The aim of this phase Ila trial is to provide evidence on safety, tolerability and symptomatic efficacy of the ROCK-inhibitor Fasudil in patients with early Parkinson's disease (PD). Fasudil has shown neuroprotective and pro-regenerative effects, modulated microglial activity and attenuated alpha-synuclein aggregation in PD models in vitro and in vivo. It has been licensed in Japan since 1995 for the treatment of vasospasms and has a beneficial safety profile arguing for its repurposing. Up to 15 trial centers in Germany will recruit patients. Blinded trial medication will be prepared and shipped by the University Pharmacy Leipzig. Fasudil in two dosages or placebo will be administered orally twice daily to 75 early PD patients for a total of 3 weeks. Safety, tolerability and symptomatic efficacy endpoints will be assessed up to 4 weeks after end of treatment. Its well-known safety profile and the lack of disease-modifying treatments for PD justifies its use in patients with early Parkinson's disease. ROCK-PD is a prerequisite for subsequent long-term clinical trials assessing disease-modification in PD in addition to symptomatic efficacy.

开始日期2023-09-11

申办/合作机构

Technische Universität München

JPRN-jRCTs031220704 / Recruiting临床2期IIT

Safety and Efficacy Exploratory Study of the Use of Fasudil hydrochloride for Vasospasm on arteriovenous fistula construction - SAEF-AVF study

开始日期2023-05-30

申办/合作机构-

100 项与盐酸法舒地尔相关的临床结果

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100 项与盐酸法舒地尔相关的转化医学

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100 项与盐酸法舒地尔相关的专利（医药）

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302

项与盐酸法舒地尔相关的文献（医药）

2024-09-01·No shinkei geka. Neurological surgery

[Postoperative Management of Aneurysmal Subarachnoid Hemorrhage].

Review

作者: Endo, Hidenori ; Sakata, Hiroyuki

Delayed cerebral ischemia(DCI) is one of the most significant complications of subarachnoid hemorrhage. Despite significant evolution in understanding DCI pathophysiology, vasospasm affecting cerebral vessels of large and moderate diameters remain the only clinically measurable component of DCI and is therefore the primary target for intervention in the postoperative management of subarachnoid hemorrhage. In Japan, fasudil hydrochloride and ozagrel sodium are widely used to prevent vasospasms; however, their effects are sometimes insufficient. Clazosentan, a selective endothelin receptor subtype A antagonist, reduces vasospasm-related morbidity and all-cause mortality following aneurysmal subarachnoid hemorrhage. This was demonstrated in a recent randomized phase 3 trial, leading to the approval of clazosentan by the Pharmaceuticals and Medical Devices Agency in Japan. Recent advances in our understanding of subarachnoid hemorrhage will facilitate improved management to reduce the incidence of DCI.

2024-09-01·AGING CELL

Sevoflurane‐induced overexpression of extrasynaptic α5‐GABA_AR via the RhoA/ROCK2 pathway impairs cognitive function in aged mice

Article

作者: Luo, Yuan ; Wang, Yongan ; Wang, Sixuan ; Wang, Shengran ; Wu, Jiangnan ; Wang, Zhun ; Zhang, Mengxue ; Yin, Yiqing ; Dong, Jinpeng

Abstract:

