Fingolimod (FTY-720)

别名: FTY720 (free base); FTY720; 162359-55-9; 2-Amino-2-(4-octylphenethyl)propane-1,3-diol; 2-Amino-2-[2-(4-octylphenyl)ethyl]propane-1,3-diol; Fingolimod [INN]; 2-Amino-2-[2-(4-octylphenyl)ethyl]-1,3-propanediol; Fty-720; fingolimodum; Fingolimod HCl; FTY-720; FTY 720; Trade name: Gilenia and Gilenya. 芬戈莫德; 2-氨基-2-(2-(4-辛基苯基)乙基-1,3-丙二醇; 2-氨基-2-[2-(4-辛基苯基)乙基]-1,3-丙二醇; 品牌 芬戈莫德对照品; 芬戈莫德碱; 芬戈莫德杂质;芬戈利德;芬戈莫德-D4;芬格莫德及中间体
目录号: V17861 纯度: ≥98%
Fingolimod(以前称为 FTY720;FTY-720;FTY 720;商品名 Gilenia 和 Gilenya)是一种批准用于治疗多发性硬化症的药物,是一种有效的 S1P(1-磷酸鞘氨醇)拮抗剂,具有抗癌活性。
Fingolimod (FTY-720) CAS号: 162359-55-9
产品类别: New1
产品仅用于科学研究,不针对患者销售
规格 价格 库存 数量
10mg
50mg
100mg
250mg
500mg
1g
5g

Other Forms of Fingolimod (FTY-720):

  • Fingolimod-d4 (FTY720 free based-d4)
  • Fingolimod-d4 hydrochloride (FTY720-d4)
  • 盐酸芬戈莫德
  • 芬戈莫德磷酸盐
点击了解更多
InvivoChem产品被CNS等顶刊论文引用
纯度/质量控制文件

