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Local and Systemic Safety and Tolerability of Ascending Doses of TOP-N53, a Nitric Oxide (NO)-Releasing Phosphodiesterase-5 (PDE5) Inhibitor, Administered Topically, on Wounds in Patients With Digital Ulcers (DU) in Systemic Sclerosis (SSc) in an Open-label, Vehicle-controlled, Phase 2a, Multi-center Clinical Trial

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Trial Profile

Local and Systemic Safety and Tolerability of Ascending Doses of TOP-N53, a Nitric Oxide (NO)-Releasing Phosphodiesterase-5 (PDE5) Inhibitor, Administered Topically, on Wounds in Patients With Digital Ulcers (DU) in Systemic Sclerosis (SSc) in an Open-label, Vehicle-controlled, Phase 2a, Multi-center Clinical Trial

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 24 Jun 2026

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At a glance

  • Drugs TOP N53 (Primary) ; Sildenafil
  • Indications Skin ulcer
  • Focus Adverse reactions; First in man; Therapeutic Use
  • Sponsors Topadur Pharma

Most Recent Events

  • 15 Jun 2026 Planned End Date changed from 31 Mar 2026 to 31 Oct 2026.
  • 15 Jun 2026 Planned primary completion date changed from 31 Mar 2026 to 31 Oct 2026.
  • 09 Sep 2025 According to Topadur Pharma media release, the company is expanding the study by including selected clinical centers to support recruitment and strengthen the clinical dataset.

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