Drug intelligence / Profile preview

Zuidex

Development stage
Unknown
Lead developer
Galderma
Administration
Urethral Injection
01

Overview

Zuidex is an injectable bulking agent composed of non-animal stabilized hyaluronic acid (NASHA) and dextranomer microspheres (Dx), developed by Q-Med AB (now part of Galderma) for the treatment of female stress urinary incontinence (SUI). The NASHA/Dx gel is administered into the mid-urethral or periurethral submucosa using the Zuidex system, which includes a specialized Implacer device designed for non-endoscopic delivery. The mechanism of action is purely mechanical; the injected gel creates a bolus that increases urethral resistance and improves the mucosal seal, thereby preventing involuntary urine leakage during physical exertion. Although the same NASHA/Dx formulation is marketed as Deflux for vesicoureteral reflux and Solesta for fecal incontinence, Zuidex specifically targets SUI. It received approval in the European Union and Canada but was not approved in the United States following clinical trials that indicated potential safety issues, such as sterile abscess formation, and insufficient efficacy compared to surgical alternatives.

Brand names
Zuidex
Other names
NASHA/Dx gelDefluxSolesta

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