ronopterin (VAS203) / Vasopharm - LARVOL DELTA

Neuroprotective and neuroregenerative drugs after severe traumatic brain injury : A narrative review from a clinical perspective. (PubMed, Wien Klin Wochenschr) - "Some pharmacologic attempts that appeared very promising in experimental settings have had disappointing clinical results (progesterone, cyclosporine A, ronopterin, erythropoietin, dexanabinol)...Some medications appear to be beneficial: N‑methyl-D-aspartate receptor (NMDA) antagonists (esketamine, amantadine, Mg++) reduce excitotoxicity and statins and cerebrolysin are known to counteract neuroinflammation. By supporting the impaired mitochondrial energy supply, oxidative processes are inhibited and neuroregenerative processes, such as neurogenesis, angiogenesis and synaptogenesis are promoted by citicoline and cerebrolysin. First clinical evidence shows an improvement in cognitive and thymopsychic outcomes, underlined by own clinical experience combining different therapeutic approaches. Accordingly, adjuvant treatment with neuroprotective substances appears to be a promising option, although more randomized prospective studies are still needed."

Journal • Review • CNS Disorders • Critical care • Inflammation • Vascular Neurology

Efficacy of Ronopterin (VAS203) in Patients with Moderate and Severe Traumatic Brain Injury (NOSTRA phase III trial): study protocol of a confirmatory, placebo-controlled, randomised, double blind, multi-centre study. (PubMed, Trials) - P3 | "The trial aims to provide evidence on the efficacy and safety of Ronopterin in patients with traumatic brain injury."

Clinical • Journal • P3 data • CNS Disorders • Vascular Neurology

NOSTRA-III: Efficacy of VAS203 (Ronopterin) in Patients With Moderate and Severe Traumatic Brain Injury (clinicaltrials.gov) - P3; N=224; Completed; Sponsor: Vasopharm GmbH; Active, not recruiting ➔ Completed

Clinical • Trial completion • CNS Disorders • Vascular Neurology

Effects of the nitric oxide synthase inhibitor ronopterin (VAS203) on renal function in healthy volunteers. (PubMed, Br J Clin Pharmacol) - "Our phase-I-study in healthy humans indicate that VAS203 (10 mg/kg body weight) reduces renal perfusion and glomerular function within the physiological range mainly due to vasoconstriction at the preglomerular site."

Clinical • Journal • Renal Disease

Correction to: Efficacy of Ronopterin (VAS203) in Patients with Moderate and Severe Traumatic Brain Injury (NOSTRA phase III trial): study protocol of a confirmatory, placebocontrolled, randomised, double blind, multi-centre study. (PubMed, Trials) - "After publication of our article [1] the authors have notified us that one of the names has been incorrectly spelled."

Clinical • Journal • P3 data

NOSTRA-III: Efficacy of VAS203 (Ronopterin) in Patients With Moderate and Severe Traumatic Brain Injury (clinicaltrials.gov) - P3; N=224; Active, not recruiting; Sponsor: Vasopharm GmbH; Recruiting ➔ Active, not recruiting; Trial completion date: Nov 2019 ➔ Jun 2020; Trial primary completion date: Nov 2019 ➔ Jun 2020

Clinical • Enrollment closed • Trial completion date • Trial primary completion date