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Inclisiran (ALN-PCSsc)

别名: 因利司然
目录号: V73397 纯度: ≥98%
COA 产品数据 产品说明书 SDS
Inclisiran (ALN-PCSsc) 是一种双链小干扰 RNA (siRNA) 分子，可以抑制 PCSK-9 转录。
Inclisiran (ALN-PCSsc) CAS号: 1639324-58-5
产品类别: Ser Thr Protease
产品仅用于科学研究，不针对患者销售
规格 价格 库存 数量
1mg
Other Sizes
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产品描述
Inclisiran (ALN-PCSsc) 是一种双链小干扰 RNA (siRNA) 分子，可以抑制 PCSK-9 转录。 Inclisiran 可用于高脂血症和心血管疾病 (CVD) 的研究。
生物活性&实验参考方法
体外研究 (In Vitro)
Inclisiran 是一种双链小 RNA 分子。它通过阻止前蛋白转化酶枯草杆菌蛋白酶 9 (PCSK-9) 的转录发挥作用。这减少了肝细胞中 PCSK-9 的量，进而增加了肝细胞膜中低密度脂蛋白 (LDL) 受体的表达。最终，这会降低循环中的低密度脂蛋白胆固醇 (LDL-C) 水平。
毒性/毒理 (Toxicokinetics/TK)
妊娠期和哺乳期影响
◉ 哺乳期用药概述
目前尚无关于哺乳期使用inclisiran的临床信息。由于inclisiran是一种大分子寡核苷酸，其在乳汁中的含量可能非常低，婴儿的吸收量也可能极少。如果母亲需要使用inclisiran，则不应停止哺乳。在获得更多数据之前，哺乳期应谨慎使用inclisiran，尤其是在哺乳新生儿或早产儿时。
◉ 对母乳喂养婴儿的影响
截至修订日期，未找到相关的已发表信息。
◉ 对泌乳和母乳的影响
截至修订日期，未找到相关的已发表信息。
参考文献

