A once-daily GLP-1 receptor agonist modeled on exendin-4, the Gila monster peptide behind exenatide, with six lysines added to one end. Its short action mainly blunts the rise in blood sugar after the meal that follows the injection.
Evidence. Approved for type 2 diabetes in the EU (Lyxumia, 2013) and the US (Adlyxin, 2016), but both lixisenatide-only pens are gone: Adlyxin left the US market in 2023 and Lyxumia’s EU license was withdrawn in December 2025. It remains in Soliqua 100/33 (Suliqua in the EU), a daily pen combined with insulin glargine. ELIXA (6,068 adults after a heart attack or unstable angina) found no heart benefit or harm, and a 2024 phase 2 trial in early Parkinson’s disease was positive.
What it’s used for
Approved uses first, then uses tested in people, then claims that rest on animal studies or user reports.
Type 2 diabetes
LabelApproved for adults, alone (withdrawn in the US and EU) or in Soliqua with insulin glargine. Over 30 weeks, HbA1c, a 3-month blood sugar average, fell 1.6 points on the combination vs 1.3 on glargine.
Lowering heart attack and stroke risk
TrialNot shown: in ELIXA (6,068 adults with type 2 diabetes and a recent heart attack or unstable angina), heart events hit 13.4% vs 13.2% on placebo over 25 months: no harm, no benefit.
Parkinson’s disease
TrialPromising, unconfirmed: in a 12-month phase 2 trial of 156 people with early Parkinson’s, motor scores held steady vs a 3-point worsening on placebo; 46% had nausea. A larger exenatide trial was negative.
Weight loss
TrialSmall, never approved for it: added to metformin, weight fell 2.7 kg vs 1.7 kg on placebo over 24 weeks. Combined with insulin glargine, weight stayed about level (a 0.3 kg loss).
Label: an approved use. Trial: tested in people, with the result.
Approved in the US as Adlyxin (2016), discontinued in 2023, and as Soliqua 100/33 (2016), a daily pen combining it with insulin glargine for adults with type 2 diabetes, which is still marketed. FDA’s Purple Book lists Adlyxin’s license as voluntarily revoked.
Approval history
2013EU (EMA): Lyxumia: type 2 diabetes in adults
2016US FDA: Adlyxin: type 2 diabetes in adults
2016US FDA: Soliqua 100/33: insulin glargine plus lixisenatide, type 2 diabetes in adults
2017EU (EMA): Suliqua: insulin glargine plus lixisenatide, type 2 diabetes in adults
2023US FDA: Adlyxin: withdrawn from the US market
2025EU (EMA): Lyxumia: EU authorization withdrawn at Sanofi’s request
European Union
Lyxumia’s EU authorization was withdrawn on December 18, 2025, at Sanofi’s request. Suliqua (with insulin glargine, authorized January 2017) remains authorized for type 2 diabetes in adults.
United Kingdom
No lixisenatide product appears in the MHRA products database (checked October 8, 2026): neither Lyxumia nor Suliqua is listed.
Canada
Adlyxine was cancelled after marketing in 2023. Soliqua (with insulin glargine) has been marketed since September 2018 as a prescription drug.
Australia
Prescription only (Schedule 4), but no lixisenatide product has current Australian product information.
Sport (WADA 2026)
Not banned in sportLixisenatide isn’t named on the 2026 list, and S0 does not apply to an approved drug. But Soliqua and Suliqua also contain insulin glargine, and insulins are banned at all times (S4.4.2), so athletes need a therapeutic use exemption.
Sport status follows the WADA Prohibited List in force since January 1, 2026; athletes should confirm with their anti-doping organization. Checked October 5, 2026. Status outside the US checked October 7, 2026 against EMA, MHRA, Health Canada and TGA records. By country: EU, UK, Canada, Australia. Status of every compound.
How it works
Lixisenatide is a synthetic GLP-1 receptor agonist modeled on exendin-4, a Gila monster peptide. Switching on the GLP-1 receptor raises insulin release only when blood sugar is high, lowers glucagon, a hormone that raises blood sugar, and slows stomach emptying. Because it acts for only a few hours, its main effect is on the rise in blood sugar after the meal that follows the injection; in a label study the effect was largest at that first meal.
