Inclisiran clinical trials
Inclisiran is named as an intervention in 15 current clinical trials in our China, USA, Spain, Taiwan, UK, France, Italy, Netherlands, Germany, Poland, Turkey, Brazil, Switzerland, Austria, Czechia, Canada, Israel, South Korea, India, Belgium, Portugal, Singapore, Australia, Sweden, Denmark, Mexico, Norway and Japan registers. 9 are recruiting patients now. The most common phase is Phase 3. The sponsor with the most trials is Novartis Pharmaceuticals (11). The most-studied condition is Hypercholesterolaemia. The EU clinical trials register (CTIS) separately lists 1 authorised or ongoing trial.
Where Inclisiran is approved
All regulators →Of the three regulators tracked here, the first to approve Inclisiran was the EU, on 9 Dec 2020. It is approved in 3 of the 3 regulators tracked here.
- 1 EU safety letter (DHPC), latest: quality defect for Leqvio, 21 Dec 2023
From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.
Inclisiran patents and exclusivity
Expiry tracker →Protections still running for marketed products containing Inclisiran, as listed by the regulators. Expired patents and exclusivities, and discontinued products, are not shown.
- 10 listed patents; the last listed expires 25 Aug 2036 (US 10851377).
- Latest patent on the drug substance itself: 18 Aug 2034 (US 10125369).
- Exclusivity ODE-555: Orphan drug exclusivity: as an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (ldl-c) in pediatric patients age…, until 12 Feb 2033.
- Exclusivity I-985: New indication: indicated as an adjunct to diet and exercise to reduce ldl-c in pediatric patients 12 years and older with homozygous famil…, until 12 Feb 2029.
- Exclusivity NPP: New patient population, until 12 Feb 2029.
- Exclusivity NCE: New chemical entity, until 22 Dec 2026.
Reproduced from the FDA Orange Book and Purple Book (checked 8 Nov 2026) and the European Commission's Union Register of medicinal products (CC BY 4.0; the EU expiry date is calculated exactly as the Commission's register displays it). Listed patents and dates are as submitted to or published by the regulator and may not reflect litigation, invalidation, settlements, lapsed fees or later extensions. This is not legal advice or a freedom-to-operate opinion, and it does not say when a generic or biosimilar will launch.
What health systems spend on Inclisiran
All medicines →From NHSBSA Prescription Cost Analysis (Open Government Licence v3.0) and CMS State Drug Utilization Data. Both are gross amounts: neither system publishes its discounts or rebates per drug. Products combining several substances are not counted here.
How Inclisiran works
All drug targets →- PCSK9 mRNA rnai inhibitor Rnai inhibitorTarget: PCSK9 proprotein convertase subtilisin/kexin type 9ChEMBL only
- Cardiovascular disorderPhase 3
- Non-obstructive coronary artery diseasePhase 3
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL5095052, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 13624, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.
NICE appraisals of Inclisiran
All NICE appraisals →NICE, which decides whether the NHS in England should fund new medicines, has published 1 technology appraisal of Inclisiran. 1 is current, and 1 of it recommends it for at least some patients.
| Appraisal | NICE recommendation | Published | Status |
|---|---|---|---|
| Inclisiran for treating primary hypercholesterolaemia or mixed dyslipidaemia NICE TA733 | Optimised Only in research | 6 Oct 2021 | Current |
NICE decisions apply to the NHS in England. In Ireland the HSE decides on reimbursement, advised by the National Centre for Pharmacoeconomics. Titles, categories and dates link to the guidance on nice.org.uk. © NICE 2026 technology appraisal guidance. Available from www.nice.org.uk/guidance. All rights reserved. Subject to Notice of rights. NICE guidance is prepared for the National Health Service in England. All NICE guidance is subject to regular review and may be updated or withdrawn. NICE accepts no responsibility for the use of its content in this product/publication.
Patient leaflets for Inclisiran
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 1 product on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- EUEuropean Union: LeqvioEMA product information: package leaflet and summary of product characteristics in every EU language.
- UKUnited Kingdom: Search MHRA ProductsPatient information leaflets and SmPCs for UK-licensed products.
- USUnited States: Search DailyMedFDA-approved labels, including patient and medication guides.
Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.
Trials by status
Trials by phase
Clinical trials of Inclisiran
15 trialsRegisters 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.
Inclisiran in the EU trials register (CTIS)
1 trialAuthorised or ongoing trials in the EU Clinical Trials Information System that list a product containing Inclisiran. Many trials are registered in both CTIS and ClinicalTrials.gov, so these are shown separately rather than added to the count above. Trials with a site in Ireland are listed first.
| Study | Phase | Status | Sponsor | Countries |
|---|---|---|---|---|
|
Effect of Inclisiran on LDL-C Levels and Coronary Plaque Burden Assessed by Ultra-High Resolution Photon-Counting CT Angiography
2026-526046-28-00 · CTIS ↗ · Cardiovascular Diseases
|
Phase 4 | Authorised | Policlinico San Donato S.p.A | Italy |
Inclisiran across our data
Ireland · EU · USThe 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.
- Leqvio 284 mg solution for injection in pre-filled syringeNovartis Europharm Limited · EU/1/20/1494/001
Supply shortages
No entry for Inclisiran in the EMA, FDA or German BfArM shortage lists we track.
Conditions studied with Inclisiran
13 conditionsAll 13 conditions
| Condition (as registered) | Trials |
|---|---|
| Hypercholesterolaemia | 2 |
| Hypercholesterolemia | 2 |
| Acute Coronary Syndrome | 2 |
| Primary Prevention of Atherosclerotic Cardiovascular Disease | 1 |
| Heterozygous or Homozygous Familial Hypercholesterolemia | 1 |
| Familial Hypercholesterolemia - Homozygous | 1 |
| Familial Hypercholesterolemia - Heterozygous | 1 |
| Inclisiran Formulation | 1 |
| Atherosclerotic Cardiovascular Disease (ASCVD) | 1 |
| Primary Aldosteronism | 1 |
| Plaque, Atherosclerotic | 1 |
| Ischemic Heart Disease | 1 |
| Acute Coronary Syndromes (ACS) | 1 |
Sponsors
lead sponsor per trial| Lead sponsor | Trials |
|---|---|
| Novartis Pharmaceuticals | 11 |
| Third Military Medical University | 1 |
| Jose Seijas Amigo | 1 |
| Federico II University | 1 |
| Seoul National University Bundang Hospital | 1 |
By country register
A trial with sites in more than one country appears in each of those registers. CTIS does not publish a recruiting flag; its trials may also appear in the registers above.
Related compounds
Questions about Inclisiran trials
How many clinical trials are testing Inclisiran?
15 current trials in our China, USA, Spain, Taiwan, UK, France, Italy, Netherlands, Germany, Poland, Turkey, Brazil, Switzerland, Austria, Czechia, Canada, Israel, South Korea, India, Belgium, Portugal, Singapore, Australia, Sweden, Denmark, Mexico, Norway and Japan registers name Inclisiran (also registered as KJX839) as a drug or biological intervention, as of the registry sync on 9 November 2026. Completed and withdrawn studies are not counted.
Are Inclisiran trials recruiting patients?
Yes. 9 of the 15 trials are recruiting: 4 with sites in China, 5 with sites in USA, 3 with sites in Spain, 3 with sites in Taiwan, 3 with sites in UK, 3 with sites in France, 3 with sites in Italy, 3 with sites in Netherlands, 4 with sites in Germany, 3 with sites in Poland, 3 with sites in Turkey, 3 with sites in Brazil, 2 with sites in Switzerland, 2 with sites in Austria, 2 with sites in Czechia, 2 with sites in Canada, 2 with sites in Israel, 1 with sites in South Korea, 1 with sites in India, 1 with sites in Belgium, 1 with sites in Portugal, 1 with sites in Australia, 1 with sites in Norway and 1 with sites in Japan. 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?
Novartis Pharmaceuticals (11), Third Military Medical University (1), Jose Seijas Amigo (1) and Federico II University (1), among 5 lead sponsors in total. 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 — 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.
- ClinicalTrials.gov (U.S. National Library of Medicine) ↗ Trial IDs, titles, intervention names and synonyms, phase, overall status, lead sponsor and conditions for every trial on this page
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 9 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.