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Drug ReportsRepaglinide
Prandin, Novonorm(repaglinide)
Enyglid, NovoNorm, Prandimet, Prandin, Repaglinide (repaglinide) is a small molecule pharmaceutical. Repaglinide was first approved as Prandin on 1997-12-22. It is used to treat type 2 diabetes mellitus in the USA. It has been approved in Europe to treat type 2 diabetes mellitus. The pharmaceutical is active against ATP-binding cassette sub-family C member 8.
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FDA approval date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
nutritional and metabolic diseasesD009750
endocrine system diseasesD004700
Trade Name
FDA
EMA
No data
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Metformin hydrochloride
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Repaglinide
Tradename
Company
Number
Date
Products
PRANDIMETNovo NordiskN-022386 DISCN2008-06-23
2 products, RLD
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Repaglinide
Tradename
Company
Number
Date
Products
PRANDINGemini LaboratoriesN-020741 DISCN1997-12-22
3 products, RLD
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Labels
FDA
EMA
Brand Name
Status
Last Update
prandinNew Drug Application2017-12-28
repaglinideANDA2024-05-14
Indications
FDA
EMA
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
A: Alimentary tract and metabolism drugs
— A10: Drugs used in diabetes
— A10B: Blood glucose lowering drugs, excl. insulins
— A10BD: Combinations of oral blood glucose lowering drugs
— A10BD14: Metformin and repaglinide
— A10BX: Other blood glucose lowering drugs, excl. insulins in atc
— A10BX02: Repaglinide
HCPCS
No data
Clinical
Clinical Trials
82 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_0001360E11326211243
Diabetes mellitusD003920HP_0000819E08-E13416191141
InflammationD007249MP_0001845————1—1
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
FibrosisD005355————2—24
Cystic fibrosisD003550EFO_0000390E84——2—24
HypertensionD006973EFO_0000537I10—12——2
Cardiovascular diseasesD002318HP_0001626———1—12
HypercholesterolemiaD006937HP_0003124———1——1
Coronary diseaseD003327————1——1
AtherosclerosisD050197EFO_0003914I25.1——1——1
Chronic renal insufficiencyD051436—N18—11——1
Kidney diseasesD007674EFO_0003086N08—11——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
HyperglycemiaD006943HP_0003074R73.9—1———1
Fragile x syndromeD005600—Q99.211———1
SyndromeD013577——11———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients———16————16
Drug interactionsD004347——2———13
NeoplasmsD009369—C802————2
Mitochondrial diseasesD028361EFO_0000591—1————1
StrokeD020521EFO_0000712I63.91————1
HypersensitivityD006967HP_0012393T78.401————1
Parkinson diseaseD010300EFO_0002508G201————1
RecurrenceD012008——1————1
Ovarian neoplasmsD010051EFO_0003893C561————1
Ovarian epithelial carcinomaD000077216——1————1
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Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Heart failureD006333HP_0001635I50————22
Diabetes complicationsD048909——————11
Morbid obesityD009767EFO_0001074—————11
ObesityD009765EFO_0001073E66.9————11
Bariatric surgeryD050110——————11
PancreatitisD010195HP_0001733K85————11
Pancreatic neoplasmsD010190EFO_0003860C25————11
Type 1 diabetes mellitusD003922EFO_0001359E10————11
Prediabetic stateD011236EFO_1001121R73.03————11
Glucose intoleranceD018149HP_0000833R73.03————11
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameRepaglinide
INNrepaglinide
Description
Repaglinide is a member of piperidines.
Classification
Small molecule
Drug classantidiabetic, sodium glucose co-transporter 2 (SGLT2) inhibitors, not phlorozin derivatives
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
CCOc1cc(CC(=O)N[C@@H](CC(C)C)c2ccccc2N2CCCCC2)ccc1C(=O)O
Identifiers
PDB—
CAS-ID135062-02-1
RxCUI—
ChEMBL IDCHEMBL1272
ChEBI ID8805
PubChem CID65981
DrugBankDB00912
UNII ID668Z8C33LU (ChemIDplus, GSRS)
Target
Agency Approved
ABCC8
ABCC8
Organism
Homo sapiens
Gene name
ABCC8
Gene synonyms
HRINS, SUR, SUR1
NCBI Gene ID
Protein name
ATP-binding cassette sub-family C member 8
Protein synonyms
ATP-binding cassette transporter sub-family C member 8, ATP-binding cassette, sub-family C (CFTR/MRP), member 8, sulfonylurea receptor (hyperinsulinemia), Sulfonylurea receptor 1
Uniprot ID
Mouse ortholog
Abcc8 (20927)
ATP-binding cassette sub-family C member 8 (B2RUS7)
Alternate
No data
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
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Estimated US medical usage
Repaglinide
Total medical expenditures per year (USD, in millions)
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 3,628 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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3,737 adverse events reported
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