Lixisenatide is a short-acting GLP-1 receptor agonist for type 2 diabetes, injected once a day before breakfast. Its main effect is on the blood-sugar rise after the meal it precedes. It was never approved for weight loss, and in trials it lowered body weight by only about 1–3 kg. Today it is sold mainly as part of Soliqua 100/33 (Suliqua in the EU), a fixed-ratio pen with insulin glargine.
The single most important fact: standalone lixisenatide has largely left the market. The US product Adlyxin has a DailyMed marketing end date of September 30, 2023, and the European Commission withdrew the EU brand Lyxumia on December 18, 2025 at Sanofi’s request for commercial reasons (EMA Lyxumia page). For anyone interested in body composition, it is a weak drug: the weekly GLP-1 drugs produce far more fat loss.
This page summarizes what the FDA labels, clinical trials and regulators report. It is for education only and is not medical advice.
| Property | Detail |
|---|---|
| Drug class | GLP-1 receptor agonist, short-acting; derived from exendin-4 |
| Developer / codes | Sanofi; research codes AVE0010 and ZP10A |
| Structure | 44-amino-acid peptide: exendin-4 sequence ending in six lysines; C₂₁₅H₃₄₇N₆₁O₆₅S, about 4,858 g/mol |
| Route | Subcutaneous injection once daily, within 1 hour before the first meal |
| Labeled doses | Adlyxin: 10 mcg daily for 14 days, then 20 mcg daily; Soliqua: 5–20 mcg daily, fixed to 15–60 units of insulin glargine |
| Half-life | About 3 hours |
| Brands | Adlyxin (US, approved July 27, 2016; no longer marketed); Lyxumia (EU, 2013–2025); Soliqua 100/33 (US) and Suliqua (EU) with insulin glargine |
| Weight-loss approval | None |
| WADA status | Not prohibited and not on the Monitoring Program; the insulin glargine in Soliqua is prohibited (S4.4.2) |
What it is
Lixisenatide is a synthetic peptide built on exendin-4, a hormone-like peptide first found in Gila monster venom and also the basis of exenatide. PubChem lists its 44-residue sequence, which ends in a run of six lysines and an amidated C-terminus, and records the early code ZP10A (PubChem). Sanofi developed it under the code AVE0010 through the GetGoal phase 3 program (Bain, Diabetes Ther 2014).
Like other GLP-1 receptor agonists, it:
- increases insulin release when blood sugar is high;
- lowers glucagon, a hormone that raises blood sugar;
- slows stomach emptying, which flattens the glucose spike after a meal;
- reduces appetite.
What makes it different is how briefly it acts. With a half-life of about 3 hours, a morning dose mainly covers breakfast. It does not bind albumin the way liraglutide and semaglutide do, so it does not keep the receptor activated around the clock. That is why it lowers fasting glucose and body weight much less than the long-acting drugs.
Laboratory work also suggests it is a somewhat weaker agonist than its parent peptide. In cell studies, lixisenatide bound the GLP-1 receptor as tightly as exendin-4 but was about five times less potent at triggering cAMP signaling, and the receptor returned to the cell surface more slowly. In mice, this translated into smaller effects on blood sugar and food intake (Pickford et al., Br J Pharmacol 2020).
How it compares with related drugs
| Drug | Dosing | Weight-loss approval | Library page |
|---|---|---|---|
| Exenatide | Twice daily or weekly | No | Exenatide |
| Lixisenatide | Once daily | No | This page |
| Liraglutide | Once daily | Yes (3.0 mg) | Liraglutide |
| Dulaglutide | Once weekly | No | Dulaglutide |
| Semaglutide | Once weekly (injection) | Yes (2.4 mg) | Semaglutide |
| Tirzepatide | Once weekly | Yes | Tirzepatide |
Pharmacokinetics
The current Soliqua 100/33 label (revised March 2026) gives the pharmacokinetics of the lixisenatide component (Soliqua label, DailyMed):
| Parameter | Value |
|---|---|
| Time to peak (median, in the combination) | 2.5–3.0 h |
| Terminal half-life (multiple doses, type 2 diabetes) | About 3 h |
| Apparent clearance | About 35 L/h |
| Protein binding | 55% |
| Elimination | Presumed glomerular filtration and breakdown by protein-cleaving enzymes |
Because it is a foreign-sequence peptide, the immune system often reacts to it. In a pooled analysis of nine placebo-controlled studies, 70% of people on lixisenatide had antibodies at week 24. In the 2.4% with the highest antibody levels, blood-sugar response was weaker, and antibody-positive patients had more allergic and injection-site reactions (Adlyxin label, DailyMed).