LabelBased on the product label.
Not known
Whether its thyroid C-cell tumors in rodents matter for people is unknown, though the US labels carry no boxed warning. Antibodies that can cross-react with natural GLP-1 and glucagon form in most users; their clinical meaning isn’t known.
Protocol
Label
Soliqua 100/33
Soliqua 100/33: 15–60 units once daily, within 1 hour before the first meal. Each unit holds 1 unit of insulin glargine and 0.33 mcg of lixisenatide, so 60 units (the maximum) gives 20 mcg. The dose moves 2–4 units a week with fasting glucose.
Label
Adlyxin
10 mcg once daily for 14 days, then 20 mcg once daily from day 15, within 1 hour before the first meal of the day. Adlyxin was discontinued in the US in 2023.
Trial
LIXIPARK, NEJM 2024
10 mcg daily for 14 days, then 20 mcg daily (10 mcg if not tolerated) for 12 months in early Parkinson’s disease.
Frequency
Once daily
Route
Subcutaneous injection
Timing
Within 1 hour before the first meal of the day, preferably the same meal each day (labels).
Cycle
Continuous. The labels treat it as long-term therapy, not a cycle.
Week 15913172125
Continuous, shown over 26 weeks
Common protocols
The ways Lixisenatide is most often run, each tagged with where it comes from.
Soliqua 100/33 (with insulin glargine)
Label
Dose
15–60 units (5–20 mcg lixisenatide)
How often
Once daily, within 1 hour before the first meal
How long
Long-term
Starts at 15 units, or 30 units if already on 30–60 units of basal insulin, then moves 2–4 units a week. Replaces separate basal insulin or GLP-1 drugs.
Lixisenatide alone (Adlyxin, Lyxumia)
Label
Dose
10 mcg, then 20 mcg
How often
Once daily, within 1 hour before the first meal
How long
Long-term
20 mcg from day 15. Discontinued in the US (2023) and withdrawn in the EU (December 2025).
Parkinson’s disease (LIXIPARK)
Trial
Dose
10 mcg, then 20 mcg
How often
Once daily
How long
12 months
Phase 2 in 156 people with early Parkinson’s: motor scores held steady vs a 3-point worsening on placebo. Not an approved use.
Adlyxin start (lixisenatide alone)
Period
Dose
Days 1–14
10 mcg
Day 15 on (maintenance)
20 mcg
The 10 mcg starter dose eases stomach side effects and doesn’t control blood sugar on its own (label). Soliqua is dosed in units of insulin instead, starting at 15 or 30 units.
Taking it
Where it goes
Under the skin of the belly, thigh or upper arm (labels). Rotate sites within the same area from one injection to the next.
If you miss a dose
Adlyxin label: if a dose is missed, inject it within 1 hour before the next meal. Soliqua label: resume with the next scheduled daily dose; don’t take an extra or larger dose to make up for it.
Drink enough fluids; heavy vomiting or diarrhea can injure the kidneys.
Low blood sugar with basal insulin plus a sulfonylurea (Adlyxin label: 47% vs 22% symptomatic)
The label suggests lowering the sulfonylurea or insulin dose when starting.
Allergic reactions, including anaphylaxis (label: 0.2% vs 0.1% on placebo)
Rash, swelling or trouble breathing need prompt care; the label says to stop.
Injection-site reactions (Adlyxin label: 4% vs 2%), more common with antibodies
Rotate sites. Persistent reactions or weakening control may mean antibodies; the label suggests other treatment.
Stop and get medical help
Swelling of the face or throat, trouble breathing or a severe rash; severe belly pain that won’t go away (may spread to the back); or signs of dehydration such as very little urine. Get medical help.
Can it cause …?
The side effects people ask about most, answered one by one. Each answer says where it comes from.
Tiredness
Not reportedTiredness isn’t among the label’s common side effects, from placebo-controlled trials of 2,869 people on lixisenatide for about 22 weeks on average.
Headache
LabelHeadache: 9% vs 6% on placebo with lixisenatide alone, and 5.4% with Soliqua in its 30-week trials.
