Inclisiran
- Generic Name
- Inclisiran
- Brand Names
- Leqvio
- Drug Type
- Biotech
- Chemical Formula
- -
- CAS Number
- 1639324-58-5
- Unique Ingredient Identifier
- UOW2C71PG5
- Background
Inclisiran is a long-acting, synthetic small interfering RNA (siRNA) directed against proprotein convertase subtilisin-kexin type 9 (PCSK9), which is a serine protease that regulates plasma low-density lipoprotein cholesterol (LDL-C) levels. By binding to PCSK9 messenger RNA, inclisiran prevents protein translation of PCSK9, leading to decreased concentratio...
- Indication
In Europe, inclisiran is indicated for the treatment of primary hypercholesterolemia (heterozygous familial and non-familial) or mixed dyslipidemia in adults, as an adjunct to diet. It can be used in combination with a statin or statin with other lipid-lowering therapies in patients who cannot reach LDL-C goals with the maximum tolerated dose of a statin. In...
- Associated Conditions
- Atherosclerotic Cardiovascular Diseases, Heterozygous Familial Hypercholesterolemia (HeFH), Mixed Dyslipidemias, Primary Hypercholesterolemia
- Associated Therapies
- -
Study to Evaluate Safety, Tolerability and Efficacy of Inclisiran in Children With Homozygous Familial Hypercholesterolemia
- Conditions
- Interventions
- First Posted Date
- 2024-09-19
- Last Posted Date
- 2024-11-22
- Lead Sponsor
- Novartis Pharmaceuticals
- Target Recruit Count
- 9
- Registration Number
- NCT06597006
Study to Evaluate Efficacy and Safety of Inclisiran in Children With Heterozygous Familial Hypercholesterolemia
- Conditions
- Interventions
- First Posted Date
- 2024-09-19
- Last Posted Date
- 2024-12-20
- Lead Sponsor
- Novartis Pharmaceuticals
- Target Recruit Count
- 51
- Registration Number
- NCT06597019
- Locations
- 🇲🇾
Novartis Investigative Site, Kuala Lumpur, Wilayah Persekutuan, Malaysia
Effect of Small Interfering RNA Inclisiran on Carotid Plaques As Assessed by Carotid Ultrasound
- Conditions
- Interventions
- First Posted Date
- 2024-09-06
- Last Posted Date
- 2024-09-06
- Target Recruit Count
- 40
- Registration Number
- NCT06586684
The Prevent Coronary Artery Disease Trial
- First Posted Date
- 2024-07-10
- Last Posted Date
- 2024-07-10
- Lead Sponsor
- Icahn School of Medicine at Mount Sinai
- Target Recruit Count
- 1600
- Registration Number
- NCT06494501
- Locations
- 🇺🇸
Mount Sinai Fuster Heart Hospital, New York, New York, United States
Continuity of Care Between Primary Care Cardiology and Specialty Services for Patients With Chronic Ischemic Heart Disease
- Conditions
- Interventions
- First Posted Date
- 2024-05-20
- Last Posted Date
- 2024-05-20
- Lead Sponsor
- Jose Seijas Amigo
- Target Recruit Count
- 50
- Registration Number
- NCT06421363
- Locations
- 🇪🇸
Centro de Salud de Milladoiro, Ames, A Coruña, Spain
🇪🇸Centro de Salud de Ribeira, Ribeira, A Coruña, Spain
🇪🇸Cenro de Salud de La Estrada, A Estrada, A Coruña, Spain
A Clinical Study to Evaluate the Safety and Effectiveness of Inclisiran Sodium in Indian Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia
- Conditions
- Interventions
- First Posted Date
- 2024-04-26
- Last Posted Date
- 2024-12-09
- Lead Sponsor
- Novartis Pharmaceuticals
- Target Recruit Count
- 65
- Registration Number
- NCT06386419
- Locations
- 🇮🇳
Novartis Investigative Site, Bangalore, Karnataka, India
Intravascular Imaging Study of the Effect of Inclisiran on Plaque in Patients With Acute Myocardial Infarction
- Conditions
- Interventions
- First Posted Date
- 2024-04-18
- Last Posted Date
- 2024-09-27
- Lead Sponsor
- Novartis Pharmaceuticals
- Target Recruit Count
- 318
- Registration Number
- NCT06372925
- Locations
- 🇨🇳
Novartis Investigative Site, Harbin, Heilongjiang, China
Multicenter Study on the Evaluation of Adherence, Persistence and Efficacy of Treatment With Inclisiran in Italy
- First Posted Date
- 2024-02-29
- Last Posted Date
- 2024-03-19
- Lead Sponsor
- Federico II University
- Target Recruit Count
- 1000
- Registration Number
- NCT06287177
- Locations
- 🇮🇹
Federico II University of Naples, Department of Advanced Biomedical Sciences, Napoli, Italy
VictORION-INCLUSION: Evaluating Inclisiran for Cholesterol Managment in Heart Disease
- First Posted Date
- 2024-02-08
- Last Posted Date
- 2024-11-21
- Lead Sponsor
- Duke University
- Target Recruit Count
- 1440
- Registration Number
- NCT06249165
- Locations
- 🇺🇸
University of Missouri, Columbia, Missouri, United States
🇺🇸University of Nebraska, Omaha, Nebraska, United States
🇺🇸University of North Carolina, Chapel Hill, North Carolina, United States
Efficacy and Safety of Inclisiran as Monotherapy in Chinese Adults With Low or Moderate ASCVD Risk and Elevated Low-density Lipoprotein Cholesterol.
- Conditions
- Interventions
- First Posted Date
- 2023-06-05
- Last Posted Date
- 2024-12-05
- Lead Sponsor
- Novartis Pharmaceuticals
- Target Recruit Count
- 207
- Registration Number
- NCT05888103
- Locations
- 🇨🇳
Novartis Investigative Site, Tianjin, China
Drug Development Updates
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