A prospective, single centre, double-blinded, randomised trial with an objective to evaluate the efficacy and safety of an SPC of Cilnidipine (10mg) + Telmisartan (40mg) compared to Telmisartan (40mg) and explore the effects of the SPC on renal outcomes in 200 Indian Diabetic hypertensive patients. The study drug will be Cilacar T (10/40)

开始日期2022-04-01

申办/合作机构

J.B. Chemicals & Pharmaceuticals Ltd.

ACTRN12621000459820 / Recruiting临床2期

A Randomized, Placebo-controlled Phase 2a Study to Assess the Safety and Efficacy of Cilnidipine (10 mg and 20 mg) Alone and in Combination with 5 mg Tadalafil, in Participants with Diagnosis of Secondary Raynaud’s Disease,

开始日期2021-06-11

申办/合作机构-

CTRI/2021/03/031882 / Not yet recruiting临床3期

A Prospective Randomized Double-blind Double-dummy Parallel-group Investigator-initiated Study to Compare the Efficacy and Safety of Cilnidipine 10 mg Tablets versus CilacarÂ® Tablets 10 mg in Patients with Essential Hypertension

开始日期2021-03-15

申办/合作机构

MacLeods Pharmaceuticals Ltd.

100 项与西尼地平相关的临床结果

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100 项与西尼地平相关的转化医学

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100 项与西尼地平相关的专利（医药）

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304

项与西尼地平相关的文献（医药）

2024-04-01·Computational biology and chemistry

Effects of 1,4-dihydropyridine derivatives on cell injury and mTOR of HepG2 and 3D-QSAR study

Article

作者: Xia, Guiqiong ; Liu, Huan ; Han, Wenna ; Zhu, Siyu ; Huang, Zhuoquan ; Liu, Chunhong ; Li, Zhongyi

1,4-dihydropyridine derivatives (1,4-DHPs) are a class of drugs used to treat cardiovascular diseases, but these drugs can cause liver injury. To reveal the toxicity characteristics of these compounds, we used a series of assays, including cell viability, enzyme activity detection, and western blotting, to investigate the toxicity of seven kinds of 1,4-DHPs (0-100 μM) on HepG2 cells and establish 3D-QSAR model based on relevant toxicity data. After HepG2 cells were treated with 1,4-DHPs for 24 h, high-dose (100 μM) 1,4-DHPs decreased cell viability to varying degrees, while ROS and MDA contents were significantly increased, and ATP content was reduced. Moreover, with the concentration of 100 μM 1,4-DHPs (Nimodipine, Nitrendipine, Cilnidipine, and Manidipine) were markedly inhibited the phosphorylation levels of mTOR protein. The results of the 3D-QSAR model showed that the non-cross validation coefficient (R²) and cross validation coefficient (Q²) of the model were 0.982 and 0.652, respectively. Combined with external validation and the Williams diagram, the model showed good predictability and application domain. Based on the CoMSIA 3D contour map, the introduction of large volume and hydrogen bond receptor groups on the carbonyl oxygen side chains of the 1,4-DHPs ring 3- and 5- was beneficial for reducing the toxicity of 1,4-DHPs. The results of this study could supplement information on the cytotoxicity of 1,4-DHPs, and could provide theoretical support for predicting the toxicity of 1,4-DHPs.

2024-02-01·Journal of pharmacological sciences

Supersulfide prevents cigarette smoke extract-induced mitochondria hyperfission and cardiomyocyte early senescence by inhibiting Drp1-filamin complex formation

Article

作者: Mi, Xinya ; Zhou, Liuchenzi ; Nishida, Motohiro ; Nishimura, Akiyuki ; Kato, Yuri ; Kanda, Yasunari ; Ito, Tomoya ; Ibuki, Yuko

Smoking is one of the most serious risk factors for cardiovascular diseases. Although cigarette mainstream and sidestream smoke are significant contributors to increased cardiovascular mortality and morbidity, the underlying mechanism is still unclear. Here, we report that exposure of rat neonatal cardiomyocytes to cigarette smoke extract (CSE) induces mitochondrial hyperfission-mediated myocardial senescence. CSE leads to mitochondrial fission and reactive oxygen species (ROS) production through the complex formation between mitochondrial fission factor Drp1 and actin-binding protein, filamin A. Pharmacological perturbation of interaction between Drp1 and filamin A by cilnidipine and gene knockdown of Drp1 or filamin A inhibited CSE-induced mitochondrial hyperfission and ROS production as well as myocardial senescence. We previously reported that Drp1 activity is controlled by supersulfide-induced Cys644 polysulfidation. The redox-sensitive Cys644 was critical for CSE-mediated interaction with filamin A. The administration of supersulfide donor, Na₂S₃ also improved mitochondrial hyperfission-mediated myocardial senescence induced by CSE. Our results suggest the important role of Drp1-filamin A complex formation on cigarette smoke-mediated cardiac risk and the contribution of supersulfide to mitochondrial fission-associated myocardial senescence.

