What Is Adlyxin?

1. What was Adlyxin approved for?

One indication: to improve glycemic control in adults with type 2 diabetes, alongside diet and exercise. The Medication Guide added that it was not for type 1 diabetes and had not been studied in children. It never had a weight-loss or cardiovascular indication: in GetGoal-Mono, the 12-week monotherapy trial, weight fell 1.9 kg on Adlyxin versus 2.0 kg on placebo, not a significant difference, and in the head-to-head GetGoal-X trial it produced less weight loss than exenatide (94.5 to 91.7 kg versus 96.7 to 92.9 kg). Unlike the weekly drugs approved after it, its outcomes trial found no cardiovascular benefit to add. Anyone searching for a weight-loss GLP-1 today should look at semaglutide or tirzepatide instead.

The label also said Adlyxin had not been studied in patients with gastroparesis and was not recommended for them, and that other antidiabetic therapies should be considered for anyone with a history of pancreatitis.

Mechanically, lixisenatide is a GLP-1 receptor agonist: it raises glucose-dependent insulin release, lowers glucagon secretion, and slows gastric emptying. In a pharmacology study, a 20 mcg dose reduced postprandial blood glucose AUC over 300 minutes by 387 mg·h/dL against placebo after a standardized meal, an effect strongest at the first meal of the day and weaker at later meals, which is the pharmacologic reason the dose was tied to that first meal. At 1.5 times the recommended dose, it did not prolong the QTc interval to a clinically relevant extent, and no increase in heart rate was seen in placebo-controlled studies.

2. How was Adlyxin dosed?

Each pen held 14 doses. The morning-meal rule follows from the half-life: with the drug cleared in hours, injecting it before the day’s first meal put its peak where the glucose rise was. A missed dose was taken within the hour before the next meal, never doubled. Injection sites were the abdomen, thigh, or upper arm, rotated with each dose. The label required training with a practice injection before first use, and a visual check each time: the solution had to be clear and colorless, discarded if cloudy or particulate.

Storage followed the pen’s life in two stages. Before first use, both pens went in a refrigerator at 36°F to 46°F (2°C to 8°C), never frozen, kept in the original carton to block light. After the first injection, the same pen could sit at room temperature up to 86°F (30°C), cap replaced after each use, but had to be discarded 14 days after that first dose regardless of doses left in it.

3. What did the Adlyxin trials show?

In the GetGoal program, lixisenatide lowered HbA1c against placebo across five separate efficacy sections — alone, added to metformin, added to a sulfonylurea, added to pioglitazone, or added to basal insulin — each run with and without a second oral drug. In GetGoal-Mono, the 12-week monotherapy trial, the placebo-adjusted least-squares mean HbA1c difference was 0.54 to 0.66 percentage points, depending on titration schedule. The number that defined the drug came from ELIXA, its cardiovascular outcomes trial: 6,068 adults with type 2 diabetes and a recent acute coronary syndrome, median follow-up 25 months, major cardiovascular events in 13.4% on lixisenatide against 13.2% on placebo, hazard ratio 1.02.

That established cardiovascular safety for the GLP-1 class in 2015; the reductions came the following year from liraglutide and semaglutide. FDA approval in 2016 rested on the GetGoal program, 13 trials in more than 5,000 adults worldwide, plus ELIXA’s safety finding. The lixisenatide page has the trial detail.

4. What were the side effects?

There was no boxed warning and no medullary thyroid carcinoma contraindication, unlike Victoza, Ozempic, Trulicity, and Mounjaro. The label’s carcinogenicity section (13.1) does report findings in rodents: statistically significant increases in thyroid C-cell adenomas in mice and rats, and a numerical increase in C-cell carcinomas in rats. The class warnings on pancreatitis, hypoglycemia with insulin or a sulfonylurea, acute kidney injury from dehydration, and hypersensitivity applied. Across clinical trials there were 21 pancreatitis cases among Adlyxin patients against 14 on comparators, an incidence of 21 versus 17 per 10,000 patient-years; some of those patients had risk factors such as prior gallstones or alcohol use. In ELIXA, cholelithiasis occurred in 0.4% on Adlyxin against 0.2% on placebo, and acute cholecystitis in 0.3% against 0.2%.

5. Who could and couldn’t take it?

Adlyxin delayed gastric emptying, which slowed absorption of other oral drugs taken around the same time. The label gave two concrete rules: oral contraceptives had to be taken at least 1 hour before an Adlyxin injection or at least 11 hours after it, and drugs that depend on a threshold concentration to work, such as antibiotics, had to be taken at least 1 hour before the Adlyxin dose.

