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

What is lixisenatide?

Lixisenatide is a type 2 diabetes drug, not a wellness, weight-loss or performance peptide. The label calls it "a synthetic analogue of human GLP-1" that "acts as a GLP-1 receptor agonist" ¹. GLP-1, glucagon-like peptide-1 ¹, is a hormone the gut releases after a meal; a receptor agonist ¹ is a molecule that switches on the same receptor the hormone uses. Other GLP-1 receptor agonists include exenatide and dulaglutide, each named one in its FDA label ², ⁷. GLP-1 is an incretin, a gut hormone that, after release into the blood, enhances glucose-dependent insulin secretion ².

The molecule is a chain of 44 amino acids, modified at one end, weighing about 4.9 kilodaltons, the unit used for a molecule's mass ¹. Sanofi-Aventis U.S. holds the FDA application for it, numbered 208471 ³, ⁴. Lixisenatide was approved alone as Adlyxin and, with insulin glargine, as Soliqua 100/33 ³, ⁵, ⁴.

Is lixisenatide FDA-approved?

Yes, FDA approved lixisenatide as the prescription medicine Adlyxin on July 27, 2016, and FDA's Purple Book now lists Adlyxin as discontinued ³, ⁴. FDA approved it as NDA 208471, and its records now file it as BLA 208471, a biologics license application, the form of approval FDA gives a biological product ³, ⁴. The label approves it "as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus," and that is its only approved use ¹. The label lists no indication for weight loss or obesity ¹.

FDA's two records of Adlyxin disagree on whether it is still marketed. The Purple Book, FDA's database of licensed biological products, lists both Adlyxin strengths with the marketing status "Disc" ⁴. The Purple Book's glossary reads that mark as "The product has been discontinued," and it records no FDA finding on the reason ⁴. Drugs@FDA lists both with marketing status "Prescription" as of November 9, 2026, the date of its data ³. The same record shows a labeling supplement approved on March 12, 2026 ³.

FDA's drug shortages and discontinuations database held no lixisenatide entry as of November 10, 2026, so FDA states no reason there. A consumer pharmacy-discount site, not a primary source, reports that Sanofi announced on October 20, 2022 that it would stop selling Adlyxin in the United States ⁸. The same page says the drug stays on sale in other countries ⁸.

Lixisenatide is also approved in a combination product. Soliqua 100/33 combines it with insulin glargine, a long-acting insulin analog ⁵. FDA approved it on November 21, 2016 under an NDA, now BLA 208673, and Drugs@FDA lists it as "Prescription" as of November 9, 2026 ³.

Its label indicates it "as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus" ⁵. The same label says that use "with any other product containing lixisenatide or another glucagon-like peptide-1 (GLP-1) receptor agonist is not recommended" ⁵. The route to Soliqua 100/33 is a licensed clinician's prescription ⁵.

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How does lixisenatide work?

The label of this approved drug puts the mechanism in one sentence: lixisenatide "increases glucose-dependent insulin release, decreases glucagon secretion, and slows gastric emptying" ¹. Glucose-dependent ¹ means the insulin signal comes when blood sugar is high, not at all times. Glucagon is the pancreatic hormone that raises blood sugar, and gastric emptying is the passage of food from the stomach into the intestine. Slowed emptying also holds back medicines taken by mouth, and the label names antibiotics, acetaminophen and oral contraceptives as the ones to watch ¹.

A clinical pharmacology study is a study of how a drug acts in the body. In one, adults with type 2 diabetes on Adlyxin had a fasting plasma glucose 33.8 mg/dL lower than on placebo ¹. Their glucose rise after a standardized test meal was smaller too, most at the first meal of the day and less at later meals ¹. The label gives neither the number of participants nor the study's length ¹. No rise in mean heart rate was seen in placebo-controlled studies ¹.

What does the research show?

The evidence is at the top tier, FDA approval on randomized trials, in which patients are assigned by chance to the drug or to placebo, an inactive injection ¹. A large heart outcomes trial followed ⁶. The label's trials tested lixisenatide alone, added to oral diabetes drugs and added to basal insulin, against placebo, exenatide and insulin glulisine ¹. HbA1c, or hemoglobin A1c, is the blood measure of glucose control these trials used ¹. A published meta-analysis pooled five placebo-controlled lixisenatide trials "from the GetGoal programme," and the exenatide trial was published as GetGoal-X ⁹, ¹⁰.

Alone against placebo: a 12-week double-blind trial, where no one knew who had the drug, randomized 241 adults with type 2 diabetes not controlled by diet and exercise ¹. HbA1c fell by 0.83 points in the 119 on lixisenatide and by 0.18 in the 122 on placebo ¹. The difference was 0.65 points, with a 95 percent confidence interval, the range in which the true difference most likely lies, of 0.40 to 0.90 ¹. An HbA1c below 7 percent was reached by 44 percent on lixisenatide against 24 percent on placebo ¹. Weight loss did not differ: 1.9 kilograms against 2.0 ¹.

