TOP-N53 / Topadur Pharma - LARVOL DELTA

TOP-N53-02: Safety and Tolerability of TOP-N53 Applied on Digital Ulcers in Patients With Systemic Sclerosis (clinicaltrials.gov) - P2 | N=15 | Recruiting | Sponsor: Topadur Pharma AG | Trial completion date: Mar 2026 ➔ Oct 2026 | Trial primary completion date: Mar 2026 ➔ Oct 2026

Trial completion date • Trial primary completion date • Immunology • Scleroderma • Systemic Sclerosis

TOP-N53-02: Safety and Tolerability of TOP-N53 Applied on Digital Ulcers in Patients With Systemic Sclerosis (clinicaltrials.gov) - P2 | N=15 | Recruiting | Sponsor: Topadur Pharma AG | Trial completion date: Aug 2025 ➔ Mar 2026 | Trial primary completion date: Aug 2025 ➔ Mar 2026

Trial completion date • Trial primary completion date • Immunology • Scleroderma • Systemic Sclerosis

TOP-N53-02: Safety and Tolerability of TOP-N53 Applied on Digital Ulcers in Patients With Systemic Sclerosis (clinicaltrials.gov) - P2 | N=15 | Recruiting | Sponsor: Topadur Pharma AG

New P2 trial • Immunology • Scleroderma • Systemic Sclerosis

Formulation and dermal delivery of a new active pharmaceutical ingredient in an in vitro wound model for the treatment of chronic ulcers. (PubMed, Eur J Pharm Biopharm) - "The aim of this study was to investigate dermal delivery of the new active pharmaceutical ingredient (API) TOP-N53 into diabetic foot ulcer using an in vitro wound model consisting of pig ear dermis and elucidate the impact of drug formulation and wound dressing taking into consideration clinical relevance and possible bacterial infection...The employed in vitro wound model was useful for the assessment of drug delivery and the development of a drug therapy concept for chronic diabetic foot ulcer in the home care setting. Mechanistic insights about formulation and dressing performance may be applied to drug delivery in other skin conditions such as digital ulcer."

Journal • Preclinical • Infectious Disease

Dual-Acting Nitric Oxide Donor and Phosphodiesterase Inhibitor TOP-N53 Increases Lifespan and Health Span of Caenorhabditis elegans. (PubMed, MicroPubl Biol) - "The control of aging and age-related diseases by nitric oxide (NO) and cGMP signaling is a broadly conserved process from worms to human. Here we show that TOP-N53, a dual-acting NO donor and PDE5 inhibitor, can increase both lifespan and health span in C. elegans ."

Journal