Sotagliflozin Explained

Pronounce:
Tradename:Zynquista, Inpefa
Dailymedid:Sotagliflozin
Routes Of Administration:By mouth
Class:SGLT2 inhibitor
Atc Prefix:A10
Atc Suffix:BK06
Legal Us:Rx-only
Legal Us Comment:[1]
Legal Eu:Rx-only
Cas Number:1018899-04-1
Pubchem:24831714
Drugbank:12713
Chemspiderid:27289071
Unii:6B4ZBS263Y
Kegg:D10669
Chebi:229226
C:21
H:25
Cl:1
O:5
S:1
Smiles:CCOC1=CC=C(C=C1)CC2=C(C=CC(=C2)[C@H]3[C@@H]([C@H]([C@@H]([C@H](O3)SC)O)O)O)Cl
Stdinchi:1S/C21H25ClO5S/c1-3-26-15-7-4-12(5-8-15)10-14-11-13(6-9-16(14)22)20-18(24)17(23)19(25)21(27-20)28-2/h4-9,11,17-21,23-25H,3,10H2,1-2H3/t17-,18-,19+,20+,21-/m1/s1
Stdinchikey:QKDRXGFQVGOQKS-CRSSMBPESA-N

Sotagliflozin, sold under the brand name Inpefa among others, is a medication used to reduce the risk of death due to heart failure. It is a sodium-glucose cotransporter 2 (SGLT2) inhibitor. It is taken by mouth.

The most common side effect is genital infection in women. Other common side effects include diabetic ketoacidosis, diarrhea, and genital infection in men.

Sotagliflozin was approved for medical use in the European Union in April 2019, as Zynquista, for the treatment for type 1 diabetes, and in the United States in May 2023,[2] to reduce the risk of death due to heart failure.[3] The marketing authorization for sotagliflozin was withdrawn in the EU in August 2022.[4]

Medical uses

In the United States, sotagliflozin is indicated 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, chronic kidney disease, and other cardiovascular risk factors. Sotaglifozin is a sodium-glucose co-transporter 1 and 2 inhibitor that reduces both postprandial glucose and insulin levels by delaying intestinal glucose absorption, decreases gastric inhibitory polypeptide, and elevations in glucagon-like peptide and peptide yy levels are consistent with local inhibition of intestinal SGLT1.[5] Combination of insulin with sotaglifozin 200 and 400 mg led to a significant lowering of systolic and diastolic blood pressure and multiple indirect markers of arterial stiffness, including pulse pressure, without changes in pulse rates.[6] Also, it decreased the incidence of myocardial infarction and stroke, pointing to a potential side effect of SGLT1 inhibition.[7]

History

The US Food and Drug Administration (FDA) approved sotagliflozin based on evidence from two clinical trials of 11,806 total participants with heart failure or with type 2 diabetes, chronic kidney disease, and other cardiovascular risk factors. The trials were conducted at 322 sites in 32 countries (SOLOIST/NCT03521934[8]) and 750 sites in 42 countries (SCORED/NCT03315143[9]) primarily in Europe, South America, and North America. Both trials were used for primary determination of the benefits and side effects of the drug. The benefits and side effects of sotagliflozin were evaluated in the two clinical trials. In both trials, participants were randomly assigned to receive either sotagliflozin or placebo by mouth once a day. Neither the participants nor the healthcare providers knew which treatment was being given until after the trial was completed. The benefit of sotagliflozin was evaluated by measuring the number of predefined events (death from cardiovascular causes, need for hospitalization for heart failure, or urgent medical care visit for heart failure) occurring in the patient population receiving sotagliflozin versus placebo.