Safety and effectiveness were never established in pediatric patients. In pregnancy, animal studies at high exposures showed fetal skeletal and visceral defects, so the label allowed use only if the benefit outweighed the risk. No dose adjustment was needed for mild renal impairment (eGFR 60 to 89) or moderate impairment (eGFR 30 to under 60), though closer monitoring was advised at both; Adlyxin was not recommended in end-stage renal disease. The label carried no separate hepatic-impairment dosing section. In clinical studies, 1,837 patients (25%) were 65 or older and 288 (4%) were 75 or older; the label found no overall difference in safety or effectiveness by age, while noting individual sensitivity could not be ruled out.

6. What replaced Adlyxin?

There is no like-for-like successor, and no conversion between Adlyxin’s micrograms and any other product’s milligrams. The reason Adlyxin lost is the reason those drugs won: a molecule active for hours cannot match one active for a week on fasting glucose, weight, or outcomes. Its surviving niche, in Soliqua, is the one place a short-acting agonist has a job of its own. For a log, an old Adlyxin entry is product, date, micrograms, injection site, and the meal it preceded. How GLP-1 tracking works covers what to record.

7. Adlyxin FAQ

• Did Adlyxin cause weight loss?

  It was never approved for weight loss, and no weight-loss indication is on the label. In trials, weight change was modest: in the GetGoal-Mono monotherapy trial, weight fell 1.9 kg on Adlyxin versus 2.0 kg on placebo, no significant difference. In the GetGoal-X head-to-head trial, Adlyxin produced less weight loss than exenatide (94.5 to 91.7 kg versus 96.7 to 92.9 kg). People looking for weight loss today should see [semaglutide](/what-is-semaglutide) or [tirzepatide](/what-is-tirzepatide), both approved for it.

• What were the side effects of Adlyxin?

  Mostly gastrointestinal: nausea in 25% versus 6% on placebo, vomiting in 10% versus 2%, plus headache, diarrhea, and dizziness at lower rates. It carried no thyroid C-cell boxed warning and no medullary thyroid carcinoma contraindication, though the label's carcinogenicity section reports increased thyroid C-cell adenomas in mice and rats, and a numerical increase in carcinomas in rats. Pancreatitis, hypoglycemia with insulin or a sulfonylurea, and kidney injury from dehydration were also labeled risks.

• Why was Adlyxin discontinued?

  Sanofi announced the U.S. discontinuation for business reasons, effective January 1, 2023, and the DailyMed record's marketing end date is September 30, 2023. The drug was outcompeted by the weekly GLP-1 agonists, which lower HbA1c and weight more and, unlike Adlyxin, showed cardiovascular benefit. The EU brand Lyxumia was withdrawn in December 2025.

• What was the Adlyxin dose?

  10 mcg once daily for 14 days, then 20 mcg once daily, injected under the skin within 60 minutes before the first meal of the day. A missed dose was taken within the hour before the next meal, never doubled.

• What replaced Adlyxin?

  Nothing identical. Lixisenatide continues inside Soliqua 100/33, a fixed-ratio pen with insulin glargine, for people who also need basal insulin. People on Adlyxin alone were typically moved by their prescriber to a weekly GLP-1 agonist such as Ozempic, Trulicity, or Mounjaro, each of which starts at its own first dose.

• Is Adlyxin the same as Soliqua?

  No. Adlyxin was lixisenatide alone. Soliqua 100/33 combines insulin glargine and lixisenatide in one pen, at 15 to 60 units of insulin with 5 to 20 mcg of lixisenatide. The lixisenatide dose in Soliqua is set by the insulin dose, not chosen separately.

• How was the Adlyxin pen stored?

  Before first use, in a refrigerator at 36°F to 46°F (2°C to 8°C), never frozen, kept in its original carton away from light. After the first injection, the same pen could be kept at room temperature up to 86°F (30°C), cap replaced after each use, and had to be discarded 14 days after that first use even if doses remained.

• Did Adlyxin interact with other medications?

  It delayed gastric emptying, which could slow absorption of oral drugs. The label told patients to take oral contraceptives at least 1 hour before an Adlyxin injection or at least 11 hours after it, and to take antibiotics or other drugs that depend on a threshold concentration at least 1 hour before the Adlyxin dose.

• Could Adlyxin be used in pregnancy, children, or kidney disease?

  Safety and effectiveness were never established in pediatric patients. Animal studies showed fetal risk at high exposures, so the label said to use it in pregnancy only if the benefit justified the risk. No dose adjustment was needed for mild or moderate renal impairment (eGFR down to 30 mL/min/1.73 m2), but it was not recommended in end-stage renal disease.

8. Sources