Perioperative neurocognitive disorder (PND) is a serious neurologic complication in aged patients and might be associated with sevoflurane exposure. However, the specific pathogenesis is still unclear. The distribution of α5‐GABAAR, a γ‐aminobutyric acid type A receptor (GABAAR) subtype, at extrasynaptic sites is influenced by the anchor protein radixin, whose phosphorylation is regulated via the RhoA/ROCK2 signaling pathway and plays a crucial role in cognition. However, whether sevoflurane affects the ability of radixin phosphorylation to alter extrasynaptic receptor expression is unknown. Aged mice were exposed to sevoflurane to induce cognitive impairment. Both total proteins and membrane proteins were extracted for analysis. Cognitive function was evaluated using the Morris water maze and fear conditioning test. Western blotting was used to determine the expression of ROCK2 and the phosphorylation of radixin. Furthermore, the colocalization of p‐radixin and α5‐GABAAR was observed. To inhibit ROCK2 activity, either an adeno‐associated virus (AAV) or fasudil hydrochloride was administered. Aged mice treated with sevoflurane exhibited significant cognitive impairment accompanied by increased membrane expression of α5‐GABAAR. Moreover, the colocalization of α5‐GABAAR and p‐radixin increased after treatment with sevoflurane, and this change was accompanied by an increase in ROCK2 expression and radixin phosphorylation. Notably, inhibiting the RhoA/ROCK2 pathway significantly decreased the distribution of extrasynaptic α5‐GABAAR and improved cognitive function. Sevoflurane activates the RhoA/ROCK2 pathway and increases the phosphorylation of radixin. Excess α5‐GABAAR is anchored to extrasynaptic sites and impairs cognitive ability in aged mice. Fasudil hydrochloride administration improves cognitive function.

2024-07-01·Journal of Orthopaedic Translation

Augmentation of functional recovery via ROCK/PI3K/AKT pathway by Fasudil Hydrochloride in a rat sciatic nerve transection model

Article

作者: Dou, Shuang ; Xie, Yun ; Fang, Fang ; Ren, Zhenyu ; Wang, Hai ; Zhuang, Yuehong ; Xu, Dan ; Jing, Xing

Backgrounds:

The functional recovery after peripheral nerve injury remains unsatisfactory. This study aims to perform a comprehensive evaluation of the efficacy of Fasudil Hydrochloride at treating the sciatic nerve transection injury in rats and the mechanism involved.

Materials and methods:

In animal experiments, 75 Sprague Dawley rats that underwent transection and repair of the right sciatic nerve were divided into a control, Fasudil, and Fas + LY group, receiving daily intraperitoneal injection of saline, Fasudil Hydrochloride (10 mg/kg), and Fasudil Hydrochloride plus LY294002 (5 mg/kg), respectively. At day 3 after surgery, the expression of ROCK2, p-PI3K, and p-AKT in L_4-5 DRG and the lumbosacral enlargement was determined using Western blotting. At day 7 and 14, axon density in the distal stump was evaluated with immunostaining using the anti-Neurofilament-200 antibody. At day 30, retrograde tracing by injecting Fluoro-gold in the distal stump was performed. Three months after surgery, remyelination was analyzed with immostaining using the anti-MPZ antibody and the transmission electron microscope; Moreover, Motion-Evoked Potential, and recovery of sensorimotor functions was evaluated with a neuromonitor, Footprint, Hot Plate and Von Frey Filaments, respectively. Moveover, the Gastrocnemius muscles were weighed, and then underwent H＆E staining, and staining of the neuromuscular junction using α-Bungarotoxin to evaluate the extent of atrophy and degeneration of the endplates in the Gastrocnemius. In vitro, spinal motor neurons (SMNs) and dorsal root ganglia (DRG) were cultured to examine the impact of Fasudil Hydrochloride and LY294002 on the axon outgrowth.

Results:

Three days after injury, the expression of ROCK2 increased significantly (P＜0.01), and Fasudil application significantly increased the expression of p-PI3K and p-AKT in L_4-6 DRG and the lumbosacral enlargement (P < 0.05). At day 7 and 14 after surgery, a higher axon density could be observed in the Fasudil group(P < 0.05). At day 30 after surgery, a larger number of motor and sensory neurons absorbing Fluoro-gold could be observed in the Fasudil group (P < 0.01) Three months after surgery, a greater thickness of myelin sheath could be observed in the Fasudil group (P < 0.05). The electrophysiological test showed that a larger amplitude of motion-evoked potential could be triggered in the Fasudil group (P < 0.01). Behavioral tests showed that a higher sciatic function index and a lower threshold for reacting to heat and mechanical stimuli could be measured in the Fasudil group. (P < 0.01). The wet weight ratio of the Gastrocnemius muscles and the area of the cross section of its myofibrils were greater in the Fasudil group (P < 0.01), which also demonstrated a higer ratio of axon-endplate connection and a larger size of endplates (P < 0.05). And there were no significant differences for the abovementioned parameters between the control and Fas + LY groups (P＞0.05). In vitro studies showed that Fasudil could significantly promote axon growth in DRG and SMNs, and increase the expression of p-PI3K and p-AKT, which could be abolished by LY294002 (P < 0.05).

