Lixisenatide

Fat LossFDA-approved GLP-1 receptor agonistEstablished

Lixisenatide is an FDA-approved GLP-1 receptor agonist. Lixisenatide is an exendin-4 analog carrying a C-terminal polylysine extension that increases its affinity for the GLP-1 receptor and its resistance to enzymatic degradation. Its short duration of action produces a pronounced effect on gastric emptying, which is the main driver of its comparatively larger reduction in post-prandial glucose relative to fasting glucose.

Calculate Dose

For research use only.

Key Facts

CAS: 320367-13-3
Molecular Weight (MW): 4858 g/mol
Half-life: —
FDA status: Approved
Evidence level: FDA Approved
Human dose established: Yes
Administration Route: Subcutaneous
Frequency: Once daily
Last updated: Nov 7, 2026
Reviewed: Nov 7, 2026

Research summary

Once-daily short-acting GLP-1 receptor agonist derived from exendin-4, approved for glycaemic control in adults with type 2 diabetes and also formulated in fixed-ratio combination with insulin glargine.

Research evidence

Regulatory review (FDA label)1 reviewed source
Controlled human trials2 reviewed sources
Early or uncontrolled human studiesNone in reviewed sources
Lab & animal studiesNone in reviewed sources

How it works

Each step shows whether the sources Peptide Library has reviewed include that kind of research. Counts are reviewed sources, not every study ever published. Reviews and programme summaries that describe human use are shown as "reported", not as trials, and registered trials without published results are listed but not counted. A higher step means research has progressed further; it does not mean a compound works better or is safer. Compounds whose evidence has not been reviewed yet show "Not reviewed" instead of a guess.

Peptide Library's Lixisenatide profile summarises 5 cited studies listed in the Science section, the compound's regulatory status, and research-protocol parameters reported for it. It is a research reference, not medical advice.

Lixisenatide dosage evidence

Lixisenatide has an FDA-approved human dosage only as part of Soliqua 100/33, a fixed combination with insulin glargine for adults with type 2 diabetes. Soliqua starts at 15 or 30 units once daily (5 or 10 mcg of lixisenatide) and is adjusted weekly up to 60 units (20 mcg of lixisenatide). No standalone lixisenatide (Adlyxin) label is listed on DailyMed as of this review; in the ELIXA and LIXIPARK trials it was given at 10 mcg once daily for 2 weeks, then 20 mcg once daily.

FDA Approved

Dosage evidence summary for Lixisenatide
Human dosing established	Yes
Studied dose range	5–20 mcg once daily (lixisenatide component of Soliqua; 10–20 mcg in trials)
Route	Subcutaneous
Frequency	Once daily
Duration studied	Continuous
Titration	Soliqua: up or down by 2–4 units every week to the fasting glucose goal, maximum 60 units (20 mcg lixisenatide). Trials: 10 mcg for 2 weeks, then 20 mcg.
Evidence level	FDA Approved
Last reviewed	2026-11-07

Research-reported dosing

Doses as studied, one row per regimen. Different trials used different regimens; they are listed separately rather than averaged.

Research-reported dosing for Lixisenatide, one row per studied regimen
Study / context	Population	Dose	Route	Frequency	Duration	Outcome studied	Source
FDA label — Soliqua 100/33 (insulin glargine and lixisenatide), type 2 diabetesFDA-approved label · FDA prescribing information, combination product	Adults with type 2 diabetes mellitus	Start 15 units (5 mcg lixisenatide) if insulin-naive, on a GLP-1 agonist or on under 30 units of basal insulin; start 30 units (10 mcg) if on 30–60 units of basal insulin; maximum 60 units (20 mcg lixisenatide)	Subcutaneous	Once daily	Continuous; titrated weekly	Glycemic control	SOLIQUA 100/33 (insulin glargine and lixisenatide) injection — FDA prescribing information, DailyMed
ELIXA — NCT01147250, phase 3, results postedClinical trial · Phase 3 randomised placebo-controlled trial	Adults with type 2 diabetes and a recent acute coronary syndrome (n=6068)	10 mcg for 2 weeks, then 20 mcg maintenance (could be lowered to 15 or 10 mcg)	Subcutaneous, within 1 hour before breakfast	Once daily	Median follow-up 25 months	Noninferior to placebo for major cardiovascular events; not superior	NCT01147250 — Evaluation of Cardiovascular Outcomes in Patients With Type 2 Diabetes After Acute Coronary Syndrome During Treatment With Lixisenatide (ELIXA)
LIXIPARK — NCT03439943, phase 2Clinical trial · Phase 2 randomised placebo-controlled trial	Adults with early Parkinson's disease, diagnosed under 3 years earlier (n=156)	10 mcg a day for 14 days, then 20 mcg a day (could be lowered to 10 mcg)	Subcutaneous	Once daily	12 months, then a 2-month washout	Less motor disability progression than placebo at 12 months; nausea in 46%	NCT03439943 — Study to Evaluate the Effect of Lixisenatide in Patient With Parkinson's Disease (LIXIPARK)

Where sources disagree

On DailyMed the only current US label with lixisenatide is Soliqua 100/33, where it always comes with insulin glargine (100 units glargine to 33 mcg lixisenatide per mL). Soliqua is dosed in units of the combination, not in micrograms of lixisenatide.
The Parkinson's disease result is from one phase 2 trial; it is not an approved use.

