Ryzodeg 70/30, 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
Therapeutic Areas
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 aspart
+
Insulin degludec
Tradename | Proper name | Company | Number | Date | Products |
|---|---|---|---|---|---|
| Ryzodeg 70/30 | insulin degludec and insulin aspart | Novo Nordisk | N-203313 DISCN | 2015-09-25 | 1 products |
Hide discontinued
Insulin degludec
Tradename | Proper name | Company | Number | Date | Products |
|---|---|---|---|---|---|
| Tresiba | insulin degludec | Novo Nordisk | N-203314 RX | 2015-09-25 | 3 products |
Insulin degludec
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Liraglutide
Tradename | Proper name | Company | Number | Date | Products |
|---|---|---|---|---|---|
| Xultophy 100/3.6 | insulin degludec and liraglutide | Novo Nordisk | N-208583 RX | 2016-11-21 | 1 products |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| insulin degludec | Biologic Licensing Application | 2024-06-03 |
| tresiba | Biologic Licensing Application | 2024-02-22 |
| xultophy 100/3.6 | Biologic Licensing Application | 2023-07-10 |
Indications
FDA
EMA
Agency Specific
FDA
EMA
No data
Patent Expiration
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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
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Clinical
Clinical Trials
342 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 | HP_0000819 | E08-E13 | 91 | 17 | 100 | 45 | 48 | 299 |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | 20 | 11 | 75 | 33 | 45 | 183 |
| Type 1 diabetes mellitus | D003922 | EFO_0001359 | E10 | 58 | 8 | 26 | 18 | 20 | 129 |
| Hypoglycemia | D007003 | HP_0001943 | E16.2 | — | — | 1 | 2 | 1 | 4 |
| Hyperglycemia | D006943 | HP_0003074 | R73.9 | — | — | — | 2 | 2 | 4 |
| Fibrosis | D005355 | — | — | — | — | 1 | 1 | — | 2 |
| Renal insufficiency | D051437 | HP_0000083 | N19 | 1 | — | — | 1 | — | 2 |
| Cystic fibrosis | D003550 | EFO_0000390 | E84 | — | — | — | 1 | — | 1 |
| Atherosclerosis | D050197 | EFO_0003914 | I25.1 | — | — | — | 1 | — | 1 |
| Arteriosclerosis | D001161 | EFO_0009086 | I70 | — | — | — | 1 | — | 1 |
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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 |
| Pharmacokinetics | D010599 | — | — | — | 1 | 1 | — | — | 1 |
| Pharmacological phenomena | D000069437 | — | — | — | 1 | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Exercise | D015444 | EFO_0000483 | — | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 25 | — | — | — | — | 25 |
| Alzheimer disease | D000544 | EFO_0000249 | F03 | 1 | — | — | — | — | 1 |
| Cognitive dysfunction | D060825 | HP_0001268 | G31.84 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Critical illness | D016638 | — | — | — | — | — | — | 3 | 3 |
| Diabetes complications | D048909 | — | — | — | — | — | — | 2 | 2 |
| Placebos | D010919 | — | — | — | — | — | — | 1 | 1 |
| Body weight | D001835 | EFO_0004338 | — | — | — | — | — | 1 | 1 |
| Ketosis | D007662 | HP_0002919 | R82.4 | — | — | — | — | 1 | 1 |
| Diabetic ketoacidosis | D016883 | EFO_1000897 | — | — | — | — | — | 1 | 1 |
| Knee prosthesis | D007720 | — | — | — | — | — | — | 1 | 1 |
| Gastroparesis | D018589 | EFO_1000948 | K31.84 | — | — | — | — | 1 | 1 |
| Pancreatitis | D010195 | HP_0001733 | K85 | — | — | — | — | 1 | 1 |
| Abdominal pain | D015746 | HP_0002027 | R10.9 | — | — | — | — | 1 | 1 |
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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.
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| 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
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Tresiba – Novo Nordisk
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Xultophy – Novo Nordisk
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Ryzodeg – Novo Nordisk
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Estimated US medical usage
Insulin degludec
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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Price per prescription (USD)
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Trends
PubMed Central
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Additional graphs summarizing 2,361 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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11,066 adverse events reported
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