Peptide education
Lixisenatide
Adlyxin · AVE0010
Lixisenatide is a short-acting GLP-1 receptor agonist. In the United States it is a component of Soliqua 100/33, a prescription combination with insulin glargine for adults with type 2 diabetes.
Lixisenatide has diabetes trial evidence, but the product matters: historical Adlyxin findings describe lixisenatide alone, while Soliqua combines it with insulin glargine and has its own dosing and safety rules.
Overview
Quick answer
Adlyxin was a standalone lixisenatide product. FDA now lists its presentations as discontinued and its license as voluntarily revoked. Soliqua is a separate, licensed product that also contains insulin.
What does lixisenatide do?
It activates the GLP-1 receptor, increases glucose-dependent insulin release, reduces glucagon, and slows gastric emptying. In Soliqua, insulin glargine adds a separate blood-glucose-lowering action.
What is Soliqua approved for?
Soliqua 100/33 is labeled with diet and exercise to improve blood glucose control in adults with type 2 diabetes. It is not labeled for chronic weight management.
What happened to Adlyxin?
The FDA Purple Book lists the standalone Adlyxin presentations as discontinued and the license as voluntarily revoked. The historical Adlyxin label should not be mistaken for current availability.
Are Adlyxin and Soliqua doses interchangeable?
No. Adlyxin contained lixisenatide alone. Soliqua delivers a fixed ratio of insulin glargine and lixisenatide, so its pen units specify both ingredients and its label uses a different starting and titration scheme.
Did lixisenatide reduce cardiovascular events in ELIXA?
ELIXA met its noninferiority criterion against placebo in people with type 2 diabetes and a recent acute coronary syndrome. It did not show superiority for the cardiovascular composite.
Evidence
Evidence snapshot
In a 12-week trial, standalone lixisenatide improved HbA1c versus placebo in adults not taking glucose-lowering drugs at entry.
In basal-insulin-treated adults, the fixed-ratio combination improved HbA1c more than insulin glargine at the 30-week primary assessment.
The primary composite occurred in 13.4% with lixisenatide and 13.2% with placebo over a median 25 months. The trial did not show superiority.
FDA lists Adlyxin as discontinued and voluntarily revoked, while Soliqua 100/33 is listed as a licensed prescription product.
Soliqua's label includes hypoglycemia, pancreatitis, serious hypersensitivity, kidney injury related to dehydration, and other warnings.
Claims
Common claims vs evidence
| Claim | Human evidence | Mechanistic evidence | Verdict |
|---|---|---|---|
| Lixisenatide improves glucose control in type 2 diabetes. | GetGoal-Mono found improvements in HbA1c and post-meal glucose with standalone lixisenatide versus placebo. A separate trial studied the insulin glargine and lixisenatide combination. | GLP-1 receptor activation changes glucose-dependent insulin and glucagon secretion and slows gastric emptying. | Supported in the studied diabetes populations. Standalone and combination findings must be attributed to the products actually tested. |
| ELIXA proves that lixisenatide prevents cardiovascular events. | In people with type 2 diabetes after a recent acute coronary syndrome, the lixisenatide group met the trial's noninferiority criterion against placebo, but the primary composite was not reduced significantly. | No. Noninferiority is not evidence of superiority, and the trial did not test Soliqua as a cardiovascular risk-reduction product. | |
| Soliqua is just another name for standalone lixisenatide. | GetGoal-Mono studied lixisenatide alone; LixiLan-L studied the combination of insulin glargine and lixisenatide. | No. Soliqua combines insulin glargine and lixisenatide; historical Adlyxin contained lixisenatide alone. The insulin component changes dose interpretation and adds important risks, including hypoglycemia. | |
| A compounded product can be assumed equivalent to Soliqua. | No human study comparing a compounded product with Soliqua is cited here. | Not established. Soliqua has a specified fixed-ratio formulation and pen. FDA says compounded drugs are not FDA-approved and are not verified by FDA for safety, effectiveness, and quality before marketing. Sharing an ingredient name does not prove matching composition, concentration, sterility, or clinical performance. |
Bottom line
Main takeaway
Soliqua contains two medicines, not just lixisenatide. The older standalone Adlyxin product is listed as discontinued.
