Drug intelligence / Profile preview

bravyl

Development stage
Phase 2
Lead developer
Woolsey Pharmaceuticals
Modality
Small Molecules
Administration
Oral
01

Overview

BRAVYL is an investigational oral formulation of fasudil, a potent Rho-kinase (ROCK) inhibitor developed by Woolsey Pharmaceuticals for the treatment of neurodegenerative diseases, primarily amyotrophic lateral sclerosis (ALS). Fasudil has been clinically used in Japan and China as an intravenous therapy for cerebral vasospasm since 1995. BRAVYL is designed to inhibit ROCK1 and ROCK2 enzymes, which are implicated in neuronal cell death, inflammation, and impaired nerve regeneration. In ALS patients, BRAVYL has demonstrated the ability to significantly reduce neurofilament light chain (NfL), a biomarker of neuronal damage, as well as decrease TDP-43 aggregation and cytoplasmic redistribution—key pathological features in ALS progression. The drug is being evaluated in Phase 2 clinical trials for ALS with promising safety and efficacy results. Additional indications under investigation include Alzheimer’s disease, frontotemporal dementia, CADASIL (a hereditary vascular dementia), levodopa-induced dyskinesia in Parkinson’s disease, 16p11.2 deletion syndrome (an autism spectrum disorder), schizophrenia, progressive supranuclear palsy (PSP), corticobasal syndrome (CBS), among others[1][2][4][5][6][7][8].

Brand names
BRAVYL
Other names
oral fasudilfasudil (oral formulation)
02

Targets

ROCK1 (Rho-associated coiled-coil containing protein kinase 1)ROCK2 (Rho-associated coiled-coil containing protein kinase 2)

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