Evolocumab clinical trials
Evolocumab is named as an intervention in 7 current clinical trials in our China, USA, Sweden, Turkey, Brazil, France and Italy registers. 4 are recruiting patients now. The most common phase is Phase 4. The sponsor with the most trials is Amgen (1). The most-studied condition is Cardiovascular Disease.
Where Evolocumab is approved
All regulators →Of the three regulators tracked here, the first to approve Evolocumab was the EU, on 17 Jul 2015. It is approved in 3 of the 3 regulators tracked here.
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.
What health systems spend on Evolocumab
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 Evolocumab works
All drug targets →- Subtilisin/kexin type 9 inhibitor InhibitorTarget: PCSK9 proprotein convertase subtilisin/kexin type 9✓ In ChEMBL and the Guide to Pharmacology
- COVID-19Phase 3
- Combined hyperlipidemiaPhase 3
- Acute coronary syndromePhase 3
- HyperlipidemiaPhase 3
- Type 2 diabetes mellitusPhase 3
- Non-ST Elevation Myocardial InfarctionPhase 2
- ST Elevation Myocardial InfarctionPhase 2
- SepsisPhase 2
- Acute myocardial infarctionPhase 2
- Coronary atherosclerosisPhase 2
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL2364655, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 7343, 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 Evolocumab
All NICE appraisals →NICE, which decides whether the NHS in England should fund new medicines, has published 1 technology appraisal of Evolocumab. 1 is current, and 1 of it recommends it for at least some patients.
| Appraisal | NICE recommendation | Published | Status |
|---|---|---|---|
| Evolocumab for treating primary hypercholesterolaemia and mixed dyslipidaemia NICE TA394 | Optimised | 22 Jun 2016 | 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 Evolocumab
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 3 products on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- EUEuropean Union: RepathaEMA 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.
Reference identifiers for Evolocumab
- ATC code
- C10AX13
- ChEMBL
- CHEMBL2364655
- DrugBank
- DB09303
- CAS number
- 1256937-27-5
- FDA UNII
- LKC0U3A8NJ
- Wikidata
- Q15623825
- Wikipedia
- Evolocumab
Codes that identify this medicine in other databases, from Wikidata (CC0), matched by its ChEMBL ID. The ATC code is the WHO classification of what the medicine is used for.
Trials by status
Trials by phase
Clinical trials of Evolocumab
7 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.
Evolocumab 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)
3 single-substance products containing Evolocumab on the HPRA medicines list.
- Repatha 140 mg solution for injection in pre-filled penAmgen Europe B.V. · EU/1/15/1016/002-005
- Repatha 140 mg solution for injection in pre-filled syringeAmgen Europe B.V., · EU/1/15/1016/001
- Repatha 420 mg solution for injection in cartridgeAmgen Europe B.V. · EU/1/15/1016/006-007
Supply shortages
No entry for Evolocumab in the EMA, FDA or German BfArM shortage lists we track.
Conditions studied with Evolocumab
13 conditionsAll 13 conditions
| Condition (as registered) | Trials |
|---|---|
| Cardiovascular Disease | 1 |
| Myocardial Infarction | 1 |
| Stroke | 1 |
| Coronary Revascularization | 1 |
| Hypertriglyceridemia Induced Acute Pancreatitis | 1 |
| Acute Ischemic Stroke | 1 |
| Coronary | 1 |
| Coronary Artery Disease | 1 |
| Ischemic Stroke | 1 |
| Large-Artery Atherosclerosis (Embolus/Thrombosis) | 1 |
| STEMI - ST Elevation Myocardial Infarction | 1 |
| NSTEMI - Non-ST Segment Elevation MI | 1 |
| Hypercholesterolemia | 1 |
Sponsors
lead sponsor per trialBy country register
| Register | Trials | Recruiting |
|---|---|---|
| Clinical trials in China | 4 | 3 |
| Clinical trials in USA | 1 | 0 |
| Clinical trials in Sweden | 1 | 0 |
| Clinical trials in Turkey | 1 | 0 |
| Clinical trials in Brazil | 1 | 0 |
| Clinical trials in France | 1 | 0 |
| Clinical trials in Italy | 1 | 1 |
A trial with sites in more than one country appears in each of those registers.
Related compounds
Questions about Evolocumab trials
How many clinical trials are testing Evolocumab?
7 current trials in our China, USA, Sweden, Turkey, Brazil, France and Italy registers name Evolocumab (also registered as AMG 145) as a drug or biological intervention, as of the registry sync on 9 November 2026. Completed and withdrawn studies are not counted.
Are Evolocumab trials recruiting patients?
Yes. 4 of the 7 trials are recruiting: 3 with sites in China and 1 with sites in Italy. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Who sponsors Evolocumab clinical trials?
Amgen (1), General Hospital of Shenyang Military Region (1), Nanfang Hospital, Southern Medical University (1) and West China Hospital (1), among 7 lead sponsors in total. The number in brackets is how many trials each organisation leads.
Is Evolocumab licensed in Ireland?
Yes. The HPRA medicines list includes 3 single-substance products containing Evolocumab, for example Repatha 140 mg solution for injection in pre-filled pen (Amgen Europe B.V.). A licence does not mean a product is currently marketed or reimbursed; see each product's record.
Is there a Evolocumab shortage?
Not in the lists we track: Evolocumab 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 Evolocumab 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 Evolocumab 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 Evolocumab (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.