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# Sanofi NDA for Type 1 Diabetes Drug Accepted by FDA
- URL: https://www.fdaweb.com/sanofi-nda-for-type-1-diabetes-drug-accepted-by-fda/
- Published: 2018-05-23T12:00:00.000Z
- Updated: 2026-09-15T00:07:12.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141522

FDA has accepted for review a Sanofi NDA for Zynquista (sotagliflozin), an oral treatment added to insulin therapy to improve blood sugar control in adults with Type 1 diabetes. The oral dual inhibitor of SGLT-1 and SGLT-2, proteins that influence how the intestines and kidneys absorb and eliminate sugar, has been given a 3/22/2019 user fee review action target date. The submission is based on data from the inTandem clinical trial program which includes three Phase 3 clinical trials assessing the safety and efficacy of Zynquista in about 3,000 adults with inadequately controlled Type 1 diabetes.