Soliqua's dose is expressed in units of the combination. Changing the dose changes the amounts of insulin and lixisenatide together.
GetGoal-Mono and ELIXA evaluated standalone lixisenatide; LixiLan-L evaluated a fixed-ratio insulin combination. ELIXA's noninferiority result is not a cardiovascular superiority claim.
Identity
What it is
Lixisenatide is a GLP-1 receptor agonist given by subcutaneous injection. Its gastric-emptying effect is relevant to post-meal glucose and to the absorption of certain oral medicines.
Soliqua combines insulin glargine and lixisenatide in a fixed ratio. FDA lists the prior standalone Adlyxin presentations as discontinued and voluntarily revoked.
Use context
Routes, doses, and cycle patterns
Soliqua's pen units deliver fixed amounts of both insulin glargine and lixisenatide. The former standalone product, Adlyxin, contained lixisenatide alone.
Human studies and product labels
Soliqua 100/33 label
- Purpose
- Glycemic control in adults with type 2 diabetes
- Context
- FDA-reviewed combination product label
- Route
- Subcutaneous injection
- Amount
- Starting dose is 15 or 30 units depending on prior treatment; maximum 60 units daily
- Frequency
- Once daily within the hour before the first meal of the day
- Duration
- Label describes ongoing treatment and weekly dose adjustment based on glucose control
Fifteen units contain 15 units of insulin glargine and 5 mcg of lixisenatide; 30 units contain 30 units of insulin and 10 mcg of lixisenatide. At the 60-unit maximum, the lixisenatide component is 20 mcg. The label directs discontinuation of prior basal insulin or a GLP-1 receptor agonist before starting Soliqua; the prescriber manages the transition. The starting dose depends on prior treatment, and the label describes weekly adjustments based on glucose control.
Historical Adlyxin label
- Purpose
- Glycemic control in adults with type 2 diabetes
- Context
- Historical standalone FDA label; product discontinued
- Route
- Subcutaneous injection
- Amount
- 10 mcg daily for 14 days, followed by 20 mcg daily
- Frequency
- Once daily within the hour before the first meal of the day
- Duration
- Initiation schedule described in the historical label
Adlyxin contained lixisenatide alone. FDA now lists it as discontinued with a voluntarily revoked license. The label described the initial 10 mcg phase as intended to reduce gastrointestinal reactions and not effective for adult glycemic control.
GetGoal-Mono trial regimen
- Purpose
- Glycemic outcomes in adults with type 2 diabetes
- Context
- Randomized monotherapy trial
- Route
- Subcutaneous injection
- Amount
- Two escalation schedules reached 20 mcg daily; placebo groups were pooled
- Frequency
- Once daily
- Duration
- 12 weeks
The trial studied standalone lixisenatide, not the fixed-ratio insulin combination.
What varies
- Product: Soliqua contains insulin glargine as well as lixisenatide; Adlyxin was standalone.
- Timing: the Soliqua label places administration within the hour before the first meal.
- Other medicines: delayed gastric emptying can affect oral drug absorption; the label includes timing guidance for selected medicines.
- Kidney and glucose monitoring: dehydration-related kidney injury and hypoglycemia are label warnings.
Research
Research evidence
Randomized studies cover standalone lixisenatide and the fixed-ratio combination with insulin glargine. ELIXA tested cardiovascular safety after acute coronary syndrome; it did not establish a cardiovascular benefit.