纯度: ≥98%

产品描述
芬戈莫德(以前称为 FTY720;FTY-720;FTY 720;商品名 Gilenia 和 Gilenya)是一种批准用于治疗多发性硬化症的药物,是一种有效的 S1P(1-磷酸鞘氨醇)拮抗剂,具有抗癌活性。它在 K562 和 NK 细胞中抑制 S1P,IC50 为 0.033 nM。它是一种从真菌中产生的民间药物。芬戈莫德首先被发现是器官移植的治疗剂。它通过对免疫系统和中枢神经系统的受体介导作用在多发性硬化症治疗中发挥作用。芬戈莫德用于治疗多发性硬化症,并具有抗肿瘤活性。
生物活性&实验参考方法
靶点
sphingosine 1-phosphate (S1P)(IC50 = 0.033 nM, in K562 and NK cells); PAK1
体外研究 (In Vitro)
在与 NK 细胞一起存活之前,单核细胞衍生的未成熟树突状细胞 (iDC) 暴露于不同剂量的 S1P 中不同的时间。在这些培养皿中,自体或同种异体 iDC 暴露于 0.2-20 μM S1P 四个小时,可显着屏蔽 NK 细胞。对于自体 iDC 和同种异体 iDC,S1P 的 IC50 值分别确定为 160 nM 和 34 nM。随后,不同剂量的芬戈莫德或 SEW2871 能够抵消 S1P 的抑制作用,IC50 值分别为 173 或 15 nM [1]。据观察,真菌莫德通过阻止细胞中溶血磷脂酶的自动移动性而引起LPA的合成。轴突发育的重要组成部分,轴突 cAMP 浓度,与芬戈林治疗有很强的相关性。此外,芬戈莫德显着降低了神经中枢的 LPA 水平。髓磷脂厚度的改善与 PF-8380 治疗有关 [2]。
体内研究 (In Vivo)
挤出后 14 天,芬戈莫德治疗导致野生型 C57BL/6 喷嘴中的神经显着增加。另一方面,用芬戈莫德治疗的 T 缺陷 B 缺失的 Foxn1-/-nozzles 表现出增强的神经再生。尽管用芬戈莫德治疗的 Foxn1-/- 喷嘴和对照 Foxn1-/- 喷嘴的神经生长平均速率表明 T 缺陷影响神经再生。尽管只有 Foxn1-/-治疗的小鼠的表现显着优于 C57BL/6,并且在功能检查中表现更好 [2],但有可能发挥作用。离体放射性自动结合用于量化用芬戈莫德治疗动物 28 天后发生的 18F-GE180 示踪剂结合量。结果显示,芬戈莫德治疗后18F-GE180的结合电位显着降低(P<0.0001)。
酶活实验
利用ELISA阵列试剂盒检测细胞因子和趋化因子释放[1]
DC或NK细胞以1×106个细胞/ml的细胞浓度与培养基或与2μM S1P、10nM SEW2871、10nMFTY720或它们的组合孵育。DC也与1μg/ml LPS一起孵育。孵育24小时后,收获细胞,并将细胞悬浮液以1000×g离心10分钟,然后收集上清液。如制造商的用户手册所述,使用多分析ELISArray试剂盒检测各种细胞因子和趋化因子的水平。该试剂盒分析IL-1β、IL-4、IL-6、IL-10、IL-12、IL-17A、IFN-γ、TNF-α、TGF-β1、MCP-1、MIP-1α和MIP-1β的释放。试剂盒提供的阴性和阳性对照也包括在内[1]。
细胞实验
未成熟DC保持完整,或与2μM S1P、10nMFTY720、10nM SEW2871或S1P与这些药物的组合孵育4小时。作为对照,使用1μg/ml LPS。将细胞洗涤并在96孔板中孵育(v-bottom,每孔2×105个细胞),再次洗涤并重悬于含有0.1%叠氮化钠的PBS缓冲液中。用1μg/ml FITC缀合的小鼠抗人CD80、1μg/ml FITC缀合小鼠抗人CD43、1μg/ml FITC缀合小鼠抗人D86、1μmg/ml FITC偶联小鼠抗人HLA I类、1μg/ml FITC偶联鼠抗人HLA-DR、1μ/ml FITC偶联鼠标抗人HLA-E或1μg/ml FITC偶联小鼠IgG作为对照进行标记。将细胞洗涤两次,并在流式细胞仪中进行检查。根据同种型对照FITC缀合的小鼠IgG设置标记。[1]
为了用各种NK细胞激活受体的抗体对NK细胞进行染色,将其未经处理或与2μM S1P孵育4小时,用1μg/ml PE缀合的小鼠抗人NKp30(CD337)、1μg/ml聚乙烯缀合的鼠抗人NKp44(CD336)、1µg/ml PE缀合的鼠抗人类NKG2D(CD314)洗涤并染色,或作为对照,用1µg/ml聚乙烯缀合的小鼠IgG1在4°C下染色45分钟。NK细胞也用1μg/ml FITC偶联的抗杀伤抑制受体(KIR)/CD158抗体染色,该抗体识别KIR2DL2、KIR2DL3、KIR2DS2和KIR2DS4,并用FITC偶联小鼠IgG作为对照。将细胞洗涤两次,并在流式细胞仪中进行检查。根据同型对照PE缀合或FITC缀合的小鼠IgG设置标记。
动物实验
Methods:[3]
Chronic focal experimental autoimmune encephalitis (EAE)-like lesions were induced in Lewis rats (n = 24) via stereotactic intrastriatal injection of heat-killed bacillus Calmette-Guérin (BCG) and subsequent activation using an intradermal injection of BCG in complete Freund adjuvant. This process resulted in a delayed-type hypersensitivity (DTH)-like EAE lesion. The extent of neuroinflammation surrounding the lesion was measured using (18)F-GE180 as a PET radioligand. The imaging was performed before and after treatment with fingolimod (0.3 mg/kg/d by mouth, 28 d) or vehicle as a control. In addition to imaging, autoradiography and immunohistochemistry experiments were performed to verify the in vivo results.
Results: [3]
The chronic DTH EAE lesion led to increased ligand binding in the ipsilateral, compared with contralateral, hemisphere when PET imaging was performed with the translocator protein-binding radioligand (18)F-GE180. Treatment with fingolimod led to a highly significant reduction in the binding potential, which could be demonstrated using both in vivo and ex vivo imaging (fingolimod vs. vehicle treatment, P < 0.0001). The area of increased (18)F-GE180 signal mapped closely to the area of activated microglial cells detected by immunohistochemistry.
药代性质 (ADME/PK)
Absorption, Distribution and Excretion
Fingolimod is slowly but efficiently absorbed in the gastrointestinal tract. AUC varies greatly, depending on the patient, and pharmacokinetic studies demonstrate a range of AUC values for fingolimod. The Tmax of fingolimod ranges between 12-16 hours and its bioavailability is 90-93%. Steady-state concentrations of fingolimod are achieved within 1-2 months after initiation when it is administered in a single daily dose.
About 81% of an oral dose of fingolimod is excreted in the urine in the form of inactive metabolites. Intact fingolimod and its active metabolite account for less than 2.5% of the dose, and can be found excreted in the feces.
The volume of distribution of fingolimod is about 1200±260 L. It is approximately 86% distributed in the red blood cells (RBC).
Fingolimod blood clearance is 6.3±2.3 L/h, according to prescribing information. Another resource mentions it ranges from 6-8 L/h.
Metabolism / Metabolites
Sphingosine kinase metabolizes fingolimod to an active metabolite, fingolimod phosphate. Fingolimod metabolism occurs via 3 major metabolic pathways: firstly, phosphorylation of the (S)-enantiomer of fingolimod-phosphate (pharmacologically active), secondly, oxidation by cytochrome P450 4F2 (CYP4F2), and thirdly, fatty acid-like metabolism to various inactive metabolites. The formation of inactive non-polar ceramide analogs of fingolimod also occurs during its metabolism.
Biological Half-Life
The half-life of fingolimod and its active metabolite ranges from 6-9 days.
毒性/毒理 (Toxicokinetics/TK)
Hepatotoxicity
In large randomized controlled trials of fingolimod in patients with multiple sclerosis, serum ALT elevations above 3 times ULN were reported in 8% to 14% of fingolimod compared to 2% to 3% of placebo recipients. The enzyme elevations were usually transient and not associated with symptoms or jaundice and required drug discontinuation in less than 1% of cases. No instances of acute hepatitis or clinically apparent liver injury were reported in the preregistration trials of fingolimod. Subsequent to its approval and more wide scale use, however, instances of clinically apparent liver injury attributed to fingolimod were reported including cases of acute liver failure requiring emergency liver transplantation. The onset of liver injury was often within days or weeks of starting treatment and the pattern of liver enzyme elevations was usually hepatocellular. In addition, at least one instance of reactivation of hepatitis B in an inactive HBsAg carrier has been reported. Thus, mild-to-moderate and transient serum enzyme elevations during therapy are not uncommon, and clinically apparent liver injury with jaundice due to fingolimod can occur.
Likelihood score: C (probable cause of clinically apparent liver injury as well as reactivation of hepatitis B in susceptible patients).
Effects During Pregnancy and Lactation
◉ Summary of Use during Lactation
Although fingolimod and its active metabolite are highly bound in maternal plasma and unlikely to reach the breastmilk in large amounts, it is potentially toxic to the breastfed infant. Because there is no published experience with fingolimod during breastfeeding, expert opinion generally recommends that it should be avoided during breastfeeding, especially while nursing a newborn or preterm infant. However, the manufacturer's labeling does not recommend against its use in breastfeeding.
◉ Effects in Breastfed Infants
Relevant published information was not found as of the revision date.
◉ Effects on Lactation and Breastmilk
Relevant published information was not found as of the revision date.
Protein Binding
The protein binding of fingolimod and its active metabolite exceeds 99.7%.
参考文献

[1]. FTY720 and SEW2871 reverse the inhibitory effect of S1P on natural killer cell mediated lysis of K562 tumor cells and dendritic cells but not on cytokine release. Cancer Immunol Immunother. 2010, 59(4), 575-586.