Lixisenatide dosage in published studies and labels →

Sequence & molecular data

Sequence and molecular data for Lixisenatide
Amino acid sequence	His-Gly-Glu-Gly-Thr-Phe-Thr-Ser-Asp-Leu-Ser-Lys-Gln-Met-Glu-Glu-Glu-Ala-Val-Arg-Leu-Phe-Ile-Glu-Trp-Leu-Lys-Asn-Gly-Gly-Pro-Ser-Ser-Gly-Ala-Pro-Pro-Ser-Lys-Lys-Lys-Lys-Lys-Lys
Molecular formula	C215H347N61O65S
Molecular weight	4858 g/mol
CAS number	320367-13-3
PubChem CID	90472060
FDA UNII	74O62BB01U

Identifiers link to the public PubChem, FDA Substance Registration (UNII), ChEMBL and DrugBank records for the same entity.

Science

Mechanism of Action

Lixisenatide is an exendin-4 analog carrying a C-terminal polylysine extension that increases its affinity for the GLP-1 receptor and its resistance to enzymatic degradation. Its short duration of action produces a pronounced effect on gastric emptying, which is the main driver of its comparatively larger reduction in post-prandial glucose relative to fasting glucose.

Studies

Research statistics

599 PubMed publications · 36.8% human clinical research · 66 registered trials

Counts of published research through 2026-11-01, not evidence that it works. Publications by year, study types and trials · How publications are counted

Regulatory & research status

Lixisenatide is an FDA-approved product for specific labelled indications. Approval does not extend to the research contexts described on this page, and approved products are prescription medicines.

Regulatory and research status for Lixisenatide
FDA status	Approved
Research status	Approved product (see FDA status)
Availability	Prescription-Only
WADA (sport)	Unknown / Not Listed
Library classification	FDA-Approved

How FDA approval, compounding and research-only status differ

Benefits

—

Lixisenatide side effects

No side effects listed yet for this entry.

Storage & stability

This compound is not supplied as a powder to be mixed, so the freeze-dried powder and reconstitution handling described for research peptides does not apply. Storage conditions are product-specific: follow the label or packaging of the product itself.

Lixisenatide: frequently asked questions

What is Lixisenatide?

How does Lixisenatide work?

Is Lixisenatide FDA approved?

Yes. Lixisenatide is approved by the FDA, and approved products are prescription medicines. Approval is always for specific indications studied in clinical trials, so an approved status does not mean the compound is approved for every use it is discussed for. Research-chemical material sold under the same name is not the approved product.

What is the amino acid sequence of Lixisenatide?

Lixisenatide has the sequence His-Gly-Glu-Gly-Thr-Phe-Thr-Ser-Asp-Leu-Ser-Lys-Gln-Met-Glu-Glu-Glu-Ala-Val-Arg-Leu-Phe-Ile-Glu-Trp-Leu-Lys-Asn-Gly-Gly-Pro-Ser-Ser-Gly-Ala-Pro-Pro-Ser-Lys-Lys-Lys-Lys-Lys-Lys, giving a chain of 44 amino acids. Its molecular formula is C215H347N61O65S.

What peptides are similar to Lixisenatide?

Compounds most often compared with Lixisenatide include Semaglutide, Tirzepatide, Retatrutide and Liraglutide. They are grouped by shared mechanism or research area rather than by equivalence, and their regulatory status and evidence base differ.

References

Trial of Lixisenatide in Early Parkinson's Disease — N Engl J Med, 2024
External reference
Lixisenatide in Patients with Type 2 Diabetes and Acute Coronary Syndrome — N Engl J Med, 2015
External reference
Adverse drug reactions of GLP-1 agonists: A systematic review of case reports — Diabetes Metab Syndr, 2022
External reference
Cardiovascular outcomes with glucagon-like peptide-1 receptor agonists in patients with type 2 diabetes: a meta-analysis — Lancet Diabetes Endocrinol, 2018
External reference
Lixisenatide: first global approval — Drugs, 2013
External reference

Related research, comparisons & guides

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Compiled by Peptide Library Editorial · Reviewed Aug 30, 2026 · Updated Nov 7, 2026 · Version 2

This Lixisenatide profile is compiled from published literature (5 cited studies linked above), public regulatory records and chemical registries. It describes what research reports; it is not medical advice, and nothing here is a dosing recommendation for humans. Peptide Library does not sell peptides. Editorial policy · How profiles are compiled · Report an error

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