Lexicon Data Shows Sotagliflozin Benefits Persist in Mild CKD, NDA Resubmission on Track

Event summary

  • Lexicon Pharmaceuticals presented post-hoc analysis data at the ATTD conference showing sotagliflozin’s efficacy in patients with type 1 diabetes with mildly reduced kidney function (CKD Class 2 & 3A).
  • The data, pooled from two 52-week trials, demonstrated improvements in HbA1c, body weight, systolic blood pressure, and insulin use compared to placebo.
  • Sotagliflozin also reduced hypoglycemia events across all kidney function subgroups.
  • Lexicon plans to resubmit its New Drug Application (NDA) for sotagliflozin in type 1 diabetes in 2026, informed by FDA feedback and the STENO1 study.
  • Sotagliflozin inhibits SGLT2 and SGLT1, impacting glucose regulation and has been studied in approximately 20,000 patients.

The big picture

Lexicon’s sotagliflozin represents a potential expansion of the SGLT2 inhibitor market into type 1 diabetes, a significant unmet need. The positive data regarding kidney function expands the potential patient pool, but also introduces a layer of complexity regarding safety and regulatory approval. The reliance on the STENO1 study underscores the company's need for external validation to support its NDA resubmission and commercial prospects.

What we're watching

Regulatory Risk
The FDA’s response to the resubmitted NDA will be critical; the previous rejection highlights potential concerns beyond efficacy in specific patient populations.
Clinical Adoption
The extent to which clinicians adopt sotagliflozin in patients with mild CKD will depend on the perceived risk-benefit profile, particularly given the potential for adverse events in more advanced kidney disease.
STENO1 Results
The full results of the STENO1 study, funded by a third party, will provide further validation of sotagliflozin’s efficacy and safety profile, potentially influencing commercial uptake.

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