[2]. Fingolimod promotes peripheral nerve regeneration via modulation of lysophospholipid signaling. J Neuroinflammation. 2016 Jun 10;13(1):143.

[3]. In vivo PET imaging demonstrates diminished microglial activation after fingolimod treatment in an animal model of multiple sclerosis. J Nucl Med. 2015 Feb;56(2):305-10.

[4]. Modification of lymphocyte migration to Peyer's patches by inhibition of sphingosine-1-phosphate lyase ameliorates murine colitis. J Gastroenterol Hepatol. 2018 Jan 15.

其他信息
Pharmacodynamics
In multiple sclerosis, fingolimod binds to sphingosine receptors, reducing its associated neuroinflammation.In COVID-19, it may reduce lung inflammation and improve the clinical outcomes of patients with this disease. Fingolimod causes a transient reduction in heart rate and AV conduction during treatment initiation. It has the potential to prolong the QT interval.
*注: 文献方法仅供参考, InvivoChem并未独立验证这些方法的准确性
化学信息 & 存储运输条件
分子式
C19H33NO2
分子量
307.478
精确质量
307.251
元素分析
C, 74.22; H, 10.82; N, 4.56; O, 10.41
CAS号
162359-55-9
相关CAS号
Fingolimod-d4;1346747-38-3;Fingolimod-d4 hydrochloride;1346604-90-7;Fingolimod hydrochloride;162359-56-0; 162359-55-9; 402615-91-2 (phosphate); 207113-62-0 (octanoic acid); 1242271-26-6 (palmitamide); 207113-64-2 (hexanoic acid)
PubChem CID
107970
外观&性状
White to off-white solid powder
密度
1.0±0.1 g/cm3
沸点
479.5±45.0 °C at 760 mmHg
熔点
102-107
闪点
243.8±28.7 °C
蒸汽压
0.0±1.3 mmHg at 25°C
折射率
1.531
LogP
5.25
tPSA
66.48
氢键供体(HBD)数目
3
氢键受体(HBA)数目
3
可旋转键数目(RBC)
12
重原子数目
22
分子复杂度/Complexity
258
定义原子立体中心数目
0
InChi Key
KKGQTZUTZRNORY-UHFFFAOYSA-N
InChi Code
InChI=1S/C19H33NO2/c1-2-3-4-5-6-7-8-17-9-11-18(12-10-17)13-14-19(20,15-21)16-22/h9-12,21-22H,2-8,13-16,20H2,1H3
化学名
2-Amino-2-[2-(4-octylphenyl)ethyl]-1,3-propandiol
别名
FTY720 (free base); FTY720; 162359-55-9; 2-Amino-2-(4-octylphenethyl)propane-1,3-diol; 2-Amino-2-[2-(4-octylphenyl)ethyl]propane-1,3-diol; Fingolimod [INN]; 2-Amino-2-[2-(4-octylphenyl)ethyl]-1,3-propanediol; Fty-720; fingolimodum; Fingolimod HCl; FTY-720; FTY 720; Trade name: Gilenia and Gilenya.
HS Tariff Code
2934.99.9001
存储方式

Powder      -20°C    3 years

                     4°C     2 years

In solvent   -80°C    6 months

                  -20°C    1 month

运输条件
Room temperature (This product is stable at ambient temperature for a few days during ordinary shipping and time spent in Customs)
溶解度数据
溶解度 (体外实验)
Ethanol : ~7.69 mg/mL (~25.01 mM)
DMSO : ~2 mg/mL (~6.50 mM)
溶解度 (体内实验)
配方 1 中的溶解度: ≥ 1 mg/mL (3.25 mM) (饱和度未知) in 10% EtOH + 40% PEG300 + 5% Tween80 + 45% Saline (这些助溶剂从左到右依次添加,逐一添加), 澄清溶液。
例如,若需制备1 mL的工作液,将 100 μL 10.0 mg/mL 澄清乙醇储备液加入到 400 μL PEG300 中,混匀;然后向上述溶液中加入50 μL Tween-80,混匀;加入450 μL生理盐水定容至1 mL。
*生理盐水的制备:将 0.9 g 氯化钠溶解在 100 mL ddH₂O中,得到澄清溶液。

配方 2 中的溶解度: ≥ 1 mg/mL (3.25 mM) (饱和度未知) in 10% EtOH + 90% (20% SBE-β-CD in Saline) (这些助溶剂从左到右依次添加,逐一添加), 澄清溶液。
例如,若需制备1 mL的工作液,可将 100 μL 10.0 mg/mL 澄清乙醇储备液加入 900 μL 20% SBE-β-CD 生理盐水溶液中,混匀。
*20% SBE-β-CD 生理盐水溶液的制备(4°C,1 周):将 2 g SBE-β-CD 溶解于 10 mL 生理盐水中,得到澄清溶液。

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配方 3 中的溶解度: ≥ 1 mg/mL (3.25 mM) (饱和度未知) in 10% EtOH + 90% Corn Oil (这些助溶剂从左到右依次添加,逐一添加), 澄清溶液。
例如,若需制备1 mL的工作液,可将 100 μL 10.0 mg/mL 澄清 EtOH 储备液添加到 900 μL 玉米油中并充分混合。