[1]. Inclisiran for the Treatment of Cardiovascular Disease: A Short Review on the Emerging Data and Therapeutic Potential. Ther Clin Risk Manag. 2020 Oct 28;16:1031-1037.
其他信息
Cemdisiran 目前正在临床试验 NCT03841448（一项 Cemdisiran 治疗成人免疫球蛋白 A 肾病 (Igan) 的研究）中进行研究。
Cemdisiran 是一种专有制剂，由靶向补体途径末端补体成分 5 (C5) 的小干扰 RNA (siRNA) 与 N-乙酰半乳糖胺 (GalNAc) 配体偶联而成，具有治疗补体介导疾病（例如阵发性睡眠性血红蛋白尿症 (PNH)）的潜在用途。皮下注射 Cemdisiran 后，GalNAc 配体部分特异性地与肝细胞上表达的去唾液酸糖蛋白受体 (ASGPR) 结合并被其摄取。在细胞内，siRNA 与 C5 mRNA 结合，从而抑制 C5 蛋白的翻译和表达。这可以降低血浆C5水平，防止C5裂解成促炎成分，并阻断补体介导的溶血。C5是一种补体途径蛋白，在肝脏中高表达。
另见：Inclisiran（注释已移至）。
药物适应症
Leqvio适用于患有原发性高胆固醇血症（杂合子家族性和非家族性）或混合型血脂异常的成人患者，作为饮食的辅助治疗：与他汀类药物联合使用，或他汀类药物与其他降脂疗法联合使用，用于无法通过最大耐受剂量他汀类药物达到LDL-C目标的患者；单独口服或与其他降脂疗法联合使用，用于他汀类药物不耐受或他汀类药物禁忌的患者。
*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
C78H140N11O34P
分子量
1806.97328567505
精确质量
1805.93
CAS号
1639324-58-5
PubChem CID
126480325
外观&性状
White to off-white solid powder
LogP
-8
tPSA
663
氢键供体(HBD)数目
22
氢键受体(HBA)数目
34
可旋转键数目(RBC)
66
重原子数目
124
分子复杂度/Complexity
2950
定义原子立体中心数目
17
SMILES
P(=O)(O)(O)OC[C@@H]1C[C@H](CN1C(CCCCCCCCCCC(NC(COCCC(NCCCNC(CCCCO[C@H]1[C@@H]([C@H]([C@H]([C@@H](CO)O1)O)O)NC(C)=O)=O)=O)(COCCC(NCCCNC(CCCCO[C@H]1[C@@H]([C@H]([C@H]([C@@H](CO)O1)O)O)NC(C)=O)=O)=O)COCCC(NCCCNC(CCCCO[C@H]1[C@@H]([C@H]([C@H]([C@@H](CO)O1)O)O)NC(C)=O)=O)=O)=O)=O)O
InChi Key
LQRNAUZEMLGYOX-LZVIIAQDSA-N
InChi Code
InChI=1S/C78H140N11O34P/c1-50(93)85-66-72(108)69(105)55(43-90)121-75(66)117-35-15-12-21-58(97)79-29-18-32-82-61(100)26-38-114-47-78(88-64(103)24-10-8-6-4-5-7-9-11-25-65(104)89-42-54(96)41-53(89)46-120-124(111,112)113,48-115-39-27-62(101)83-33-19-30-80-59(98)22-13-16-36-118-76-67(86-51(2)94)73(109)70(106)56(44-91)122-76)49-116-40-28-63(102)84-34-20-31-81-60(99)23-14-17-37-119-77-68(87-52(3)95)74(110)71(107)57(45-92)123-77/h53-57,66-77,90-92,96,105-110H,4-49H2,1-3H3,(H,79,97)(H,80,98)(H,81,99)(H,82,100)(H,83,101)(H,84,102)(H,85,93)(H,86,94)(H,87,95)(H,88,103)(H2,111,112,113)/t53-,54+,55+,56+,57+,66+,67+,68+,69-,70-,71-,72+,73+,74+,75+,76+,77+/m0/s1
化学名
[(2S,4R)-1-[12-[[1,3-bis[3-[3-[5-[(2R,3R,4R,5R,6R)-3-acetamido-4,5-dihydroxy-6-(hydroxymethyl)oxan-2-yl]oxypentanoylamino]propylamino]-3-oxopropoxy]-2-[[3-[3-[5-[(2R,3R,4R,5R,6R)-3-acetamido-4,5-dihydroxy-6-(hydroxymethyl)oxan-2-yl]oxypentanoylamino]propylamino]-3-oxopropoxy]methyl]propan-2-yl]amino]-12-oxododecanoyl]-4-hydroxypyrrolidin-2-yl]methyl dihydrogen phosphate
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

注意： 请将本产品存放在密封且受保护的环境中（例如氮气保护），避免吸湿/受潮。
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)
H2O: 5 mg/mL (0.31 mM)
溶解度 (体内实验)
注意: 如下所列的是一些常用的体内动物实验溶解配方，主要用于溶解难溶或不溶于水的产品（水溶度<1 mg/mL）。 建议您先取少量样品进行尝试，如该配方可行，再根据实验需求增加样品量。
注射用配方
(IP/IV/IM/SC等)
注射用配方1: DMSO : Tween 80： Saline = 10 : 5 : 85 (如： 100 μL DMSO → 50 μL Tween 80 → 850 μL Saline)
*生理盐水/Saline的制备：将0.9g氯化钠/NaCl溶解在100 mL ddH ₂ O中，得到澄清溶液。
注射用配方 2: DMSO : PEG300 ：Tween 80 : Saline = 10 : 40 : 5 : 45 (如： 100 μL DMSO → 400 μL PEG300 → 50 μL Tween 80 → 450 μL Saline)
注射用配方 3: DMSO : Corn oil = 10 : 90 (如： 100 μL DMSO → 900 μL Corn oil)
示例: 以注射用配方 3 (DMSO : Corn oil = 10 : 90) 为例说明, 如果要配制 1 mL 2.5 mg/mL的工作液, 您可以取 100 μL 25 mg/mL 澄清的 DMSO 储备液，加到 900 μL Corn oil/玉米油中, 混合均匀。
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注射用配方 4: DMSO : 20% SBE-β-CD in Saline = 10 : 90 [如：100 μL DMSO → 900 μL (20% SBE-β-CD in Saline)]
*20% SBE-β-CD in Saline的制备（4°C，储存1周）：将2g SBE-β-CD (磺丁基-β-环糊精) 溶解于10mL生理盐水中，得到澄清溶液。
注射用配方 5: 2-Hydroxypropyl-β-cyclodextrin : Saline = 50 : 50 (如： 500 μL 2-Hydroxypropyl-β-cyclodextrin (羟丙基环胡精)→ 500 μL Saline)
注射用配方 6: DMSO : PEG300 : Castor oil : Saline = 5 : 10 : 20 : 65 (如： 50 μL DMSO → 100 μL PEG300 → 200 μL Castor oil → 650 μL Saline)
注射用配方 7: Ethanol : Cremophor : Saline = 10： 10 : 80 (如： 100 μL Ethanol → 100 μL Cremophor → 800 μL Saline)
注射用配方 8: 溶解于Cremophor/Ethanol (50 : 50), 然后用生理盐水稀释。
注射用配方 9: EtOH : Corn oil = 10 : 90 (如： 100 μL EtOH → 900 μL Corn oil)
注射用配方 10: EtOH : PEG300：Tween 80 : Saline = 10 : 40 : 5 : 45 (如： 100 μL EtOH → 400 μL PEG300 → 50 μL Tween 80 → 450 μL Saline)

