What Is Lixisenatide?
Published May 6, 2026
Lixisenatide is an active ingredient that can look oddly half-present in U.S. drug records. The standalone brand, Adlyxin, has 2023 marketing end dates in DailyMed. The molecule still shows up in Soliqua 100/33, where it is paired with insulin glargine. Same molecule. Different product story.
Key Takeaways
- Lixisenatide is an active ingredient, not a brand name.
- DailyMed describes Adlyxin as lixisenatide injection and a GLP-1 receptor agonist for adults with type 2 diabetes.
- DailyMed's Adlyxin product records list September 30, 2023 as the marketing end date for standalone Adlyxin packages.
- Lixisenatide still appears in U.S. labeling through Soliqua 100/33, which combines insulin glargine and lixisenatide.
- A 2024 NEJM phase 2 trial studied lixisenatide in 156 people with early Parkinson's disease, but that is research context, not a diabetes-label change.
1. What Is Lixisenatide?
Lixisenatide is a glucagon-like peptide-1, or GLP-1, receptor agonist active ingredient. The DailyMed Adlyxin label describes Adlyxin as lixisenatide injection for subcutaneous use, initially approved in the U.S. in 2016 for adults with type 2 diabetes.
The molecule name is the starting point. “Lixisenatide” tells you the active ingredient. It does not tell you, by itself, whether someone means old Adlyxin paperwork, the current Soliqua combination label, European Lyxumia records, or a research record.
The naming stack helps:
| Layer | Lixisenatide example | What it tells you |
|---|---|---|
| Active ingredient | Lixisenatide | The molecule. |
| Class wording | GLP-1 receptor agonist | The receptor category used in Adlyxin labeling. |
| Former standalone U.S. brand | Adlyxin | Lixisenatide-alone brand context. |
| Current U.S. combination context | Soliqua 100/33 | Insulin glargine plus lixisenatide. |
| Former EU brand context | Lyxumia | European lixisenatide brand whose EU marketing authorisation was withdrawn in 2025. |
So, no, lixisenatide is not another name for semaglutide or liraglutide. It is its own active ingredient.
3. Is Lixisenatide Still in U.S. Labeling?
Yes, through Soliqua 100/33. Current openFDA NDC data for lixisenatide-containing products returns Soliqua 100/33, with insulin glargine 100 units/mL and lixisenatide 33 mcg/mL. The current DailyMed Soliqua label uses the same combination wording.
That is the part people miss. Standalone Adlyxin ending does not mean the word “lixisenatide” disappeared from U.S. labels. It means the remaining U.S. label context is different: a fixed-ratio combination with insulin glargine.
If a medication list says “lixisenatide,” ask the next question. Was it Adlyxin, Soliqua 100/33, Lyxumia, or a study drug? That second field changes the record.
4. What Did the Adlyxin Label Say?
The Adlyxin label described a once-daily injection for adults with type 2 diabetes, used with diet and exercise. It listed 10 mcg once daily for 14 days, then 20 mcg once daily starting on Day 15, and it said Adlyxin was administered within one hour before the first meal of the day.
The label also drew boundaries. It said Adlyxin was not for type 1 diabetes, had not been studied in people with chronic pancreatitis or a history of unexplained pancreatitis, had not been studied in people with gastroparesis, and was not recommended in people with gastroparesis.
The dose forms in DailyMed were:
| Standalone Adlyxin product | Label concentration | Dose language |
|---|---|---|
| Starter pack | 50 mcg/mL and 100 mcg/mL pens | Fourteen 10 mcg doses, then 20 mcg dosing. |
| Maintenance pack | 100 mcg/mL pen | Fourteen 20 mcg doses per pen. |
5. Lixisenatide vs Soliqua 100/33
Soliqua 100/33 contains lixisenatide, but it is not lixisenatide alone. The Soliqua label lists insulin glargine and lixisenatide in one fixed-ratio pen for adults with type 2 diabetes.
That insulin component changes everything about the way the name should be recorded. A note that says only “GLP-1” leaves out insulin glargine. A note that says only “insulin” leaves out lixisenatide. And a note that says “Adlyxin” is wrong if the product was actually Soliqua.
Keep the fields separate:
| Name | Active ingredient context | Useful reading |
|---|---|---|
| Lixisenatide | Molecule name | Active ingredient, not a brand. |
| Adlyxin | Lixisenatide alone | Former standalone U.S. brand context. |
| Soliqua 100/33 | Insulin glargine plus lixisenatide | Current fixed-ratio combination context. |
For the combination product, see What Is Soliqua?. It covers the 100/33 number, displayed units, insulin glargine, and why the product should not be shortened to “lixisenatide.”
6. Is Lixisenatide the Same as Liraglutide or Semaglutide?
Lixisenatide, liraglutide, and semaglutide are different active ingredients. They all sit in GLP-1 receptor agonist labeling, but their brand contexts, product status, and dosing-language histories differ.
This is where broad shorthand gets sloppy. Saying only “GLP-1” can blur different molecules, labels, and product statuses.
| Active ingredient | Common U.S. brand context | Label-status shorthand |
|---|---|---|
| Lixisenatide | Adlyxin, Soliqua 100/33 | Standalone Adlyxin has 2023 marketing end dates; Soliqua remains a combination context. |
| Liraglutide | Victoza, Saxenda | Once-daily GLP-1 brand family with separate diabetes and weight-management contexts. |
| Semaglutide | Ozempic, Wegovy, Rybelsus | Semaglutide brand family across injectable and oral contexts. |
| Dulaglutide | Trulicity | GLP-1 receptor agonist brand context. |
| Tirzepatide | Mounjaro, Zepbound | GIP receptor and GLP-1 receptor agonist wording. |
This table is a naming map, not a clinical comparison.
