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AboutPricing
Drug ReportsInsulin degludec
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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Events Timeline
Commercial
Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
nutritional and metabolic diseasesD009750
endocrine system diseasesD004700
immune system diseasesD007154
Trade Name
FDA
EMA
Tresiba
Combinations
Xultophy (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 70/30insulin degludec and insulin aspartNovo NordiskN-203313 DISCN2015-09-25
1 products
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Insulin degludec
Tradename
Proper name
Company
Number
Date
Products
Tresibainsulin degludecNovo NordiskN-203314 RX2015-09-25
3 products
Insulin degludec
+
Liraglutide
Tradename
Proper name
Company
Number
Date
Products
Xultophy 100/3.6insulin degludec and liraglutideNovo NordiskN-208583 RX2016-11-21
1 products
Labels
FDA
EMA
Brand Name
Status
Last Update
insulin degludecBiologic Licensing Application2024-06-03
tresibaBiologic Licensing Application2024-02-22
xultophy 100/3.6Biologic Licensing Application2024-11-01
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
type 2 diabetes mellitusEFO_0001360D003924E11
type 1 diabetes mellitusEFO_0001359D003922E10
hyperglycemia—D006943R73.9
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
341 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 mellitusD003920EFO_0000400E08-E13777761932211
Type 2 diabetes mellitusD003924EFO_0001360E11175601831131
Type 1 diabetes mellitusD003922EFO_0001359E104921831082
AtherosclerosisD050197EFO_0003914I25.1———1—1
ArteriosclerosisD001161EFO_0009086I70———1—1
Indications Phases 3
No data
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———20————20
Renal insufficiencyD051437—N191————1
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameInsulin degludec
INNinsulin 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)Loading
Structure (InChI/SMILES or Protein Sequence)—
Identifiers
PDB—
CAS-ID844439-96-9
RxCUI1670007
ChEMBL IDCHEMBL2107869
ChEBI ID—
PubChem CID—
DrugBankDB09564
UNII ID54Q18076QB (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
Xultophy – Novo Nordisk
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Tresiba – Novo Nordisk
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Ryzodeg – Novo Nordisk
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Tabular view
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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Refill frequency
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Price per prescription (USD)
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 2,566 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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12,009 adverse events reported
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