口服配方
口服配方 1: 悬浮于0.5% CMC Na (羧甲基纤维素钠)
口服配方 2: 悬浮于0.5% Carboxymethyl cellulose (羧甲基纤维素)
示例: 以口服配方 1 (悬浮于 0.5% CMC Na)为例说明, 如果要配制 100 mL 2.5 mg/mL 的工作液, 您可以先取0.5g CMC Na并将其溶解于100mL ddH2O中，得到0.5%CMC-Na澄清溶液；然后将250 mg待测化合物加到100 mL前述 0.5%CMC Na溶液中，得到悬浮液。
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口服配方 3: 溶解于 PEG400 (聚乙二醇400)
口服配方 4: 悬浮于0.2% Carboxymethyl cellulose (羧甲基纤维素)
口服配方 5: 溶解于0.25% Tween 80 and 0.5% Carboxymethyl cellulose (羧甲基纤维素)
口服配方 6: 做成粉末与食物混合

注意: 以上为较为常见方法，仅供参考， InvivoChem并未独立验证这些配方的准确性。具体溶剂的选择首先应参照文献已报道溶解方法、配方或剂型，对于某些尚未有文献报道溶解方法的化合物，需通过前期实验来确定（建议先取少量样品进行尝试），包括产品的溶解情况、梯度设置、动物的耐受性等。
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 0.5534 mL 2.7671 mL 5.5341 mL
5 mM 0.1107 mL 0.5534 mL 1.1068 mL
10 mM 0.0553 mL 0.2767 mL 0.5534 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
计算 重置

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。
计算 重置

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
计算 重置

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。
/
计算 重置

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。
+
+
+
计算 重置

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：取 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
A Study Investigating Subcutaneously Administered Pozelimab in Combination With Cemdisiran or Cemdisiran Alone in Adult Participants With Geographic Atrophy
CTID: NCT06541704
Phase: Phase 3    Status: Recruiting
Date: 2024-11-25
Management of LDL-cholesterol With Inclisiran + Usual Care Compared to Usual Care Alone in Participants With a Recent Acute Coronary Syndrome
CTID: NCT04873934
Phase: Phase 3    Status: Completed
Date: 2024-11-25
A Study to Test How Safe Pozelimab and Cemdisiran Combination Therapy and Cemdisiran Alone Are and How Well They Work in Adult Patients With Generalized Myasthenia Gravis
CTID: NCT05070858
Phase: Phase 3    Status: Recruiting
Date: 2024-11-22
Study to Evaluate Safety, Tolerability and Efficacy of Inclisiran in Children With Homozygous Familial Hypercholesterolemia
CTID: NCT06597006
Phase: Phase 3    Status: Not yet recruiting
Date: 2024-11-22
A Study in Adult Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) to Evaluate How Safe Long-term Treatment With Pozelimab + Cemdisiran Combination Therapy is and How Well it Works.
CTID: NCT05744921
Phase: Phase 3    Status: Recruiting
Date: 2024-11-22
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VictORION-INCLUSION: Evaluating Inclisiran for Cholesterol Managment in Heart Disease
CTID: NCT06249165
Phase: Phase 4    Status: Recruiting
Date: 2024-11-21

