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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Study first post date
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| nutritional and metabolic diseases | D009750 |
| endocrine system diseases | D004700 |
Trade Name
FDA
EMA
Repaglinide (discontinued: Prandin, Repaglinide)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Metformin hydrochloride
+
Repaglinide
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| PRANDIMET | Novo Nordisk | N-022386 DISCN | 2008-06-23 | 2 products, RLD |
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Repaglinide
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| PRANDIN | Gemini Laboratories | N-020741 DISCN | 1997-12-22 | 3 products, RLD |
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Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| prandin | New Drug Application | 2017-12-28 |
| repaglinide | ANDA | 2025-06-05 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| 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
— 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
85 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 | EFO_0000400 | E08-E13 | 3 | 1 | 4 | 11 | 7 | 26 |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | 2 | 1 | 2 | 11 | 6 | 22 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Fibrosis | D005355 | — | — | — | — | 2 | — | 1 | 3 |
| Cystic fibrosis | D003550 | EFO_0000390 | E84 | — | — | 2 | — | 1 | 3 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hyperglycemia | D006943 | — | R73.9 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Prediabetic state | D011236 | EFO_1001121 | R73.03 | — | — | — | — | 1 | 1 |
| Glucose intolerance | D018149 | HP_0000833 | R73.03 | — | — | — | — | 1 | 1 |
| Exocrine pancreatic insufficiency | D010188 | — | K86.81 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Repaglinide |
| INN | repaglinide |
| Description | Repaglinide is a member of piperidines. |
| Classification | Small molecule |
| Drug class | antidiabetic, sodium glucose co-transporter 2 (SGLT2) inhibitors, not phlorozin derivatives |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CCOc1cc(CC(=O)N[C@@H](CC(C)C)c2ccccc2N2CCCCC2)ccc1C(=O)O |
Identifiers
| PDB | — |
| CAS-ID | 135062-02-1 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1272 |
| ChEBI ID | 8805 |
| PubChem CID | 65981 |
| DrugBank | DB00912 |
| UNII ID | 668Z8C33LU (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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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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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 3,918 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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3,862 adverse events reported
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