Nausea or vomiting
LabelNausea 25% and vomiting 10% vs 6% and 2% on placebo, mostly in the first 3 weeks. With Soliqua’s gradual dosing, nausea was 10%.
Diarrhea or constipation
LabelDiarrhea 8% vs 6%, indigestion 3.2% vs 0.2% and constipation 2.8% vs 1.8% on placebo; 4.3% stopped for gut side effects vs 0.5%.
Dizziness
LabelDizziness: 7% vs 4% on placebo. Shakiness or dizziness can also signal low blood sugar, which is more likely with insulin or a sulfonylurea.
Trouble sleeping
Not reportedTrouble sleeping isn’t listed in the label, whose placebo-controlled trials included 2,869 people on lixisenatide.
Hair loss
LabelHair loss appears among reports after approval, so how often it happens is unknown. It wasn’t among the common side effects in trials.
Acne, rash or skin changes
LabelInjection-site reactions 4% vs 2% on placebo, more with antibodies; hives and other allergic reactions 0.4% vs 0.2%. Soliqua’s insulin can thicken or dent skin at overused sites.
Water retention or swelling
LabelSoliqua’s insulin glargine can cause salt retention and swelling, especially when poor control improves quickly. Serious allergic swelling (angioedema) has occurred; the labels say to stop and get help.
Joint or muscle pain
Not reportedJoint or muscle pain isn’t among the label’s common side effects, from placebo-controlled trials of 2,869 people on lixisenatide.
Anxiety, low mood or irritability
Not reportedAnxiety and low mood aren’t listed in the labels. FDA’s 2026 review of 91 GLP-1 drug trials found no rise in depression, anxiety or suicidal thoughts.
Low or high blood sugar
LabelIt lowers blood sugar. Symptomatic lows hit 2–3% alone or with metformin (placebo 1–2%), but 28% with basal insulin and 47% with basal insulin plus a sulfonylurea.
Fast heartbeat or blood pressure changes
LabelAverage heart rate didn’t rise in placebo-controlled studies, and QT, a heart rhythm measure, didn’t lengthen at 1.5 times the dose. ELIXA found no excess heart events.
More hunger
LabelSoliqua’s label lists decreased appetite among gut side effects. Alone, lixisenatide cut weight 1 kg more than placebo over 24 weeks; Soliqua’s insulin can add weight.
Liver strain
LabelLiver strain isn’t a listed side effect. Gallbladder problems are: in ELIXA, gallstones 0.4% vs 0.2% and acute gallbladder inflammation 0.3% vs 0.2% on placebo.
Kidney problems
LabelKidney injury, sometimes needing dialysis, has been reported, mostly after vomiting or diarrhea. Not recommended in end-stage kidney disease; exposure more than doubled in severe impairment.
Cancer risk
LabelThyroid C-cell tumors rose in rats and mice at high exposures, but the US labels carry no boxed warning. ELIXA found no rise in pancreatic tumors versus placebo.
Label: from the prescribing information. Not reported: studied in people and not reported. A side effect that hasn’t been reported can still happen, especially with long or high-dose use. Any of these across every compound: the side-effect finder.
Who should avoid it
What its label rules out or warns about, most important first.
Severe allergy to lixisenatide
LabelRuled out by the labels; anaphylaxis occurred in trials (about 0.2% vs 0.1% on placebo). The labels advise close monitoring after anaphylaxis or angioedema with another GLP-1 drug.
During low blood sugar (Soliqua)
LabelSoliqua also contains insulin glargine, so it is ruled out during an episode of low blood sugar.
End-stage kidney disease
LabelNot recommended: there is no experience when eGFR, a measure of kidney function, is under 15. Exposure more than doubled in severe impairment, so the labels advise close monitoring.
Severe gastroparesis (very slow stomach emptying)
LabelNot recommended by the labels; lixisenatide slows stomach emptying, and severe stomach and gut reactions have been reported with GLP-1 drugs.
Pregnancy
LabelHuman data are too limited to judge the risk; in rats and rabbits it caused malformations at about 1 and 6 times human exposure. The labels advise use only if the benefit justifies the risk.
Planned surgery or deep sedation
LabelRare reports describe stomach contents entering the lungs under anesthesia, because the stomach empties slowly. The labels say to tell the care team beforehand; whether pausing the drug helps is unknown.
