> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Lexicon Submits New Data to FDA on Zynquista
- URL: https://www.fdaweb.com/lexicon-submits-new-data-to-fda-on-zynquista/
- Published: 2025-09-22T12:00:00.000Z
- Updated: 2026-09-14T15:22:17.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159911

Lexicon Pharmaceuticals says FDA is requiring additional time to review its new clinical data submitted earlier this month in an effort to advance its stalled NDA for its diabetes drug Zynquist (sotagliflozin). The company is seeking to address concerns raised in a 12/2024 [complete response letter](https://www.lexpharma.com/media-center/news/2024-12-20-lexicon-announces-receipt-of-complete-response-letter-for-zynquista-sotagliflozin?ref=fdaweb.com) that cited an elevated risk of diabetic ketoacidosis (DKA) with the oral SGLT1/SGLT2 inhibitor when used as an adjunct to insulin in adults with Type 1 diabetes.

The additional data came from three ongoing investigator-initiated studies: the STENO1 trial at the Steno Diabetes Center, the SUGARNSALT trial at the Joslin Diabetes Center, and the SOPHIST study at the University of Dundee, the company says. FDA had granted the company a Type D meeting to discuss potential regulatory paths forward, and feedback, which was expected by the end of the month, is now expected in the fourth quarter, it adds.

Despite gaining European approval in 2019, sotagliflozin’s regulatory path in the U.S. has been challenging. Late last year, FDA’s Endocrinologic and Metabolic Drugs Advisory Committee voted 11 to 3 against recommending approval due to DKA concerns. A previous submission was denied in a 2019 complete response letter, which cited deficiencies such as data demonstrating that the addition of sotagliflozin to insulin is associated with an increased risk of DKA.

Two Lexicon dispute resolution requests have been rejected by CDER based on a determination that the drug’s DKA risk outweighed its benefits.