A Study to Evaluate How Safe Pozelimab + Cemdisiran Combination Therapy is and How Well it Works in Adult Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) Who Have Not Recently Received or Have Not Received Complement Inhibitor Treatment
CTID: NCT05133531
Phase: Phase 3    Status: Recruiting
Date: 2024-10-29
Trial to Evaluate Efficacy and Safety of LIB003 and Inclisiran in High-risk CVD Patients
CTID: NCT05004675
Phase: Phase 3    Status: Completed
Date: 2024-10-23
Study to Evaluate Efficacy and Safety of Inclisiran in Children With Heterozygous Familial Hypercholesterolemia
CTID: NCT06597019
Phase: Phase 3    Status: Not yet recruiting
Date: 2024-10-18
Study in Primary Care Evaluating Inclisiran Delivery Implementation + Enhanced Support
CTID: NCT04807400
Phase: Phase 3    Status: Completed
Date: 2024-10-09
Efficacy and Safety of Inclisiran as Monotherapy in Patients With Primary Hypercholesterolemia Not Receiving Lipid-lowering Therapy.
CTID: NCT05763875
Phase: Phase 3    Status: Completed
Date: 2024-10-01
Long-term Safety and Tolerability of Inclisiran in Participants With HeFH or HoFH Who Have Completed the Adolescent ORION-16 or ORION-13 Studies
CTID: NCT05682378
Phase: Phase 3    Status: Recruiting
Date: 2024-10-01
A Clinical Study to Evaluate the Safety and Effectiveness of Inclisiran Sodium in Indian Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia
CTID: NCT06386419
Phase: Phase 4    Status: Not yet recruiting
Date: 2024-09-27
Intravascular Imaging Study of the Effect of Inclisiran on Plaque in Patients With Acute Myocardial Infarction
CTID: NCT06372925
Phase: Phase 4    Status: Recruiting
Date: 2024-09-27
Study to Evaluate Efficacy and Safety of Inclisiran in Adolescents With Heterozygous Familial Hypercholesterolemia
CTID: NCT04652726
Phase: Phase 3    Status: Active, not recruiting
Date: 2024-09-25
Study to Evaluate Efficacy and Safety of Inclisiran in Adolescents With Homozygous Familial Hypercholesterolemia
CTID: NCT04659863
Phase: Phase 3    Status: Active, not recruiting
Date: 2024-09-25
Efficacy and Safety of Inclisiran as Monotherapy in Chinese Adults With Low or Moderate ASCVD Risk and Elevated Low-density Lipoprotein Cholesterol.
CTID: NCT05888103
Phase: Phase 3    Status: Active, not recruiting
Date: 2024-09-24
Effect of Small Interfering RNA Inclisiran on Carotid Plaques As Assessed by Carotid Ultrasound
CTID: NCT06586684
Phase: Phase 4    Status: Not yet recruiting
Date: 2024-09-19
Efficacy and Safety of the Combination of Pozelimab and Cemdisiran Versus Continued Eculizumab or Ravulizumab Treatment in Adult Patients With Paroxysmal Nocturnal Hemoglobinuria
CTID: NCT05131204
Phase: Phase 3    Status: Terminated
Date: 2024-09-19
A Randomized Study to Evaluate the Effect of an 'Inclisiran First' Implementation Strategy Compared to Usual Care in Patients With Atherosclerotic Cardiovascular Disease and Elevated LDL-C Despite Receiving Maximally Tolerated Statin Therapy (VICTORION-INITIATE)
CTID: NCT04929249
Phase: Phase 3    Status: Completed
Date: 2024-09-19
A Study of Cemdisiran in Adults With Immunoglobulin A Nephropathy (IgAN)
CTID: NCT03841448
Phase: Phase 2    Status: Terminated
Date: 2024-08-09
PET Imaging of Inflammation and Lipid Lowering Study
CTID: NCT04073797
Phase: N/A    Status: Recruiting
Date: 2024-07-19
The Prevent Coronary Artery Disease Trial
CTID: NCT06494501
Phase: Phase 3    Status: Recruiting
Date: 2024-07-10
Continuity of Care Between Primary Care Cardiology and Specialty Services for Patients With Chronic Ischemic Heart Disease
CTID: NCT06421363
