Tresiba(insulin degludec)
Ryzodeg, Tresiba, Xultophy (insulin degludec) is a protein pharmaceutical. Insulin degludec was first approved as Tresiba on 2013-01-20. 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
Tresiba
CombinationsXultophy (discontinued: Ryzodeg)
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 degludec
Tradename | Proper name | Company | Number | Date | Products |
|---|---|---|---|---|---|
| Tresiba | insulin degludec | Novo Nordisk Inc. | N-203314 RX | 2015-09-25 | 3 products |
Insulin aspart
+
Insulin degludec
Tradename | Proper name | Company | Number | Date | Products |
|---|---|---|---|---|---|
| Ryzodeg 70/30 | insulin degludec and insulin aspart | Novo Nordisk Inc. | N-203313 DISCN | 2015-09-25 | 1 products |
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Insulin degludec
+
Liraglutide
Tradename | Proper name | Company | Number | Date | Products |
|---|---|---|---|---|---|
| Xultophy 100/3.6 | insulin degludec and liraglutide | Novo Nordisk Inc. | N-208583 RX | 2016-11-21 | 1 products |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| tresiba | Biologic Licensing Application | 2022-07-01 |
| xultophy 100/3.6 | Biologic Licensing Application | 2019-11-15 |
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
No data
Patent Expiration
No data
ATC Codes
A: Alimentary tract and metabolism drugs
— A10: Drugs used in diabetes
— A10A: Insulins and analogues
— A10AD: Insulins and analogues for injection used in diabetes, intermediate- or long-acting combined with fast-acting
— A10AD06: Insulin degludec and insulin aspart
— A10AE: Insulins and analogues for injection, long-acting
— A10AE06: Insulin degludec
— A10AE56: Insulin degludec and liraglutide
HCPCS
No data
Clinical
Clinical Trials
200 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 | 13 | 8 | 60 | 12 | 25 | 117 |
| Type 1 diabetes mellitus | D003922 | EFO_0001359 | E10 | 27 | 5 | 17 | 9 | 11 | 69 |
| Diabetes mellitus | D003920 | EFO_0000400 | E08-E13 | — | — | 1 | 1 | 1 | 3 |
| Hypoglycemia | D007003 | HP_0001943 | E16.2 | — | — | — | 1 | — | 1 |
| Diabetic nephropathies | D003928 | EFO_0000401 | — | — | — | 1 | — | 1 | |
| Renal insufficiency | D051437 | HP_0000083 | N19 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Liver cirrhosis | D008103 | EFO_0001422 | K74.0 | — | — | 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 | — | 17 | — | — | — | — | 17 |
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | INSULIN DEGLUDEC |
| INN | insulin degludec |
| Description | Insulin degludec (INN/USAN) is an ultralong-acting basal insulin analogue that was developed by Novo Nordisk under the brand name Tresiba. It is administered via subcutaneous injection once daily to help control the blood sugar level of those with diabetes. It has a duration of action that lasts up to 42 hours (compared to 18 to 26 hours provided by other marketed long-acting insulins such as insulin glargine and insulin detemir), making it a once-daily basal insulin, that is one that provides a base insulin level, as opposed to the fast- and short-acting bolus insulins.
|
| Classification | Protein |
| Drug class | — |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | 844439-96-9 |
| RxCUI | 1670007 |
| ChEMBL ID | CHEMBL2107869 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB09564 |
| UNII ID | 54Q18076QB (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
Tresiba - Novo Nordisk
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Xultophy - Novo Nordisk
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Ryzodeg - Novo Nordisk
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 1,841 documents
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Safety
Black-box Warning
Black-box warning for: Xultophy 100/3.6
Adverse Events
Top Adverse Reactions
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22,773 adverse events reported
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