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Drug ReportsSotagliflozin
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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3M
6M
YTD
1Y
2Y
5Y
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FDA approval date
EMA approval date
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Study 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
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
INPEFALexicon PharmaceuticalsN-216203 RX2023-05-26
2 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
inpefaNew Drug Application2024-01-15
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
Expiration
Code
SOTAGLIFLOZIN, INPEFA, LEXICON PHARMS INC
2028-05-26NCE
Patent Expiration
Patent
Expires
Flag
FDA Information
Sotagliflozin, Inpefa, Lexicon Pharms Inc
82171562030-10-07DS, DP
84764132028-05-29DS, DPU-3628
77815772028-05-04DS, DPU-3628
ATC Codes
A: Alimentary tract and metabolism drugs
— A10: Drugs used in diabetes
— A10B: Blood glucose lowering drugs, excl. insulins
— A10BK: Sodium-glucose co-transporter 2 (sglt2) inhibitors
— A10BK06: Sotagliflozin
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
Heart failureD006333EFO_0003144I50—241—7
ThrombosisD013927—————1—1
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Diabetes mellitusD003920EFO_0000400E08-E13101018——37
Type 2 diabetes mellitusD003924EFO_0001360E1110213——25
Type 1 diabetes mellitusD003922EFO_0001359E10275——13
Kidney diseasesD007674EFO_0003086N08—14——5
Renal insufficiencyD051437—N192—2——4
Chronic renal insufficiencyD051436—N18——3——3
Diabetic nephropathiesD003928EFO_0000401——21——3
Hypertrophic cardiomyopathyD002312EFO_0000538I42.11—1——2
CardiomyopathiesD009202EFO_0000318I421—1——2
HypertrophyD006984EFO_0002460—1—1——2
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Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
HypertensionD006973EFO_0000537I10—1———1
Kidney transplantationD016030———1———1
AlbuminuriaD000419EFO_0004285R80.9—1———1
Diabetes complicationsD048909———1———1
HypoxiaD000860—R09.02—1———1
NephritisD009393—N05—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 diseasesD008107EFO_0001421K70-K771————1
Hepatic insufficiencyD048550——1————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
SarcoidosisD012507EFO_0000690D80-D89————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameSotagliflozin
INNsotagliflozin
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 classphlorozin derivatives, phenolic glycosides
Image (chem structure or protein)Loading
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-ID1018899-04-1
RxCUI—
ChEMBL IDCHEMBL3039507
ChEBI ID—
PubChem CID24831714
DrugBankDB12713
UNII ID6B4ZBS263Y (ChemIDplus, GSRS)
Target
Agency Approved
SLC5A2
SLC5A2
SLC5A1
SLC5A1
Organism
Homo sapiens
Gene name
SLC5A2
Gene synonyms
SGLT2
NCBI Gene ID
6524
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
P31639
Mouse ortholog
Slc5a2 (246787)
sodium/glucose cotransporter 2 (Q923I7)
Alternate
No data
Variants
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 1,676 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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270 adverse events reported
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