Empagliflozin

Not to be confused with Giardia.

Empagliflozin
Clinical data
Trade namesJardiance, others
Other namesBI-10773
AHFS/Drugs.comMonograph
MedlinePlusa614043
License data
Pregnancy
category
Routes of
administration		By mouth
Drug classSodium-glucose cotransporter-2 (SGLT2) inhibitor[2]
ATC code
Legal status
Legal status
Identifiers
IUPAC name
  • (2S,3R,4R,5S,6R)-2-[4-Chloro-3-[[4-[(3S)-oxolan-3-yl]oxyphenyl]methyl]phenyl]-6-(hydroxymethyl)oxane-3,4,5-triol
CAS Number
PubChem CID
IUPHAR/BPS
DrugBank
ChemSpider
UNII
KEGG
ChEBI
ChEMBL
CompTox Dashboard (EPA)
ECHA InfoCard100.122.058
Chemical and physical data
FormulaC23H27ClO7
Molar mass450.91 g·mol−1
3D model (JSmol)
SMILES
  • OC[C@H]1O[C@@H](c2ccc(Cl)c(Cc3ccc(O[C@H]4CCOC4)cc3)c2)[C@H](O)[C@@H](O)[C@@H]1O
InChI
  • InChI=1S/C23H27ClO7/c24-18-6-3-14(23-22(28)21(27)20(26)19(11-25)31-23)10-15(18)9-13-1-4-16(5-2-13)30-17-7-8-29-12-17/h1-6,10,17,19-23,25-28H,7-9,11-12H2/t17-,19+,20+,21-,22+,23-/m0/s1
  • Key:OBWASQILIWPZMG-QZMOQZSNSA-N

Empagliflozin, sold under the brand name Jardiance (/ˈdʒɑːrdiəns/ JAR-dee-əns), among others, is an antidiabetic medication used to improve glucose control in people with type 2 diabetes and/or for patients with established heart failure with reduced ejection fraction (HFrEF). Studies have shown great benefits for heart failure (HF) outcomes and decreased hospitalisations.[12][2][14][15] It is taken by mouth.[2]

Common side effects of empagliflozin include genital yeast infections and hypotension, particularly in patients with volume depletion. [2][16][17] Other symptoms such as nausea and vomiting may occur and seem more pronounced in combination with metformin. [16][17] Rare but serious adverse events, such as euglycemic diabetic ketoacidosis (DKA) which may present with hyperventilation, lethargy, or mental status changes have been reported but are infrequent in trials.[16][17] Other serious but rare serious adverse events include Fournier's gangrene, a severe skin infection of the groin, and diabetic ketoacidosis that may occur even with normal blood glucose levels.[2][18] Use during pregnancy or breastfeeding is not recommended.[19]

Empagliflozin is a SGLT2 inhibitor: a reversible inhibitor of the sodium glucose co-transporter-2 (SGLT-2). It reduces the kidney’s glucose reabsorption and excretes the excess glucose through the urine, thus its place in the treatment of type two diabetes. It is dependent on blood glucose concentrations and the glomerular filtration rate of the kidney. This excretion of glucose in the urine, which does not seem to disturb other blood electrolytes, is accompanied by some diuresis which may be what contributes to many other physiological functions, potentially explaining its place in heart failure treatment.[20][21][22]

Empagliflozin was approved for medical use in the United States and in the European Union in 2014.[13][23][24] It is on the World Health Organization's List of Essential Medicines.[25] In 2022, it was the 56th most commonly prescribed medication in the United States, with more than 12 million prescriptions.[26][27] It has received approval as a generic medication from the US Food and Drug Administration (FDA).[28]

