with Type 2 Diabetes, and its abstract calls the agent LAPS Exendin-4 (HM11260C), and that is what ties the three names together. Describes it as a conjugate of exendin-4 linked to a non-glycosylated Fc molecule, studied on a flexible regimen from weekly to monthly, with cohort A at 6 mg weekly and cohort B at 16 mg monthly. Gives no half-life itself; it points to a companion poster on the phase 2 dose-finding study reporting a half-life of about 158 hours and a flat pharmacokinetic profile, and that is where the figure on this page comes from.
- Hanmi conference poster, ADA 2014, 1009-P(2014)Titled A Long-Acting Exendin-4 Analog Conjugate to the Human Fc Fragment Reveals Low Immunogenic Potential. Describes the construct as a human Fc fragment attached at the 27th amino acid of CA-Exendin-4 by site-specific conjugation, in three parts: a CA-Exendin-4 core carrying a single amino acid modification relative to exendin-4, a flexible linker to limit loss of activity, and an aglycosylated Fc to improve solubility. This poster does not use the name efpeglenatide, so the identity link rests on the 2015 poster above.
- Gerstein and colleagues, New England Journal of Medicine, the AMPLITUDE-O trial(2021)Cardiovascular and Renal Outcomes with Efpeglenatide in Type 2 Diabetes, volume 385, issue 10, pages 896 to 907, September 2, 2021. Weekly subcutaneous efpeglenatide at 4 or 6 mg against placebo in 4,076 randomized patients, 2,717 on drug and 1,359 on placebo, all with type 2 diabetes and HbA1c above 7 percent plus established cardiovascular disease or kidney disease and a further risk factor. Mean age 65, 33 percent female, mean diabetes duration 15 years, follow-up 1.8 years. The primary composite of death, myocardial infarction or stroke occurred in 7.0 percent against 9.2 percent, P of 0.007. By dose, 6 mg gave a hazard ratio of 0.65 with a 95 percent interval of 0.50 to 0.86 while 4 mg gave 0.82 with an interval of 0.63 to 1.06. Cardiovascular mortality at 6 mg was 0.55 with an interval of 0.35 to 0.88. The kidney outcome occurred in 13.0 percent against 18.4 percent, P below 0.001, with 6 mg at 0.61 and an interval of 0.42 to 0.87. Figures read from the American College of Cardiology trial summary; the DOI was resolved at Crossref.
Beyond these, 73 records are indexed. Browse the records