The Spanish Agency for Medicines and Health Products (AEMPS) authorized Pharmamel to conduct a Phase II clinical trial, the first trial of its kind with an intravenous injection of melatonin in patients. Professors Darío Acuña-Castroviejo and Germaine Escames of the University of Granada conducted research in animal models of sepsis, demonstrating that melatonin can counteract the exaggerated immune response, reduce inflammation and oxidative stress, and improve mitochondrial function in sepsis.
These findings resulted in the patenting of the melatonin injection formulation and the application for a clinical trial in patients with sepsis. The trial results showed a significant reduction in mortality, a decrease in hospital stay, and improvements in inflammatory and oxidative stress markers.