Lexicon Pharmaceuticals presented a post‑hoc analysis of its sotagliflozin data at the 19th International Conference on Advanced Technologies & Treatments for Diabetes (ATTD) in Barcelona on March 12, 2026. The analysis examined how kidney function influences the long‑term efficacy and safety of sotagliflozin in people with type 1 diabetes, using pooled data from two 52‑week, placebo‑controlled trials of 200 mg and 400 mg doses added to optimized insulin therapy.
Across patients with normal kidney function and those with mildly reduced function, sotagliflozin produced clinically meaningful improvements in HbA1c, body weight, systolic blood pressure, and total insulin use. The benefits were slightly attenuated in patients with CKD Class 3A, but the drug still maintained a favorable safety profile, with no increase in diabetic ketoacidosis events and a reduction in clinically significant hypoglycemia.
The data are intended to support Lexicon’s ongoing regulatory strategy for its type 1 diabetes program, ZYNQUISTA, and to inform potential partnership discussions. The company remains on track to resubmit its New Drug Application in 2026, following a complete response letter from the FDA in December 2024 that highlighted concerns about ketoacidosis.
"Recognizing that a patient’s kidney function can impact the efficacy of SGLT inhibitors, we conducted this post‑hoc analysis of clinical data from two identically‑designed trials in patients with type 1 diabetes and were encouraged to find that treatment with sotagliflozin resulted in improvements in multiple efficacy measures after one year in both those with normal kidney function and those with mildly reduced kidney function," said Dr. Craig Granowitz, Senior Vice President and Chief Medical Officer.
The presentation marks the first new clinical data disclosed by Lexicon since its pivot to an R&D‑focused partnership model. By demonstrating that sotagliflozin retains efficacy across a range of kidney functions and maintains a robust safety profile, the company aims to strengthen its position with regulators and attract strategic partners, potentially accelerating the drug’s approval timeline and future commercialization prospects.
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