Steglatro(ertugliflozin)
Segluromet, Steglatro, Steglujan (ertugliflozin) is a small molecule pharmaceutical. Ertugliflozin was first approved as Steglatro on 2017-12-19. It has been approved in Europe to treat type 2 diabetes mellitus. The pharmaceutical is active against sodium/glucose cotransporter 2. In addition, it is known to target sodium/glucose cotransporter 1.
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Commercial
Trade Name
FDA
EMA
Steglatro
CombinationsSegluromet, Steglujan
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Ertugliflozin
Tradename | Company | Number | Date | Products |
---|---|---|---|---|
STEGLATRO | Merck Sharp & Dohme | N-209803 RX | 2017-12-19 | 2 products, RLD, RS |
Ertugliflozin
+
Metformin hydrochloride
Tradename | Company | Number | Date | Products |
---|---|---|---|---|
SEGLUROMET | Merck Sharp & Dohme | N-209806 RX | 2017-12-19 | 4 products, RLD, RS |
Ertugliflozin
+
Sitagliptin phosphate
Tradename | Company | Number | Date | Products |
---|---|---|---|---|
STEGLUJAN | Merck Sharp & Dohme | N-209805 RX | 2017-12-19 | 2 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
---|---|---|
segluromet | New Drug Application | 2022-11-20 |
steglatro | New Drug Application | 2022-11-07 |
steglujan | New Drug Application | 2021-11-19 |
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
Expiration | Code | ||
---|---|---|---|
ERTUGLIFLOZIN, STEGLATRO, MSD SUB MERCK | |||
2024-09-17 | M-275 | ||
ERTUGLIFLOZIN / METFORMIN HYDROCHLORIDE, SEGLUROMET, MSD SUB MERCK | |||
2024-09-17 | M-275 | ||
ERTUGLIFLOZIN / SITAGLIPTIN PHOSPHATE, STEGLUJAN, MSD SUB MERCK | |||
2024-09-17 | M-275 |
Patent Expiration
Patent | Expires | Flag | FDA Information |
---|---|---|---|
Ertugliflozin / Metformin Hydrochloride, Segluromet, Msd Sub Merck | |||
9308204 | 2030-10-21 | DP | |
9439902 | 2030-10-21 | U-2214 | |
Ertugliflozin / Sitagliptin Phosphate, Steglujan, Msd Sub Merck | |||
9439901 | 2030-10-21 | U-2214 | |
7326708 | 2026-11-24 | DS, DP | U-2214 |
Ertugliflozin, Steglatro, Msd Sub Merck | |||
8080580 | 2030-07-13 | DS, DP | U-2214 |
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
— A10BD23: Metformin and ertugliflozin
— A10BD24: Sitagliptin and ertugliflozin
— A10BK: Sodium-glucose co-transporter 2 (sglt2) inhibitors
— A10BK04: Ertugliflozin
HCPCS
No data
Clinical
Clinical Trials
35 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 mellitus | D003924 | EFO_0001360 | E11 | 8 | 3 | 11 | 3 | — | 25 |
Heart failure | D006333 | EFO_0003144 | I50 | — | 2 | 3 | 1 | — | 6 |
Hypertension | D006973 | EFO_0000537 | I10 | — | 1 | — | 2 | — | 3 |
Diabetic nephropathies | D003928 | EFO_0000401 | — | — | — | 2 | — | 2 | |
Diastolic heart failure | D054144 | EFO_1000899 | I50.30 | — | — | — | 1 | — | 1 |
Liver cirrhosis | D008103 | EFO_0001422 | K74.0 | — | — | — | 1 | — | 1 |
Fatty liver | D005234 | — | — | — | 1 | — | 1 | ||
Body weight changes | D001836 | — | — | — | 1 | — | 1 | ||
Glycemic control | D000085002 | — | — | — | 1 | — | 1 | ||
Waist circumference | D055105 | EFO_0004342 | — | — | — | 1 | — | 1 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Implantable defibrillators | D017147 | EFO_0010674 | — | — | 1 | — | — | 1 | |
Cardiac resynchronization therapy | D058406 | — | — | 1 | — | — | 1 | ||
Left ventricular dysfunction | D018487 | — | — | 1 | — | — | 1 | ||
Mitral valve insufficiency | D008944 | HP_0001653 | — | — | 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 | — | 2 | — | — | — | — | 2 | ||
Cardiovascular diseases | D002318 | EFO_0000319 | I98 | 1 | — | — | — | — | 1 |
Insulin resistance | D007333 | EFO_0002614 | 1 | — | — | — | — | 1 | |
Atherosclerosis | D050197 | EFO_0003914 | I25.1 | 1 | — | — | — | — | 1 |
Hepatic insufficiency | D048550 | 1 | — | — | — | — | 1 | ||
Renal insufficiency | D051437 | HP_0000083 | N19 | 1 | — | — | — | — | 1 |
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common name | ERTUGLIFLOZIN |
INN | ertugliflozin |
Description | Ertugliflozin is a diarylmethane. |
Classification | Small molecule |
Drug class | phlorozin derivatives, phenolic glycosides |
Image (chem structure or protein) | |
Structure (InChI/SMILES or Protein Sequence) | CCOc1ccc(Cc2cc([C@]34OC[C@](CO)(O3)[C@@H](O)[C@H](O)[C@H]4O)ccc2Cl)cc1 |
Identifiers
PDB | — |
CAS-ID | 1210344-57-2 |
RxCUI | 1992672 |
ChEMBL ID | CHEMBL1770248 |
ChEBI ID | — |
PubChem CID | 44814423 |
DrugBank | DB11827 |
UNII ID | 6C282481IP (ChemIDplus, GSRS) |
Target
Agency Approved
SLC5A2
SLC5A2
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
SLC5A1
SLC5A1
Organism
Homo sapiens
Gene name
SLC5A1
Gene synonyms
NAGT, SGLT1
NCBI Gene ID
Protein name
sodium/glucose cotransporter 1
Protein synonyms
High affinity sodium-glucose cotransporter, Na+/glucose cotransporter 1, solute carrier family 5 (sodium/glucose cotransporter), member 1, Solute carrier family 5 member 1
Uniprot ID
Mouse ortholog
Slc5a1 (20537)
sodium/glucose cotransporter 1 (Q8C3K6)
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 1,270 documents
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Safety
Black-box Warning
Black-box warning for: Segluromet
Adverse Events
Top Adverse Reactions
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3,679 adverse events reported
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