Phase: Phase 4    Status: Not yet recruiting
Date: 2024-05-20
Multicenter Study on the Evaluation of Adherence, Persistence and Efficacy of Treatment With Inclisiran in Italy
CTID: NCT06287177
Phase:    Status: Recruiting
Date: 2024-03-19
Pozelimab and Cemdisiran Combination Treatment in Adult Participants With Paroxysmal Nocturnal Hemoglobinuria Who Have Received Pozelimab Monotherapy
CTID: NCT04811716
Phase: Phase 2    Status: Completed
Date: 2023-11-27
Impact of Optimal Pharmacotherapy on Lipid Profile and Qualitative Features of Atherosclerotic Plaques
CTID: NCT05639218
Phase:    Status: Active, not recruiting
Date: 2023-11-22
A Randomized Trial Assessing the Effects of Inclisiran on Clinical Outcomes Among People With Cardiovascular Disease
CTID: NCT03705234
Phase: Phase 3    Status: Active, not recruiting
Date: 2023-11-02
Compassionate Use of Pozelimab and Cemdisiran Combination Therapy in Patients With Paroxysmal Nocturnal Hemoglobinuria
CTID: NCT06028594
Phase S
A RANDOMIZED, OPEN-LABEL ECULIZUMAB AND RAVULIZUMAB CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF POZELIMAB AND CEMDISIRAN COMBINATION THERAPY IN PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA WHO ARE CURRENTLY TREATED WITH ECULIZUMAB OR RAVULIZUMAB
CTID: null
Phase: Phase 3    Status: Completed, Prematurely Ended
Date: 2022-05-02
Randomized, Open Label, Phase 3 Study to Evaluate the Efficacy and Safety of Lerodalcibep (LIB003) compared to Inclisiran in Patients With Cardiovascular Disease, or at High Risk for Cardiovascular Disease, on Stable Lipid-Lowering Therapy Requiring Additional Low-Density Lipoprotein Cholesterol Reduction (LIBerate-VI)
CTID: null
Phase: Phase 3    Status: Ongoing, Completed
Date: 2022-04-21
A RANDOMIZED, OPEN-LABEL, RAVULIZUMAB-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF POZELIMAB AND CEMDISIRAN COMBINATION THERAPY IN PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA WHO ARE COMPLEMENT INHIBITOR TREATMENT-NAIVE OR HAVE NOT RECENTLY RECEIVED COMPLEMENT INHIBITOR THERAPY
CTID: null
Phase: Phase 3    Status: Ongoing
Date: 2022-04-04
Efficacy, safety, tolerability and quality of life of ongoing individually optimized lipid-lowering therapy with or without inclisiran (KJX839) – a randomized, placebo-controlled, double-blind multicenter phase IV study in participants with hypercholesterolemia
CTID: null
Phase: Phase 4    Status: Trial now transitioned, Ongoing
Date: 2022-02-14
POESIA Study: Pleiotropic effects of PCSK 9 inhibition and bempedoic acid - Changes in Platelet Function and Inflammation Markers
CTID: null
Phase: Phase 3    Status: Ongoing
Date: 2022-01-20
A randomized, double-blind, placebo -controlled, multicenter trial, assessing the impact of inclisiran on major adverse cardiovascular events in participants with established cardiovascular disease (VICTORION-2 PREVENT)
CTID: null
Phase: Phase 3    Status: Trial now transitioned, Ongoing
Date: 2021-11-15
A Randomized, Open-label, Two-arm Study to Evaluate the Safety, Efficacy, and Pharmacodynamic Effects of Pozelimab and Cemdisiran Combination Treatment in Patients with Paroxysmal Nocturnal Hemoglobinuria Who Have Received Pozelimab Monotherapy
CTID: null
Phase: Phase 2    Status: Completed
Date: 2021-05-07
Two part (double-blind) inclisiran versus placebo [Year 1] followed by open-label inclisiran [Year 2] randomized multicentre study to evaluate safety, tolerability, and efficacy of inclisiran in adolescents (12 to less than 18 years) with homozygous familial hypercholesterolemia and elevated LDL-cholesterol (ORION-13)
