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Also known as Sotagliflozin
Sotagliflozin Low Dose · 1 trial · 1 indication
Beta hydroxybutyrate (BHB) time \> 0.6 millimole per liter (mmol/L) as measured by the DGK during the 200mg dosing period in the MDI vs. HCL groups.
Beta hydroxybutyrate (BHB) time \> 0.6 mmol/L as measured by the DGK during the 400mg dosing period in the MDI vs. HCL groups.
| Arm | Type | Description |
|---|---|---|
| Treatment Group A | EXPERIMENTAL | 200mg sotagliflozin for 6 weeks, washout for 2 weeks, then receive 400mg sotagliflozin for 6 weeks |
| Treatment Group B | EXPERIMENTAL | 400mg sotagliflozin for 6 weeks, washout for 2 weeks, then receive 200mg sotagliflozin for 6 weeks |
| Name | Type | Description |
|---|---|---|
| Sotagliflozin Low Dose | DRUG | 200 mg Sotagliflozin, once daily for 6 weeks |
| Sotagliflozin High Dose | DRUG | 400 mg Sotagliflozin, once daily for 6 weeks |
| Dual Continuous Glucose and Ketone Monitor | DEVICE | Abbott Libre X dual continuous glucose and ketone monitor (DGK) device. |
Inclusion Criteria: 1. All individuals between the ages of \>18 years old, inclusive, at the time of screening; 2. Individuals able to become pregnant must: 1. be ≥1 year post-menopausal or documented as being surgically sterile, or 2. agree to use two methods of contraception during the ent...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| FibroBiologics, Inc. | FBLG | 1 | PHASE1 | Undisclosed |
| MiMedx Group, Inc. | MDXG | 2 | N/A | Undisclosed |
| Integra LifeSciences Holdings Corporation | IART | 1 | N/A | Undisclosed |
| Organogenesis Holdings, Inc. Class A | ORGO | 1 | N/A | Undisclosed |
| Healthcare Services Group, Inc. | HCSG | 1 | N/A | Undisclosed |
Sotagliflozin is an investigational small molecule being studied for Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus, renal impairment, hepatic impairment, and hypertrophic cardiomyopathy, including obstructive and non-obstructive forms. It is in Phase 3 clinical development for symptomatic hypertrophic cardiomyopathy.
Sotagliflozin is a small molecule that targets sodium-glucose cotransporters, which are involved in glucose reabsorption in the kidneys and intestines. By inhibiting these targets, it aims to reduce glucose levels and address metabolic imbalances in conditions like Type 1 Diabetes.
Sotagliflozin is being developed by Lexicon Pharmaceuticals, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker LXRX. The company is conducting clinical trials to evaluate the drug's safety and efficacy across multiple indications.
Sotagliflozin is in Phase 3 clinical development for symptomatic obstructive and non-obstructive hypertrophic cardiomyopathy. It is also being studied in earlier-phase trials for Type 1 Diabetes and heart failure. The drug is investigational and not yet approved by regulatory authorities.
Sotagliflozin is being evaluated in several trials, including NCT06481891, a Phase 3 study in hypertrophic cardiomyopathy with 500 participants, and NCT06435156, a Phase 2 study in Type 1 Diabetes and heart failure with 320 participants. Other trials include NCT02647918 and NCT05696366.
Sotagliflozin is also known as Sotagliflozin Low Dose. The drug is being studied at various doses in clinical trials, and the low-dose formulation is part of the same development program by Lexicon Pharmaceuticals.