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Zynquista FDA Approval Status

Last updated by Judith Stewart, BPharm on July 23, 2024.

FDA Approved: No
Brand name: Zynquista
Generic name: sotagliflozin
Company: Lexicon Pharmaceuticals, Inc.
Treatment for: Diabetes, Type 1

Zynquista (sotagliflozin) is a dual sodium-glucose co-transporter-1 and -2 inhibitor in development as an adjunct to insulin therapy for glycemic control in adults with type 1 diabetes and chronic kidney disease (CKD).

Development timeline for Zynquista

DateArticle
Jul 16, 2024Lexicon Pharmaceuticals Receives December 20, 2024 PDUFA Goal Date for Sotagliflozin Type 1 Diabetes NDA Resubmission
Jun 21, 2024Lexicon Pharmaceuticals Resubmits Sotagliflozin NDA for Type 1 Diabetes
Mar 12, 2024New Post Hoc Analysis of inTandem3 Study Demonstrates Improvements in Glycemic Control With Sotagliflozin Treatment in Patients With Type 1 Diabetes and Chronic Kidney Disease
Feb 28, 2022Lexicon Voluntarily Withdraws Sotagliflozin New Drug Application and Plans Prompt Resubmission Targeted Early Q2 2022
Mar 25, 2019FDA Issues Complete Response Letter for Zynquista (sotagliflozin)
Jan 17, 2019FDA Advisory Committee Votes on Zynquista (sotagliflozin) as Treatment for Adults with Type 1 Diabetes
May 22, 2018FDA to Review Zynquista (sotagliflozin) as Potential Treatment for Type 1 Diabetes
Mar 26, 2018Lexicon Pharmaceuticals Announces Regulatory Submissions for Sotagliflozin to Treat Adults with Type 1 Diabetes

Further information

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