๐Ÿ‡ฎ๐Ÿ‡ชIreland
16ยฐC Partly Cloudy ยท Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Priya Life Science Compound trial record
Trackers Drugs Trial finder
Compound · clinical trials

Inclisiran clinical trials

Source: ClinicalTrials.gov, U.S. National Library of Medicine — the 7 trials in our USA, China, UK and India registers that name Inclisiran as an intervention. Synced 25 Sep 2026
7Current trials
6Recruiting now
1Lead sponsor
4Country registers
Maintained by Sreepriya Prasannan
MSc Digital Transformation of Life Sciences (Innopharma Education / Griffith College); MSc & BSc Botany HSE Spark Ignite 2026 โ€” Top 14 finalist
Compiled from ClinicalTrials.gov registry records ยท Last verified ยท Editorial standards
At a glance

Inclisiran is named as an intervention in 7 current clinical trials in our USA, China, UK and India registers. 6 are recruiting patients now. The most common phase is Phase 3. The lead sponsor is Novartis Pharmaceuticals. The most-studied condition is Familial Hypercholesterolemia - Heterozygous.

Inclisiran also has an approved-drug profile on this site (FDA label data): Leqvio (Inclisiran) →

Trials by status

  • Recruiting686%
  • Active, closed114%

Trials by phase

  • Phase 3571%
  • Phase 2114%
  • Phase 4114%
01

Clinical trials of Inclisiran

7 trials
StudyPhaseStatusLead sponsorRegisters
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 · ClinicalTrials.gov ↗ · Heterozygous or Homozygous Familial Hypercholesterolemia
Phase 3 Recruiting Novartis Pharmaceuticals UK, USA
Study to Evaluate Safety, Tolerability and Efficacy of Inclisiran in Children With Homozygous Familial Hypercholesterolemia
NCT06597006 · ClinicalTrials.gov ↗ · Familial Hypercholesterolemia - Homozygous
Phase 3 Recruiting Novartis Pharmaceuticals UK, USA, China
Study to Evaluate Efficacy and Safety of Inclisiran in Children With Heterozygous Familial Hypercholesterolemia
NCT06597019 · Familial Hypercholesterolemia - Heterozygous
Phase 3 Recruiting Novartis Pharmaceuticals UK, USA, China
Lp(a) Lowering Study of Pelacarsen (TQJ230) With Background Inclisiran in Participants With Elevated Lp(a) and Established ASCVD
NCT06813911 · Atherosclerotic Cardiovascular Disease (ASCVD)
Phase 3 Recruiting Novartis Pharmaceuticals UK, USA, China
Evaluation of Efficacy and Safety of Early in Hospital Initiation of Inclisiran Treatment in Patients With Acute Coronary Syndromes
NCT07102628 · ClinicalTrials.gov ↗ · Acute Coronary Syndrome
Phase 3 Recruiting Novartis Pharmaceuticals India, China
A Study to Evaluate the Pharmacodynamics of a Combination of QCZ484 and Inclisiran in Participants With Hypertension and Concomitant Hypercholesterolemia
NCT07610278 · ClinicalTrials.gov ↗ · Hypercholesterolaemia
Phase 2 Recruiting Novartis Pharmaceuticals USA
Intravascular Imaging Study of the Effect of Inclisiran on Plaque in Patients With Acute Myocardial Infarction
NCT06372925 · ClinicalTrials.gov ↗ · Plaque, Atherosclerotic
Phase 4 Active, closed Novartis Pharmaceuticals China

Registers list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.

02

Inclisiran across our data

Ireland · EU · US

The same active substance in our other registers, matched by its exact name. Each entry links to the register record it comes from.

Licensed in Ireland (HPRA)

1 single-substance product containing Inclisiran on the HPRA medicines list.

All 1 Irish product →

Supply shortages

No entry for Inclisiran in the EMA, FDA or German BfArM shortage lists we track.

Recent approvals

  • LeqvioFDA · 22 Dec 2021 · New Drug (NDA) · Novartis
03

Conditions studied with Inclisiran

7 conditions
Familial Hypercholesterolemia - Heterozygous1Atherosclerotic Cardiovascular Disease (ASCVD)1Heterozygous or Homozygous Familial Hypercholesterolemia1Familial Hypercholesterolemia - Homozygous1Hypercholesterolaemia1Acute Coronary Syndrome1Plaque, Atherosclerotic1
04

Sponsors

lead sponsor per trial
Lead sponsorTrials
Novartis Pharmaceuticals7
05

By country register

RegisterTrialsRecruiting
Clinical trials in USA55
Clinical trials in China54
Clinical trials in UK44
Clinical trials in India11

A trial with sites in more than one country appears in each of those registers.

06

Related compounds

07

Questions about Inclisiran trials

How many clinical trials are testing Inclisiran?

7 current trials in our USA, China, UK and India registers name Inclisiran as a drug or biological intervention, as of the registry sync on 25 September 2026. Completed and withdrawn studies are not counted.

Are Inclisiran trials recruiting patients?

Yes. 6 of the 7 trials are recruiting: 5 with sites in USA, 4 with sites in China, 4 with sites in UK and 1 with sites in India. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.

Who sponsors Inclisiran clinical trials?

The lead sponsor is Novartis Pharmaceuticals. The number in brackets is how many trials each organisation leads.

Is Inclisiran licensed in Ireland?

Yes. The HPRA medicines list includes 1 single-substance product containing Inclisiran, for example Leqvio 284 mg solution for injection in pre-filled syringe (Novartis Europharm Limited). A licence does not mean a product is currently marketed or reimbursed; see each product's record.

Is there a Inclisiran shortage?

Not in the lists we track: Inclisiran has no entry in the EMA, FDA or German BfArM shortage registers as of their latest sync.

Where does this information come from?

Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Inclisiran works or whether it is effective, and it is not medical advice.

How this page is built

Everything on this page is copied from public ClinicalTrials.gov registry records โ€” it is not written from memory, and nothing here describes how Inclisiran works or whether it is effective. Each trial links to its own record so you can check it yourself.

This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Inclisiran (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 25 Sep 2026.

Please verify before you rely on this. This page is general information for life-science and pharmaceutical professionals. It is not medical advice, and it has not been reviewed by a clinician โ€” our editorial team holds life-science qualifications, not clinical ones. It is not exhaustive and may not reflect the most recent label change. Always check the official prescribing information (US Prescribing Information or EU SmPC) and speak to your doctor or pharmacist before acting on anything here. Drugs in the same class are not automatically interchangeable, and approvals, brand names and indications differ between the US, the EU/Ireland (EMA/HPRA) and other regions. Spotted an error? Tell us โ€” we correct promptly and log it.