Approved medical use and current status
Status checked on November 7, 2026:
- United States, Adlyxin. FDA approved Adlyxin on July 27, 2016. The application, originally an NDA, was deemed a biologics license application (BLA 208471) in March 2020 (Drugs@FDA). DailyMed lists a marketing end date of September 30, 2023 for all Adlyxin packages (Adlyxin label, DailyMed). Sanofi’s own discontinuation notice was not available for us to check.
- United States, Soliqua 100/33. Still marketed. It is approved with diet and exercise for glycemic control in adults with type 2 diabetes. Dosing starts at 15 units (5 mcg lixisenatide) and goes up to 60 units (20 mcg). The label says not to combine it with any other GLP-1 receptor agonist (Soliqua label).
- European Union. Lyxumia was authorized on February 1, 2013 and withdrawn on December 18, 2025 because Sanofi permanently stopped marketing it “for commercial reasons” (EMA). Suliqua (insulin glargine plus lixisenatide), authorized January 11, 2017, remains authorized (EMA).
- Not a weight-loss drug. No regulator has approved lixisenatide for obesity.
What the research shows
Blood sugar in type 2 diabetes (GetGoal program)
Sanofi ran 11 randomized phase 3 trials. Across them, HbA1c (average blood sugar over about three months) fell by 0.7 to 1.0 percentage points from baseline, and 2.5–10.4% of participants stopped for adverse events (Bain, Diabetes Ther 2014). Three representative trials:
| Trial | Design | HbA1c result | Weight result |
|---|---|---|---|
| GetGoal-Mono (Fonseca et al., Diabetes Care 2012) | 361 adults, monotherapy vs placebo, 12 weeks | −0.54 to −0.66 points vs placebo | About −2 kg in all groups, including placebo |
| GetGoal-L (Riddle et al., Diabetes Care 2013) | 495 adults on basal insulin, add-on vs placebo, 24 weeks | −0.4 points vs placebo | −1.3 kg vs placebo |
| GetGoal-X (Rosenstock et al., Diabetes Care 2013) | 634 adults on metformin, vs exenatide twice daily, 24 weeks | −0.79 vs −0.96 points (non-inferior) | 94.5 → 91.7 kg vs 96.7 → 92.9 kg |
In GetGoal-Mono the strongest effect was after meals: glucose excursion during a standard breakfast fell by about 75%. In GetGoal-X, lixisenatide caused less symptomatic hypoglycemia (2.5% vs 7.9%) and less nausea (24.5% vs 35.1%) than exenatide.
Cardiovascular outcomes (ELIXA)
ELIXA randomized 6,068 adults with type 2 diabetes who had a heart attack or hospitalization for unstable angina in the previous 180 days, and followed them for a median of 25 months (Pfeffer et al., NEJM 2015).
| Outcome | Lixisenatide | Placebo | Hazard ratio (95% CI) |
|---|---|---|---|
| Cardiovascular death, heart attack, stroke or unstable angina | 13.4% | 13.2% | 1.02 (0.89–1.17) |
| Hospitalization for heart failure | — | — | 0.96 (0.75–1.23) |
| Death from any cause | — | — | 0.94 (0.78–1.13) |
The result showed lixisenatide was safe for the heart (non-inferior to placebo) but did not reduce cardiovascular events. It also did not raise rates of pancreatitis, pancreatic tumors, severe hypoglycemia or allergic reactions. Later trials of long-acting drugs such as liraglutide and semaglutide did show cardiovascular benefit.