Conclusions:

Fasudil can augment axon regeneration and remyelination, and functional recovery after sciatic nerve injury by activating the PI3K/AKT pathway.

The translational potential of this article:

The translation potential of this article is that we report for the first time that Fasudil Hydrochloride has a remarkable efficacy at improving axon regeneration and remyelination following a transection injury of the right sciatic nerve in rats through the ROCK/PI3K/AKT pathway, which has a translational potential to be used clinically to treat peripheral nerve injury.

项与盐酸法舒地尔相关的新闻（医药）

2024-11-12

·PRNewswire

Woolsey Pharmaceuticals Completes Patient Recruitment for High-Dose Cohort of ALS Study

NEW YORK, Nov. 12, 2024 /PRNewswire/ -- Woolsey Pharmaceuticals today announced the successful completion of patient recruitment (n=31) in the high-dose (300 mg/day) cohort of the REAL study, which is assessing BRAVYL® (oral fasudil) for the treatment of Amyotrophic Lateral Sclerosis (ALS). This follows promising biomarker and clinical findings from the study's standard-dose cohort. At the 180 mg/day dose (n=31), the biomarker Neurofilament Light (NfL), a sensitive indicator of neuronal damage and rate of ALS progression, decreased by 15% from baseline to 6 months (p=0.0006); of note, increased levels of NfL are associated with more rapid decline in function. Additionally, there were directionally positive clinical improvements compared to a matched historical control — a 17% lower decline in ALSFRS-R, a 37% lower decline in slow vital capacity (SVC), and a 56% lower decline in muscle strength. Moreover, greater decreases in NfL were correlated with less deterioration on the ALSFRS-R (p=0.028). Given these encouraging biomarker and clinical findings at the 180 mg/day dose, along with an excellent safety profile, Woolsey Pharmaceuticals made the decision to re-open the REAL study to explore the effects of BRAVYL at an increased dose of 300 mg/day. "Experience with this higher dose in ALS patients will be invaluable as we progress to a larger study," said Sven Jacobson, CEO of Woolsey Pharmaceuticals. "Furthermore, recently published results from a university-led, three-arm, double-blind study of fasudil in ALS patients found a relationship between dose and improved motor neuron function, which is very encouraging for our ongoing research," Jacobson stated, referencing "Safety, tolerability, and efficacy of fasudil in amyotrophic lateral sclerosis [ROCK-ALS]: a phase 2, randomised, double-blind, placebo-controlled trial, Jan C Koch et at, The Lancet Neurology, November 2024)." Study results from the 300 mg/day dosing cohort are expected to be released by mid-2025. About ALS ALS is a fatal neurodegenerative disease characterized by inevitable, and often rapid, decline in patients as the disorder advances. Mean survival time is only two to five years. Accordingly, the ability to impede worsening represents a meaningful advancement in efforts to enhance the prognosis and quality of life of individuals impacted by the devastating condition. About Woolsey Pharmaceuticals Woolsey Pharmaceuticals' mission is to help usher in a new era of neurodegenerative disease treatment, saving and improving the lives of patients in need. SOURCE Woolsey Pharmaceuticals, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

临床2期临床结果

2024-11-11

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带量采购

2024-07-08

·PRNewswire

Woolsey Pharmaceuticals Announces Treatment Of First Patient with Higher-Dose BRAVYL in The REAL Amyotrophic Lateral Sclerosis (ALS) Study (NCT05218668)

