Lixisenatide

What it is

Lixisenatide is the active substance FDA records as UNII 74O62BB01U; AVE0010 is its development name. Adlyxin and Lyxumia are product names. Soliqua 100/33 is something else again: a fixed combination of insulin glargine and lixisenatide, not an alias.

Findings depend on the specified injectable finished product, population, exposure, and combination. They do not transfer automatically to other GLP-1 receptor agonists, nonapproved formulations, or a product whose identity is not tied to the FDA or study record.

Why people care

Interest includes diabetes, weight, and incretin-class comparisons. The evidence requires separation of the labeled diabetes use from general weight-loss claims, and separation of Adlyxin, the Soliqua fixed combination, other GLP-1 receptor agonists, and unidentified products.

What humans actually show

Lixisenatide has an FDA-approved use to improve glycemic control in adults with type 2 diabetes and randomized human evidence in that population. The current Purple Book marks the single-ingredient Adlyxin presentations discontinued without reporting a discontinuation date, while lixisenatide also remains a component of the approved Soliqua fixed combination.

• randomized human — 361 adults with type 2 diabetes not receiving glucose-lowering treatment; Route: Subcutaneous trial product; Outcome: Hemoglobin A1c, body weight, and adverse events over 12 weeks: Placebo-adjusted hemoglobin A1c changes were -0.54 and -0.66 percentage points for the two lixisenatide schedules. Nausea occurred in 23% assigned lixisenatide and 4.1% assigned placebo; the abstract reported no significant body-weight difference from placebo. The seam: Short-duration glycemic trial; Defined type 2 diabetes population; Did not demonstrate a placebo-separated body-weight benefit; Does not establish interchangeability or authenticate another product.
• randomized human — 6,068 adults with type 2 diabetes and a recent acute coronary syndrome; Route: Subcutaneous trial product; Outcome: Composite cardiovascular outcome over a median 25 months: The primary outcome occurred in 13.4% assigned lixisenatide and 13.2% assigned placebo, hazard ratio 1.02 (95% CI 0.89 to 1.17). Lixisenatide met the prespecified noninferiority boundary and did not show superiority. The seam: Selected high-cardiovascular-risk diabetes population; Noninferiority is not cardiovascular benefit; Does not establish an obesity indication; Does not transfer to an unidentified product.
• randomized human — 1,170 adults with type 2 diabetes randomized to insulin glargine/lixisenatide, insulin glargine, or lixisenatide; Route: Subcutaneous fixed-combination or component trial products; Outcome: Hemoglobin A1c, hypoglycemia, and gastrointestinal adverse events over 30 weeks: Mean hemoglobin A1c reductions were 1.6, 1.3, and 0.9 percentage points; 74%, 59%, and 33% reached a value below 7%. Documented symptomatic hypoglycemia was similar for the combination and insulin glargine, while nausea occurred in 9.6% with the combination and 24% with lixisenatide. The seam: Open-label design; Glycemic rather than general weight-loss trial; Fixed-combination evidence does not validate arbitrary insulin combinations; Results apply to the specified trial products and population.

Mechanistic and nonhuman evidence

• mechanistic — FDA-approved product pharmacology; Route: Labeled injectable product; Outcome: GLP-1 receptor activity, glucose-dependent insulin release, glucagon secretion, and gastric emptying: FDA labeling identifies lixisenatide as a GLP-1 receptor agonist and describes glucose-dependent insulin release, reduced glucagon secretion, and delayed gastric emptying. The seam: Mechanism does not establish an unlabeled clinical outcome; Delayed gastric emptying creates interaction and procedure boundaries; Label pharmacology does not authenticate another product.
• animal — Animal reproductive studies summarized in FDA labeling; Route: Specified nonhuman exposures; Outcome: Embryofetal and developmental findings: The Adlyxin label reports animal reproductive findings that inform its pregnancy risk summary. The seam: Nonhuman evidence; Exposure and species dependent; Does not provide a human pregnancy event rate; Does not establish efficacy.

FDA and U.S. status

FDA's current Adlyxin label supports use as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. The Purple Book marks the two Adlyxin presentations discontinued but does not provide a discontinuation date, while current FDA labeling also supports the insulin glargine/lixisenatide fixed combination Soliqua 100/33. Approval, indication, and current presentation availability are separate questions.

Risks and warning limits

• approved label — Warnings and Precautions: Current Adlyxin labeling warns about hypersensitivity and anaphylaxis, acute pancreatitis, hypoglycemia with insulin or insulin secretagogues, never sharing an Adlyxin prefilled pen between patients even if the needle is changed, acute kidney injury due to volume depletion, severe gastrointestinal reactions, immunogenicity, acute gallbladder disease, and pulmonary aspiration during general anesthesia or deep sedation.
• approved label — Postmarketing Experience: The label separately records intestinal obstruction and severe constipation including fecal impaction as postmarketing gastrointestinal events. Voluntary reports cannot establish frequency or a causal relationship reliably.
• approved label: Common adverse reactions in FDA labeling include nausea, vomiting, headache, diarrhea, dizziness, and hypoglycemia.
• human trial: GetGoal-Mono reported nausea in 23% of participants assigned lixisenatide and 4.1% assigned placebo over 12 weeks.