Parkinson’s disease (LIXIPARK)
In a phase 2 trial, 156 people with early Parkinson’s disease received daily lixisenatide or placebo for 12 months. Motor scores were essentially unchanged on lixisenatide (−0.04 points) but worsened by 3.04 points on placebo (difference 3.08, 95% CI 0.86–5.30). Nausea occurred in 46% and vomiting in 13% of the lixisenatide group (Meissner et al., NEJM 2024). The authors called for longer and larger trials. Parkinson’s disease is not an approved use.
Weight and body composition
Lixisenatide’s effect on weight is small, and in GetGoal-Mono weight fell by about the same amount on placebo. We found no published DXA or MRI study of lixisenatide’s effect on lean mass or fat mass. Body-composition data for GLP-1 drugs come from obesity-dose trials of semaglutide, liraglutide and tirzepatide. A 2026 meta-analysis of those trials found an average absolute lean-mass loss of 1.74 kg, while lean mass as a share of body weight rose by 1.81% (Laverde et al., Int J Obes 2026). Lixisenatide was never tested at doses meant for obesity, so these results cannot be applied to it.
For anabolics.app readers, the practical point is simple. Lixisenatide is a meal-time glucose drug. It is not a cutting agent and has no evidence for muscle preservation or performance. No study has examined it in people using testosterone or anabolic steroids.
Side effects and risks
Common side effects
From the placebo-controlled trials in the Adlyxin label (Adlyxin label):
| Adverse reaction | Lixisenatide | Placebo |
|---|---|---|
| Nausea | 25% | 6% |
| Vomiting | 10% | 2% |
| Headache | 9% | 6% |
| Diarrhea | 8% | 6% |
| Dizziness | 7% | 4% |
Hypoglycemia
Lixisenatide alone rarely causes low blood sugar, but risk rises sharply with insulin or a sulfonylurea. In the label’s trials, symptomatic hypoglycemia occurred in 2% on monotherapy (2% on placebo), 15% with a sulfonylurea (11% on placebo), and 47% with basal insulin plus a sulfonylurea (22% on placebo). In GetGoal-L, 1.2% of people on lixisenatide plus basal insulin had severe hypoglycemia vs none on placebo (Riddle et al., 2013).
Thyroid findings in rodents
Unlike the weekly GLP-1 drugs, the Adlyxin and Soliqua labels carry no boxed warning about thyroid C-cell tumors. The rodent data are not clean, however. In two-year studies, thyroid C-cell adenomas increased in male mice at very high doses and in rats at all doses tested, and rats showed a numerical increase in C-cell carcinomas at exposures more than 56 times the human dose (Adlyxin label). Whether this matters for humans is not known.
Other cautions
The label’s other warnings are the usual class set: pancreatitis, allergic reactions, kidney injury from dehydration caused by vomiting or diarrhea, gallbladder disease, and slower absorption of oral drugs taken around the injection. People with end-stage kidney disease should not use it.
Legal status and use in sport
Lixisenatide is a prescription drug. It is not named on the WADA 2026 Prohibited List, and GLP-1 receptor agonists as a class are not banned. It is not covered by S0 either, because it still has a current regulatory approval as part of Soliqua and Suliqua. It is also not on the 2026 Monitoring Program, which lists only markers of semaglutide and tirzepatide (WADA 2026 Monitoring Program).
The catch for tested athletes is the combination product. Soliqua and Suliqua contain insulin glargine, and insulins are prohibited at all times under S4.4.2 of the 2026 List. A diabetic athlete using Soliqua would need a Therapeutic Use Exemption for the insulin component.
Anti-doping laboratories can already detect lixisenatide. A 2026 method using antibody-based purification and high-resolution mass spectrometry reached a detection limit of 48 pg/mL in serum (Borschel et al., J Chromatogr B 2026).
Key takeaways
- A short-acting, once-daily GLP-1 drug. Lixisenatide is a 44-amino-acid exendin-4 analogue with a half-life of about 3 hours that mainly blunts the glucose rise after breakfast.
