Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Mefenamic acid · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| SAR439954 with or without mefenamic acid | EXPERIMENTAL | Period 1: single oral dose of 400 mg sotagliflozin Period 2: initial loading dose of 500 mg in the morning of Day 1, followed by 250 mg from Day 1 H6 to Day 7 of mefenamic acid and a single oral dose of sotagliflozin on Day 2 |
| Name | Type | Description |
|---|---|---|
| Sotagliflozin (SAR439954) | DRUG | Pharmaceutical form: tablet Route of administration: oral |
| Mefenamic acid | DRUG | Pharmaceutical form: capsule Route of administration: oral |
Inclusion criteria : * Healthy male or female subjects, between 18 and 55 years of age, inclusive. * Body weight between 50.0 and 100.0 kg, inclusive, if male, and between 40.0 and 90.0 kg, inclusive, if female. * Certified as healthy by a comprehensive clinical assessment (detailed medical history...
Mefenamic acid is being studied in a Phase 1 drug interaction trial in diabetes mellitus, where it was given to healthy volunteers to assess how it affects the pharmacokinetics and pharmacodynamics of sotagliflozin. It is not an approved diabetes treatment; the trial evaluated it as an interacting medication rather than as a therapy for diabetes itself.
Mefenamic acid targets PTGS2 and PTGS1, also known as cyclooxygenase-2 and cyclooxygenase-1. It acts as an inhibitor of these enzymes. This target profile is the basis for its classification as a small molecule and for the drug interaction study conducted with sotagliflozin in healthy subjects.
Sanofi, which trades under the ticker SNY, is the developer associated with mefenamic acid in this diabetes mellitus research program. The company sponsored the Phase 1 interaction study evaluating the drug alongside sotagliflozin in healthy male and female subjects.
Mefenamic acid is in Phase 1 development for diabetes mellitus. The single registered trial, NCT03070678, has completed, and no active trials are ongoing. The study was an uncontrolled, non-randomized, open-label interaction study, so the program remains at an early clinical stage.
Mefenamic acid has been studied in one completed clinical trial, NCT03070678, titled an interaction study to evaluate the effects of mefenamic acid on the pharmacokinetics and pharmacodynamics of sotagliflozin in healthy male and female subjects. It enrolled 16 healthy volunteers aged 18 years and older in France.