Adlyxin, Lyxumia (lixisenatide)
Adlyxin, Lyxumia, Soliqua, Suliqua (lixisenatide) is a protein pharmaceutical. Lixisenatide was first approved as Lyxumia on 2013-01-31. It is used to treat type 2 diabetes mellitus in the USA. It has been approved in Europe to treat type 2 diabetes mellitus. The pharmaceutical is active against glucagon-like peptide 1 receptor.
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FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| nutritional and metabolic diseases | D009750 |
| endocrine system diseases | D004700 |
Trade Name
FDA
EMA
Combinations
Soliqua
Drug Products
FDA
EMA
Reference product - 351(a)
Reference product - 351(a)
Interchangeable product - 351(k)
Interchangeable product - 351(k)
Biosimilar product - 351(k)
Biosimilar product - 351(k)
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| soliqua 100/33 | Biologic Licensing Application | 2023-10-10 |
Indications
FDA
EMA
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
A: Alimentary tract and metabolism drugs
— A10: Drugs used in diabetes
— A10A: Insulins and analogues
— A10AE: Insulins and analogues for injection, long-acting
— A10AE54: Insulin glargine and lixisenatide
— A10B: Blood glucose lowering drugs, excl. insulins
— A10BJ: Glucagon-like peptide-1 (glp-1) analogues
— A10BJ03: Lixisenatide
HCPCS
No data
Clinical
Clinical Trials
74 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | 4 | 5 | 32 | 15 | 6 | 62 |
| Diabetes mellitus | D003920 | HP_0000819 | E08-E13 | 7 | 5 | 26 | 10 | 5 | 52 |
| Type 1 diabetes mellitus | D003922 | EFO_0001359 | E10 | 1 | — | — | 2 | — | 3 |
| Healthy volunteers/patients | — | — | — | — | — | — | 1 | 1 | 2 |
| Diabetic nephropathies | D003928 | EFO_0000401 | — | — | — | — | 1 | — | 1 |
| Kidney diseases | D007674 | EFO_0003086 | N08 | — | — | — | 1 | — | 1 |
| Hypoglycemia | D007003 | HP_0001943 | E16.2 | — | — | — | 1 | — | 1 |
| Pituitary diseases | D010900 | — | E23.7 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Acute coronary syndrome | D054058 | EFO_0005672 | — | — | — | 1 | — | — | 1 |
| Syndrome | D013577 | — | — | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Parkinson disease | D010300 | EFO_0002508 | G20 | — | 1 | — | — | — | 1 |
| Gastroparesis | D018589 | EFO_1000948 | K31.84 | 1 | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Gastroesophageal reflux | D005764 | EFO_0003948 | K21 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Cardiovascular diseases | D002318 | HP_0001626 | — | — | — | — | — | 2 | 2 |
| Heart failure | D006333 | HP_0001635 | I50 | — | — | — | — | 1 | 1 |
| Retinal diseases | D012164 | HP_0000479 | H35.9 | — | — | — | — | 1 | 1 |
| Weight loss | D015431 | HP_0001824 | — | — | — | — | — | 1 | 1 |
| Male infertility | D007248 | EFO_0004248 | N46 | — | — | — | — | 1 | 1 |
| Infertility | D007246 | HP_0000789 | — | — | — | — | — | 1 | 1 |
| Intracytoplasmic sperm injections | D020554 | — | — | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Lixisenatide |
| INN | lixisenatide |
| Description | Lixisenatide (trade name Lyxumia in the European Union and Adlyxin in the U.S. and manufactured by Sanofi) is a once-daily injectable GLP-1 receptor agonist for the treatment of type 2 diabetes.
|
| Classification | Protein |
| Drug class | peptides |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | — |
| RxCUI | — |
| ChEMBL ID | CHEMBL2108336 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB09265 |
| UNII ID | 74O62BB01U (ChemIDplus, GSRS) |
Target
Alternate
No data
Variants
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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2,616 adverse events reported
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