NEW YORK, July 8, 2024 /PRNewswire/ -- Woolsey Pharmaceuticals, a clinical-stage drug development company, announced that the first patient has started treatment at 300 mg/day in the REAL study, which is evaluating the effects of BRAVYL in Amyotrophic Lateral Sclerosis (ALS). As recently announced, participants treated with 180 mg/day BRAVYL in the REAL study experienced a 15.5% decrease (improvement) in NfL from baseline to 6 months (p<0.001). Since NfL in the ALS population tends to increase by a mean of 11% in 6 months, this suggests that 180 mg/day BRAVYL could potentially reduce NfL up to 26% versus a control group. Moreover, greater decreases in NfL were correlated with less deterioration on the ALSFRS-R (Spearman's coefficient = -0.45, p=0.028) implying that early clinical benefits of reducing NfL may be seen contemporaneously with the NfL reductions by BRAVYL. A "propensity matched" analysis was performed wherein 12-month clinical outcomes from REAL were compared with those from a matched cohort selected by identifying 31 patients from the Ceftriaxone ALS Study database that were most similar (based on pre-treatment age, ALSFRS-R, time from onset of ALS, and other important parameters) to each REAL patient. The rate of deterioration in ALSFRS-R was improved in REAL vs. the matched controls by 28% (p=0.12). REAL patients also had a 42% (p=0.05) slower deterioration in SVC (breathing) and a 50% (p=0.06) slower rate of muscle strength decline, driven mostly by lower limb muscles with a 71% (p=0.04) reduction in weakening and a more modest 37% (p=0.22) reduction in weakening of upper limb muscles. An analysis that matched REAL patients recruited in Australia to the Australian MND Registry (a longitudinal registry, not a study) yielded directionally similar ALSFRS-R and SVC findings while muscle strength could not be analyzed as the registry does not contain such data. "The dosing of the first participant at 300 mg is another important program milestone," notes Sven Jacobson, CEO of Woolsey. "This next phase will allow us to evaluate the safety and tolerability of a higher dose, in preparation for our planned phase 2b study. Our goal is to continue to advance development of BRAVYL for people living with ALS, in hopes that we can slow the progression of the disease and improve their quality of life." ABOUT ALS ALS is a fatal neurodegenerative disease characterized by inevitable, and often rapid, decline in patients as the disorder advances (mean survival time is only two to five years). Accordingly, the ability to impede any worsening represents a meaningful advancement in efforts to enhance the prognosis and quality of life of individuals impacted by this devastating condition. ABOUT WOOLSEY PHARMACEUTICALS Woolsey Pharmaceuticals is expanding the boundaries of medical science. Our lead indication is Amyotrophic Lateral Sclerosis (ALS), a progressive and debilitating disease that ultimately is fatal. Our mission is to help usher in a new era of neurodegenerative disease treatment, saving and improving the lives of patients in need. SOURCE Woolsey Pharmaceuticals, Inc.

临床结果临床2期

100 项与盐酸法舒地尔相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D03115	盐酸法舒地尔	C04AX32	DB08162

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
脑缺血	日本	Asahi Kasei Corp.	1995-06-30
颅内血管痉挛	日本	Asahi Kasei Corp.	1995-06-30

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
肌萎缩侧索硬化	临床2期	美国	Woolsey Pharmaceuticals, Inc.初创企业	2021-12-22
肌萎缩侧索硬化	临床2期	澳大利亚	Woolsey Pharmaceuticals, Inc.初创企业	2021-12-22