请根据您的实验动物和给药方式选择适当的溶解配方/方案:
1、请先配制澄清的储备液(如:用DMSO配置50 或 100 mg/mL母液(储备液));
2、取适量母液,按从左到右的顺序依次添加助溶剂,澄清后再加入下一助溶剂。以 下列配方为例说明 (注意此配方只用于说明,并不一定代表此产品 的实际溶解配方):
10% DMSO → 40% PEG300 → 5% Tween-80 → 45% ddH2O (或 saline);
假设最终工作液的体积为 1 mL, 浓度为5 mg/mL: 取 100 μL 50 mg/mL 的澄清 DMSO 储备液加到 400 μL PEG300 中,混合均匀/澄清;向上述体系中加入50 μL Tween-80,混合均匀/澄清;然后继续加入450 μL ddH2O (或 saline)定容至 1 mL;

3、溶剂前显示的百分比是指该溶剂在最终溶液/工作液中的体积所占比例;
4、 如产品在配制过程中出现沉淀/析出,可通过加热(≤50℃)或超声的方式助溶;
5、为保证最佳实验结果,工作液请现配现用!
6、如不确定怎么将母液配置成体内动物实验的工作液,请查看说明书或联系我们;
7、 以上所有助溶剂都可在 Invivochem.cn网站购买。
制备储备液 1 mg 5 mg 10 mg
1 mM 3.2522 mL 16.2612 mL 32.5224 mL
5 mM 0.6504 mL 3.2522 mL 6.5045 mL
10 mM 0.3252 mL 1.6261 mL 3.2522 mL

1、根据实验需要选择合适的溶剂配制储备液 (母液):对于大多数产品,InvivoChem推荐用DMSO配置母液 (比如:5、10、20mM或者10、20、50 mg/mL浓度),个别水溶性高的产品可直接溶于水。产品在DMSO 、水或其他溶剂中的具体溶解度详见上”溶解度 (体外)”部分;

2、如果您找不到您想要的溶解度信息,或者很难将产品溶解在溶液中,请联系我们;

3、建议使用下列计算器进行相关计算(摩尔浓度计算器、稀释计算器、分子量计算器、重组计算器等);

4、母液配好之后,将其分装到常规用量,并储存在-20°C或-80°C,尽量减少反复冻融循环。

计算器

摩尔浓度计算器可计算特定溶液所需的质量、体积/浓度,具体如下:

  • 计算制备已知体积和浓度的溶液所需的化合物的质量
  • 计算将已知质量的化合物溶解到所需浓度所需的溶液体积
  • 计算特定体积中已知质量的化合物产生的溶液的浓度
使用摩尔浓度计算器计算摩尔浓度的示例如下所示:
假如化合物的分子量为350.26 g/mol,在5mL DMSO中制备10mM储备液所需的化合物的质量是多少?
  • 在分子量(MW)框中输入350.26
  • 在“浓度”框中输入10,然后选择正确的单位(mM)
  • 在“体积”框中输入5,然后选择正确的单位(mL)
  • 单击“计算”按钮
  • 答案17.513 mg出现在“质量”框中。以类似的方式,您可以计算体积和浓度。

稀释计算器可计算如何稀释已知浓度的储备液。例如,可以输入C1、C2和V2来计算V1,具体如下:

制备25毫升25μM溶液需要多少体积的10 mM储备溶液?
使用方程式C1V1=C2V2,其中C1=10mM,C2=25μM,V2=25 ml,V1未知:
  • 在C1框中输入10,然后选择正确的单位(mM)
  • 在C2框中输入25,然后选择正确的单位(μM)
  • 在V2框中输入25,然后选择正确的单位(mL)
  • 单击“计算”按钮
  • 答案62.5μL(0.1 ml)出现在V1框中
g/mol

分子量计算器可计算化合物的分子量 (摩尔质量)和元素组成,具体如下:

注:化学分子式大小写敏感:C12H18N3O4  c12h18n3o4
计算化合物摩尔质量(分子量)的说明:
  • 要计算化合物的分子量 (摩尔质量),请输入化学/分子式,然后单击“计算”按钮。
分子质量、分子量、摩尔质量和摩尔量的定义:
  • 分子质量(或分子量)是一种物质的一个分子的质量,用统一的原子质量单位(u)表示。(1u等于碳-12中一个原子质量的1/12)
  • 摩尔质量(摩尔重量)是一摩尔物质的质量,以g/mol表示。
/

配液计算器可计算将特定质量的产品配成特定浓度所需的溶剂体积 (配液体积)

  • 输入试剂的质量、所需的配液浓度以及正确的单位
  • 单击“计算”按钮
  • 答案显示在体积框中
动物体内实验配方计算器(澄清溶液)
第一步:请输入基本实验信息(考虑到实验过程中的损耗,建议多配一只动物的药量)
第二步:请输入动物体内配方组成(配方适用于不溶/难溶于水的化合物),不同的产品和批次配方组成不同,如对配方有疑问,可先联系我们提供正确的体内实验配方。此外,请注意这只是一个配方计算器,而不是特定产品的确切配方。
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+
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计算结果:

工作液浓度 mg/mL;

DMSO母液配制方法 mg 药物溶于 μL DMSO溶液(母液浓度 mg/mL)。如该浓度超过该批次药物DMSO溶解度,请首先与我们联系。

体内配方配制方法μL DMSO母液,加入 μL PEG300,混匀澄清后加入μL Tween 80,混匀澄清后加入 μL ddH2O,混匀澄清。

(1) 请确保溶液澄清之后,再加入下一种溶剂 (助溶剂) 。可利用涡旋、超声或水浴加热等方法助溶;
            (2) 一定要按顺序加入溶剂 (助溶剂) 。

