How many clinical trials are studying Inclisiran?

7 recruiting trials in our tracked data involve Inclisiran.

What conditions is Inclisiran being studied for?

In our tracked recruiting trials, Inclisiran is being studied in trials for High cholesterol, Heart failure, Hypercholesterolemia.

Inclisiran: clinical trials recruiting now

Q: Is Inclisiran FDA-approved?

Yes. According to the FDA drug label available through openFDA, Inclisiran is an FDA-approved drug.

Recruiting trials

Conditions studied

US states with sites

Countries

FDA drug label

FDA-approved: Yes. Inclisiran appears in the FDA drug-label database. Marketed as LEQVIO.

FDA-approved use

LEQVIO ® is indicated as an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in: adults with hypercholesterolemia. adults and pediatric patients aged 12 years and older with heterozygous familial hypercholesterolemia (HeFH). pediatric patients aged 12 years and older with homozygous familial hypercholesterolemia (HoFH). Cardiovascular outcomes trials have demonstrated that reducing LDL-C lowers the risk for major adverse cardiovascular events (MACE) in adults at increased risk when treated with statins or monoclonal antibody proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitors as an add-on to statin therapy. LEQVIO is a small interfering RNA (siRNA) directed to proprotein convertase subtilisin kexin type 9 (PCSK9) mRNA indicated as an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in: adults with hypercholesterolemia. ( 1 ) adults and pediatric patients aged 12 years and older with heterozygous familial hypercholesterolemia (HeFH). ( 1 ) pediatric patients aged 12 years and older with homozygous familial hypercholesterolemia (HoFH). ( 1 ) Cardiovascular outcomes trials have demonstrated that reducing…

FDA label via openFDA

Phase breakdown

Phase 2 1 Phase 3 3 Phase 4 1 Not applicable 2

Conditions being studied

Condition	Trials
High cholesterol · Inclisiran for High cholesterol	7
Heart failure	2
Hypercholesterolemia	2
Atherosclerotic Cardiovascular Disease (ASCVD)	1
Familial Hypercholesterolemia - Heterozygous	1
Familial Hypercholesterolemia - Homozygous	1
Heterozygous or Homozygous Familial Hypercholesterolemia	1
Hypercholesterolaemia	1
Hypertension	1
Primary Hypercholesterolemia or Mixed Dyslipidemia	1

Recruiting trials involving Inclisiran

A Study to Evaluate the Pharmacodynamics of a Combination of QCZ484 and Inclisiran in Participants With Hypertension and Concomitant Hypercholesterolemia
NCT07610278 · Phase: Phase 2 · Ages: 18 Years to 75 Years · Sex: All (male and female) · 58 locations
Dual PCSK9 Inhibition With Inclisiran and Alirocumab in Secondary Prevention
NCT07581808 · Phase: Phase 4 · Ages: 18 Years and older · Sex: All (male and female) · 1 location
Leqvio rPMS (Regulatory Post-Marketing Surveillance in Korea)
NCT06770543 · Phase: Not specified · Ages: 18 Years to 100 Years · Sex: All (male and female) · 4 locations
Long-term Safety and Tolerability of Inclisiran in Participants With HeFH or HoFH Who Have Completed the Pediatric ORION-16, ORION-13, ORION-20, or ORION-19 Studies
NCT05682378 · Phase: Phase 3 · Ages: 12 Years to 100 Years · Sex: All (male and female) · 52 locations
Multicenter Study on the Evaluation of Adherence, Persistence and Efficacy of Treatment With Inclisiran in Italy
NCT06287177 · Phase: Not specified · Ages: 18 Years and older · Sex: All (male and female) · 1 location
Study to Evaluate Efficacy and Safety of Inclisiran in Children With Heterozygous Familial Hypercholesterolemia
NCT06597019 · Phase: Phase 3 · Ages: 6 Years to 11 Years · Sex: All (male and female) · 66 locations
Study to Evaluate Safety, Tolerability and Efficacy of Inclisiran in Children With Homozygous Familial Hypercholesterolemia
NCT06597006 · Phase: Phase 3 · Ages: 2 Years to 11 Years · Sex: All (male and female) · 19 locations

Common questions

Is Inclisiran FDA-approved?

Yes, marketed as LEQVIO.

How many recruiting trials involve Inclisiran?

7 recruiting trials across 10 conditions.

Is this list of trials complete?

No. For the full record, search ClinicalTrials.gov.