Children and teens
LabelNot approved: safety and effectiveness haven’t been established under 18 for lixisenatide or Soliqua.
Interactions
Only interactions stated on a product label or measured in a human study are listed.
Insulin or sulfonylureas (insulin-boosting diabetes pills such as glipizide)
LabelLow blood sugar is more likely: with basal insulin plus a sulfonylurea, 47% had symptomatic lows vs 22% on placebo. The label advises considering lower doses when starting.
Birth-control pills
LabelTaken 1 or 4 hours after lixisenatide, ethinyl estradiol’s peak level fell 52% and 39%. The labels say to take the pill at least 1 hour before, or 11 hours after, the injection.
Drugs that need a minimum level (such as antibiotics) or a quick effect (such as acetaminophen)
LabelSlower stomach emptying delays absorption: acetaminophen’s peak fell about 30% when taken after a dose. The labels advise taking these at least 1 hour before the injection.
Narrow-margin oral drugs (such as warfarin or digoxin)
LabelPeak levels fell (warfarin 19%, digoxin 26%) and came later, with no change in total exposure or INR, a clotting test. The labels advise monitoring such drugs.
Other GLP-1 drugs
LabelSoliqua’s label says not to combine it with any other product containing lixisenatide or another GLP-1 receptor agonist.
Drugs that change blood sugar or hide low blood sugar (with Soliqua)
LabelBecause Soliqua contains insulin, the label lists drugs that raise or lower its effect, such as steroids, and beta-blockers, which can mask low blood sugar.
Label: a product label rules it out, warns about it or lists the interaction. This isn’t a complete list: a pharmacist or doctor can check a specific medicine or condition. Every documented interaction, by medicine: drug interactions.
Special situations
What the label and studies say about pregnancy, breastfeeding, kidney and liver problems, age and surgery.
Pregnancy
LabelHuman data are too limited. In rats and rabbits, lixisenatide caused malformations at about 1 and 6 times human exposure; insulin glargine studies show no clear risk. The labels advise use only if the benefit justifies the risk.
Breastfeeding
LabelNo human data. In rats, about 9% of the drug and its breakdown products passed into milk. The labels weigh breastfeeding’s benefits against possible risks to the baby.
Kidney problems
LabelNo dose change for mild or moderate impairment, but watch for stomach side effects and kidney changes. Only 5 people with severe impairment were studied, and end-stage kidney disease is not recommended.
Liver problems
LabelNot studied. The Adlyxin label doesn’t expect liver problems to change drug levels; Soliqua’s says glucose checks and dose changes may be needed because of its insulin.
Older adults
LabelNo overall differences in safety or effectiveness; a quarter of trial participants were 65 or older and 4% were 75 or older. Soliqua’s label advises cautious dosing to avoid low blood sugar.
Children and teens
LabelNot approved under 18; safety and effectiveness haven’t been established in children for lixisenatide or Soliqua.
Surgery and anesthesia
LabelIt slows stomach emptying, and rare reports describe stomach contents entering the lungs under anesthesia or deep sedation. The labels say to tell the care team beforehand; whether pausing helps is unknown.
Blood sugar, especially with insulin or a sulfonylurea
HbA1c
Potassium if at risk of low potassium (Soliqua)
Kidney function if vomiting or diarrhea is heavy
Often paired with
Usually run on its own.
Human studies
5 key published human studies, with how many people took part. Animal studies aren’t listed here.
20156,068 people
Heart death, heart attack, stroke or unstable angina in 13.4% vs 13.2% on placebo (HR 1.02) after a recent heart attack or unstable angina: no added risk, no benefit.
Design
Randomized double-blind placebo-controlled trial
Dose
20 mcg daily (after 10 mcg for 2 weeks)
Length
Median 25 months
Pfeffer et al., N Engl J Med 2015 (ELIXA), PMID 26630143
2024156 people
Motor scores changed by −0.04 points vs +3.04 on placebo (difference 3.08); nausea 46% and vomiting 13% on lixisenatide.