- Standalone forms are gone. Adlyxin’s US marketing ended in 2023 and the EU withdrew Lyxumia in December 2025; it survives inside Soliqua 100/33 and Suliqua with insulin glargine.
- Modest effects. HbA1c fell 0.7–1.0 points across the GetGoal trials, and weight changed by only about 1–3 kg.
- Heart-neutral. ELIXA showed no increase or decrease in major cardiovascular events (HR 1.02).
- No body-composition case. There are no lean-mass studies, it was never tested at obesity doses, and it is not a meaningful cutting drug.
- Allowed in sport, but Soliqua is not. Lixisenatide itself is not prohibited, but the insulin glargine in Soliqua falls under WADA S4.4.2.
Sources
- Sanofi. Adlyxin (lixisenatide) injection prescribing information. Revised September 2023. DailyMed.
- Sanofi. Soliqua 100/33 (insulin glargine and lixisenatide) injection prescribing information. Revised March 2026. DailyMed.
- Food and Drug Administration. Drugs@FDA: BLA 208471, Adlyxin (lixisenatide). Drugs@FDA.
- European Medicines Agency. Lyxumia (lixisenatide): withdrawn EPAR. EMA.
- European Medicines Agency. Suliqua (insulin glargine / lixisenatide): EPAR. EMA.
- National Center for Biotechnology Information. PubChem Compound Summary for CID 90472060, Lixisenatide. PubChem.
- Bain SC. The clinical development program of lixisenatide: a once-daily glucagon-like peptide-1 receptor agonist. Diabetes Ther. 2014;5(2):367–383. PubMed.
- Pickford P, Lucey M, Fang Z, et al. Signalling, trafficking and glucoregulatory properties of glucagon-like peptide-1 receptor agonists exendin-4 and lixisenatide. Br J Pharmacol. 2020;177(17):3905–3923. PubMed.
- Fonseca VA, Alvarado-Ruiz R, Raccah D, et al. Efficacy and safety of the once-daily GLP-1 receptor agonist lixisenatide in monotherapy: a randomized, double-blind, placebo-controlled trial in patients with type 2 diabetes (GetGoal-Mono). Diabetes Care. 2012;35(6):1225–1231. PubMed.
- Riddle MC, Aronson R, Home P, et al. Adding once-daily lixisenatide for type 2 diabetes inadequately controlled by established basal insulin: a 24-week, randomized, placebo-controlled comparison (GetGoal-L). Diabetes Care. 2013;36(9):2489–2496. PubMed.
- Rosenstock J, Raccah D, Korányi L, et al. Efficacy and safety of lixisenatide once daily versus exenatide twice daily in type 2 diabetes inadequately controlled on metformin: a 24-week, randomized, open-label, active-controlled study (GetGoal-X). Diabetes Care. 2013;36(10):2945–2951. PubMed.
- Pfeffer MA, Claggett B, Diaz R, et al. Lixisenatide in Patients with Type 2 Diabetes and Acute Coronary Syndrome. N Engl J Med. 2015;373(23):2247–2257. PubMed.
- Meissner WG, Remy P, Giordana C, et al. Trial of Lixisenatide in Early Parkinson’s Disease. N Engl J Med. 2024;390(13):1176–1185. PubMed.
- Laverde LP, Muñoz-Velandia OM, Alfonso D, Gómez Medina AM. Effect of GLP-1 receptor agonists at doses for obesity management on muscle health: systematic review and meta-analysis of randomized controlled trials (RCTs). Int J Obes (Lond). 2026;50(8):1638–1646. PubMed.
- Borschel L, Thomas A, Studer D, et al. Development and validation of qualitative methods for the detection of GLP-1 receptor agonists in serum and dried blood spots by LC-HRMS/MS for doping control purposes. J Chromatogr B Analyt Technol Biomed Life Sci. 2026;1285:125326. PubMed.
- World Anti-Doping Agency. The 2026 Prohibited List. WADA 2026 Prohibited List.
- World Anti-Doping Agency. The 2026 Monitoring Program. WADA.