Fasudil is a Rho-kinase (ROCK) inhibitor primarily used for its vasodilatory and neuroprotective effects. It acts by inhibiting the RhoA/Rho-kinase signaling pathway, which plays a key role in vascular smooth muscle contraction, endothelial dysfunction, inflammation, and fibrosis.
Fasudil is administered intravenously and is approved in some countries (e.g., Japan and China) for the treatment of cerebral vasospasm following subarachnoid hemorrhage and for certain vascular disorders.
Indications include:
∙ Cerebral vasospasm after subarachnoid hemorrhage
∙ Pulmonary hypertension (investigational/off-label)
∙ Stroke, spinal cord injury, and other CNS disorders (under clinical investigation)
∙ Diabetic complications (investigational)
Parent: Fasudil
Impurities in fasudil arise from its multi-step synthetic process involving isoquinoline and sulfonamide intermediates, as well as from degradation under light, pH extremes, or thermal stress. Since it is administered intravenously, impurity control must meet strict ICH Q3A/B and pharmacopeial requirements.
Process-Related Impurities
Degradation Impurities
Elemental Impurities
Analytical Techniques for Impurity Detection
Fasudil is used to treat cerebral vasospasm after subarachnoid hemorrhage and is being studied for pulmonary hypertension, stroke recovery, and other vascular or neurological disorders.
It inhibits Rho-kinase, a key enzyme in vascular smooth muscle contraction, leading to vasodilation, improved blood flow, and anti-inflammatory effects.
No. Fasudil is currently approved in Japan and China but remains investigational in many other countries, including the US and EU.
Fasudil is sensitive to light and hydrolysis. It should be stored in light-protective containers and prepared immediately before use to maintain stability in solution.
