Apidra(insulin glulisine)
Apidra (insulin glulisine) is a protein pharmaceutical. Insulin glulisine was first approved as Apidra on 2004-04-16. It has been approved in Europe to treat diabetes mellitus.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| nutritional and metabolic diseases | D009750 |
| endocrine system diseases | D004700 |
Trade Name
FDA
EMA
Apidra (discontinued: Apidra)
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 |
|---|---|---|
| apidra | 2008-11-06 | |
| apidra apidra solostar | Biologic Licensing Application | 2025-11-25 |
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
HCPCS
No data
Clinical
Clinical Trials
124 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Diabetes mellitus | D003920 | EFO_0000400 | E08-E13 | 7 | 1 | 15 | 22 | 7 | 52 |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | 3 | 1 | 12 | 30 | 4 | 50 |
| Type 1 diabetes mellitus | D003922 | EFO_0001359 | E10 | 4 | 9 | 11 | 18 | 7 | 49 |
| Insulin resistance | D007333 | EFO_0002614 | E88.819 | 1 | 6 | 2 | 5 | — | 14 |
| Hyperglycemia | D006943 | — | R73.9 | — | — | 3 | 5 | 3 | 11 |
| Diabetic nephropathies | D003928 | EFO_0000401 | — | — | — | — | 1 | 1 | 2 |
| Kidney diseases | D007674 | EFO_0003086 | N08 | — | — | — | 1 | 1 | 2 |
| Lipodystrophy | D008060 | — | E88.1 | — | — | — | 1 | — | 1 |
| Liver cirrhosis | D008103 | EFO_0001422 | K74.0 | — | — | — | 1 | — | 1 |
| Fibrosis | D005355 | — | — | — | — | — | 1 | — | 1 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Myocardial infarction | D009203 | EFO_0000612 | I21 | — | — | 2 | — | — | 2 |
| Leukemia | D007938 | — | C95 | — | — | 1 | — | — | 1 |
| St elevation myocardial infarction | D000072657 | — | — | — | — | 1 | — | — | 1 |
| Infarction | D007238 | EFO_0009463 | — | — | — | 1 | — | — | 1 |
| Cardiovascular diseases | D002318 | EFO_0000319 | I98 | — | — | 1 | — | — | 1 |
| Respiratory aspiration | D053120 | EFO_1001839 | — | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hypoglycemia | D007003 | — | E16.2 | — | 6 | — | — | — | 6 |
| Alzheimer disease | D000544 | EFO_0000249 | F03 | — | 2 | — | — | — | 2 |
| Cognitive dysfunction | D060825 | — | G31.84 | — | 1 | — | — | — | 1 |
| Cognition disorders | D003072 | — | — | — | 1 | — | — | — | 1 |
| Gestational diabetes | D016640 | — | O24.4 | — | 1 | — | — | — | 1 |
| Pregnancy in diabetics | D011254 | — | O24.91 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 1 | — | — | — | — | 1 |
| Down syndrome | D004314 | EFO_0001064 | Q90 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Diabetes complications | D048909 | — | — | — | — | — | — | 1 | 1 |
| Chronic obstructive pulmonary disease | D029424 | EFO_0000341 | J44.9 | — | — | — | — | 1 | 1 |
| Lung diseases | D008171 | EFO_0003818 | J98.4 | — | — | — | — | 1 | 1 |
| Obstructive lung diseases | D008173 | — | — | — | — | — | — | 1 | 1 |
| Glucose metabolism disorders | D044882 | — | — | — | — | — | — | 1 | 1 |
| Metabolic diseases | D008659 | EFO_0000589 | E88.9 | — | — | — | — | 1 | 1 |
| Immune system diseases | D007154 | — | D89.9 | — | — | — | — | 1 | 1 |
| Metabolic syndrome | D024821 | EFO_0000195 | E88.810 | — | — | — | — | 1 | 1 |
| Endocrine system diseases | D004700 | EFO_0001379 | E34.9 | — | — | — | — | 1 | 1 |
| Autoimmune diseases | D001327 | EFO_0000540 | M30-M36 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Insulin glulisine |
| INN | insulin glulisine |
| Description | Insulin glulisine recombinant |
| Classification | Protein |
| Drug class | — |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | 6GV0 |
| CAS-ID | — |
| RxCUI | — |
| ChEMBL ID | CHEMBL1201613 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB01309 |
| UNII ID | 7XIY785AZD (ChemIDplus, GSRS) |
Target
No data
Variants
No data
Financial
Revenue by drug
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Estimated US medical usage
Insulin glulisine
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Number of purchases
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Refill frequency
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 1,259 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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6,246 adverse events reported
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