Design
Phase 2 randomized double-blind placebo-controlled trial in early Parkinson’s disease
Dose
20 mcg daily (after 10 mcg for 14 days)
Length
12 months, plus 2-month washout
Meissner et al., N Engl J Med 2024 (LIXIPARK), PMID 38598572
20161,170 people
HbA1c fell 1.6 points on the combination vs 1.3 on glargine and 0.9 on lixisenatide; nausea 9.6% vs 24% on lixisenatide alone.
Design
Open-label randomized trial vs each component
Dose
Insulin glargine plus lixisenatide in fixed ratio vs glargine alone or lixisenatide 20 mcg
Length
30 weeks
Rosenstock et al., Diabetes Care 2016 (LixiLan-O), PMID 27527848
2016736 people
HbA1c fell 1.1 vs 0.6 points in people already on basal insulin; weight fell 0.7 kg vs a 0.7 kg gain, with similar rates of low blood sugar.
Design
Open-label randomized trial vs insulin glargine
Dose
Insulin glargine plus lixisenatide in fixed ratio vs glargine, up to 60 units a day
Length
30 weeks
Aroda et al., Diabetes Care 2016 (LixiLan-L), PMID 27650977
2013634 people
HbA1c fell 0.79 vs 0.96 points (noninferior), with less nausea (24.5% vs 35.1%) and less low blood sugar (2.5% vs 7.9%).
Design
Open-label randomized trial vs exenatide
Dose
20 mcg daily vs exenatide 10 mcg twice daily, with metformin
Length
24 weeks
Rosenstock et al., Diabetes Care 2013 (GetGoal-X), PMID 23698396
Registered trials that are still running, or that finished without published results, most important first. Checked on ClinicalTrials.gov, October 7, 2026.
Phase 4NCT07307235
Insulin glargine plus lixisenatide vs usual insulin care in 1,316 Chinese adults with type 2 diabetes not controlled on pills: HbA1c at 24 weeks
Recruiting since December 2025; completion expected December 2027
Phase 4NCT06671587
Soli-CGM: insulin glargine plus lixisenatide vs insulin glargine alone in 678 Chinese adults new to insulin, measured with continuous glucose monitors over 20 weeks
Recruiting since December 2024; completion was expected September 2026
Phase 4NCT07117240
Insulin glargine plus lixisenatide vs standard insulin therapy in 100 people with diabetes caused by steroid treatment, over 6 months
Enrolling by invitation since July 2025; completion expected July 2028
Phase 4NCT07274644
Insulin glargine plus lixisenatide vs insulin glargine on liver fat over 12 weeks in 36 adults with type 2 diabetes and fatty liver disease (MASLD)
Active, not recruiting; completion was expected July 2026, no results yet
Phase 4NCT06716424
Single-arm safety study of insulin glargine plus lixisenatide in 105 adults with type 2 diabetes in India, over 25 weeks
Completed June 2026; no results posted or published
Lixisenatide’s evidence comes from blood-sugar trials of 12–30 weeks and from ELIXA, which followed 6,068 people with a recent heart attack or unstable angina for a median 25 months and found no heart benefit. The labels include only 5 people with severe kidney impairment, none with end-stage disease, and no liver study. The Parkinson’s result rests on one 12-month phase 2 trial of 156 people.
How it’s supplied
Ready-made pens of Soliqua 100/33 (100 units insulin glargine and 33 mcg lixisenatide per mL); the lixisenatide-only pens (10 and 20 mcg doses) are discontinued in the US and EU. The pen measures each dose, so there’s nothing to mix or draw up.
No mixing: Soliqua pens are ready-made and dial 15–60 units, each unit carrying fixed amounts of both drugs, so the lixisenatide dose can’t be set on its own. Never mix it with other insulins.
Datasheet
Half-life
about 3 hoursLabelAfter repeated subcutaneous doses in adults with type 2 diabetes; levels peak 1–3.5 hours after injection.
Type
Peptide, 44 amino acids
Molecular weight
4,858.5 g/mol
Formula
C215H347N61O65S
Sequence
HGEGTFTSDLSKQMEEEAVRLFIEWLKNGGPSSGAPPSKKKKKK-NH2Exendin-4 without proline 38, plus six lysines
Storage before use
Not a powder: pens hold a ready-made solution. Before first use, refrigerate at 2–8 °C, protected from light; never freeze.
