Steglatro(ertugliflozin)
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
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| nutritional and metabolic diseases | D009750 |
| endocrine system diseases | D004700 |
Trade Name
FDA
EMA
Steglatro (generic drugs available since 2023-07-13)
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 | 2023-09-12 |
| steglatro | New Drug Application | 2024-01-08 |
| steglujan | New Drug Application | 2023-10-20 |
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
42 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 | 4 | 1 | 27 |
| Heart failure | D006333 | HP_0001635 | I50 | — | 2 | 3 | 1 | — | 6 |
| Hypertension | D006973 | EFO_0000537 | I10 | — | 1 | — | 2 | — | 3 |
| Diabetic nephropathies | D003928 | EFO_0000401 | — | — | — | — | 2 | — | 2 |
| Covid-19 | D000086382 | — | U07.1 | — | — | — | 1 | — | 1 |
| Diastolic heart failure | D054144 | EFO_1000899 | I50.30 | — | — | — | 1 | — | 1 |
| Liver cirrhosis | D008103 | EFO_0001422 | K74.0 | — | — | — | 1 | — | 1 |
| Fatty liver | D005234 | EFO_0003934 | — | — | — | — | 1 | — | 1 |
| Body weight changes | D001836 | — | — | — | — | — | 1 | — | 1 |
| Glycemic control | D000085002 | — | — | — | — | — | 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 | — | — | — | 1 | 3 |
| Cardiovascular diseases | D002318 | HP_0001626 | — | 1 | — | — | — | — | 1 |
| Insulin resistance | D007333 | HP_0000855 | E88.819 | 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
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Myocardial infarction | D009203 | EFO_0000612 | I21 | — | — | — | — | 1 | 1 |
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 | — |
| 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
No data
Financial
Revenue by drug
$
€
£
₣
No data
Estimated US medical usage
Ertugliflozin
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 1,559 documents
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Safety
Black-box Warning
Black-box warning for: Segluromet
Adverse Events
Top Adverse Reactions
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596 adverse events reported
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