Drug intelligence / Profile preview

tolevamer potassium-sodium

Development stage
Phase 3
Lead developer
Sanofi
Modality
Small Molecules, Biodegradable Polymers → Polymer-based Nanoparticles → Nanoparticles → Drug Delivery Systems
Administration
Oral
01

Overview

Tolevamer potassium-sodium is a high-molecular-weight, anionic polymer developed as a non-antibiotic therapy for *Clostridioides difficile*-associated diarrhea (CDAD). It acts by binding and neutralizing *C. difficile* toxins A and B in the gut, thereby preventing their pathogenic effects without disrupting normal gut flora. Unlike earlier sodium-only formulations, the potassium-sodium salt was designed to minimize the risk of hypokalemia associated with diarrhea. Tolevamer is not absorbed systemically; it remains in the gastrointestinal tract and is excreted unchanged in feces. The drug was investigated as an alternative to antibiotics but did not meet primary efficacy endpoints in phase III trials, leading to termination of its development[2][3][5].

Brand names
Tolevamer
Other names
polystyrene sulfonatepoly(styrene-4-sulfonic acid)polystyrenesulfonic acidpolystyrene sulfonic acid
02

Targets

TcdA (Clostridioides difficile toxin A)TcdB (Clostridioides difficile large clostridial toxin family)

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