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
- -
A Randomized Trial Assessing the Effects of Inclisiran on Clinical Outcomes Among People With Cardiovascular Disease
- Conditions
- Interventions
- First Posted Date
- 2018-10-15
- Last Posted Date
- 2024-12-05
- Lead Sponsor
- University of Oxford
- Target Recruit Count
- 16124
- Registration Number
- NCT03705234
- Locations
- 🇬🇧
CTSU, University of Oxford, Oxford, Oxfordshire, United Kingdom
🇺🇸TIMI Study Group, Boston, Massachusetts, United States
Trial to Evaluate the Effect of Inclisiran Treatment on Low Density Lipoprotein Cholesterol (LDL-C) in Subjects With Heterozygous Familial Hypercholesterolemia (HeFH)
- Conditions
- Interventions
- First Posted Date
- 2018-01-11
- Last Posted Date
- 2020-10-28
- Lead Sponsor
- The Medicines Company
- Target Recruit Count
- 482
- Registration Number
- NCT03397121
- Locations
- 🇺🇸
Site 90001-047, Boca Raton, Florida, United States
🇨🇦Site 90011-005, Chicoutimi, Quebec, Canada
🇺🇸Site 90001-005, Mission Viejo, California, United States
A Study of Inclisiran in Participants With Renal Impairment Compared to Participants With Normal Renal Function (ORION-7)
- First Posted Date
- 2017-05-18
- Last Posted Date
- 2018-11-09
- Lead Sponsor
- The Medicines Company
- Target Recruit Count
- 31
- Registration Number
- NCT03159416
- Locations
- 🇳🇿
Auckland Clinical Studies Limited, Auckland, New Zealand
🇳🇿Christchurch Clinical Studies Trust, Christchurch, New Zealand
An Extension Trial of Inclisiran in Participants With Cardiovascular Disease and High Cholesterol
- Conditions
- Interventions
- First Posted Date
- 2017-02-23
- Last Posted Date
- 2023-03-24
- Lead Sponsor
- Novartis Pharmaceuticals
- Target Recruit Count
- 382
- Registration Number
- NCT03060577
- Locations
- 🇬🇧
Novartis Investigative Site, Worcester, United Kingdom
A Study of ALN-PCSSC in Participants With Homozygous Familial Hypercholesterolemia (HoFH)
- Conditions
- Interventions
- First Posted Date
- 2016-11-15
- Last Posted Date
- 2020-05-18
- Lead Sponsor
- The Medicines Company
- Target Recruit Count
- 9
- Registration Number
- NCT02963311
- Locations
- 🇺🇸
Research Site 201001, Los Angeles, California, United States
🇳🇱Research Site 231001, Amsterdam, Netherlands
🇿🇦Research Site 227001, Parktown, Johannesburg, South Africa
Trial to Evaluate the Effect of ALN-PCSSC Treatment on Low Density Lipoprotein Cholesterol (LDL-C)
- Conditions
- Interventions
- First Posted Date
- 2015-11-05
- Last Posted Date
- 2019-05-17
- Lead Sponsor
- The Medicines Company
- Target Recruit Count
- 501
- Registration Number
- NCT02597127
- Locations
- 🇳🇱
Admiraal de Ruyter Hospital, Cardiology, Goes, Netherlands
🇨🇦Institut de Recherches Cliniques de Montreal, Montreal, Quebec, Canada
🇨🇦ECOGENE-21 Clinical Trials Center, Chicoutimi, Quebec, Canada
A Phase 1 Study of an Investigational Drug, ALN-PCSSC, in Subjects With Elevated Low Density Lipoprotein Cholesterol (LDL-C)
- Conditions
- Interventions
- First Posted Date
- 2014-12-11
- Last Posted Date
- 2015-12-17
- Lead Sponsor
- Alnylam Pharmaceuticals
- Target Recruit Count
- 70
- Registration Number
- NCT02314442
- Locations
- 🇬🇧
Covance Clinical Research Unit, Leeds, United Kingdom
🇬🇧Richmond Pharmacology, London, United Kingdom
Drug Development Updates
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