Lantus(insulin glargine)
Basaglar, Lantus, Optisulin, Rezvoglar, Semglee, Soliqua, Suliqua, Toujeo (insulin glargine) is a protein pharmaceutical. Insulin glargine was first approved as Lantus on 2000-04-20. It is used to treat hyperglycemia, type 1 diabetes mellitus, and type 2 diabetes mellitus in the USA. It has been approved in Europe to treat diabetes mellitus and type 2 diabetes mellitus.
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Commercial
Trade Name
FDA
EMA
Basaglar, Lantus, Rezvoglar, Semglee, Toujeo
CombinationsSoliqua
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)
Insulin glargine
Insulin glargine
+
Lixisenatide
Tradename | Proper name | Company | Number | Date | Products |
|---|---|---|---|---|---|
| Soliqua 100/33 | insulin glargine and lixisenatide | Sanofi | N-208673 RX | 2016-11-21 | 1 products |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| basaglar basaglar | Biologic Licensing Application | 2021-02-22 |
| lantus solostar | Biologic Licensing Application | 2023-06-06 |
| rezvoglar kwikpen | Biologic Licensing Application | 2023-05-02 |
| semglee | Biologic Licensing Application | 2021-07-13 |
| soliqua 100/33 | Biologic Licensing Application | 2021-08-04 |
| toujeo | Biologic Licensing Application | 2023-04-27 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| hyperglycemia | HP_0003074 | D006943 | R73.9 |
| type 1 diabetes mellitus | EFO_0001359 | D003922 | E10 |
| type 2 diabetes mellitus | EFO_0001360 | D003924 | E11 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
insulin glargine, Semglee, Mylan Pharmaceuticals Inc. | |||
| 11/15/2022 | Interchangeable excl. | ||
Patent Expiration
No data
HCPCS
No data
Clinical
Clinical Trials
540 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 | 25 | 12 | 135 | 153 | 14 | 339 |
| Type 1 diabetes mellitus | D003922 | EFO_0001359 | E10 | 39 | 7 | 37 | 27 | 10 | 118 |
| Diabetes mellitus | D003920 | EFO_0000400 | E08-E13 | 3 | 5 | 6 | 12 | 5 | 31 |
| Hyperglycemia | D006943 | HP_0003074 | R73.9 | 1 | — | 4 | 11 | 2 | 18 |
| Diabetic ketoacidosis | D016883 | EFO_1000897 | — | 1 | — | 3 | 4 | 8 | |
| Chronic renal insufficiency | D051436 | N18 | — | — | 1 | 1 | 1 | 3 | |
| Non-alcoholic fatty liver disease | D065626 | EFO_0003095 | K75.81 | — | — | — | 3 | — | 3 |
| Coronary artery disease | D003324 | I25.1 | — | — | — | 3 | — | 3 | |
| Hypoglycemia | D007003 | HP_0001943 | E16.2 | — | — | — | 2 | 1 | 3 |
| Cardiovascular diseases | D002318 | EFO_0000319 | I98 | — | — | 1 | 1 | — | 2 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Obesity | D009765 | EFO_0001073 | E66.9 | — | — | 2 | — | 1 | 3 |
| Prediabetic state | D011236 | EFO_1001121 | R73.03 | — | — | 2 | — | — | 2 |
| Leukemia | D007938 | C95 | — | — | 2 | — | — | 2 | |
| Lymphoma | D008223 | C85.9 | — | — | 1 | — | — | 1 | |
| Varicose ulcer | D014647 | — | — | 1 | — | — | 1 | ||
| Wound healing | D014945 | GO_0042060 | — | — | 1 | — | — | 1 | |
| Stroke | D020521 | EFO_0000712 | I63.9 | — | — | 1 | — | — | 1 |
| Myocardial infarction | D009203 | EFO_0000612 | I21 | — | — | 1 | — | — | 1 |
Indications Phases 2
No data
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | 15 | — | — | — | — | 15 | ||
| Diabetic retinopathy | D003930 | EFO_0003770 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Diabetic neuropathies | D003929 | EFO_1000783 | — | — | — | — | 1 | 1 | |
| Kidney transplantation | D016030 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | INSULIN GLARGINE |
| INN | insulin glargine |
| Description | Insulin glargine recombinant |
| Classification | Protein |
| Drug class | — |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | 4IYD, 4IYF, 5VIZ |
| CAS-ID | 160337-95-1 |
| RxCUI | 274783 |
| ChEMBL ID | CHEMBL1201497 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB00047 |
| UNII ID | 2ZM8CX04RZ (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
Lantus - Sanofi
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Toujeo - Sanofi
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Basaglar - Eli Lilly
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 7,887 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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12,775 adverse events reported
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