TOP-N53

TOP-N53 is a first-in-class, dual-acting small molecule drug candidate developed for the topical treatment of chronic non-healing wounds such as diabetic foot ulcers and digital ulcers in systemic sclerosis. It acts as both a nitric oxide (NO) donor and a selective phosphodiesterase type 5 (PDE5) inhibitor. This bifunctional mechanism synergistically elevates intracellular cyclic guanosine monophosphate (cGMP) levels by stimulating soluble guanylate cyclase (sGC) through NO release and reducing cGMP degradation via PDE5 inhibition. The resulting increase in cGMP enhances microcirculation, promotes angiogenesis, supports wound re-epithelialization, and induces autophagy in skin fibroblasts—key processes for effective wound healing. Preclinical studies have shown that TOP-N53 is more potent than existing PDE5 inhibitors like sildenafil and demonstrates significant efficacy without notable toxicity or scarring. The drug is currently in Phase 1 clinical trials for diabetic foot ulcer and skin ulcer indications[1][2][3][4][5][6][7]. **Developer:** Topadur Pharma

Other names

nitric oxide-releasing phosphodiesterase-5 inhibitorNO-PDE5iNO-PDE-5iNO-PDE 5i