临床试验信息
Study to Evaluate the Effectiveness and Safety of Ozanimod Compared to Fingolimod in Children and Adolescents With Relapsing Remitting Multiple Sclerosis
CTID: NCT06408259
Phase: Phase 3    Status: Not yet recruiting
Date: 2024-11-29
Examining the Risk of Skin Cancer in Multiple Sclerosis Patients Using Fingolimod: a Population-Based Study
CTID: NCT06705608
Phase:    Status: Completed
Date: 2024-11-26
Fingolimod as a Treatment of Cerebral Edema After Intracerebral Hemorrhage
CTID: NCT04088630
PhaseEarly Phase 1    Status: Completed
Date: 2024-11-20
Study of Efficacy and Safety of Fingolimod (Gilenya) 0.5 mg in Chinese Patients With Relapsing Multiple Sclerosis (RMS) Patients
CTID: NCT04667949
Phase: Phase 4    Status: Active, not recruiting
Date: 2024-11-20
Safety and Efficacy Study of Fingolimod in Taiwanese Adults (≥ 20years) With Relapsing Remitting Multiple Sclerosis
CTID: NCT04480853
Phase: Phase 4    Status: Recruiting
Date: 2024-11-15
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Efficacy and Safety of Ofatumumab and Siponimod Compared to Fingolimod in Pediatric Patients With Multiple Sclerosis
CTID: NCT04926818
Phase: Phase 3    Status: Recruiting
Date: 2024-10-04