2023-11-01·European review for medical and pharmacological sciences

Assessing the hypolipidemic and gastro-liver protective activity of herbal combination with emphasis on PPI amid selected multiple antihypertensive drug combination in experimental animal models.

Article

作者: Ayaz, A K ; Metab, A ; Monisa, R P ; Abdullah, F A ; Israt, J T ; Thamer, H A ; Taqweem, U H ; Rahma, I ; Azad, A K ; Aziz, T ; Shopnil, A

OBJECTIVE:

Peptic ulcer (PU) and hypertension are chronic diseases affecting up to 10% and 30% of the adult population worldwide. Most of these patients will require treatment with a combination of antihypertensive medicines, which have adverse effects on the body's different organs. This study specifically focused on antihypertensive multi-drug induced PU disease and disturbance of liver function.

MATERIALS AND METHODS:

During a 14-day oral administration of antihypertensive drugs, Cilnidipine (1 mg/kg), Rosuvastatin (1 mg/kg), Bisoprolol (0.52 mg/kg), and Clopidogrel (7.81 mg/kg) were observed for their effects on the stomach lining and liver function in Wister albino rats. This study aimed to assess the potential of an herbal combination of (BO) + (BA) + (ZO) 0.26 mg/kg body weight (b.w.) Powder and water mixture on the ulcer, lipid profile, and liver function for 14 days in the treatment of the indomethacin-induced gastric ulcers in rats at doses of 30 mg/kg b.w. for three days. Esomeprazole (20 mg/kg b.w.) is used as a standard reference to evaluate antiulcer activity in rat models. The experiment suggests that the gastroprotective effect of the herbal combination can be attributed to its reducing effect on the peptic and the Serum Glutamic Pyruvic Transaminase (SGPT) levels and within the normal range of 34.67 ± 0.88 IU/L.

RESULTS:

The results for Total Cholesterol (TC), Triglyceride (TG), High-density lipoprotein (HDL) and Low-density lipoprotein (LDL) of the herbal combination were 52 ± 9.81495 (mg/dl), 70 ± 12.12435 (mg/dl), 23.33 ± 6.06446 (mg/dl), 14.5 ± 1.32790 (mg/dl), respectively, where the standard group (atorvastatin) 5 mg/kg TC, TG, HDL and LDL were 69.77 ± 9.92 (mg/dl), 47.7 ± 10.35 (mg/dl), 33.43 ± 5.70 (mg/dl), 26.8 ± 3.70 (mg/dl), and control group total cholesterol, triglyceride, HDL and LDL were 68.67 ± 2.20 (mg/dl), 124.07 ± 2.94 (mg/dl), 49.14 ± 1.05 (mg/dl), 54.11 ± 1.15 (mg/dl).

CONCLUSIONS:

CThis investigation reported that antihypertensive drugs did not produce gastrointestinal (GI) toxicity, and the morphological structure of the organ was not changed. So, it could be concluded that the herbal combination used in this experiment has a promising role in controlling lipid profile, liver function, and antiulcer effects. Moreover, multiple drug therapy for hypertension does not cause any harm to the stomach. Further investigations might be carried out on a larger scale to make these statements more valid.

项与西尼地平相关的新闻（医药）

2023-06-21

·PRNewswire

AISA Pharma Announces Start of Phase 2b Profervia® Study for Raynaud's Phenomenon in Systemic Sclerosis (SSc)

