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
- -
Efficacy and Safety of Inclisiran as Monotherapy in Patients With Primary Hypercholesterolemia Not Receiving Lipid-lowering Therapy.
- Conditions
- Interventions
- First Posted Date
- 2023-03-10
- Last Posted Date
- 2024-10-01
- Lead Sponsor
- Novartis Pharmaceuticals
- Target Recruit Count
- 350
- Registration Number
- NCT05763875
- Locations
- 🇺🇸
Southern Clin Research Clinic ., Zachary, Louisiana, United States
🇲🇽Novartis Investigative Site, Queretaro, Mexico
🇺🇸Hillcrest Medical Research, DeLand, Florida, United States
Long-term Safety and Tolerability of Inclisiran in Participants With HeFH or HoFH Who Have Completed the Adolescent ORION-16 or ORION-13 Studies
- Conditions
- Interventions
- First Posted Date
- 2023-01-12
- Last Posted Date
- 2024-09-30
- Lead Sponsor
- Novartis Pharmaceuticals
- Target Recruit Count
- 154
- Registration Number
- NCT05682378
- Locations
- 🇺🇸
Excel Medical Clinical Trials LLC, Boca Raton, Florida, United States
🇺🇸Icahn School of Med at Mt Sinai ., New York, New York, United States
🇺🇸Cincinnati Childrens Hospital MC ., Cincinnati, Ohio, United States
Impact of Optimal Pharmacotherapy on Lipid Profile and Qualitative Features of Atherosclerotic Plaques
- Conditions
- First Posted Date
- 2022-12-06
- Last Posted Date
- 2023-11-22
- Lead Sponsor
- Pauls Stradins Clinical University Hospital
- Target Recruit Count
- 50
- Registration Number
- NCT05639218
- Locations
- 🇱🇻
Pauls Stradins Clinical University Hospital, Riga, Latvia
Trial to Evaluate Efficacy and Safety of LIB003 and Inclisiran in High-risk CVD Patients
- Conditions
- Interventions
- First Posted Date
- 2021-08-13
- Last Posted Date
- 2024-10-23
- Lead Sponsor
- LIB Therapeutics LLC
- Target Recruit Count
- 166
- Registration Number
- NCT05004675
- Locations
- 🇫🇷
Hopitaux de Marseille, Marseille, Cedex 05, France
🇩🇪Universitätsklinikum Heidelberg - Medizinische Klinik, Heidelberg, Germany
🇫🇷CHU de Nantes - Hôpital Nord Laennec, Nantes, Cedex 01, France
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)
- First Posted Date
- 2021-06-18
- Last Posted Date
- 2023-12-20
- Lead Sponsor
- Novartis Pharmaceuticals
- Target Recruit Count
- 450
- Registration Number
- NCT04929249
- Locations
- 🇺🇸
ARcare Center for Clinical Research ., Little Rock, Arkansas, United States
🇺🇸ARcare Center for Clinical Research, Little Rock, Arkansas, United States
🇺🇸Keck Medical Center USC ., Los Angeles, California, United States
Management of LDL-cholesterol With Inclisiran + Usual Care Compared to Usual Care Alone in Participants With a Recent Acute Coronary Syndrome
- First Posted Date
- 2021-05-05
- Last Posted Date
- 2024-11-25
- Lead Sponsor
- Novartis Pharmaceuticals
- Target Recruit Count
- 400
- Registration Number
- NCT04873934
- Locations
- 🇺🇸
St Louis Heart and Vascular, Saint Louis, Missouri, United States
🇺🇸Cox Health, Springfield, Missouri, United States
🇺🇸Advanced Heart Care, LLC, Bridgewater, New Jersey, United States
Study in Primary Care Evaluating Inclisiran Delivery Implementation + Enhanced Support
- First Posted Date
- 2021-03-19
- Last Posted Date
- 2024-10-09
- Lead Sponsor
- Novartis Pharmaceuticals
- Target Recruit Count
- 892
- Registration Number
- NCT04807400
- Locations
- 🇬🇧
Novartis Investigative Site, Manchester, United Kingdom
Study to Evaluate Efficacy and Safety of Inclisiran in Adolescents With Homozygous Familial Hypercholesterolemia
- Conditions
- Interventions
- First Posted Date
- 2020-12-09
- Last Posted Date
- 2024-06-17
- Lead Sponsor
- Novartis Pharmaceuticals
- Target Recruit Count
- 13
- Registration Number
- NCT04659863
- Locations
- 🇺🇸
Excel Medical Clinical Trials LLC, Boca Raton, Florida, United States
🇱🇧Hotel Dieu de France Hospital, Ashrafieh, Lebanon
🇹🇷Novartis Investigative Site, Izmir, Turkey
Study to Evaluate Efficacy and Safety of Inclisiran in Adolescents With Heterozygous Familial Hypercholesterolemia
- Conditions
- Interventions
- First Posted Date
- 2020-12-03
- Last Posted Date
- 2024-08-12
- Lead Sponsor
- Novartis Pharmaceuticals
- Target Recruit Count
- 141
- Registration Number
- NCT04652726
- Locations
- 🇺🇸
Tucson Medical Center, Tucson, Arizona, United States
🇺🇸Icahn School of Medicine at Mount Sinai, New York, New York, United States
🇺🇸Wake Forest U of Health Sciences, Winston-Salem, North Carolina, United States
PET Imaging of Inflammation and Lipid Lowering Study
- Conditions
- Interventions
- First Posted Date
- 2019-08-29
- Last Posted Date
- 2024-07-19
- Lead Sponsor
- University of Cambridge
- Target Recruit Count
- 63
- Registration Number
- NCT04073797
- Locations
- 🇬🇧
University of Cambridge, Cambridge, United Kingdom
Drug Development Updates
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