  1. ^ "Empagliflozin (Jardiance) Use During Pregnancy". Drugs.com. 30 August 2018. Archived from the original on 5 August 2019. Retrieved 10 February 2020.
  2. ^ a b c d e "Empagliflozin Monograph for Professionals". Drugs.com. AHFS. Archived from the original on 6 April 2019. Retrieved 21 December 2018.
  3. ^ "AusPAR: Empagliflozin". Therapeutic Goods Administration (TGA), Commonwealth of Australia. 8 November 2017. Retrieved 24 March 2022.
  4. ^ "Jardiance". Boehringer Ingelheim Pty Ltd. Therapeutic Goods Administration (TGA), Commonwealth of Australia. Archived from the original on 18 March 2023.
  5. ^ "Prescription medicines: registration of new chemical entities in Australia, 2014". Therapeutic Goods Administration (TGA), Commonwealth of Australia. 21 June 2022. Archived from the original on 10 April 2023. Retrieved 10 April 2023.
  6. ^ "Prescription medicines and biologicals: TGA annual summary 2017". Therapeutic Goods Administration (TGA), Commonwealth of Australia. 21 June 2022. Retrieved 31 March 2024.
  7. ^ "Health Canada New Drug Authorizations: 2015 Highlights". Health Canada. 4 May 2016. Retrieved 7 April 2024.
  8. ^ "Jardiance Product information". Health Canada. 11 August 2015. Retrieved 8 September 2024.
  9. ^ "Jardiance Product information". Health Canada. 11 August 2015. Retrieved 8 September 2024.
  10. ^ "Jardiance 10 mg film-coated tablets – Summary of Product Characteristics (SmPC)". (emc). Archived from the original on 20 September 2020. Retrieved 10 February 2020.
  11. ^ "Jardiance 25 mg film-coated tablets – Summary of Product Characteristics (SmPC)". (emc). 23 October 2019. Archived from the original on 22 September 2020. Retrieved 10 February 2020.
  12. ^ a b Cite error: The named reference Jardiance FDA label was invoked but never defined (see the help page).
  13. ^ a b Cite error: The named reference Jardiance EPAR was invoked but never defined (see the help page).
  14. ^ Davies MJ, D'Alessio DA, Fradkin J, Kernan WN, Mathieu C, Mingrone G, et al. (December 2018). "Management of hyperglycaemia in type 2 diabetes, 2018. A consensus report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD)". Diabetologia. 61 (12): 2461–2498. doi:10.1007/s00125-018-4729-5. PMID 30288571.
  15. ^ Packer M, Anker SD, Butler J, Filippatos G, Pocock SJ, Carson P, et al. (October 2020). "Cardiovascular and Renal Outcomes with Empagliflozin in Heart Failure". The New England Journal of Medicine. 383 (15): 1413–1424. doi:10.1056/NEJMoa2022190. hdl:2066/230126. PMID 32865377.
  16. ^ a b c Packer M, Anker SD, Butler J, Filippatos G, Ferreira JP, Pocock SJ, et al. (January 2021). "Effect of Empagliflozin on the Clinical Stability of Patients With Heart Failure and a Reduced Ejection Fraction: The EMPEROR-Reduced Trial". Circulation. 143 (4): 326–336. doi:10.1161/CIRCULATIONAHA.120.051783. PMC 7834905. PMID 33081531.
  17. ^ a b c Herrington WG, Staplin N, Wanner C, Green JB, Hauske SJ, Emberson JR, et al. (EMPA-Kidney Collaborative Group) (January 2023). "Empagliflozin in Patients with Chronic Kidney Disease". The New England Journal of Medicine. 388 (2): 117–127. doi:10.1056/NEJMoa2204233. PMC 7614055. PMID 36331190.
  18. ^ "FDA warns about rare occurrences of a serious infection of the genital area with SGLT2 inhibitors for diabetes". U.S. Food and Drug Administration (FDA). 9 February 2019. Archived from the original on 13 December 2019. Retrieved 18 March 2019.
  19. ^ British national formulary: BNF 76 (76 ed.). Pharmaceutical Press. 2018. p. 691. ISBN 9780857113382.
  20. ^ "Empagliflozin Monograph for Professionals". Drugs.com. AHFS. Archived from the original on 6 April 2019. Retrieved 21 December 2018.
  21. ^ Boorsma EM, Beusekamp JC, Ter Maaten JM, Figarska SM, Danser AHJ, Van Veldhuisen DJ, et al. Effects of empagliflozin on renal sodium and glucose handling in patients with acute heart failure. European Journal of Heart Failure. 2021;23(1):68-78.
  22. ^ MIMS Online [Internet]. Sydney: MIMS Australia; c2010.  Jardiance (Empagliflozin) [cited 2025 May 06]. Available from: https://www.mimsonline.com.au
  23. ^ Cite error: The named reference FDA PR 20140801 was invoked but never defined (see the help page).
  24. ^ "Drug Approval Package: Jardiance (empagliflozin) Tablets NDA #204629". U.S. Food and Drug Administration (FDA). 8 September 2014. Archived from the original on 11 February 2020. Retrieved 10 February 2020.
  25. ^ World Health Organization (2023). The selection and use of essential medicines 2023: web annex A: World Health Organization model list of essential medicines: 23rd list (2023). Geneva: World Health Organization. hdl:10665/371090. WHO/MHP/HPS/EML/2023.02.
  26. ^ "The Top 300 of 2022". ClinCalc. Archived from the original on 30 August 2024. Retrieved 30 August 2024.
  27. ^ "Empagliflozin Drug Usage Statistics, United States, 2013 - 2022". ClinCalc. Retrieved 30 August 2024.
  28. ^ "2022 First Generic Drug Approvals". U.S. Food and Drug Administration (FDA). 3 March 2023. Archived from the original on 14 January 2024. Retrieved 14 January 2024.
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