Lexicon Pharmaceuticals Faces Setback in Type 1 Diabetes Drug Development

Lexicon Pharmaceuticals has encountered another regulatory hurdle in its quest to bring Zynquista (sotagliflozin) to market for type 1 diabetes patients. The U.S. Food and Drug Administration (FDA) has requested additional time to review the company's latest submissions, further delaying the drug's potential approval.

FDA Extends Review Timeline

The FDA was initially expected to provide feedback from a type D meeting by the end of September. However, the agency has now pushed this timeline into the fourth quarter of 2025. This delay comes after Lexicon submitted additional data from three ongoing studies earlier this month to support Zynquista's risk-benefit profile in type 1 diabetes.

This latest setback follows a complete response letter issued by the FDA in December 2024, which prompted Lexicon to seek a type D meeting to discuss the next steps in the regulatory process. The company's efforts to move forward with Zynquista have been met with significant challenges, including a previous FDA rejection and unfavorable advisory committee recommendation.

Zynquista's Rocky Regulatory Path

Zynquista, an oral medication designed to be taken alongside insulin, aims to improve glycemic control in patients with type 1 diabetes. The drug's active ingredient, sotagliflozin, is a dual inhibitor of SGLT2 and SGLT1 proteins, which play crucial roles in glucose absorption in the kidneys and gastrointestinal tract, respectively.

While sotagliflozin received FDA approval in May 2023 for heart failure under the brand name Inpefa, its journey in diabetes treatment has been fraught with difficulties. In October 2024, the FDA's Endocrinologic and Metabolic Drugs Advisory Committee voted 11-3 against recommending Zynquista for type 1 diabetes, citing concerns over an elevated risk of diabetic ketoacidosis.

Implications for Lexicon and Patients

The repeated delays and regulatory challenges faced by Zynquista highlight the complexities of bringing new diabetes treatments to market, particularly when safety concerns arise. For Lexicon Pharmaceuticals, these setbacks represent significant hurdles in their efforts to expand their product portfolio and address unmet needs in diabetes care.

As the company awaits the FDA's feedback in the fourth quarter, the future of Zynquista in type 1 diabetes remains uncertain. The outcome of this extended review period will be crucial in determining whether Lexicon can address the agency's concerns and potentially bring this dual SGLT inhibitor to patients with type 1 diabetes.