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Sotagliflozin

Generic Name
Sotagliflozin
Brand Names
Inpefa
Drug Type
Small Molecule
Chemical Formula
C21H25ClO5S
CAS Number
1018899-04-1
Unique Ingredient Identifier
6B4ZBS263Y
Background

Sotagliflozin is a dual inhibitor of SGLT1 and SGLT2, the first of its kind, which is approved for use in the EU, in combination with insulin, to improve glycemic control in patients with type 1 diabetes mellitus (T1DM) and a BMI ≥27 kg/m. Its potency in inhibiting SGLT2 is similar to that of other SGLT2 inhibitors, such as canagliflozin and dapagliflozin, but its potency in inhibiting SGLT1 is >10-fold higher than its predecessors. The added inhibition of intestinal SGLT1 delays glucose absorption in the distal small intestine and colon, thereby reducing post-prandial glucose levels.

Sotagliflozin was approved by the EMA under the brand name "Zynquista" on April 26, 2019, for the treatment of type 1 diabetes. A similar approval has also been sought in the US, but the FDA has since published a proposal to refuse the approval because the data submitted did not show that it was safe under the proposed conditions of use. On March 22, 2022, the marketing authorization of sotagliflozin for the treatment of type 1 diabetes mellitus was withdrawn by the EMA due to commercial reasons.

In May 2023, sotagliflozin was approved by the FDA to reduce the risk of cardiovascular death and heart failure in patients with high risk factors.[]

Indication

用于体重指数≥27kg/m2且接受最佳胰岛素疗法仍无法达到足够血糖控制的1型糖尿病（T1D）成人患者。

Associated Conditions
Cardiovascular Mortality, Heart Failure
Clinical Trials
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FDA Advisory Committee Rejects Zynquista for Type 1 Diabetes and Chronic Kidney Disease

• The FDA's Endocrinologic and Metabolic Drugs Advisory Committee voted against approving Zynquista (sotagliflozin) for adults with type 1 diabetes and chronic kidney disease. • The committee cited concerns that the benefits of Zynquista do not outweigh the risks in the proposed patient population. • Lexicon Pharmaceuticals expressed disappointment but remains hopeful, emphasizing the unmet need for new treatments in this area. • Some committee members supported sotagliflozin for specific subpopulations of T1D and CKD patients, where benefits may outweigh risks.
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