What remains unknown

• Current real-world availability of the Purple Book presentations marked discontinued was not established.
• Long-term benefit and risk outside the labeled adult type 2 diabetes population remain outside the approved-use boundary.
• Safety and efficacy of self-assembled combinations, nonapproved formulations, and nonapproved indications are not established by the fixed-combination record.
• The identity and quality of a product not tied to an FDA application or a study record cannot be inferred from the lixisenatide name.

Product identity and quality limits

• FDA's UNII record identifies the substance and does not approve or authenticate a finished product.
• Adlyxin and Soliqua 100/33 are different finished products; the latter is a fixed insulin glargine/lixisenatide combination, not an alias.
• A Purple Book discontinuation field concerns the listed presentations and does not allow an unverified product to inherit the approval.
• An import-alert listing is an enforcement and admission record, not proof of approval, purity, sterility, equivalence, or product identity.

What has been studied together

• Insulin glargine fixed combination — studied fixed combination: LixiLan-O directly studied the specified insulin glargine/lixisenatide fixed combination, and FDA labeling supports Soliqua 100/33 for its exact use. This does not validate arbitrary self-assembled combinations.
• Insulin or insulin secretagogues — known label boundary: Adlyxin labeling states that concomitant use increases hypoglycemia risk. This is a labeled interaction boundary, not a protocol.
• Oral medications — known label boundary: The approved label states that delayed gastric emptying can affect absorption of oral medicines and provides product-specific precautions. This draft does not convert them into reader instructions.
• Other GLP-1 receptor agonists — duplicate pathway overlap: Soliqua labeling states that concomitant use with another GLP-1 receptor agonist is not recommended. No additional benefit or compatibility should be inferred.

What people are hearing

These are claims this profile checks, not established conclusions.

• Claim under review: “A discontinued Adlyxin presentation means lixisenatide has no current FDA-approved use.”
• Claim under review: “Lixisenatide diabetes trials establish a general weight-loss indication.”
• Claim under review: “Soliqua or class evidence proves every lixisenatide combination is supported.”

Questions readers raise

• No reproducible community sample was collected for this profile.

The community-signal layer is not efficacy or safety evidence. Its current limits are:

• No reproducible community sample has been collected for this profile.
• Self-reports would be subject to selection and reporting bias.
• The product, formulation, route, indication, and concurrent medicines in a self-report could not be verified.
• Diabetes care, diet, activity, and other medicines could confound an anecdote.
• Reported glycemic, weight, and adverse outcomes could not be independently verified.
• Anecdotes cannot establish efficacy, safety, approval, product identity, or interaction compatibility.

What would change this answer

• A later FDA approval, withdrawal, labeling update, or Purple Book status change would change the current regulatory and warning boundary.
• Controlled trials for an exact additional indication, product, and population could change the evidence boundary, but would not themselves change the approved indication.
• Finished-product analytical and regulatory records could change the inability to transfer approved or trial-product identity to another product.

Sources and records

• WADA — 2026 Prohibited List

• FDA GSRS substance record for lixisenatide — U.S. Food and Drug Administration
• Adlyxin prescribing information, March 2026 — U.S. Food and Drug Administration
• Adlyxin supplement approval letter, March 12, 2026 — U.S. Food and Drug Administration
• Purple Book product details for Adlyxin — U.S. Food and Drug Administration
• Soliqua 100/33 prescribing information — U.S. Food and Drug Administration
• Drugs@FDA exact-substance API search for lixisenatide — U.S. Food and Drug Administration
• FDA Import Alert 66-80 — U.S. Food and Drug Administration
• Efficacy and safety of lixisenatide once daily in type 2 diabetes insufficiently controlled on diet and exercise — Diabetes Care / PubMed
• Lixisenatide in patients with type 2 diabetes and acute coronary syndrome — New England Journal of Medicine / PubMed
• Benefits of lixisenatide plus insulin glargine as a fixed-ratio combination in people with type 2 diabetes — Diabetes Care / PubMed
• NCT00688701: GetGoal-Mono — ClinicalTrials.gov
• NCT01147250: ELIXA — ClinicalTrials.gov
• NCT02058147: LixiLan-O — ClinicalTrials.gov
• ClinicalTrials.gov intervention search for lixisenatide — U.S. National Library of Medicine
• PubMed title search for lixisenatide — U.S. National Library of Medicine