CTID: null
Phase: Phase 3    Status: Ongoing, Completed
Date: 2020-12-30
Two part (double-blind inclisiran versus placebo [Year 1] followed by open-label inclisiran [Year 2]) randomized multicenter study to evaluate safety, tolerability, and efficacy of inclisiran in adolescents (12 to less than 18 years) with heterozygous familial hypercholesterolemia and elevated LDL-cholesterol (ORION-16)
CTID: null
Phase: Phase 3    Status: Ongoing, Completed
Date: 2020-12-21
The relationship of cholesterol-lowering drugs with steroid HORMONEs, bile acids, vitamin D, the immune system and related diseases such as depression and osteoporosis
CTID: null
Phase: Phase 4    Status: Ongoing
Date: 2020-07-09
A PHASE II, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL TO EVALUATE THE SAFETY AND EFFICACY OF CEMDISIRAN (ALN-CC5) FOLLOWING WITHDRAWAL OF CHRONIC ECULIZUMAB THERAPY
CTID: null
Phase: Phase 2    Status: Prematurely Ended
Date: 2019-11-28
A Phase 2, Randomized, Double-blind, Placebo-controlled Study of Cemdisiran in Adult Patients with IgA Nephropathy
CTID: null
Phase: Phase 2    Status: GB - no longer in EU/EEA, Prematurely Ended
Date: 2019-06-11
A long term extension trial of the Phase III lipid-lowering trials to assess the effect of long term dosing of inclisiran given as subcutaneous injections in subjects with high cardiovascular risk and elevated LDL-C (ORION-8)
CTID: null
Phase: Phase 3    Status: GB - no longer in EU/EEA, Completed
Date: 2019-02-05
HPS-4/TIMI 65/ORION-4: A double-blind randomized placebo-controlled trial assessing the effects of inclisiran on clinical outcomes among people with atherosclerotic cardiovascular disease
CTID: null
Phase: Phase 3    Status: GB - no longer in EU/EEA
Date: 2018-06-11
A PLACEBO-CONTROLLED, DOUBLE-BLIND, RANDOMIZED TRIAL TO EVALUATE THE EFFECT OF 300 MG OF INCLISIRAN SODIUM GIVEN AS SUBCUTANEOUS INJECTIONS IN SUBJECTS WITH HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA (HeFH) AND ELEVATED LOW-DENSITY LIPOPROTEIN CHOLESTEROL (LDL-C)
CTID: null
Phase: Phase 3    Status: Completed
Date: 2018-01-04
A PLACEBO-CONTROLLED, DOUBLE-BLIND, RANDOMIZED TRIAL TO EVALUATE THE EFFECT OF 300 MG OF INCLISIRAN SODIUM GIVEN AS SUBCUTANEOUS INJECTIONS IN SUBJECTS WITH ATHEROSCLEROTIC CARDIOVASCULAR DISEASE (ASCVD) OR ASCVD-RISK EQUIVALENTS AND ELEVATED LOW-DENSITY LIPOPROTEIN CHOLESTEROL (LDL-C)
CTID: null
Phase: Phase 3    Status: Completed
Date: 2017-12-12
A Phase 2, Open Label, Multicenter Study of ALN-CC5 Administered Subcutaneously in Adult Patients with Atypical Hemolytic Uremic Syndrome
CTID: null
Phase: Phase 2    Status: Completed, Prematurely Ended
Date: 2017-08-18
An Open-Label, Single-Arm, Multicenter Pilot Study to Evaluate Safety, Tolerability, and Efficacy of ALN-PCSSC in Subjects with Homozygous Familial Hypercholesterolemia
CTID: null
Phase: Phase 2    Status: Completed
Date: 2017-06-20
An open label, active comparator extension trial to assess the effect of long term dosing of inclisiran and evolocumab given as subcutaneous injections in subjects with high cardiovascular risk and elevated LDL-C (ORION-3)
CTID: null
Phase: Phase 2    Status: Ongoing, GB - no longer in EU/EEA, Completed
Date: 2017-02-24
A placebo-controlled, double-blind, randomized trial to compare the effect of different doses of ALN-PCSSC given as single or multiple subcutaneous injections in subjects with high cardiovascular risk and elevated LDL-C.
CTID: null
Phase: Phase 2    Status: Completed
Date: 2015-12-16

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