A Study To Evaluate Safety And Efficacy Of Ocrelizumab In Comparison With Fingolimod In Children And Adolescents With Relapsing-Remitting Multiple Sclerosis
CTID: NCT05123703
Phase: Phase 3    Status: Recruiting
Date: 2024-10-01
Safety and Effectiveness of Generic Fingolimod (Sphingomod®, Hikma) in Patients With Relapsing-Remitting Multiple Sclerosis in Egypt
CTID: NCT05423769
Phase:    Status: Completed
Date: 2024-08-23
Fingolimod for Type 2 Diabetes Mellitus
CTID: NCT05307731
Phase: Phase 4    Status: Recruiting
Date: 2024-07-30
Safety and Efficacy of Fingolimod in Pediatric Patients With Multiple Sclerosis
CTID: NCT01892722
Phase: Phase 3    Status: Recruiting
Date: 2024-07-10
The Gilenya Pregnancy Registry
CTID: NCT01285479
Phase:    Status: Recruiting
Date: 2024-03-15
Fingolimod in Minimal Invasive Treatment of Intracerebral Hemorrhage
CTID: NCT06087965
Phase: Phase 1/Phase 2    Status: Not yet recruiting
Date: 2023-10-18
A Study to Assess Pregnancy Outcomes in Women Exposed to Diroximel Fumarate
CTID: NCT05688436
Phase:    Status: Recruiting
Date: 2023-10-13
Fingolimod in Treating Patients With Chemotherapy-Induced Neuropathy
CTID: NCT03943498
PhaseEarly Phase 1    Status: Completed
Date: 2023-09-11
Fingolimod in Preventing Paclitaxel-Associated Neuropathy in Patients With Breast Cancer
CTID: NCT03941743
Phase: Phase 1    Status: Completed
Date: 2023-07-21
Combinating Fingolimod With Alteplase Bridging With Thrombectomy in Acute Ischemic Stroke
CTID: NCT04675762
Phase: Phase 2    Status: Recruiting
Date: 2023-04-18
Fingolimod for the Abrogation of Interstitial Fibrosis and Tubular Atrophy Following Kidney Transplantation
CTID: NCT05285878
Phase: Phase 2    Status: Enrolling by invitation
Date: 2023-01-26
Relationship Between Oral DMT Burden and Adherence in MS
CTID: NCT04676204
Phase:    Status: Enrolling by invitation
Date: 2022-08-31
Fingolimod in Endovascular Treatment of Ischemic Stroke
CTID: NCT04629872
Phase: Phase 2    Status: Unknown status
Date: 2022-04-13
Safety Study in Patients With Multiple Sclerosis Treated Fingolimod or Other Approved Disease-modifying Therapies
CTID: NCT01442194
Phase:    Status: Completed
Date: 2022-01-14
Oral Bio-equivalence Study
CTID: NCT05145621
Phase: Phase 1    Status: Completed
Date: 2021-12-21
Impact of Fingolimod Adherence on Outcomes
CTID: NCT05141669
Phase:    Status: Completed
Date: 2021-12-16
A Study of Immune Phenotype Biomarkers in Patients With Relapsing Multiple Sclerosis (RMS) After Treatment With 0.5mg Fingolimod
CTID: NCT03257358
Phase: Phase 4    Status: Completed
Date: 2021-10-07
Combinating Fingolimod With Alteplase Bridging With Mechanical Thrombectomy in Acute Ischemic Stroke
CTID: NCT02956200
Phase: Phase 2    Status: Withdrawn
Date: 2021-07-22
Long-term Safety and Tolerability of 0.5 mg Fingolimod in Patients With Relapsing Forms of Multiple Sclerosis
CTID: NCT01201356
Phase: Phase 3    Status: Completed
Date: 2021-04-21
Long-term, Open-label, Multicenter Study Assessing Long-term Cardiovascular Risks
CTID: NCT02232061
Phase: Phase 4    Status: Completed
Date: 2021-02-10
Revascularization Pretreated With Fingolimod in Acute Stroke
CTID: NCT04718064
Phase: N/A    Status: Unknown status
Date: 2021-01-22
Evaluation of Patient Retention of Fingolimod vs. Currently Approved Disease Modifying Therapy in Patients With Relapsing Remitting Multiple Sclerosis.
CTID: NCT01623596
Phase: Phase 4    Status: Completed
Date: 2021-01-05
Pharmacokinetics (PK) and Metabolism of FTY720 in Patients With Severe Renal Impairment and Healthy Matched Subjects.
CTID: NCT00731523
Phase: Phase 1    Status: Completed
Date: 2020-12-09
Fingolimod in COVID-19
CTID: NCT04280588
Phase: Phase 2    Status: Withdrawn
Date: 2020-11-13
A 3-year Multi-center Study to Describe Changes of OCT Parameters Under Treatment With Gilenya®
CTID: NCT01705236
Phase: Phase 4    Status: Completed
Date: 2020-03-02
Fingolimod Versus Dimethyl-fumarate in Multiple Sclerosis
CTID: NCT03345940
Phase: Phase 4    Status: Terminated
Date: 2019-10-31
Fingolimod Effect on Cytokine and Chemokine Levels
CTID: NCT02373098
Phase: Phase 4    Status: Completed
Date: 2019-09-30
MS Study Evaluating Safety and Efficacy of Two Doses of Fingolimod Versus Copaxone
CTID: NCT01633112
Phase: Phase 3    Status: Terminated
Date: 2019-05-28
Evaluating of the Effect of Fingolimod With Fish Oil on Relapsing-Remitting Multiple Sclerosis Patients
CTID: NCT02939079
Phase: Phase 2/Phase 3    Status: Completed
Date: 2019-05-14
Fingolimod in Schizophrenia Patients
CTID: NCT01779700
Phase: Phase 2    Status: Completed
Date: 2019-04-16
Effect of Fingolimod on Neurodegeneration
CTID: NCT02575365
Phase: Phase 4    Status: Terminated
Date: 2019-02-27
Follow up Study of Patients on Fingolimod Who Were Enrolled in the Original Biobank Study (CFTY720DDE01)
CTID: NCT02720107
Phase: Phase 4    Status: Completed
Date: 2019-02-08
Efficacy of Fingolimod in de Novo Patients Versus Fingolimod in Patients Previously Treated With a First Line Disease Modifying Therapy
CTID: NCT01498887
Phase: Phase 4    Status: Completed
Date: 2019-01-25
Bioequivalence Study of a Test Capsule Formulation of Fingolimod With the Reference Capsule Formulation of Fingolimod
CTID: NCT03757338
Phase: Phase 1    Status: Completed
Date: 2018-11-29
Efficacy and Safety of FTY720 for Acute Stroke
CTID: NCT02002390
Phase: Phase 2    Status: Completed
Date: 2018-10-17
Study to Assess Safety and Efficacy of Fingolimod in Children With Rett Syndrome
CTID: NCT02061137
Phase: Phase 1/Phase 2    Status: Completed
Date: 2018-06-15
Evaluate Efficacy and Safety of Fingolimod 0.5 mg Orally Once Daily Versus Placebo in Chronic Inflammatory Demyelinating Polyradiculoneuropathy Patients.
CTID: NCT01625182
Phase: Phase 3    Status: Completed
Date: 2017-10-30
Efficacy and Safety of Fingolimod in Patients With Relapsing-remitting Multiple Sclerosis With Optional Extension Phase
CTID: NCT00340834
Phase: Phase 3    Status: Completed
Date: 2017-09-21
A Safety Study of Fingolimod With Radiation and Temozolomide in Newly Diagnosed High Grade Glioma
CTID: NCT02490930
PhaseEarly Phase 1    Status: Completed
Date: 2017-09-13
Impact of Natalizumab Versus Fingolimod in Relapsing-Remitting Multiple Sclerosis (RRMS) Participants
CTID: NCT02342704
Phase: Phase 4    Status: Terminated
Date: 2017-06-09
Safety and Efficacy of Fingolimod in MS Patients in China
CTID: NCT01941004
