Inpefa, Zynquista(sotagliflozin)
Inpefa, Zynquista (sotagliflozin) is a small molecule pharmaceutical. Sotagliflozin was first approved as Zynquista on 2019-04-26. It has been approved in Europe to treat type 1 diabetes mellitus. The pharmaceutical is active against sodium/glucose cotransporter 2 and sodium/glucose cotransporter 1.
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Commercial
Therapeutic Areas
Trade Name
FDA
EMA
Inpefa
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Sotagliflozin
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| INPEFA | Lexicon Pharmaceuticals | N-216203 RX | 2023-05-26 | 2 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| inpefa | New Drug Application | 2024-01-15 |
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
SOTAGLIFLOZIN, INPEFA, LEXICON PHARMS INC | |||
| 2028-05-26 | NCE | ||
HCPCS
No data
Clinical
Clinical Trials
61 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 | 10 | 9 | 17 | 1 | 1 | 37 |
| Type 1 diabetes mellitus | D003922 | EFO_0001359 | E10 | 2 | 6 | 4 | 1 | 1 | 13 |
| Heart failure | D006333 | HP_0001635 | I50 | — | 2 | 3 | 1 | 1 | 7 |
| Kidney diseases | D007674 | EFO_0003086 | N08 | — | — | 4 | 1 | — | 5 |
| Diabetic nephropathies | D003928 | EFO_0000401 | — | — | 1 | 1 | 1 | — | 3 |
| Albuminuria | D000419 | EFO_0004285 | R80.9 | — | — | — | 1 | — | 1 |
| Diabetes complications | D048909 | — | — | — | — | — | 1 | — | 1 |
| Hypoxia | D000860 | HP_0012418 | R09.02 | — | — | — | 1 | — | 1 |
| Nephritis | D009393 | — | N05 | — | — | — | 1 | — | 1 |
| Thrombosis | D013927 | — | — | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | 10 | 2 | 13 | — | — | 25 |
| Renal insufficiency | D051437 | HP_0000083 | N19 | 2 | — | 1 | — | 1 | 4 |
| Chronic renal insufficiency | D051436 | — | N18 | — | — | 3 | — | — | 3 |
| Hypertrophic cardiomyopathy | D002312 | EFO_0000538 | I42.1 | 1 | — | 1 | — | — | 2 |
| Cardiomyopathies | D009202 | EFO_0000318 | I42 | 1 | — | 1 | — | — | 2 |
| Hypertrophy | D006984 | EFO_0002460 | — | 1 | — | 1 | — | — | 2 |
| Chronic kidney failure | D007676 | EFO_0003884 | N18.9 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hypertension | D006973 | EFO_0000537 | I10 | — | 1 | — | — | — | 1 |
| Kidney transplantation | D016030 | — | — | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 14 | — | — | — | — | 14 |
| Liver diseases | D008107 | HP_0002910 | K70-K77 | 1 | — | — | — | — | 1 |
| Hepatic insufficiency | D048550 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Cardiovascular diseases | D002318 | HP_0001626 | — | — | — | — | — | 1 | 1 |
| Sarcoidosis | D012507 | EFO_0000690 | D80-D89 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Sotagliflozin |
| INN | sotagliflozin |
| Description | Sotagliflozin is an S-glycosyl compound that is 1-thio-beta-L-xylopyranose in which the anomeric hydroxy group is replaced by a 4-chloro-3-[(4-ethoxyphenyl)methyl]phenyl group and the thiol is replaced by a methylsulfanediyl group. It is an inhibitor of SGLT1 and SGLT2 that is approved to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in adults with heart failure or type 2 diabetes mellitus, chronic kidney disease, and other cardiovascular risk. It has a role as a sodium-glucose transport protein subtype 2 inhibitor, a hypoglycemic agent, an antihypertensive agent, a cardioprotective agent and a sodium-glucose transport protein subtype 1 inhibitor. It is a C-glycosyl compound, an aromatic ether, a member of monochlorobenzenes and a S-glycosyl compound. |
| Classification | Small molecule |
| Drug class | phlorozin derivatives, phenolic glycosides |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CCOc1ccc(Cc2cc([C@@H]3O[C@H](SC)[C@@H](O)[C@H](O)[C@H]3O)ccc2Cl)cc1 |
Identifiers
| PDB | — |
| CAS-ID | 1018899-04-1 |
| RxCUI | — |
| ChEMBL ID | CHEMBL3039507 |
| ChEBI ID | — |
| PubChem CID | 24831714 |
| DrugBank | DB12713 |
| UNII ID | 6B4ZBS263Y (ChemIDplus, GSRS) |
Target
Agency Approved
SLC5A2
SLC5A2
SLC5A1
SLC5A1
Organism
Homo sapiens
Gene name
SLC5A2
Gene synonyms
SGLT2
NCBI Gene ID
Protein name
sodium/glucose cotransporter 2
Protein synonyms
Low affinity sodium-glucose cotransporter, Na(+)/glucose cotransporter 2, solute carrier family 5 (sodium/glucose cotransporter), member 2, solute carrier family 5 (sodium/glucose transporter), member 2, Solute carrier family 5 member 2
Uniprot ID
Mouse ortholog
Slc5a2 (246787)
sodium/glucose cotransporter 2 (Q923I7)
Alternate
No data
Variants
No data
Financial
No data
Trends
PubMed Central
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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119 adverse events reported
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