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临床结果

适应症

分期

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


REAL (PRNewswire) 人工标引	临床2期	肌萎缩侧索硬化 Neurofilament Light Chain	31	BRAVYL	遞顧簾鹽鬱獵遞顧積製(衊構醖鹽顧積餘鏇醖衊) = 簾獵鏇壓繭齋繭積膚獵鏇壓齋繭鏇鏇餘製窪鬱 (築網齋願蓋獵艱鹹簾廠 ) 更多	积极	2024-06-19
NCT03404843 (CTgov)	临床2期	心血管疾病	31	placebo (Young Saline)	衊鏇夢夢餘遞築觸齋廠(鹽簾鹽餘獵蓋淵鏇夢觸) = 願積簾築繭衊廠夢夢醖鹽鹽糧簾選製範鏇簾願 (觸觸憲憲衊簾艱廠淵憲, 夢夢鏇網築蓋齋簾築顧 ~ 醖淵壓憲積製鬱憲繭觸) 更多	-	2020-02-27
				fasudil hydrochloride (Young Fasudil)	衊鏇夢夢餘遞築觸齋廠(鹽簾鹽餘獵蓋淵鏇夢觸) = 鹹襯鬱遞窪鹹淵鹽壓簾鹽鹽糧簾選製範鏇簾願 (觸觸憲憲衊簾艱廠淵憲, 壓糧廠廠衊繭膚鑰窪獵 ~ 鏇糧鏇憲範齋網願鬱鬱) 更多
ARVO2017	N/A	视网膜脱离	-	Fasudil	淵夢艱鑰淵艱範淵壓壓(願淵選壓蓋獵構衊顧壓) = 51% reduction 製製廠鬱窪糧鬱願網觸 (鏇鏇淵觸鏇壓築襯鏇鬱 )	-	2017-05-07
NCT00670202 (CTgov)	临床2期	颈动脉狭窄	2	Fasudil Hydrochloride (Drug: Fasudil Hydrochloride)	鹽簾繭觸窪構鑰壓觸襯(顧糧齋願築鏇製餘艱艱) = 鹹餘選積獵鹹壓衊夢餘製網鏇獵遞選繭壓構艱 (膚襯繭獵蓋鏇壓窪艱顧, 憲鏇範廠鑰顧積糧網構 ~ 鬱築顧鹽築齋齋積壓蓋)	-	2017-03-29
				Placebo Oral Tablet (Drug: Placebo Oral Tablet)	鹽簾繭觸窪構鑰壓觸襯(顧糧齋願築鏇製餘艱艱) = 鑰糧憲繭繭範齋壓艱鹽製網鏇獵遞選繭壓構艱 (膚襯繭獵蓋鏇壓窪艱顧, 顧憲鏇觸遞糧鏇醖遞鏇 ~ 築鑰鹽窪壓鬱鹽繭糧糧)
PO512 (AAO2016)	N/A	糖尿病性黄斑水肿	-	IVB/IVF group	鬱鏇繭艱壓夢網餘顧夢(窪繭網構襯繭淵積夢鏇) = BCVA changes were consistent with CMT changes 艱齋鏇鏇壓鹹憲餘範築 (醖鏇廠艱夢蓋膚願製艱 )	积极	2016-10-17
				IVB group
ERS2013	N/A	肺动脉高压	6	Fasudil	選廠鏇夢遞鑰憲蓋鬱簾(積餘顧壓糧壓醖夢獵襯) = 膚構襯簾艱鹽鏇構憲醖壓遞壓衊淵繭願構築繭 (餘製蓋積窪簾願醖廠網, 18.0)	不佳	2013-09-01
				fasudil	選廠鏇夢遞鑰憲蓋鬱簾(積餘顧壓糧壓醖夢獵襯) = 衊膚壓願觸觸範願淵夢壓遞壓衊淵繭願構築繭 (餘製蓋積窪簾願醖廠網, 4.5)
ARVO2009	N/A	脉络膜新生血管	-	Fasudil 20mg/kg	齋獵鏇遞選積選鹽蓋製(鹹廠鏇淵鹹餘廠網觸顧) = 鏇網觸願膚餘膚蓋鬱鹽築艱鏇觸獵窪衊憲鏇壓 (襯製襯製夢鏇衊憲淵範 ) 更多	积极	2009-04-01
				Vehicle	齋獵鏇遞選積選鹽蓋製(鹹廠鏇淵鹹餘廠網觸顧) = 鏇鏇獵壓顧觸衊獵範淵築艱鏇觸獵窪衊憲鏇壓 (襯製襯製夢鏇衊憲淵範 ) 更多