Is efpeglenatide FDA-approved, and what does the research show?

What is efpeglenatide?

In the United States, efpeglenatide is an investigational drug, meaning one still being tested in clinical trials; the one recruiting trial cited here is in South Korea ³. It is not FDA-approved, and with no FDA-approved product there is none to prescribe in the United States ², ⁴. South Korea's Ministry of Food and Drug Safety (MFDS) approved it on October 7, 2026, as a prescription medicine (Hanmi's EPPE auto-injector) for chronic weight management in adults without diabetes ⁵. It is not a wellness or performance peptide. Trial registry entries also list it under the code names HM11260C, LAPS-Exendin and SAR439977 ⁷, ⁸.

The investigators of AMPLITUDE-O, the largest trial cited here, call efpeglenatide "an exendin-based GLP-1 receptor agonist" ¹. GLP-1, glucagon-like peptide-1, is a hormone that prompts the release of insulin after glucose is swallowed ⁹. A receptor agonist is a drug that switches on the receptor a hormone acts through. The class has two structural families, one built on human GLP-1 and one on a peptide called exendin-4 ⁹. Efpeglenatide's investigators describe a modified exendin joined to part of a human antibody by a short polymer linker, which gives it a long duration of action ¹⁰.

Other medicines of the class are used to treat type 2 diabetes, a condition of raised blood sugar, and in some cases obesity ⁹. FDA's records list no approved efpeglenatide product for either use ², ⁴. South Korea's label gives its use as chronic weight management, alongside a low-calorie diet and exercise, in adults without diabetes who have obesity or overweight with a weight-related condition ⁵.

Is efpeglenatide FDA-approved?

Efpeglenatide is not FDA-approved: Drugs@FDA lists no approved efpeglenatide product as of November 9, 2026 ². The October 2026 data file of FDA's Purple Book, its database of licensed biological products, has no efpeglenatide row either ⁴. That file's lower section lists every product in the Purple Book database for the month ⁴. With no approved product in either record, no FDA-approved label, the document that sets out a drug's uses and warnings, is cited here ², ⁴.

Trials continue. A phase 3 trial sponsored by Hanmi Pharmaceutical is recruiting in South Korea, with an estimated enrollment of 118 ³. It enrolls people whose type 2 diabetes is inadequately controlled with metformin and dapagliflozin ³. A phase 3 trial is a late-stage trial, the kind a company runs to support an application for approval. The registry estimates this one's primary completion for November 2027 ³.

ClinicalTrials.gov records four of the five phase 3 AMPLITUDE trials cited here, all four sponsored by Sanofi, as "Terminated" ⁸, ¹¹, ¹², ¹³. For AMPLITUDE-O, the largest, Sanofi's entry gives the reason as "Sponsor decision to cancel TRIAL, not related to safety concern" ⁸. The other three entries give the same reason ¹¹, ¹², ¹³. The fifth trial, AMPLITUDE-M, is recorded as completed ¹⁴. No company statement is cited here on why the four trials were "Terminated" or on who holds the rights to the drug today.

In the United States, no source cited here shows a lawful route to efpeglenatide outside a clinical trial. Compounding means a pharmacy customizing a medicine for an individual patient ⁹. FDA's list of substances nominated for pharmacy compounding under section 503A of the drug law, updated May 14, 2026, does not name efpeglenatide ¹⁵. Nor does the matching list for outsourcing facilities under section 503B, updated March 21, 2025 ¹⁶.

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How does efpeglenatide work?

Efpeglenatide is a GLP-1 receptor agonist, so its proposed actions are those of its class ¹. In type 2 diabetes the insulin release that GLP-1 prompts can be blunted or absent ⁹. At the levels a drug supplies, GLP-1 can revive that insulin release ⁹.

Drugs of the class also delay the emptying of the stomach ⁹. They hold back the pancreas's production of glucagon, a hormone that raises blood sugar, when blood sugar is high ⁹. A clinical reference chapter on the class lists "increased satiety due to direct actions on the hypothalamus" as well ⁹. Satiety is the feeling of fullness, and the hypothalamus is a part of the brain.

South Korea's label says efpeglenatide delays stomach emptying and reports a test of this in people with type 2 diabetes ⁵. No source cited here tested its other proposed actions with efpeglenatide itself. AMPLITUDE-O gave it as an injection under the skin once a week ¹, ⁸.

What does the research show?

Studied in people: AMPLITUDE-O, a randomized, double-blind, placebo-controlled phase 3 trial, 4,076 participants, first major adverse cardiovascular event ¹, ⁸. Randomized means chance decided each person's group. Placebo-controlled means a dummy injection for comparison. Double-blind means neither participants nor investigators knew who had which.

Everyone enrolled had type 2 diabetes and either a history of cardiovascular disease or current kidney disease plus at least one other cardiovascular risk factor ¹. The registry adds an entry requirement of HbA1c above 7% ⁸. HbA1c is a blood test of average blood sugar over recent months. The trial ran at 344 sites in 28 countries ¹. Participants were assigned in equal numbers to one of two weekly doses of efpeglenatide or to placebo ¹.