| Study / evidence area | Population | Design | Product context | Main outcome | Limitations | Weight |
|---|---|---|---|---|---|---|
| GetGoal-Mono | Adults with type 2 diabetes not taking glucose-lowering drugs at entry | Randomized, double-blind, placebo-controlled, 12 weeks | Standalone lixisenatide | The two escalation groups reduced HbA1c by 0.54 and 0.66 percentage points more than placebo, respectively, and improved post-meal glucose measures. | The trial was short and did not test Soliqua or establish a weight-management indication. | Strong |
| LixiLan-L | Basal-insulin-treated adults with type 2 diabetes | Randomized, open-label, active-controlled, 30-week primary assessment | Insulin glargine and lixisenatide versus insulin glargine | The fixed-ratio combination improved HbA1c more than insulin glargine in 736 randomized participants after a run-in period. | Both arms included insulin. The result does not isolate standalone lixisenatide or establish a weight-management indication. | Strong |
| ELIXA | Adults with type 2 diabetes and recent acute coronary syndrome | Randomized, double-blind, placebo-controlled cardiovascular outcomes trial | Standalone lixisenatide versus placebo added to usual care | The primary composite occurred in 13.4% versus 13.2%, respectively; hazard ratio 1.02, 95% confidence interval 0.89 to 1.17. Noninferiority was shown, but superiority was not. | The population had a recent acute coronary event. The composite included hospitalization for unstable angina as well as cardiovascular death, heart attack, and stroke, and was not a Soliqua trial. | Strong |
Cautions
Safety and unknowns
- Soliqua contains insulin and can cause hypoglycemia. It is contraindicated during an episode of hypoglycemia and in people with serious hypersensitivity to either component or an excipient.
- Nausea, vomiting, and diarrhea may occur. The label warns about acute pancreatitis, serious hypersensitivity, acute kidney injury related to dehydration, and severe gastrointestinal reactions. Soliqua is not recommended for severe gastroparesis or end-stage renal disease.
- The label also warns about hypokalemia, gallbladder disease, and pulmonary aspiration during general anesthesia or deep sedation. Adding another lixisenatide-containing product or GLP-1 receptor agonist is not recommended.
- Lixisenatide delays gastric emptying and may affect oral medication absorption. The Soliqua label gives timing instructions for oral contraceptives and certain other drugs. Pregnancy and breastfeeding should be reviewed with a clinician.
Product quality
Product identity and quality
Soliqua has a defined ratio of insulin glargine to lixisenatide and a pen that displays the dose in units. Its formulation and device are part of the product, not interchangeable features.
FDA says compounded drugs are not FDA-approved and are not verified for safety, effectiveness, or quality before marketing.
Product and ingredients
The Soliqua label identifies both active ingredients and their fixed ratio. A standalone preparation does not contain the same combination.
Dose and device
Soliqua's pen units correspond to amounts of both medicines. The label warns against transferring the product from its pen to a syringe.
Storage
Storage and handling instructions are specific to the labeled product.
Mechanism
How it is proposed to work
Lixisenatide mimics GLP-1 signaling and slows stomach emptying. In Soliqua, it works alongside insulin glargine, which acts through a different pathway to lower blood glucose.
The label describes glucose-dependent insulin release and reduced glucagon secretion from lixisenatide. Insulin glargine acts on insulin receptors to regulate glucose metabolism.
Details
Technical details
Sources
References
- 1.
DailyMed. Soliqua 100/33 prescribing information
Product-specific indication, fixed-ratio dosing, interactions, and warnings for insulin glargine and lixisenatide.
- 2.
FDA. Adlyxin historical prescribing information
Historical standalone product label; FDA now lists Adlyxin as discontinued and voluntarily revoked.
- 3.
FDA. FDA Purple Book: Adlyxin and Soliqua 100/33
FDA lists the Adlyxin presentations as discontinued and voluntarily revoked, and Soliqua 100/33 as licensed.
- 4.
PubMed. Lixisenatide in patients with type 2 diabetes and acute coronary syndrome: ELIXA
doi:10.1056/NEJMoa1509225 PMID:26630143 NCT01147250
Randomized cardiovascular outcomes trial of lixisenatide versus placebo after acute coronary syndrome.
- 5.
PubMed Central. Lixisenatide monotherapy in type 2 diabetes: GetGoal-Mono
doi:10.2337/dc11-1935 PMID:22432104
A 12-week placebo-controlled study of standalone lixisenatide and glycemic outcomes.
- 6.
PubMed. Insulin glargine and lixisenatide in type 2 diabetes: LixiLan-L
doi:10.2337/dc16-1495 PMID:27650977
Randomized trial of the fixed-ratio combination compared with insulin glargine in basal-insulin-treated adults.
- 7.
FDA. Compounding and the FDA: Questions and Answers
FDA explains that compounded drugs are not FDA-approved and that FDA does not verify their safety, effectiveness, or quality before marketing.