After mixing or opening
Soliqua: after first use, keep at up to 25 °C and discard 28 days later. Adlyxin (discontinued) kept 14 days at up to 30 °C.
Pens hold lixisenatide in solution with metacresol: Adlyxin 50 or 100 mcg/mL (discontinued) and Soliqua 33 mcg/mL plus 100 units/mL insulin glargine. In Soliqua the two drugs move together, so lixisenatide can’t be adjusted separately.
Cautions
Serious allergic reactions, including anaphylaxis (about 0.2% in trials vs 0.1% on placebo), head its label warnings; it’s ruled out after a severe reaction to lixisenatide.
Nausea (25% vs 6%) and vomiting (10% vs 2%) are common, mostly in the first 3 weeks. Not recommended with severe gastroparesis or end-stage kidney disease.
Pancreatitis, gallbladder disease and kidney injury from dehydration are listed risks. It slows stomach emptying, so tell the care team before surgery or sedation.
Low blood sugar is more likely with insulin or a sulfonylurea. Soliqua contains insulin: it is ruled out during low blood sugar and can lower potassium.
Antibodies form in about 70% of users; in the 2.4% with the highest levels, blood-sugar control weakened. Unlike most weekly GLP-1 drugs, the US labels carry no boxed thyroid warning.
Questions
What is lixisenatide?
A once-daily GLP-1 receptor agonist modeled on exendin-4, the Gila monster peptide behind exenatide, with six lysines added to one end. Its short action mainly blunts the rise in blood sugar after the meal that follows the injection.
How does lixisenatide work?
Lixisenatide is a synthetic GLP-1 receptor agonist modeled on exendin-4, a Gila monster peptide. Switching on the GLP-1 receptor raises insulin release only when blood sugar is high, lowers glucagon, a hormone that raises blood sugar, and slows stomach emptying. Because it acts for only a few hours, its main effect is on the rise in blood sugar after the meal that follows the injection; in a label study the effect was largest at that first meal. Whether its thyroid C-cell tumors in rodents matter for people is unknown, though the US labels carry no boxed warning. Antibodies that can cross-react with natural GLP-1 and glucagon form in most users; their clinical meaning isn’t known.
Is lixisenatide FDA-approved?
Approved in the US as Adlyxin (2016), discontinued in 2023, and as Soliqua 100/33 (2016), a daily pen combining it with insulin glargine for adults with type 2 diabetes, which is still marketed. FDA’s Purple Book lists Adlyxin’s license as voluntarily revoked.
What is the usual lixisenatide dose?
From the label (Soliqua 100/33): Soliqua 100/33: 15–60 units once daily, within 1 hour before the first meal. Each unit holds 1 unit of insulin glargine and 0.33 mcg of lixisenatide, so 60 units (the maximum) gives 20 mcg. The dose moves 2–4 units a week with fasting glucose. Adlyxin: 10 mcg once daily for 14 days, then 20 mcg once daily from day 15, within 1 hour before the first meal of the day. Adlyxin was discontinued in the US in 2023. These are the amounts sources reference, not recommendations.
How is lixisenatide given?
Ready-made pens of Soliqua 100/33 (100 units insulin glargine and 33 mcg lixisenatide per mL); the lixisenatide-only pens (10 and 20 mcg doses) are discontinued in the US and EU, injected under the skin. Within 1 hour before the first meal of the day, preferably the same meal each day (labels). The pen measures each dose, so there’s nothing to mix.
Who should avoid lixisenatide?
Severe allergy to lixisenatide: Ruled out by the labels; anaphylaxis occurred in trials (about 0.2% vs 0.1% on placebo). The labels advise close monitoring after anaphylaxis or angioedema with another GLP-1 drug. During low blood sugar (Soliqua): Soliqua also contains insulin glargine, so it is ruled out during an episode of low blood sugar. End-stage kidney disease: Not recommended: there is no experience when eGFR, a measure of kidney function, is under 15. Exposure more than doubled in severe impairment, so the labels advise close monitoring. The “Who should avoid it” section lists 4 more groups and 6 interactions.
What is the half-life of lixisenatide?