Added to metformin, a 24-week trial randomized 323 patients ¹. HbA1c fell by 0.72 points in the 161 on lixisenatide and by 0.26 in the 162 on placebo, a difference of 0.46 ¹. Weight fell by 2.7 kilograms against 1.7, a difference of 1.0 kilogram ¹. A sulfonylurea ¹ is an older pill that makes the pancreas release insulin, an insulin secretagogue in the label's words ¹. In a 24-week trial of 391 Asian patients on metformin with or without one, the HbA1c difference was 0.27 points ¹.

Added to a sulfonylurea, with or without metformin, a 24-week trial randomized 859 patients ¹. HbA1c fell by 0.77 points in the 573 on lixisenatide and by 0.18 in the 286 on placebo, a difference of 0.58 ¹. An HbA1c below 7 percent was reached by 33 percent against 13 ¹. Added to pioglitazone ¹, a pill that makes the body more responsive to insulin, the difference was 0.48 points in a 24-week trial of 484 patients ¹. Weight fell by 0.1 kilograms on lixisenatide and rose by 0.3 on placebo, with no difference reported ¹.

Added to basal insulin, a long-acting background insulin, three 24-week trials each showed a statistically significant HbA1c reduction against placebo ¹. The HbA1c difference from placebo was 0.36 points in 496 patients on basal insulin with or without metformin ¹. It was 0.76 in 311 Asian patients on basal insulin with or without a sulfonylurea, and 0.28 in 446 patients on insulin glargine and metformin ¹. In the glargine trial, weight rose by 0.3 kilograms on lixisenatide and by 1.1 on placebo ¹.

Head to head, a 24-week open-label trial randomized 634 patients on metformin to lixisenatide or exenatide twice daily ¹. HbA1c fell by 0.73 points in the 318 on lixisenatide and by 0.90 in the 316 on exenatide ¹. Lixisenatide met the trial's noninferiority margin, meaning it was no worse than exenatide by more than 0.4 points ¹. But the difference of 0.17 points in exenatide's favor was statistically significant ¹. Weight fell by 2.7 kilograms on lixisenatide and 3.7 on exenatide ¹.

Against mealtime insulin, a 26-week open-label trial randomized 894 patients on basal insulin, 298 to each of three arms ¹. The arms were lixisenatide, insulin glulisine once a day, and glulisine three times a day; glulisine is a rapid-acting mealtime insulin ¹. HbA1c fell by 0.57 points on lixisenatide, 0.53 on once-daily glulisine and 0.80 on three-times-daily glulisine ¹. Lixisenatide was noninferior to both, and lowered HbA1c less than the three-times-daily regimen by 0.23 points ¹. Weight fell by 0.64 kilograms on lixisenatide while the two glulisine arms gained 0.98 and 1.26 ¹.

Studied in people for heart outcomes: ELIXA, published in December 2015, randomized 6,068 patients with type 2 diabetes ⁶. Each had had, within the previous 180 days, a heart attack or a hospital stay for unstable angina, chest pain from a narrowed heart artery ⁶. They received lixisenatide or placebo on top of usual care and were followed for a median of 25 months ⁶. The primary outcome was a composite of cardiovascular death, heart attack, stroke or hospitalization for unstable angina ⁶.

It occurred in 406 patients (13.4 percent) on lixisenatide and 399 (13.2 percent) on placebo ⁶. That is a hazard ratio, the event rate on the drug relative to placebo, of 1.02, with a 95 percent confidence interval of 0.89 to 1.17 ⁶. The trial was built to test two things: that lixisenatide was no worse than placebo, which it showed, and that it was better, which it did not ⁶. Hospitalization for heart failure had a hazard ratio of 0.96 (0.75 to 1.23) and death from any cause 0.94 (0.78 to 1.13), neither significant ⁶.

By component, cardiovascular death occurred in 88 patients (2.9 percent) on lixisenatide and 93 (3.1 percent) on placebo ¹. Nonfatal heart attack occurred in 255 (8.4 percent) against 247 (8.1 percent) ¹. The median age was 60, 69 percent were men, the median body mass index, weight relative to height, was 29.4, and 3,034 were randomized to each arm ¹. Sanofi funded the trial ⁶. The label approves no cardiovascular use, and ELIXA is on the label as a safety result, not a benefit ¹.

