Clinical Trials

Numerous clinical trials have evaluated Fasudil across neurodegenerative, cardiovascular, ophthalmic, and oncological indications, including Parkinson's disease, amyotrophic lateral sclerosis, atherosclerosis, carotid stenosis, retinal vein occlusion, and prostate cancer. Encompassing Phase 2, Phase 3, and Phase 4 protocols, these studies feature active, recruiting, completed, and terminated statuses under academic, university hospital, and industry sponsorship. Ultimately, these investigations aim to establish the safety, tolerability, and clinical efficacy of targeting Rho kinase pathways across diverse human diseases.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06362707 RECRUITING
Cognitive Decline, Mild; Alzheimer Disease
Helse Stavanger HF
 2024-08-01 PHASE2
NCT06890858 RECRUITING
Ovarian Cancer
Zhejiang Provincial People's Hospital
 2025-04 PHASE2
NCT05931575 ACTIVE_NOT_RECRUITING
Idiopathic Parkinson´s Disease
Technical University of Munich
 2023-09-11 PHASE2
NCT05218668 ACTIVE_NOT_RECRUITING
Amyotrophic Lateral Sclerosis
Woolsey Pharmaceuticals
 2021-12-22 PHASE2
NCT06861192 RECRUITING
Prostate CA
baotai Liang
 2025-02-16 PHASE2; PHASE3
NCT07250542 RECRUITING
Prostate Cancer
baotai Liang
 2024-07-05 PHASE2
NCT03792490 COMPLETED
Amyotrophic Lateral Sclerosis
University Medical Center Goettingen
 2019-02-20 PHASE2
NCT04734379 UNKNOWN
Progressive Supranuclear Palsy; Corticobasal Syndrome
Woolsey Pharmaceuticals
 2021-01-22 PHASE2
NCT03753269 UNKNOWN
ST Segment Elevation Myocardial Infarction
RenJi Hospital
 2019-07-01 PHASE4
NCT04793659 COMPLETED
Dementia
Woolsey Pharmaceuticals
 2020-12-15 PHASE2
NCT04191954 UNKNOWN
Retinopathy of Prematurity
Shahid Beheshti University of Medical Sciences
 2019-06-02 PHASE2; PHASE3
NCT03404843 COMPLETED
Cardiovascular Diseases
Colorado State University
 2017-07-14 PHASE2
NCT03391219 UNKNOWN
Retinal Vein Occlusion
Shahid Beheshti University of Medical Sciences
 2018-01 PHASE2; PHASE3
NCT01935518 UNKNOWN
Amyotrophic Lateral Sclerosis
Peking University Third Hospital
 2013-09 PHASE2
NCT01823081 COMPLETED
Diabetic Macular Edema
Shahid Beheshti University of Medical Sciences
 2013-01 PHASE3
NCT00498615 COMPLETED
Raynaud; Scleroderma
Johns Hopkins University
 2007-04 PHASE3
NCT00670202 TERMINATED
Carotid Stenosis
Brigham and Women's Hospital
 2008-03-13 PHASE2
NCT00120718 COMPLETED
Atherosclerosis; Hypercholesterolemia
Brigham and Women's Hospital
 2002-06 PHASE2

(data from https://clinicaltrials.gov, updated on 2026-05-04)

Check the Fasudil (HA-1077) Hydrochloride product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Fasudil selectively binds and inhibits Rho-associated kinase (ROCK) while displaying calcium channel antagonist activity, thereby blocking downstream phosphorylation events and inhibiting vascular smooth muscle cell proliferation to induce vasodilation. This blockade of aberrantly active ROCK signaling pathways provides a direct biological rational for its therapeutic evaluation in clinical trials for neurodegenerative conditions such as Amyotrophic Lateral Sclerosis and Parkinson's Disease, as well as vascular and ocular disorders.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.