Phase 2 Data at EULAR Suggested Profervia® Treatment Might Influence Systemic Sclerosis (SSc) Disease Severity BOSTON, June 21, 2023 /PRNewswire/ -- Aisa Pharma, Inc. a private, clinical-stage biopharmaceutical company today announced initiation of Part 2 of the RECONNOITER Phase 2 study, evaluating Profervia®, a once-daily novel, oral calcium-channel antagonist (CCB) in patients with SSc and Raynaud's phenomenon(SSc-RP). The study is a double-blind, placebo-controlled, randomized, prospective crossover study design which will take approximately 10 months to complete. Aisa also announced the company presented initial positive safety and efficacy data from the Phase 2a RECONNOITER study at EULAR 2023 in Milan, Italy. Incidence and type of adverse events reported in the first 27 patients of the study were compared with a large metanalysis of current CCBs. Patients had a 17% incidence of AEs with Profervia® compared to 43% with current CCBs (p=0.025). Profervia® also had a greater effect on Raynaud's attack frequency (-43% versus -24% with current CCBs) and reduced SSc disease severity compared with placebo on a validated patient-reported outcome questionnaire (SHAQ) (p=0.01.) "We are excited to move forward with the second part of our Phase 2 study, and encouraged by the data presented at EULAR, which demonstrated that Profervia® may provide significant relief to patients with SSc-RP," said Andrew Sternlicht, MD, CEO and Founder of Aisa Pharma. "We will continue to validate the biologic and scientific rationale and impact of treatment on overall disease course in SSc. Almost all SSc patients suffer from Raynaud's and new treatments are urgently needed given the high morbidity and burden of the disease." About Profervia®: Profervia® is a novel form of cilnidipine, a fourth-generation calcium channel blocker (CCB). Cilnidipine is an approved and popular option to treat hypertension in select Asian countries. Cilnidipine causes vasodilation and improves function in the heart, kidney and vasculature. Cardiac, renal and vascular disease contribute to morbidity and mortality in patients with SSc. Thus, cilnidipine may improve SSc-RP, and the underlying disease. In hypertension studies, cilnidipine is better tolerated with a wider therapeutic window than US-approved CCBs used off-label for Raynaud's. Unlike other approved CCBs, cilnidipine further may have a role in certain painful conditions. About Aisa Pharma Inc. Aisa is a private biopharmaceutical company in Boston, MA. Aisa is developing Profervia® for use in patients with SSc-RP. For additional information: [email protected]; SOURCE Aisa Pharma

临床2期临床结果

2023-05-02

·Pharmaceutical Technology

Maze and Sanofi sign licence agreement for Pompe disease therapy

Muscle biopsy showing large vacuoles in a case of Pompe disease. Credit: Jensflorian / commons.wikimedia.org. Maze Therapeutics and Sanofi have signed an exclusive worldwide licence agreement for the former’s glycogen synthase 1 (GYS1) programme and oral substrate reduction therapy, MZE001, to treat Pompe disease. MZE001 is also being developed for other potential indications. Recommended Reports Reports LOA and PTSR Model - Satralizumab in Demyelinating Diseases GlobalData Reports LOA and PTSR Model - (Cilnidipine + Tadalafil) in Raynauds Disease GlobalData View all The oral GYS1 inhibitor will mitigate Pompe disease by regulating disease-causing glycogen accumulation. Maze is set to receive a payment of $150m. This payment includes upfront cash and future equity investment to secure the rights for the continued development and commercialisation of MZE001. Maze will also receive an exclusive licence for associated GYS1-targeting back-up programmes and intellectual property and a further $600m in developmental, regulatory and sales milestones along with royalties upon the successful commercialisation of MZE001. Maze has progressed MZE001 through Phase I development and recently disclosed the findings from a study involving healthy volunteers. The therapy was well tolerated when administered at doses up to 720mg twice a day in the first-in-human, placebo-controlled, double-blind single and multiple ascending dose trial. Maze Therapeutics CEO Dr Jason Coloma stated: “This agreement provides important validation for the potential of our Compass platform to elucidate novel genetic insights that inform the discovery and advancement of new medicines. “We believe the applicability of these insights is broad, and as we look ahead, Maze will focus on more common disorders where ultimately we may best apply our expertise and resources to offer the biggest impact for patients.”