Neither the label nor ELIXA reports a trial of lixisenatide for weight management or in people without diabetes ¹, ⁶. All of these trials enrolled people with type 2 diabetes, so the weight changes are that population's ¹. On lixisenatide the 24-week changes ran from a loss of 2.7 kilograms, where placebo lost 1.7, to a gain of 0.3, where placebo gained 1.1 ¹.

What are the side effects?

Stomach and gut effects lead. In the label's pool of placebo-controlled trials, 2,869 patients with type 2 diabetes took Adlyxin for a mean of 21.7 weeks, against 1,639 on placebo ¹. Nausea was reported by 25 percent on Adlyxin against 6 percent on placebo, and vomiting by 10 against 2 ¹.

Headache was reported by 9 against 6, diarrhea by 8 against 6, and dizziness by 7 against 4 ¹. A gastrointestinal reaction of any kind occurred in 39.7 percent against 18.4, and 4.3 percent stopped treatment because of one, against 0.5 percent on placebo ¹. Most occurred in the first three weeks; investigators graded 3.5 percent of them severe ¹.

Hypoglycemia, low blood sugar, depends on what else is taken: alone, 2 percent had a symptomatic episode on either arm over 12 weeks ¹. With a sulfonylurea, 15 percent did against 11 on placebo; with basal insulin, 28 against 23; with basal insulin and a sulfonylurea, 47 against 22 ¹. Severe hypoglycemia, needing another person's help, occurred in 1 percent on Adlyxin with basal insulin, with or without metformin, against none on placebo ¹. With insulin glargine and metformin it was 0.4 percent against none ¹. The label warns that patients on basal insulin or a sulfonylurea "have an increased risk of hypoglycemia, including severe hypoglycemia" ¹.

Pancreatitis occurred in 21 Adlyxin-treated patients and 14 comparator-treated patients in the trials ¹. That is 21 against 17 cases per 10,000 patient-years, a measure that adds up each patient's time on the drug ¹. Cases meeting the trial definition of anaphylaxis occurred at 0.2 percent, 16 per 10,000 patient-years, against 0.1 percent on placebo ¹. Those determined to be related to Adlyxin were 0.1 percent, 10 per 10,000 patient-years ¹.

Seventy percent of patients developed antibodies to lixisenatide, and the 2.4 percent with the highest levels showed "an attenuated glycemic response" and more allergic and injection-site reactions ¹. In ELIXA, gallstones occurred in 0.4 percent against 0.2, and acute gallbladder inflammation in 0.3 against 0.2 ¹. The ELIXA authors reported no higher rate of serious adverse events, severe hypoglycemia, pancreatitis, pancreatic tumors or allergic reactions than on placebo ⁶.

The Adlyxin label carries no boxed warning ¹. Its contraindication is "known severe hypersensitivity to lixisenatide or to any component of ADLYXIN" ¹. Its warnings cover anaphylaxis and serious hypersensitivity reactions, pancreatitis, hypoglycemia with insulin or an insulin secretagogue, acute kidney injury and severe gastrointestinal reactions ¹. They also cover immunogenicity, acute gallbladder disease and never sharing a pen ¹.

A further warning covers pulmonary aspiration, stomach contents entering the lungs, under general anesthesia or deep sedation ¹. It was reported with GLP-1 receptor agonists "despite reported adherence to preoperative fasting recommendations" ¹. Acute kidney injury, "in some cases requiring hemodialysis, in patients treated with GLP-1 receptor agonists," was reported after approval, mostly after nausea, vomiting, diarrhea or dehydration ¹. The label says Adlyxin "is not recommended in patients with end stage renal disease" ¹.

The label says Adlyxin "is not recommended in patients with severe gastroparesis," a condition in which the stomach empties slowly ¹. Reports after approval add gallbladder inflammation, gallstones needing surgery, ileus, a stoppage of the bowel, bowel obstruction, severe constipation, a distorted sense of taste, altered skin sensation and hair loss ¹. In rats, thyroid C-cell tumors, tumors of one cell type in the thyroid gland, rose at all doses, at exposures at least 15 times the human exposure ¹. In pregnancy the label says Adlyxin "should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus" ¹.

In sport

Lixisenatide is not named on the 2026 Prohibited List of WADA, the World Anti-Doping Agency, and GLP-1 receptor agonists are not a listed class ¹¹. The list names "Insulins and insulin-mimetics" in section S4.4.2, under metabolic modulators ¹¹. Soliqua 100/33 contains insulin glargine, an insulin analog, and insulins are named there ⁵, ¹¹.

What JumpstartMD offers

JumpstartMD does not prescribe lixisenatide. 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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Compounded medications are not FDA-approved, and FDA does not review their safety, effectiveness, or quality before they are marketed. A licensed clinician decides after an evaluation whether a peptide is appropriate for you, and not every patient will qualify.