7. What About Lyxumia?
Lyxumia was the European brand name for lixisenatide. The European Medicines Agency says Lyxumia received EU marketing authorisation on February 1, 2013, and that the European Commission withdrew that authorisation on December 18, 2025 at Sanofi’s request after a decision to permanently stop marketing the product for commercial reasons.
So the molecule needs a country and date attached to it. Adlyxin points to the U.S. standalone brand history. Lyxumia points to the European brand history. Soliqua points to a current U.S. combination product.
Same active ingredient, different paperwork.
That distinction prevents treating an EU withdrawal, a U.S. DailyMed marketing end date, and a current Soliqua listing as one identical event.
8. Why Does Lixisenatide Appear in Parkinson’s Research?
Lixisenatide appears in Parkinson’s research because GLP-1 receptor agonists have been studied beyond diabetes. A 2024 New England Journal of Medicine phase 2 trial studied lixisenatide in 156 participants with early Parkinson’s disease. The trial was randomized, double-blind, and placebo-controlled.
That research does not make Adlyxin a Parkinson’s drug. It does not create a U.S. Parkinson’s indication for lixisenatide, but rather means researchers tested lixisenatide in a defined study population and published phase 2 results.
This distinction matters because molecule names travel faster than labels. “Lixisenatide studied in Parkinson’s” is a research statement. “Lixisenatide approved for Parkinson’s” would be a different claim, and the reviewed sources do not support it.
9. What Safety Facts Belong With Lixisenatide?
The Adlyxin label lists warnings around anaphylaxis and serious hypersensitivity reactions, pancreatitis, pen sharing, hypoglycemia with insulin or insulin secretagogues, acute kidney injury, severe gastrointestinal adverse reactions, and immunogenicity.
The Soliqua label adds insulin-combination issues, including hypoglycemia, medication errors, and overdose risk tied to the lixisenatide component when Soliqua exceeds labeled limits. That is another reason “lixisenatide” is not enough as a medication-list entry.
For a neutral record, keep safety language tied to the product source:
| Source context | Safety wording to keep visible |
|---|---|
| Adlyxin label | GLP-1 receptor agonist warnings, including pancreatitis and serious hypersensitivity reactions. |
| Soliqua label | Combination-product warnings involving insulin glargine and lixisenatide. |
| Parkinson research | Study context only, not a labeled treatment use. |
Safety wording follows the product label, not the molecule name alone.
10. What Should You Track?
The most useful lixisenatide record has brand context, product status, source, country, date checked, and whether insulin is part of the product. Without those fields, old Adlyxin notes and current Soliqua notes start to look like the same thing.
Use a record like this:
| Field | Lixisenatide entry |
|---|---|
| Active ingredient | Lixisenatide |
| Class | GLP-1 receptor agonist |
| Former standalone U.S. brand | Adlyxin |
| Standalone U.S. product-status note | DailyMed lists September 30, 2023 marketing end dates for Adlyxin product records. |
| Current U.S. combination context | Soliqua 100/33 contains insulin glargine and lixisenatide. |
| EU brand history | Lyxumia marketing authorisation withdrawn December 18, 2025. |
| Do not blur with | Liraglutide, semaglutide, dulaglutide, tirzepatide, Adlyxin alone, Soliqua 100/33. |
For broader GLP-1 background, see What Is a GLP-1?. For the former standalone brand, see What Is Adlyxin?. For the combination product that still contains lixisenatide in U.S. labeling, see What Is Soliqua?.
Short version: lixisenatide is the molecule. Adlyxin was the standalone U.S. brand context. Soliqua is the combination-product context. Keep those apart and most confusion goes away.
11. What Is Lixisenatide FAQ
What is lixisenatide in simple terms?
Lixisenatide is a GLP-1 receptor agonist active ingredient. It was the active ingredient in Adlyxin, a once-daily injection for adults with type 2 diabetes, and it is also part of Soliqua 100/33 with insulin glargine.
Is lixisenatide the same as Adlyxin?
No. Lixisenatide is the active ingredient. Adlyxin was the standalone U.S. brand context for lixisenatide injection. DailyMed's Adlyxin product records list marketing end dates in 2023.
Is lixisenatide still used in Soliqua?
Yes. Current openFDA NDC data and the DailyMed Soliqua label list Soliqua 100/33 as insulin glargine 100 units/mL and lixisenatide 33 mcg/mL. That is a combination product, not Adlyxin alone.
Is lixisenatide a weekly GLP-1?
No. The Adlyxin label describes once-daily administration within one hour before the first meal of the day. Weekly GLP-1 wording belongs to other product labels, not standalone lixisenatide.
Was lixisenatide studied for Parkinson's disease?
Yes. A 2024 New England Journal of Medicine phase 2 trial studied lixisenatide in 156 people with early Parkinson's disease. That does not create a U.S. Parkinson's indication for lixisenatide.
12. Sources
References used for this article
- DailyMed: Adlyxin lixisenatide prescribing information
- FDA: Adlyxin lixisenatide approval letter
- DailyMed: Soliqua 100/33 insulin glargine and lixisenatide label
- openFDA: NDC data for lixisenatide-containing products
- Sanofi: FDA approval of Adlyxin in 2016
- EMA: Lyxumia lixisenatide status
- NEJM: Trial of lixisenatide in early Parkinson's disease
- DailyMed: Victoza liraglutide label
- DailyMed: Ozempic semaglutide label