About 3 hours, according to the prescribing information. After repeated subcutaneous doses in adults with type 2 diabetes; levels peak 1–3.5 hours after injection.
How should lixisenatide be stored?
Not a powder: pens hold a ready-made solution. Before first use, refrigerate at 2–8 °C, protected from light; never freeze. Soliqua: after first use, keep at up to 25 °C and discard 28 days later. Adlyxin (discontinued) kept 14 days at up to 30 °C.
Is lixisenatide banned in sport?
No. Lixisenatide isn’t named on the 2026 list, and S0 does not apply to an approved drug. But Soliqua and Suliqua also contain insulin glargine, and insulins are banned at all times (S4.4.2), so athletes need a therapeutic use exemption.
Has lixisenatide been studied in people?
Yes. The human studies section lists 5 published studies. The largest, from 2015, included 6,068 people. Heart death, heart attack, stroke or unstable angina in 13.4% vs 13.2% on placebo (HR 1.02) after a recent heart attack or unstable angina: no added risk, no benefit.
How long has lixisenatide been studied in people?
Trial ELIXA: 3,034 adults with type 2 diabetes on lixisenatide, followed for a median 25.8 months (median treatment 22.4 months).
Does lixisenatide come in other forms, like a pill or nasal spray?
Label Only daily injections under the skin are approved, alone or in a fixed-ratio pen with insulin glargine. No tablet, nasal spray or patch form is approved.
Can you drink alcohol while taking lixisenatide?
Label The labels don’t address lixisenatide and alcohol, but Soliqua’s lists alcohol among things that can raise or lower its blood-sugar effect. Heavy drinking can also cause pancreatitis.
Can lixisenatide be taken with semaglutide or tirzepatide?
Label Don’t combine two GLP-1 drugs. Soliqua’s label advises against using it with any other product containing lixisenatide or another GLP-1 drug, such as semaglutide or dulaglutide.
What happens if you take too much lixisenatide?
Label Per Soliqua’s label, 30 mcg twice daily for 13 weeks mainly raised gut side effects; excess Soliqua can also cause severe low blood sugar and low potassium. Call Poison Help (1-800-222-1222), or emergency services for severe symptoms.
Sources
Soliqua 100/33 prescribing information, rev. 03/2026 (Sanofi, DailyMed version published March 20, 2026)
FDA Purple Book: Adlyxin (BLA 208471, approved July 27, 2016) listed as discontinued from July 2023 and its license as voluntarily revoked from April 2026; Soliqua 100/33 (BLA 208673, approved November 21, 2016) licensed and marketed (September 2026 data)
EMA: Lyxumia EPAR (authorized February 2013, withdrawn December 18, 2025) and Suliqua EPAR (authorized January 11, 2017)
Pfeffer et al., ELIXA trial (NEJM 2015) PMID 26630143
Meissner et al., LIXIPARK trial in early Parkinson’s disease (NEJM 2024) PMID 38598572
FDA Purple Book monthly data (July 2023 to September 2026): Adlyxin discontinued, license voluntarily revoked; Soliqua 100/33 licensed and marketed
FDA Drug Safety Communication: removal of the suicidal behavior and ideation warning from GLP-1 receptor agonists (January 13, 2026)
Thorkildsen et al., the GLP-1 receptor agonist ZP10A, later lixisenatide (J Pharmacol Exp Ther 2003) PMID 12975499
Elkinson and Keating, Lixisenatide: first global approval (Drugs 2013) PMID 23558600
Vijiaratnam et al., Exenatide-PD3 phase 3 trial in Parkinson’s disease (Lancet 2025) PMID 39919773
FDA Global Substance Registration System record (UNII 74O62BB01U), KEGG D09729 and WHO ATC index entries for lixisenatide
EMA medicines data and EPARs for Lyxumia (withdrawn December 18, 2025) and Suliqua
MHRA products database searches for lixisenatide, Lyxumia and Suliqua (October 8, 2026)
Health Canada Drug Product Database entries for Adlyxine and Soliqua (checked October 8, 2026)
Australian Poisons Standard, October 2026 (lixisenatide in Schedule 4), and TGA product information search for lixisenatide (no documents, October 2026)
ClinicalTrials.gov registry entries for the trials listed (checked October 8, 2026)