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tolevamer · 3 trials · 5 indications
| Name | Type | Description |
|---|---|---|
| Tolevamer potassium-sodium (GT267-004) | DRUG | - |
Inclusion Criteria: * 18 years of age and above * The presence of CDAD at the time of enrollment with no other likely etiology for the diarrhea * Less than or equal to 48 hours of treatment with metronidazole, vancomycin or other antibacterial therapy specific for CDAD * Baseline serum potassium \>...
Tolevamer is an investigational small molecule being developed for the treatment of Pseudomembranous Colitis and Clostridium Enterocolitis, which are infections of the colon caused by Clostridium difficile. It is designed to address these infectious disease conditions, though it is not yet approved and remains in clinical development.
Tolevamer is being developed by Sanofi, a global pharmaceutical company traded under the ticker symbol SNY. Sanofi has conducted clinical trials to evaluate the drug's safety and efficacy for treating Clostridium difficile-associated diarrhea and related colonic infections.
Tolevamer is in Phase 3 clinical development. It has completed two Phase 3 trials and one Phase 2 trial, with a total enrollment of 1,040 participants across these studies. The drug is investigational and has not been approved by regulatory authorities.
Tolevamer has completed two Phase 3 trials: NCT00106509 and NCT00196794, each enrolling 520 patients with Clostridium difficile-associated diarrhea. It also completed a Phase 2 trial, NCT00382304, with 24 patients. All trials are completed, and no active trials are currently registered.
Tolevamer is a small molecule designed to treat Clostridium difficile infections. While its specific molecular target is not disclosed, it is being studied for its ability to address Pseudomembranous Colitis and Clostridium Enterocolitis, conditions caused by C. difficile overgrowth in the colon.