临床1期引进/卖出

2023-05-02

·Pharmaceutical Technology

Soligenix and Silk Road sign deal for Behçet’s disease treatment rights

Soligenix has the right to purchase the topical formulation. Credit: AdoreBeautyNZ from Pixabay. Soligenix has signed an exclusive option agreement with Silk Road Therapeutics for the right to acquire Pentoxifylline (PTX) topical formulation intended to treat mucocutaneous ulcers in Behçet’s disease (BD) patients. The firms did not divulge the terms of the deal. Recommended Reports Reports LOA and PTSR Model - Satralizumab in Demyelinating Diseases GlobalData Reports LOA and PTSR Model - (Cilnidipine + Tadalafil) in Raynauds Disease GlobalData View all BD is a rare multisystem inflammatory vasculitis, which currently has no treatment. The disease is characterised by severe recurrent ulcers in the oral mucosa, skin, genitalia and eyes. It is estimated to impact around 18,000 people in the US and 80,000 in Europe, while 1,000,000 people are living with the disease across the globe. Soligenix reported that PTX was found to be more effective than colchicine in a Phase II proof-of-concept (POC) trial. BD patients were randomised to receive either standard-of-care colchicine therapy or colchicine in combination with topical PTX. Patients applied the PTX mucoadhesive gel four times a day for up to 14 days for treating current mouth ulcers. They also used their standard colchicine regimen. It was found that 83% of patients treated with PTX had index ulcer area shrinkage by day two, as against 19% of patients treated with only colchicine. Meanwhile, pain scores were also reported to be reduced in patients receiving PTX. No serious adverse events were observed among the patients. Soligenix president and CEO Christopher Schaber said: “The novel muco-adherent topical formulation of PTX has the potential to fill a significant void in the current treatment armamentarium for BD, where a clear unmet medical need exists. “General agreement amongst treating physicians is that current front-line treatment/management options, such as oral and topical steroids, are largely ineffective and have a number of potentially significant safety issues when used long-term. “When transitioning to the more effective therapies, like biologics such as adalimumab and apremilast, the only approved treatment in BD, these longer-term safety concerns persist and are associated with a much higher financial burden to patients and/or payers in treating this lifelong condition.”

临床结果临床2期引进/卖出上市批准

100 项与西尼地平相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D01173	西尼地平	C08CA14	DB09232

研发状态

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10 条最早获批的记录,

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适应症	国家/地区	公司	日期
高血压	日本	Mochida Pharmaceutical Co., Ltd.	1995-01-01

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适应症	最高研发状态	国家/地区	公司	日期
缺血性卒中	临床3期	韩国	Boryung Corp.	2005-01-01
雷诺病	临床2期	美国	Aisa Pharma, Inc.	2022-07-26
硬化肼胝症	临床2期	美国	Aisa Pharma, Inc.	2022-07-26
复杂性局部疼痛综合征	临床1期	美国	Aisa Pharma, Inc.	2022-01-30
硬皮病相关的手指溃疡	临床1期	美国	Aisa Pharma, Inc.	2022-01-30

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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


ACTRN12621000459820 (GlobeNewswire) 人工标引	临床2期	系统性硬皮病 \| 传染性红斑	27	Cilnidipine+Profervia	繭遞壓簾築構襯夢糧網(淵簾糧鬱鏇網夢網蓋選) = no safety issues of concern were demonstrated in the first 27 patients 夢夢憲膚觸餘齋襯選醖 (膚淵憲網積鑰衊選製繭 )	积极	2022-07-26
MP121 (ERA2017)	N/A	透析性低血压	-	Cilnidipine 10 mg/day	廠鬱廠構淵網夢鹹積糧(獵鏇網淵願襯衊網糧淵) = 觸簾淵顧齋鹹艱構鑰構餘鏇鏇製鏇簾積鑰窪齋 (醖餘積築繭憲獵築窪鬱, 10.1)	不佳	2017-05-26
MP121 (ERA2017)	N/A	透析性低血压	-	CILNIDIPINE	廠鬱廠構淵網夢鹹積糧(獵鏇網淵願襯衊網糧淵) = 網獵廠廠鹹醖願顧願憲餘鏇鏇製鏇簾積鑰窪齋 (醖餘積築繭憲獵築窪鬱, 15.4)	不佳	2017-05-26
MO024 (ERA2017)	N/A	高血压 plasma renin \| aldosterone \| catecholamine ... 更多	-	Cilnidipine 10 mg	鑰糧積鹹齋淵鬱襯憲鹽(製鹽淵顧選衊憲憲憲願) = 範醖獵壓襯膚築觸構鏇鑰繭膚餘選壓齋襯獵鑰 (淵壓壓願鬱壓遞醖獵鹹 )	积极	2017-05-26
CARTER study (ERA2017)	N/A	蛋白尿	70	Cilnidipine + other CCBs	襯廠獵襯淵糧遞糧構醖(選選簾窪餘願觸製窪夢) = 鏇淵窪餘夢選鏇憲襯簾選襯壓繭廠遞觸製遞選 (繭範選簾獵窪願齋窪積 ) 更多	积极	2017-05-26
CARTER study (ERA2017)	N/A	蛋白尿	70	Cilnidipine	襯廠獵襯淵糧遞糧構醖(選選簾窪餘願觸製窪夢) = 繭醖齋積積觸遞網壓築選襯壓繭廠遞觸製遞選 (繭範選簾獵窪願齋窪積 ) 更多	积极	2017-05-26