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.
Download report
Favorite
Commercial
Trade Name
FDA
EMA
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)
Insulin glulisine
Tradename | Proper name | Company | Number | Date | Products |
|---|---|---|---|---|---|
| Apidra | insulin glulisine | Sanofi | N-21629 RX | 2004-04-16 | 2 products |
Show 1 discontinued
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| apidra apidra solostar | Biologic Licensing Application | 2020-11-30 |
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
HCPCS
No data
Clinical
Clinical Trials
87 clinical trials
View more details
Mock data
Subscribe for the real data
Subscribe for the real data
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 | 3 | 1 | 10 | 22 | 1 | 37 |
| Type 1 diabetes mellitus | D003922 | EFO_0001359 | E10 | 4 | 2 | 5 | 16 | 3 | 30 |
| Diabetes mellitus | D003920 | EFO_0000400 | E08-E13 | 1 | — | 3 | 2 | — | 6 |
| Hyperglycemia | D006943 | HP_0003074 | R73.9 | — | — | 1 | 4 | 1 | 6 |
| Diabetic nephropathies | D003928 | EFO_0000401 | — | — | — | 1 | — | 1 | |
| Liver cirrhosis | D008103 | EFO_0001422 | K74.0 | — | — | — | 1 | — | 1 |
| Diabetic ketoacidosis | D016883 | EFO_1000897 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Cardiovascular diseases | D002318 | EFO_0000319 | I98 | — | — | 1 | — | — | 1 |
| Myocardial infarction | D009203 | EFO_0000612 | I21 | — | — | 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 |
|---|---|---|---|---|---|---|---|---|---|
| Chronic obstructive pulmonary disease | D029424 | EFO_0000341 | J44.9 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
View more details
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 | 207748-29-6 |
| RxCUI | 400008 |
| ChEMBL ID | CHEMBL1201613 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB01309 |
| UNII ID | 7XIY785AZD (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
Mock data
Subscribe for the real data
Subscribe for the real data
Additional graphs summarizing 937 documents
View more details
Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
Mock data
Subscribe for the real data
Subscribe for the real data
90,547 adverse events reported
View more details
Premium feature
Learn more about premium features at pharmakb.com
Learn more