The primary outcome was a major adverse cardiovascular event, called MACE ¹. It counted a nonfatal heart attack, a nonfatal stroke, or death from cardiovascular or undetermined causes ¹. Over a median follow-up of 1.81 years, MACE occurred in 189 of the 2,717 participants assigned to either dose of efpeglenatide, or 7.0% ¹. It occurred in 125 of the 1,359 assigned to placebo, or 9.2% ¹.

The trial compared the groups with a hazard ratio, where a figure below 1 means fewer events over time in the efpeglenatide groups. A 95% confidence interval is the range in which the true figure plausibly lies. The hazard ratio for MACE was 0.73, with a 95% confidence interval of 0.58 to 0.92 ¹.

A combined kidney outcome, a decrease in kidney function or macroalbuminuria, was also measured ¹. Macroalbuminuria is a large amount of the protein albumin in the urine. It occurred in 353 participants assigned to efpeglenatide, 13.0%, and in 250 assigned to placebo, 18.4% ¹. The hazard ratio was 0.68, with a 95% confidence interval of 0.57 to 0.79 ¹.

An exploratory analysis of AMPLITUDE-O looked at participants also taking an SGLT2 inhibitor, another class of diabetes medicine ¹⁷. At the start 618 participants, 15.2%, were taking one ¹⁷. The hazard ratio for MACE was 0.74 without an SGLT2 inhibitor and 0.70 with one, with 95% confidence intervals of 0.58 to 0.94 and 0.37 to 1.30 ¹⁷.

The registry records AMPLITUDE-O as "Terminated" ⁸. Its participant table, the three arms added together, shows 3,184 of the 4,076 participants leaving because the study was terminated by the sponsor ⁸. AMPLITUDE-O's changes in HbA1c and body weight are not among the results cited here ¹, ¹⁷, ⁸.

Studied in people: AMPLITUDE-M, a randomized, double-blind, placebo-controlled phase 3 trial, 406 adults with type 2 diabetes inadequately controlled with diet and exercise, change in HbA1c at week 30 ¹⁴. Entry required an HbA1c between 7.0% and 10.0% ¹⁴. By the registry's participant table, each of the four arms started with 100 to 103 participants: placebo and a low, a middle and a high dose of efpeglenatide ¹⁴. Their average body mass index, or BMI, a measure of weight for height, was 34.2 at the start ¹⁴.

By the registry's posted results for AMPLITUDE-M, mean HbA1c fell by 0.46 percentage points with placebo ¹⁴. It fell by 1.14, 1.48 and 1.59 points in the low-, middle- and high-dose efpeglenatide arms ¹⁴. Mean body weight at week 30 fell by 1.35 kilograms with placebo ¹⁴. It fell by 1.01, 3.34 and 3.19 kilograms in the three efpeglenatide arms, lowest dose first ¹⁴. At week 56 the falls were 1.26 kilograms with placebo and 0.94, 3.24 and 1.82 kilograms with efpeglenatide ¹⁴.

The registry posts these means without a statistical comparison ¹⁴. They describe people with type 2 diabetes, and they say nothing about people without it.

Two more placebo-controlled phase 3 trials, both recorded as "Terminated," post results only for the participants who were measured, again without a statistical comparison ¹¹, ¹². AMPLITUDE-L enrolled 370 adults with type 2 diabetes inadequately controlled with basal insulin, alone or with oral diabetes medicines ¹¹. Basal insulin is a long-acting background insulin. Among the 245 with a week-30 measure, mean HbA1c fell by 0.33 points with placebo ¹¹. It fell by 1.27, 1.24 and 1.43 points in the three efpeglenatide arms, lowest dose first ¹¹.

Among the 247 AMPLITUDE-L participants measured for weight, mean weight at week 30 rose by 0.29 kilograms with placebo ¹¹. It fell by 0.68, 1.99 and 3.14 kilograms in the three efpeglenatide arms, lowest dose first ¹¹.

AMPLITUDE-S enrolled 312 adults with type 2 diabetes inadequately controlled with metformin, alone or with a sulfonylurea ¹². Both are diabetes medicines taken by mouth. Among the 193 measured at week 30, mean HbA1c fell by 0.27 points with placebo ¹². It fell by 1.05, 1.46 and 1.36 points in the three efpeglenatide arms, lowest dose first ¹². Among the 187 measured for weight, it fell by 1.89 kilograms with placebo and by 2.49, 2.72 and 3.87 kilograms in the same three arms ¹².

Studied in people: AMPLITUDE-D, a randomized, open-label phase 3 trial, 908 adults with type 2 diabetes inadequately controlled with metformin, change in HbA1c at week 56 ¹³. Its comparator was dulaglutide, an FDA-licensed weekly GLP-1 medicine, with no placebo arm ¹³, ⁴. Open-label means participants and investigators knew which drug was given. The registry records this trial as terminated too ¹³.

