Drug intelligence / Profile preview

dexamethasone + nystatin

Development stage
Phase 3
Lead developer
Grupo de Estudos Multicêntricos em Onco-Hematologia
Modality
Small Molecules
Administration
Topical
01

Overview

Dexamethasone + nystatin is a topical oral rinse formulation developed for the management of symptomatic oral lesions associated with chronic graft-versus-host disease (cGVHD). The formulation contains dexamethasone (0.1 mg/mL), a potent synthetic corticosteroid that acts as an anti-inflammatory and immunosuppressive agent by targeting the glucocorticoid receptor, and nystatin (100,000 UI/mL), a polyene antifungal used to prevent secondary oral candidiasis, a common complication of local steroid therapy. This combination was evaluated in a Phase 3 randomized, double-blind clinical trial (NCT01444898) led by the Grupo de Estudos Multicentricos em Onco-Hematologia (GEMOH) and investigators from the Universidade Federal do Rio de Janeiro, where it was compared against clobetasol propionate rinses in hematopoietic stem cell transplant recipients.

Other names
dexamethasone rinsedexamethasone oral solutiondexamethasone 0.1 mg/mL + nystatin 100,000 UI/mL solution
02

Targets

ErgosterolGR (Glucocorticoid receptor)

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