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Lipid & Lp(a) therapies · Live ClinicalTrials.gov data

Inclisiran (Leqvio) clinical trial pipeline

The timeline below tracks the 16 largest phase 2–4 inclisiran trials on ClinicalTrials.gov by enrolment, 3 of them actively recruiting. The next phase 3 primary completion among them is expected Oct 2026. Refreshed daily — add up to four competitors to compare pipelines side by side.

16+

Major trials tracked

12

Phase 3 trials

3

Actively recruiting

Oct 2026

Next phase 3 primary completion

49,726

Participants across trials

Novartis Pharmaceuticals

Lead sponsor by trial count

inclisiran (16)8 active2017–2034
inclisiran
Key
Actual date
Anticipated
Forecast to primary completion
RecruitingActive, not recruitingCompleted
'17
'19
'21
'23
'25
'27
'29
'31
'33
inclisiran
ORION-3P2
ORION-11P3
ORION-10P3
ORION-4P3
ORION-8P3
Study of Efficacy and Safety of Inclisiran in Asian Participants With Atherosclerotic Cardiovascular Disease (ASCVD) or ASCVD High Risk and Elevated Low Density Lipoprotein Cholesterol (LDL-C)P3
V-INCEPTIONP3
V-INITIATEP3
SPIRITP3
V-PLAQUEP3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.P3
V-MonoP3
PRECADP3
LATAM LOWERS LDL-CP4
V-INVINCIBLEP4
V-INTERVENTIONP4

Upcoming readouts

7 ahead · inclisiran

Select a trial to load its full ClinicalTrials.gov record.

Key inclisiran trials

Top 12 of the 16 tracked phase 2–4 trials, ordered by phase and status. Each links to its full ClinicalTrials.gov record.

TrialTitlePhaseStatusPrimary completion
NCT06501443LATAM LOWERS LDL-CPhase 4RecruitingNov 2026
NCT06909565V-INTERVENTION — Inclisiran Versus Placebo for the Prevention of Major Adverse Cardiovascular and Limb Events in Patients Under…Phase 4RecruitingOct 2029
NCT06941792V-INVINCIBLE — Inclisiran Effectiveness in China: a Pragmatic Randomized TrialPhase 4Active, not recruitingApr 2027
NCT06494501PRECAD — The Prevent Coronary Artery Disease TrialPhase 3RecruitingJun 2032
NCT04765657Study of Efficacy and Safety of Inclisiran in Asian Participants With Atherosclerotic Cardiovascular Disease (…Phase 3Active, not recruitingJun 2022
NCT03705234ORION-4 — A Randomized Trial Assessing the Effects of Inclisiran on Clinical Outcomes Among People With Cardiovascular D…Phase 3Active, not recruitingOct 2026
NCT05360446V-PLAQUE — Coronary Computed Tomography Study to Assess the Effect of Inclisiran in Addition to Maximally Tolerated Stati…Phase 3Active, not recruitingOct 2026
NCT05739383A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.Phase 3Active, not recruitingApr 2029
NCT03400800ORION-11 — Inclisiran for Subjects With ASCVD or ASCVD-Risk Equivalents and Elevated Low-density Lipoprotein CholesterolPhase 3CompletedJul 2019
NCT03399370ORION-10 — Inclisiran for Participants With Atherosclerotic Cardiovascular Disease and Elevated Low-density Lipoprotein C…Phase 3CompletedSept 2019
NCT04807400SPIRIT — Study in Primary Care Evaluating Inclisiran Delivery Implementation + Enhanced SupportPhase 3CompletedJan 2023
NCT03814187ORION-8 — Trial to Assess the Effect of Long Term Dosing of Inclisiran in Subjects With High CV Risk and Elevated LDL-CPhase 3CompletedFeb 2023

Related drug pipelines

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FAQ

How many clinical trials are running for inclisiran?
ClinicalTrials.gov lists more than 16 phase 2–4 inclisiran trials. This page tracks the 16 largest by enrolment: 1 phase 2, 12 phase 3, and 3 phase 4 among them, with 3 actively recruiting. Updated daily.
Where does this data come from?
All trial data is sourced from ClinicalTrials.gov (CTGov) and refreshed on this page daily.
Can I compare inclisiran against other drugs?
Yes. The free ComplyRx Trial Pipeline tool compares up to five drugs side by side on one timeline, with PNG and PDF export. Add any competitor in the search box above.
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