Phase: Phase 3    Status: Withdrawn
Date: 2017-04-21
ENGYNE Exploring Gilenya in Patients With Neutralizing Antibodies Against Interferon
CTID: NCT01621269
Phase: Phase 4    Status: Withdrawn
Date: 2017-04-20
Fingolimod Versus Interferon Beta 1b in Cognitive Symptoms
CTID: NCT01333501
Phase: Phase 4    Status: Completed
Date: 2017-03-21
Fingolimod -Response According to Coping - Evaluation
CTID: NCT01420055
Phase: Phase 4    Status: Completed
Date: 2016-11-18
Biomarker Study After Initiation of Treatment With Fingolimod (FTY720) in Patients With Relapsing-remitting Multiple Sclerosis
CTID: NCT01310166
Phase: Phase 4    Status: Completed
Date: 2016-11-18
Long-term Effect of Fingolimod on Circulating Immunocompetent Mononuclear Cells in Patients With Multiple Sclerosis
CTID: NCT01755871
Phase: Phase 4    Status: Terminated
Date: 2016-06-09
A 12 -Month, Open-label, Multi-center Study to Explore the Health Outcomes of FTY720
CTID: NCT01578330
Phase: Phase 4    Status: Completed
Date: 2016-06-07
Patients With Relapse Remitting Multiple Sclerosis (RRMS): Candidates for MS Therapy Change
CTID: NCT01317004
Phase: Phase 4    Status: Completed
Date: 2015-06-22
Fingolimod (FTY720) in Acute Demyelinating Optic Neuritis (ADON)
CTID: NCT01757691
Phase: Phase 2    Status: Terminated
Date: 2015-05-04
Safety and Tolerability of Fingolimod in Patients With Relapsing-remitting Multiple Sclerosis
CTID: NCT01497262
Phase: Phase 3    Status: Completed
Date: 2015-03-19
A Phase 1 Study to Explore the Cardiac Pharmacodynamics of MT-1303
CTID: NCT02193217
Phase: Phase 1    Status: Completed
Date: 2015-02-20
Study to Assess Immune Function and MRI Disease Activity in RRMS Patients When Switching From Natalizumab to Gilenya
CTID: NCT02325440
Phase: Phase 4    Status: Unknown status
Date: 2014-12-25
Combination of Antidepressants and Fingolimod Relapsing-remitting Multiple Sclerosis (RRMS) Patients With Depression
CTID: NCT01436643
Phase: Phase 4    Status: Terminated
Date: 2014-09-25
Disease Control and Safety in Patients With Relapsing Remitting Multiple Sclerosis (RRMS) Switching From Natalizumab to Fingolimod
CTID: NCT01499667
Phase: Phase 3    Status: Terminated
Date: 2014-08-08
Evaluation of Patient Reported Outcomes in RRMS Patients Candidates for MS Therapy Change and Transitioned to Fingolimod 0.5 mg (EPOC)
CTID: NCT01534182
Phase: Phase 4    Status: Completed
Date: 2014-08-08
-----------------
COMBAT-MS (COMparison Between All immunoTherapies for Multiple Sclerosis)
CTID: null
Phase: Phase 4    Status: Completed
Date: 2017-05-22
Evaluation of clinical response in relation to the immunological status change in RRMS patients treated with Gilenya (fingolimod) for 12 months.
CTID: null
Phase: Phase 4    Status: Prematurely Ended
Date: 2016-09-23
Effects of fingolimod on functional brain adaptation and clinical measures in multiple sclerosis
CTID: null
Phase: Phase 4    Status: Ongoing
Date: 2014-12-17
A Multicenter, Randomized, Open-Label Study to Assess the Impact of Natalizumab versus Fingolimod on Central Nervous System Tissue Damage and Recovery in Active Relapsing-Remitting Multiple Sclerosis Subjects
CTID: null
Phase: Phase 4    Status: Prematurely Ended, Completed
Date: 2014-11-10
Long-term, open-label, multicenter study assessing long-term cardiovascular risks in patients treated with fingolimod
CTID: null
Phase: Phase 4    Status: Completed
Date: 2014-07-30
Long-term follow-up at 10-years of patients enrolled in the fingolimod Phase II program in relapsing multiple sclerosis
CTID: null
Phase: Phase 4    Status: Completed
Date: 2014-04-09
A 32-week, monocentric, exploratory, single arm study to assess immune function and MRI disease activity in patients with relapsing remitting multiple sclerosis (RRMS) transferred from previous treatment with Natalizumab to Gilenya® (Fingolimod)
CTID: null
Phase: Phase 4    Status: Completed
Date: 2014-03-13
Does targeting of S1P receptors reduce microglial activation in multiple sclerosis?
CTID: null
Phase: Phase 4    Status: Completed
Date: 2013-12-20
Hematopoietic Stem Cell Therapy for Patients with Inflammatory Multiple Sclerosis Failing Alternate Approved Therapy: A Randomized Study
CTID: null
Phase: Phase 2    Status: Completed
Date: 2013-11-04
Essai de phase IV, multicentrique, ouvert, visant à tester la différence d’efficacité du Natalizumab, versus le fingolimod, 2 médicaments ayant une AMM pour le traitement de la sclérose en plaques
CTID: null
Phase: Phase 4    Status: Completed
Date: 2013-09-12
A multicenter, randomized, active-controlled study to assess the safety, tolerability, and efficacy of FTY720 in patients with acute, noninfectious intermediate, posterior and pan uveitis
CTID: null
Phase: Phase 2    Status: Completed, Prematurely Ended
Date: 2013-05-08
An open-label, single arm study to provide access to fingolimod to MS patients who completed fingolimod phase IIIb studies and who benefited from treatment with fingolimod or do not have suitable alternative treatment options, but do not have access to the reimbursed drug
CTID: null
Phase: Phase 3    Status: Prematurely Ended
Date: 2013-04-15
A two-year, double-blind, randomized, multicenter, active controlled study to evaluate the safety and efficacy of fingolimod administered orally once daily versus interferon β-1a i.m. once weekly in pediatric patients with multiple sclerosis with five-year fingolimod Extension Phase
CTID: null
Phase: Phase 3    Status: Ongoing, Trial now transitioned, GB - no longer in EU/EEA, Prematurely Ended, Completed
Date: 2013-04-02
Monitoring natural killer cells in multiple sclerosis patients treated with fingolimod: a monocentric, prospective, one year, baseline-to-treatment, open-label, single group pilot trial
CTID: null
Phase: Phase 4    Status: Completed
Date: 2013-02-13
A 48-week, double-blind, randomized, multi-center, parallelgroup study comparing structural changes in the retina and evolution of visual function after immediate versus delayed treatment with fingolimod in patients with acute demyelinating optic neuritis
CTID: null
Phase: Phase 2    Status: Completed, Prematurely Ended
Date: 2013-01-29
Open-label, single-arm extension study to the double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing the efficacy and safety of 0.5 mg FTY720 administered orally once daily versus placebo in patients with primary progressive multiple sclerosis