Society and culture

Legal status

The FDA refused its approval for use in combination with insulin for the treatment of type 1 diabetes. It is developed by Lexicon Pharmaceuticals.[10] [11] [12]

In May 2023, the US FDA approved sotagliflozin (Inpefa) to decrease the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in adults with heart failure or type 2 diabetes, chronic kidney disease, and other cardiovascular risk.[13]

Further reading

Notes and References

  1. Web site: Inpefa- sotagliflozin tablet . DailyMed . 5 June 2023 . 25 June 2023 . 26 June 2023 . https://web.archive.org/web/20230626052917/https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1a46614e-05f6-421a-b6f4-d6f8760d643a . live .
  2. Web site: Drug Trials Snapshots: Inpefa . U.S. Food and Drug Administration . 26 May 2023 . 15 July 2024.
  3. Lexicon Announces FDA Approval of Inpefa (sotagliflozin) for Treatment of Heart Failure . Lexicon Pharmaceuticals . GlobeNewswire . 26 May 2023 . 28 May 2023 . 20 October 2023 . https://web.archive.org/web/20231020200237/https://www.globenewswire.com/en/news-release/2023/05/26/2677371/0/en/Lexicon-Announces-FDA-Approval-of-INPEFA-sotagliflozin-for-Treatment-of-Heart-Failure.html . live .
  4. Web site: Zynquista EPAR . European Medicines Agency (EMA) . 27 February 2019 . 28 October 2020 . 3 November 2020 . https://web.archive.org/web/20201103173026/https://www.ema.europa.eu/en/medicines/human/EPAR/zynquista . live . Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  5. Powell DR, Zambrowicz B, Morrow L, Beysen C, Hompesch M, Turner S, Hellerstein M, Banks P, Strumph P, Lapuerta P . Sotagliflozin Decreases Postprandial Glucose and Insulin Concentrations by Delaying Intestinal Glucose Absorption . The Journal of Clinical Endocrinology and Metabolism . 105 . 4 . e1235–e1249 . April 2020 . 31837264 . 7067537 . 10.1210/clinem/dgz258 .
  6. Rodbard HW, Giaccari A, Cariou B, Garg S, Davies MJ, Seth K, Sawhney S . Effect of sotagliflozin as an adjunct to insulin therapy on blood pressure and arterial stiffness in adults with type 1 diabetes: A post hoc pooled analysis of inTandem1 and inTandem2 . Diabetes & Vascular Disease Research . 18 . 1 . 1479164121995928 . 2021 . 33611925 . 8481733 . 10.1177/1479164121995928 .
  7. Sayour AA, Ruppert M, Oláh A, Benke K, Barta BA, Zsáry E, Merkely B, Radovits T . Effects of SGLT2 Inhibitors beyond Glycemic Control-Focus on Myocardial SGLT1 . International Journal of Molecular Sciences . 22 . 18 . September 2021 . 9852 . 34576016 . 8468664 . 10.3390/ijms22189852 . free .
  8. Web site: Effect of Sotagliflozin on Cardiovascular Events in Participants With Type 2 Diabetes Post Worsening Heart Failure (SOLOIST-WHF Trial) . ClinicalTrials.gov . 15 July 2024.
  9. Web site: Effect of Sotagliflozin on Cardiovascular and Renal Events in Participants With Type 2 Diabetes and Moderate Renal Impairment Who Are at Cardiovascular Risk (SCORED) . ClinicalTrials.gov . 15 July 2024.
  10. Web site: Sotagliflozin as an Adjunct to Insulin for Type 1 Diabetes . U.S. Food and Drug Administration (FDA) . 17 January 2019. 26 April 2019 . https://web.archive.org/web/20190426081316/https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/EndocrinologicandMetabolicDrugsAdvisoryCommittee/UCM629783.pdf . dead .
  11. Sanofi: FDA advisory committee votes on Zynquista (sotagliflozin) as treatment for adults with type 1 diabetes. Sanofi. 17 January 2019. GlobeNewswire. 1 April 2019. 1 August 2019. https://web.archive.org/web/20190801114613/http://www.globenewswire.com/news-release/2019/01/17/1701736/0/en/Sanofi-FDA-advisory-committee-votes-on-Zynquista-TM-sotagliflozin-as-treatment-for-adults-with-type-1-diabetes.html. live.
  12. Sanofi: FDA advisory committee votes on Zynquista (sotagliflozin) as treatment for adults with type 1 diabetes . Sanofi . 18 January 2019 . 28 October 2020 . 29 November 2020 . https://web.archive.org/web/20201129024002/https://www.sanofi.com/media-room/press-releases/2019/2019-01-18-00-19-00-1701736 . live .
  13. Web site: Once-Daily Inpefa Approved for Treating Heart Failure .

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