In the 761 AMPLITUDE-D participants analyzed, HbA1c fell by 1.12 and 1.17 points in the two efpeglenatide arms and by 1.09 points with the comparator ¹³. The differences from the comparator were −0.03 and −0.08 points, with 95% confidence intervals of −0.20 to 0.14 and −0.25 to 0.09 ¹³. The trial tested noninferiority, meaning no worse than the comparator by more than a set margin, here 0.3 points ¹³. Weight fell by 2.87 and 3.04 kilograms with efpeglenatide and by 2.81 kilograms with the comparator ¹³. The comparison is the trial's own, in people with type 2 diabetes taking metformin.

Two registered trials enrolled adults with obesity and no diabetes, and neither has posted results on the registry ⁶, ⁷. Hanmi's phase 2, or mid-stage, trial enrolled 297 adults in the United States for 20 weeks of efpeglenatide or placebo, and was completed in 2015 ⁷. Its phase 3 trial enrolled 448 adults in South Korea and was completed in March 2026 ⁶. Entry required a BMI of 30 or more, or of 27 to under 30 with risk factors such as high blood pressure ⁶. Percent change in body weight at 40 weeks, against placebo, is one of its two primary outcomes ⁶.

The phase 2 trial's results were published in 2019 ¹⁰. South Korea's label for the product reports a phase 3 trial in 448 Korean adults without diabetes who had obesity, or overweight with a weight-related condition ⁵. By the label's estimates for the 298 and 148 analyzed, body weight fell 9.02% with efpeglenatide and 0.89% with placebo over 40 weeks, a difference of 8.13 percentage points ⁵. Its size, BMI ranges and 40-week placebo comparison match Hanmi's registered phase 3 trial in South Korea, whose record posts no results as read on November 10, 2026 ⁶, ⁵. No source cited here reports a trial of efpeglenatide in children or a head-to-head trial against semaglutide or tirzepatide.

What are the side effects?

No FDA-approved label is cited here, so the documented side effects come from the trials ², ⁴. All of the figures below are from people with type 2 diabetes.

The AMPLITUDE-O paper reports that "Diarrhea, constipation, nausea, vomiting, or bloating occurred more frequently with efpeglenatide than with placebo" ¹. The registry's safety tables count 1,355 participants on placebo, 1,360 on the lower dose and 1,358 on the higher dose ⁸. In its table of events not classed as serious, which has a 5% reporting threshold, nausea was recorded in 51, 196 and 167 of them, in that order ⁸. The same table records diarrhea in 64, 116 and 117, and vomiting in 18, 85 and 75 ⁸. It records decreased appetite in 15, 68 and 77, and hypoglycemia, low blood sugar, in 37, 73 and 53 ⁸.

Serious adverse events were recorded in 298 participants on placebo, 312 on the lower dose and 275 on the higher dose ⁸. Deaths recorded during the treatment period numbered 49, 40 and 25 ⁸. Participants who left the trial because of an adverse event numbered 49, 68 and 79 ⁸. Acute pancreatitis, a sudden inflammation of the pancreas, was listed as a serious event in four, three and two participants ⁸.

In AMPLITUDE-M's safety table, nausea was recorded in 2 of 102 participants on placebo ¹⁴. On the three efpeglenatide doses, lowest first, it was recorded in 6 of 102, 15 of 103 and 22 of 99 ¹⁴. Across the four arms in the same order, diarrhea was recorded in 9, 9, 17 and 25, and vomiting in 0, 3, 8 and 9 ¹⁴. One death was recorded, in the high-dose arm ¹⁴.

AMPLITUDE-O did not enroll everyone. It excluded people with a personal or family history of medullary thyroid cancer, a cancer that starts in the thyroid's C cells, and people with chronic pancreatitis ⁸. It also excluded people with a gastrointestinal disease that causes prolonged nausea and vomiting ⁸. Its results therefore say nothing about safety in those groups.

For the class as a whole, the reference chapter reports acute pancreatitis in users of GLP-1 drugs ⁹. Whether the drugs cause it, the chapter says, "is still unknown" ⁹. It describes thyroid C-cell changes in rodents given one drug of the class, and adds, "The effects on humans remain unclear" ⁹. South Korea's label reports thyroid C-cell tumors in rats given efpeglenatide, and says their relevance to people is not known but cannot be ruled out ⁵.

In sport

WADA, the World Anti-Doping Agency, does not name efpeglenatide on its 2026 Prohibited List ¹⁸. The list names neither its code names nor exendin, GLP-1 or GLP-1 receptor agonists as a class ¹⁸.

The list's section S0 reads: "Any pharmacological substance which is not addressed by any of the subsequent sections of the List and with no current approval by any governmental regulatory health authority for human therapeutic use (e.g. drugs under pre-clinical or clinical development or discontinued, designer drugs, substances approved only for veterinary use) is prohibited at all times" ¹⁸. Neither Drugs@FDA nor the Purple Book lists an approved efpeglenatide product ², ⁴. South Korea's Ministry of Food and Drug Safety approved efpeglenatide on October 7, 2026 ⁵. Its label gives the use as chronic weight management in adults without diabetes who have obesity or overweight with a weight-related condition ⁵.

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JumpstartMD does not prescribe efpeglenatide. Our peptide library covers it so you have the facts on its FDA status and the evidence, current as of November 10, 2026.

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