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Also known as tolevamer potassium-sodium (GT267-004)
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 developed for Clostridium enterocolitis and pseudomembranous colitis, conditions associated with Clostridium difficile infection. It was studied in patients with C. difficile-associated diarrhea. It is not an approved therapy and remains in clinical development.
Tolevamer is developed by Sanofi, which trades under the ticker SNY. The compound was studied under the code GT267-004 in Sanofi-sponsored clinical programs evaluating it in patients with C. difficile-associated diarrhea.
Tolevamer reached Phase 3 clinical development. Two completed Phase 3 trials and one completed Phase 2 trial have been conducted, with no active trials currently listed. It is an investigational agent and has not been approved by the FDA for any indication.
Tolevamer has been evaluated in completed trials including NCT00196794 and NCT00106509, both Phase 3 studies comparing GT267-004 with vancomycin and metronidazole in C. difficile-associated diarrhea, and NCT00382304, a Phase 2 absorption study in patients with C. difficile-associated diarrhea.
Yes. Tolevamer is also known as tolevamer potassium-sodium, or GT267-004. These names refer to the same investigational compound developed by Sanofi, and the GT267-004 code appears in the titles of its clinical trials.
Across its clinical program, tolevamer trials enrolled a total of 1,040 patients. The two Phase 3 studies each enrolled 520 patients, and the Phase 2 absorption study enrolled 24 patients. All trials were randomized and double-blind.