Lixisenatide
Also known as: Adlyxin, Lyxumia, Soliqua (with insulin glargine), Suliqua, AVE0010, ZP10
Key Facts: Lixisenatide
- Category
- Metabolic
- FDA Status
- FDA Approved
- Clinical Status
- FDA Approved (2016) but standalone Adlyxin discontinued in the US (last availability around January 2023) for commercial reasons. EU marketing authorisation for Lyxumia withdrawn 18 December 2025 at Sanofi's request. Still marketed in the US as Soliqua 100/33 (insulin glargine and lixisenatide).
- Banned in Sport (WADA)
- Not on the WADA Prohibited List (2026).
- Administration
- Subcutaneous injection within one hour before the first meal of the day
- Typical Dose
- 20 mcg once daily (after 10 mcg for 14 days)
- Frequency
- Once daily
- Duration
- Long-term for type 2 diabetes
How does Lixisenatide work?
Lixisenatide is a 44-amino-acid peptide based on exendin-4, with the C-terminus modified by a string of lysines. It activates the GLP-1 receptor to boost insulin release when glucose is high, lower glucagon, and slow stomach emptying. Because it is short-acting (terminal half-life about 3 hours), its strongest effect is on the blood sugar spike after the meal following the injection, rather than round-the-clock glucose. That is why it pairs well with basal insulin, which handles fasting glucose while lixisenatide covers the post-meal rise. It has only a small effect on body weight compared with modern long-acting GLP-1s.
What does the research show?
The FDA approved Adlyxin in July 2016 for adults with type 2 diabetes, based on the GetGoal trial program. The key safety study, ELIXA (NEJM 2015), randomized 6,068 people with type 2 diabetes and a recent acute coronary syndrome: cardiovascular events were 13.4% on lixisenatide versus 13.2% on placebo (hazard ratio 1.02). So it was proven safe for the heart, but unlike liraglutide, semaglutide or dulaglutide it showed no heart benefit. In trials nausea hit about 25% of users versus 6% on placebo. Soliqua 100/33 (insulin glargine plus lixisenatide) was approved in November 2016. Outside diabetes, the LIXIPARK trial (NEJM 2024, 156 people with early Parkinson's) found less worsening of motor symptoms over 12 months on lixisenatide than placebo, an intriguing signal that needs bigger trials, with frequent nausea as the trade-off. Commercially, Sanofi pulled standalone Adlyxin in the US and requested EU withdrawal of Lyxumia (December 2025) for business reasons, not safety.
FDA Approval Studies
This peptide is FDA approved. Below are the key clinical trials that supported its approval.
ELIXA
Sanofi • Phase 3 (cardiovascular outcomes)
6068
Median about 25 months
Cardiovascular death, nonfatal heart attack, nonfatal stroke, or hospitalization for unstable angina
- ✓Primary endpoint 13.4% lixisenatide vs 13.2% placebo (hazard ratio 1.02)
- ✓Noninferior to placebo for cardiovascular safety, no superiority
- ✓Population had a recent acute coronary syndrome
What doses have been studied?
Typical Dosingⓘ
Community experience
20 mcg once daily (after 10 mcg for 14 days)
10-20 mcg daily; 5-20 mcg within Soliqua
Once daily
Labeled dose for the standalone product. In Soliqua the lixisenatide dose rises with the insulin dose and is set by the prescriber. Lixisenatide is not approved for weight loss.
Research Dosingⓘ
Scientific studies
FDA-approved labeled dosing (prescription only)
Doses from Studies
10 mcg daily for 14 days, then 20 mcg daily
FDA Approved Labeling - Adlyxin prescribing information (revised 5/2025) ↗
15-60 units daily (5-20 mcg lixisenatide)
FDA Approved Labeling - Soliqua 100/33 prescribing information ↗
Duration
Long-term for type 2 diabetes
Administration
Subcutaneous injection within one hour before the first meal of the day
When and how is Lixisenatide taken?
Best Time to Take
Within one hour before the first meal of the day
Once daily, before the first meal
Food Recommendation
With or without food
Why This Timing?
It is short-acting and works mainly on the meal after the injection, so the label ties it to breakfast. If a dose is missed, the label says to inject within one hour before the next meal.
What are the side effects of Lixisenatide?
Not everyone experiences these effects. Individual responses vary based on dosage, duration, and personal factors.
- ●Nausea (25% vs 6% placebo)
- ●Vomiting (10%)
- ●Headache (9%)
- ●Diarrhea (8%)
- ●Dizziness (7%)
- ●Hypoglycemia, mainly with sulfonylureas or insulin
- ●Allergic reactions including anaphylaxis
- ●Acute pancreatitis
- ●Acute kidney injury from dehydration
- ●Gallbladder disease
- ●Antibody formation can blunt response
- ●Delayed absorption of oral drugs taken around the dose
References
- https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/208471s010lbl.pdf
- https://www.ema.europa.eu/fr/medicines/human/EPAR/lyxumia
- https://ajmc.com/view/elixa-results-on-lixisenatide-published-in-nejm
- https://clinicaltrials.gov/study/NCT03439943
- https://drugs.com/history/soliqua-100-33.html
Research This Peptide Further
Frequently Asked Questions
What does Lixisenatide do?
