Sotagliflozin

Generic Name: Sotagliflozin

Brand Names: Inpefa

Drug Type: Small Molecule

Chemical Formula: C_₂₁H_₂₅ClO_₅S

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 On March 22, 2022, the marketing authorization of sotagliflozin for the treatment of type 1 diabetes mellitus was withdrawn by the EMA due to commercial reasons.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

Efficacy and Bone Safety of Sotagliflozin 400 and 200 mg Versus Placebo in Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control

Phase 3

Terminated

Conditions: Type 2 Diabetes Mellitus

Interventions: Drug: Placebo
Drug: Sotagliflozin

First Posted Date: 2017-12-29

Last Posted Date: 2021-06-25

Lead Sponsor: Lexicon Pharmaceuticals

Target Recruit Count: 376

Registration Number: NCT03386344

Locations: 🇨🇦
Investigational Site Number 1249003, Brampton, Canada
🇨🇦
Investigational Site Number 1249005, Pointe-Claire, Canada
🇨🇦
Investigational Site Number 1249007, Vancouver, Canada

and more 50 locations

Efficacy and Safety of Sotagliflozin Versus Placebo and Empagliflozin in Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control While Taking a DPP4 Inhibitor Alone or With Metformin

Phase 3

Completed

Conditions: Type 2 Diabetes Mellitus

Interventions: Drug: Empagliflozin
Drug: Sotagliflozin
Drug: Placebo

First Posted Date: 2017-11-22

Last Posted Date: 2021-05-11

Lead Sponsor: Lexicon Pharmaceuticals

Target Recruit Count: 770

Registration Number: NCT03351478

Locations: 🇺🇸
Investigational Site Number 8408010, Knoxville, Tennessee, United States
🇺🇸
Investigational Site Number 8408038, Knoxville, Tennessee, United States
🇧🇬
Investigational Site Number 1008005, Ruse, Bulgaria

and more 157 locations

Efficacy and Safety of Sotagliflozin Versus Glimepiride and Placebo in Participants With Type 2 Diabetes Mellitus That Are Taking Metformin Monotherapy

Phase 3

Completed

Conditions: Type 2 Diabetes Mellitus

Interventions: Drug: Sotagliflozin (SAR439954)
Drug: Glimepiride
Drug: Metformin
Drug: Placebo

First Posted Date: 2017-11-06

Last Posted Date: 2021-05-11

Lead Sponsor: Lexicon Pharmaceuticals

Target Recruit Count: 954

Registration Number: NCT03332771

Locations: 🇺🇸
Investigational Site Number 8407074, Bradenton, Florida, United States
🇺🇸
Investigational Site Number 8407111, Dallas, Texas, United States
🇺🇸
Investigational Site Number 8407078, Carmichael, California, United States

and more 139 locations

Effect of Sotagliflozin on Cardiovascular and Renal Events in Participants With Type 2 Diabetes and Moderate Renal Impairment Who Are at Cardiovascular Risk

Phase 3

Terminated

Conditions: Chronic Kidney Diseases
Type 2 Diabetes Mellitus
Heart Failure

Interventions: Drug: Sotagliflozin
Drug: Placebo

First Posted Date: 2017-10-19

Last Posted Date: 2022-10-28

Lead Sponsor: Lexicon Pharmaceuticals

Target Recruit Count: 10584

Registration Number: NCT03315143

Locations: 🇧🇬
Investigational Site Number 1000014, Silistra, Bulgaria
🇺🇸
Investigational Site Number 8400104, Chicago, Illinois, United States
🇺🇸
Investigational Site Number 8400001, Chicago, Illinois, United States

and more 751 locations

Comparison of Sotagliflozin Prototype Tablets With Reference Tablet in Healthy Subjects

Phase 1

Completed

Conditions: Type 1 Diabetes Mellitus
Type 2 Diabetes Mellitus

Interventions: Drug: sotagliflozin (SAR439954)

