Hanmi's weekly exendin-based GLP-1 drug, approved in South Korea for weight management in October 2026 as Eppe. Not FDA approved.
Also called Eppe, Eppe Auto Injector, Epe, Epe Auto-Injector, Efpe, Effpe, HM11260C, SAR439977, langlenatide, AMPLITUDE-O
When Efpeglenatide's status or evidence changes, it's in the next morning's email.
Efpeglenatide is a once-weekly GLP-1 receptor agonist from Hanmi Pharmaceutical. It is built on exendin-4, the Gila monster peptide behind exenatide, and joined through a polyethylene glycol linker to a piece of a human antibody (an IgG4 Fc fragment). That bulky partner slows clearance from the body and gives it a half-life of about 5.5 to 7.5 days.
Sanofi licensed it in 2015 for type 2 diabetes and ran the AMPLITUDE program. In AMPLITUDE-O, 4,076 people with type 2 diabetes and heart or kidney disease had fewer heart attacks, strokes or cardiovascular deaths on efpeglenatide than on placebo (7.0% vs 9.2%, hazard ratio 0.73). Sanofi stopped funding the program and returned the rights in 2020, and Hanmi switched the focus to obesity.
On October 7, 2026, Korea's Ministry of Food and Drug Safety approved it as the Eppe Auto-Injector (Korean name 에페, also romanized Epe) for chronic weight management in adults without diabetes. The approval rests on a Korean phase 3 trial of 448 adults that has not yet been published. According to news reports, weight fell 9.02% versus 0.89% on placebo at 40 weeks; Hanmi's earlier interim readout reported 9.75% versus 0.95%. Either figure is less than semaglutide or tirzepatide give in their own trials. It is not approved by the FDA or EMA.
What it binds to, and what happens inside the body after that, step by step.
Efpeglenatide activates the GLP-1 receptor, like semaglutide and exenatide. That raises insulin when blood sugar is high, lowers glucagon, slows stomach emptying and reduces appetite. The antibody fragment it carries keeps it out of the kidneys and in circulation for days, so it can be given weekly.
Human results and animal results are kept apart below. A result in rats tells you a mechanism is plausible. It does not tell you what happens in a person.
An approved drug in South Korea, with multiple phase 3 RCTs: a 4,076-person cardiovascular outcomes trial showing fewer heart and kidney events in type 2 diabetes, several glucose-lowering trials, and a Korean obesity trial. The obesity phase 3 result is known only from company and news reports, not yet a peer-reviewed paper. Several Sanofi trials were stopped early for funding reasons, not safety.
4,076 adults with type 2 diabetes and heart disease or chronic kidney disease
Heart attack, stroke or cardiovascular death in 7.0% on efpeglenatide vs 9.2% on placebo over a median 1.81 years (hazard ratio 0.73); kidney events 13.0% vs 18.4%.
Read the study448 Korean adults with obesity, average BMI 32, no diabetes
According to news reports, weight fell 9.02% vs 0.89% on placebo at 40 weeks and 75.1% vs 13.5% lost at least 5%; Hanmi's interim topline reported 9.75% vs 0.95%.
Read the study297 adults with BMI 30 or higher, or 27 with a related condition
Placebo-adjusted weight loss of 6.3 to 7.2 kg over 20 weeks; 5% to 19% stopped for side effects.
Read the study406 adults with type 2 diabetes on diet and exercise only
HbA1c fell 0.5 to 1.0 points more than placebo at 30 weeks on 2, 4 or 6 mg.
Read the studyAdults with type 2 diabetes on oral drugs or basal insulin
HbA1c lowering was non-inferior to dulaglutide 1.5 mg; all three trials were stopped early by the sponsor for funding reasons.
Read the study119 adults with type 2 diabetes in two phase 2 studies
Half-life was 135 to 180 hours and peak levels came 48 to 144 hours after a dose.
Read the studyNo preclinical studies are listed as key studies here. The human data above carries the evidence.
When a new Efpeglenatide study in people is published, the daily email covers it.
These are questions the published research has not answered.
Approved by Korea's Ministry of Food and Drug Safety on October 7, 2026, as Korea's 45th domestically developed new drug (MFDS press release, October 7, 2026). Hanmi filed in December 2025, according to news reports, and news reports said launch was planned for late October 2026. The company reported that it is running a phase 3 diabetes trial in Korea and targets approval for diabetes in 2028. Not approved by the FDA or EMA. WADA: not named on the 2026 or 2027 Prohibited List and, because it now has a government approval, S0 does not apply. Unlike semaglutide and tirzepatide, it is not on the WADA Monitoring Program.
When the FDA or WADA changes Efpeglenatide's status, it's in the next morning's email.
How much of Efpeglenatide is left after a single dose
Simple first-order model from the published half-life. Real clearance varies with dose, route, kidney and liver function and formulation. This is not a dosing schedule.
This table records the doses that trials and approved labels used, with the source for each row. It is a record of research, not a recommendation, and it is open to free members.
Which symptoms are expected and which mean stop and get help: side effects and red flags.
Tap a claim to see what the studies found.
The Korean trial showed 9.02% weight loss at 40 weeks; semaglutide 2.4 mg showed 14.9% at 68 weeks in its own trial. The trials differ in length and population and were not head to head, but there is no evidence it matches semaglutide.
It is approved only in South Korea (October 2026). Sanofi's US diabetes program was stopped in 2020 and no US filing has been announced.
In AMPLITUDE-O, major cardiovascular events fell 27% in people with type 2 diabetes and heart or kidney disease. That has not been shown in people with obesity alone.
GI side effect rates in the Korean trial (nausea 16.6%, vomiting 11.6%) were lower than reported for Wegovy, but no head-to-head trial has tested this.
Supplied as a ready-to-use auto-injector, not a powder. Storage instructions from the Korean label were not available in a source we could verify.
Not applicable.
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