Lixisenatide is a short-acting, once-daily GLP-1 agonist for type 2 diabetes, discovered by Zealand Pharma and sold by Sanofi as Adlyxin (US) and Lyxumia (EU). It never caught on against weekly GLP-1 drugs, and it has mostly left the market: standalone Adlyxin was discontinued in the US with last availability around January 2023, and the EU authorisation for Lyxumia was withdrawn in December 2025. It lives on in Soliqua 100/33, a fixed combination with insulin glargine.
How does Lixisenatide work?
Lixisenatide is a 44-amino-acid peptide based on exendin-4, with the C-terminus modified by a string of lysines. It activates the GLP-1 receptor to boost insulin release when glucose is high, lower glucagon, and slow stomach emptying. Because it is short-acting (terminal half-life about 3 hours), its strongest effect is on the blood sugar spike after the meal following the injection, rather than round-the-clock glucose. That is why it pairs well with basal insulin, which handles fasting glucose while lixisenatide covers the post-meal rise. It has only a small effect on body weight compared with modern long-acting GLP-1s.
Is Lixisenatide FDA approved?
Yes, Lixisenatide is FDA approved. FDA Approved (2016) but standalone Adlyxin discontinued in the US (last availability around January 2023) for commercial reasons. EU marketing authorisation for Lyxumia withdrawn 18 December 2025 at Sanofi's request. Still marketed in the US as Soliqua 100/33 (insulin glargine and lixisenatide).
Is Lixisenatide banned in sport?
Not on the WADA Prohibited List (2026).
What are the side effects of Lixisenatide?
Reported side effects include: Nausea (25% vs 6% placebo), Vomiting (10%), Headache (9%), Diarrhea (8%), Dizziness (7%). Individual responses vary based on dosage, duration, and personal health factors.
What is the typical dose of Lixisenatide?
Community-reported common dose: 20 mcg once daily (after 10 mcg for 14 days) (Once daily). Range: 10-20 mcg daily; 5-20 mcg within Soliqua. Administration: Subcutaneous injection within one hour before the first meal of the day. Prescription drug. Dose set by prescriber per label. Not medical advice.
Related Peptides
Peptides commonly compared with Lixisenatide or used in similar applications.
Pramlintide
FDAPramlintide (Symlin) is a synthetic version of amylin, the hormone your pancreas releases alongside insulin, and it was the first amylin drug ever approved (FDA, March 2005). It was used as a mealtime add-on for type 1 and type 2 diabetes in people already on mealtime insulin. It never sold well because it meant up to three extra injections a day and a serious hypoglycemia warning, and AstraZeneca has discontinued it in the US. Today it matters mostly as the proof of concept behind newer weekly amylin drugs like cagrilintide and petrelintide.
MetabolicPancragen
Clinical TrialsPancragen is a synthetic tetrapeptide bioregulator, Lys-Glu-Asp-Trp (KEDW), from the Khavinson group, designed to target pancreatic tissue. It is studied for supporting blood-sugar control and the insulin-producing endocrine pancreas, especially in aging. It is a research compound with no approval and no published human clinical trials. The notable evidence comes from aged primates, not people.
MetabolicAICAR
Clinical TrialsAICAR is not a peptide at all. It is a small nucleoside (a building block related to the purine pathway) that cells convert into ZMP, a molecule that mimics AMP and switches on AMPK, the cell's energy sensor. It became famous in 2008 when a Salk Institute study showed sedentary mice on AICAR ran 44% further, earning it the "exercise in a pill" label. Human data tell a much less exciting story: it was tested as an intravenous drug (acadesine) for heart surgery and leukemia, the big heart trial failed, and nothing is approved.
MetabolicPemvidutide
Clinical TrialsPemvidutide is Altimmune's once-weekly GLP-1/glucagon dual agonist, now being developed mainly for MASH (fatty liver disease with inflammation, formerly called NASH). It cleared fat out of the liver fast in trials and earned FDA Breakthrough Therapy designation, and its phase 3 trial (PERFORMA) started in August 2026. It also produced decent weight loss in an obesity trial, but it is not approved anywhere and its biggest phase 2 MASH trial missed on the fibrosis endpoint at 24 weeks.
MetabolicDasiglucagon
FDADasiglucagon is a 29-amino-acid glucagon analog sold as Zegalogue, a ready-to-inject rescue pen for severe low blood sugar in people with diabetes. Its whole point is practical: old-school glucagon kits had to be mixed from a powder in the middle of an emergency, while dasiglucagon stays stable as a liquid, so a caregiver just presses an autoinjector. The FDA approved it in March 2021. It is a real, well-tested emergency drug, not a wellness peptide, and there is no sensible reason to use it outside of a hypoglycemia emergency.
MetabolicSLU-PP-332
PreclinicalSLU-PP-332 is a small synthetic molecule, not a peptide, that turns on the estrogen-related receptors (ERRalpha, beta and gamma), the master switches behind much of the body's response to endurance exercise. Researchers call it an 'exercise mimetic' because in mice it boosts mitochondria, shifts muscle toward fatigue-resistant fibers, improves stamina and trims fat without the animal moving more. It was made as a lab tool to study exercise biology. There are no human trials.
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