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Drug ReportsInsulin glargine
Lantus(insulin glargine)
Abasaglar, Abasria, Basaglar, Lantus, Optisulin, Rezvoglar, Semglee, Soliqua, Suliqua, Toujeo (insulin glargine) is a protein pharmaceutical. Insulin glargine was first approved as Lantus on 2000-04-20. 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
Basaglar, Lantus, Rezvoglar, Semglee, Toujeo (discontinued: Basaglar, Lantus, Semglee)
Combinations
Soliqua
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 glargine
Tradename
Proper name
Company
Number
Date
Products
Basaglarinsulin glargineEli LillyN-205692 RX2019-11-15
1 products
Lantusinsulin glargineSanofiN-21081 RX2000-04-20
2 products
Toujeoinsulin glargineSanofiN-206538 RX2015-02-25
2 products
Show 3 discontinued
Insulin glargine
+
Lixisenatide
Tradename
Proper name
Company
Number
Date
Products
Soliqua 100/33insulin glargine and lixisenatideSanofiN-208673 RX2016-11-21
1 products
Labels
FDA
EMA
Brand Name
Status
Last Update
basaglarNew Drug Application2019-01-28
basaglar basaglarBiologic Licensing Application2023-11-29
insulin glargineBiologic Licensing Application2025-03-03
insulin glargine insulin glargine solostarBiologic Licensing Application2024-01-03
insulin glargine solostarBiologic Licensing Application2023-11-01
insulin glargine u-300 insulin glargine u-300 maxBiologic Licensing Application2025-05-30
lantusBiologic Licensing Application2023-02-04
lantus lantus solostarBiologic Licensing Application2025-06-02
lantus solostarBiologic Licensing Application2023-07-22
rezvoglarBiologic Licensing Application2024-08-09
Show 6 more
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
Expiration
Code
insulin glargine, Semglee, Biocon Biologics Inc.
11/15/2022Interchangeable excl.
Patent Expiration
No data
ATC Codes
A: Alimentary tract and metabolism drugs
— A10: Drugs used in diabetes
— A10A: Insulins and analogues
— A10AE: Insulins and analogues for injection, long-acting
— A10AE04: Insulin glargine
— A10AE54: Insulin glargine and lixisenatide
HCPCS
No data
Clinical
Clinical Trials
717 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 mellitusD003924EFO_0001360E11524120270
Diabetes mellitusD003920EFO_0000400E08-E132—1912235
Insulin resistanceD007333EFO_0002614E88.819——15—6
Metabolic diseasesD008659EFO_0000589E88.9———1—1
Myocardial infarctionD009203EFO_0000612I21———1—1
Inferior wall myocardial infarctionD056989EFO_1000983————1—1
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Type 1 diabetes mellitusD003922EFO_0001359E107210—119
Chronic renal insufficiencyD051436—N18——2——2
HyperglycemiaD006943—R73.9——1——1
ObesityD009765EFO_0001073E66.9——1——1
Cardiovascular diseasesD002318EFO_0000319I98——1——1
OverweightD050177—E66.3——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———6————6
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Diabetic neuropathiesD003929EFO_1000783—————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameInsulin glargine
INNinsulin glargine
Description
Insulin glargine recombinant
Classification
Protein
Drug class—
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)—
Identifiers
PDB4IYD, 4IYF, 5VIZ
CAS-ID160337-95-1
RxCUI274783
ChEMBL IDCHEMBL1201497
ChEBI ID—
PubChem CID—
DrugBankDB00047
UNII ID2ZM8CX04RZ (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
$
€
£
₣
Lantus – Sanofi
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Toujeo – Sanofi
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Basaglar – Eli Lilly
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Tabular view
Estimated US medical usage
Insulin glargine
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 10,432 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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129,909 adverse events reported
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