First Posted Date: 2017-10-16

Last Posted Date: 2022-04-13

Lead Sponsor: Sanofi

Target Recruit Count: 12

Registration Number: NCT03310944

Locations: 🇩🇪
Investigational Site Number 276001, Neuss, Germany

Safety, Tolerability and Pharmacodynamic Activity of Sotagliflozin in Hemodynamically Stable Participants With Worsening Heart Failure

Phase 2

Terminated

Conditions: Cardiac Failure Aggravated

Interventions: Drug: Placebo
Drug: Sotagliflozin

First Posted Date: 2017-09-25

Last Posted Date: 2021-05-11

Lead Sponsor: Lexicon Pharmaceuticals

Target Recruit Count: 32

Registration Number: NCT03292653

Locations: 🇺🇸
Investigational Site Number 8400005, La Jolla, California, United States
🇨🇦
Investigational Site Number 1240001, Toronto, Canada
🇳🇱
Investigational Site Number 5280001, Groningen, Netherlands

and more 3 locations

Efficacy and Safety of Sotagliflozin Versus Placebo in Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control While Taking Insulin Alone or With Other Oral Antidiabetic Agents

Phase 3

Completed

Conditions: Type 2 Diabetes Mellitus

Interventions: Drug: Insulin glargine (HOE901)
Drug: Sotagliflozin
Drug: Placebo
Drug: Oral Antidiabetes Drugs (OADs)

First Posted Date: 2017-09-18

Last Posted Date: 2021-05-11

Lead Sponsor: Lexicon Pharmaceuticals

Target Recruit Count: 571

Registration Number: NCT03285594

Locations: 🇺🇸
Investigational Site Number 8406003, New Port Richey, Florida, United States
🇺🇸
Investigational Site Number 8406052, Ocoee, Florida, United States
🇺🇸
Investigational Site Number 8406043, Coral Gables, Florida, United States

and more 103 locations

Safety and Efficacy Study of Sotagliflozin on Glucose Control in Participants With Type 2 Diabetes, Moderate Impairment of Kidney Function, and Inadequate Blood Sugar Control

Phase 3

Completed

Conditions: Type 2 Diabetes Mellitus
Chronic Kidney Disease Stage 3

Interventions: Drug: Placebo
Drug: Sotagliflozin

First Posted Date: 2017-08-08

Last Posted Date: 2021-06-25

Lead Sponsor: Lexicon Pharmaceuticals

Target Recruit Count: 787

Registration Number: NCT03242252

Locations: 🇺🇸
Investigational Site Number 8404016, Savannah, Georgia, United States
🇺🇸
Investigational Site Number 8404057, Round Rock, Texas, United States
🇺🇸
Investigational Site Number 8404055, Houston, Texas, United States

and more 167 locations

A Study to Evaluate Safety and Effects of Sotagliflozin 400 and 200 mg on Glucose Control in Participants With Type 2 Diabetes, Severe Impairment of Kidney Function and Inadequate Blood Sugar Control

Phase 3

Completed

Conditions: Type 2 Diabetes Mellitus
Chronic Kidney Disease Stage 4

Interventions: Drug: Placebo
Drug: Sotagliflozin

First Posted Date: 2017-08-08

Last Posted Date: 2021-06-25

Lead Sponsor: Lexicon Pharmaceuticals

Target Recruit Count: 277

Registration Number: NCT03242018

Locations: 🇺🇸
Investigational Site Number 8405018, San Dimas, California, United States
🇺🇸
Investigational Site Number 8405021, Clearwater, Florida, United States
🇺🇸
Investigational Site Number 8405036, Dallas, Texas, United States

and more 103 locations

Sotagliflozin Bioequivalence Study

Phase 1

Completed

Conditions: Type 2 Diabetes Mellitus

Interventions: Drug: Sotagliflozin (SAR439954)

First Posted Date: 2017-07-07

Last Posted Date: 2022-04-25

Lead Sponsor: Sanofi

Target Recruit Count: 76

Registration Number: NCT03211195

Locations: 🇺🇸
Investigational Site Number 840001, Miami, Florida, United States

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