By Ryanne Paul, Integrated Diabetes Services Intern
FDA RejectsSotagliflozin Individuals with Type 1 Diabetes and Chronic Kidney Disease
The medication sotagliflozin (Zynquista) is a dual sodium-glucose cotransporter (SGLT) inhibitor.
Zynquista has been brought to the Food and Drug Administration (FDA) to be approved to be used as an adjunct medication in type 1 diabetes (T1D) and chronic kidney disease (CKD).
The first time sotagliflozin was brought to the board for FDA approval was in 2019. It was not approved because the risk of diabetes ketoacidosis (DKA) was a higher concern than any benefits it would provide. Almost a year later, Lexicon Pharmaceuticals appealed the FDA’s decision but was unsuccessful.
The FDA still had problems with DKA being an essential factor in not approving; Lexicon also lacked providing enough clinical data to support their reasoning of being beneficial for individuals with T1D and CKD.
In 2022, the FDA approved Inpefa, another brand name for sotagliflozin, to reduce heart complications in adults with T2D. Most recently, in November 2024, Lexicon resubmitted the drug- and again, it was not approved due to DKA concerns.
In conclusion, after multiple denials for sotagliflozin, Lexicon has made an announcement stating they will stop continuing to fight for this drug. They will now focus on LX9211- addressing diabetic peripheral neuropathic pain.
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2 Responses
It’s disappointing to see these repeated denials for a drug that could be so beneficial for those with T1D and CKD. If/when continuous ketone monitoring comes to the market, using SGLT2 will be “safer” but will the manufacturers be willing to pursue approval again?
Unfortunately, despite prolonged safe effective use in the EU the FDA has stonewalled approval of adjunctive medications for the treatment of Type 1 diabetes. However have gotten ADA recommendation in the 2025 standards of care for dual diagnosis for people with type 1 diabetes who have features of type 2 diabetes. I wrote an article on this topic for our January 2025 newsletter:
https://integrateddiabetes.com/changes-in-2025-that-can-have-a-big-impact-on-your-diabetes-management/