CTID: null
Phase: Phase 3    Status: Completed, Prematurely Ended
Date: 2012-11-07
Modification of the visual outcome after optic neuritis in CIS or MS by Gilenya®
CTID: null
Phase: Phase 3    Status: Prematurely Ended
Date: 2012-10-26
A 6 months, randomized, multicenter, parallel-group, open-label study to evaluate the effect of an individualized patient support program on treatment satisfaction in Fingolimod (FTY720)-treated patients with relapsing-remitting multiple sclerosis
CTID: null
Phase: Phase 4    Status: Completed
Date: 2012-10-15
Effect of fingolimod on cardiac autonomic regulation in MS-patients
CTID: null
Phase: Phase 4    Status: Completed
Date: 2012-10-12
A double-blind, randomized, multicenter, placebo-controlled, parallel-group study to evaluate the efficacy and safety of 0.5 mg fingolimod administered orally once daily versus placebo in patients with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP)
CTID: null
Phase: Phase 2, Phase 3    Status: Prematurely Ended, Completed
Date: 2012-10-08
A 3-year, multi-center study to evaluate optical coherence tomography as an outcome measure in patients with multiple sclerosis
CTID: null
Phase: Phase 3    Status: Completed
Date: 2012-09-19
A 3-year, multi-center study to describe the long term changes of optical coherence tomography (OCT) parameters in patients under treatment with Gilenya®
CTID: null
Phase: Phase 4    Status: Completed
Date: 2012-08-01
A 1-week, open-label, multi-center study to explore conduction abnormalities during first dose administration of fingolimod in patients with relapsing-remitting multiple sclerosis (START)
CTID: null
Phase: Phase 4    Status: Completed
Date: 2012-06-27
A 6-month, multicenter, randomized, controlled parallel group study to evaluate the effect of physical training on fatigue in patients with relapsing-remitting multiple sclerosis treated with fingolimod (Gilenya®), followed by a 6 month optional extension phase
CTID: null
Phase: Phase 4    Status: Completed
Date: 2011-11-08
A multi-centre, open-label, non-randomised, parallel group clinical trial to assess the efficacy of fingolimod in naïve patients versus fingolimod in patients previously treated with interferons or glatiramer acetate, based on the presence of relapses in patients with relapsing-remitting multiple sclerosis.
CTID: null
Phase: Phase 3    Status: Completed
Date: 2011-10-26
A 32-week, patient- and rater-blinded, randomized, multi-center, parallel-group study to evaluate disease control and safety in patients with relapsing remitting multiple sclerosis transferred from previous treatment with natalizumab to fingolimod (FTY720)
CTID: null
Phase: Phase 3    Status: Completed, Prematurely Ended
Date: 2011-08-26
« GRACE : Gilenya® - Réponse Au Coping - Evaluation » Etude multicentrique de phase IV, prospective, en ouvert, d'une durée de 4 mois, visant à comparer la réponse à l’initiation du fingolimod (Gilenya®) selon le profil de « coping » chez des patients adultes présentant une sclérose en plaques rémittente-récurrente très active en France.
CTID: null
Phase: Phase 4    Status: Completed
Date: 2011-06-14
“An open-label, multi-center, expanded access study with fingolimod in patients with relapsing-remitting multiple sclerosis for whom no suitable therapy exists”
CTID: null
Phase: Phase 3    Status: Completed
Date: 2011-04-12
A 6-month, Randomized, Active Comparator, Open-label, Multi-Center Study to Evaluate Patient OutComes, Safety and Tolerability of Fingolimod (FTY720) 0.5 mg/day in Patients with Relapsing Remitting Multiple Sclerosis who are candidates for MS therapy change from Previous Disease Modifying Therapy
CTID: null
Phase: Phase 3    Status: Completed
Date: 2011-03-15
A 18-month, open-label, rater-blinded, randomized, multi-center, active-controlled, parallel-group pilot study to assess efficacy and safety of fingolimod (Gilenya) in comparison to interferon beta-1b in treating the cognitive symptoms associated to relapsing-remitting multiple sclerosis and to assess possible relationship of these effects to regional brain atrophy.
CTID: null
Phase: Phase 3    Status: Completed
Date: 2010-12-28
A single arm, open-label, multicenter study evaluating the long-term safety and tolerability of 0.5 mg fingolimod (FTY720) administered orally once daily in patients with relapsing forms of multiple sclerosis.
CTID: null
Phase: Phase 3    Status: Completed
Date: 2010-08-06
A 3-month blinded, randomized, multicenter, placebo controlled study to evaluate the effect of treatment with fingolimod on the immune response following seasonal influenza vaccination and tetanus toxoid booster injection in patients with relapsing forms of multiple sclerosis.
CTID: null
Phase: Phase 2    Status: Completed
Date: 2010-07-07
A double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing the efficacy and safety of 0.5 mg fingolimod administered orally once daily versus placebo in patients with primary progressive multiple sclerosis.
CTID: null
Phase: Phase 3    Status: Completed
Date: 2009-02-04
A 24-month double-blind, randomized, multicenter, placebocontrolled, parallel-group study comparing the efficacy and safety of 0.5 mg and 1.25 mg fingolimod (FTY720) administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis.
CTID: null
Phase: Phase 3    Status: Completed
Date: 2008-09-10
A double-blind, randomized, placebo-controlled, parallel, time-lagged, ascending, multi-centre, multiple-dose study to measure the magnitude and time course of the effect of FTY720 on FEV1 and other pulmonary function tests (FVC, FEF25-75%, and FEV1/FVC) in patients with moderate asthma.
CTID: null
Phase: Phase 2    Status: Completed
Date: 2008-05-01
A 12-month double-blind, randomized, multicenter, active controlled, parallel-group study comparing the efficacy and safety of 0.5 mg and 1.25 mg fingolimod (FTY720) administered orally once daily versus interferon β-1a (Avonex®) administered i.m. once weekly in patients with relapsing-remitting multiple sclerosis with optional Extension Phase
CTID: null
Phase: Phase 3    Status: Completed
Date: 2006-10-19
A 24-month, double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing efficacy and safety of FTY720 1.25 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis
CTID: null
Phase: Phase 3    Status: Completed
Date: 2005-12-19

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