Dabigatran Etexilate clinical trials
Dabigatran Etexilate is named as an intervention in 6 current clinical trials in our USA, Denmark, UK and Poland registers. 3 are recruiting patients now. The most common phase is Phase 1. The sponsor with the most trials is Herlev and Gentofte Hospital (2). The most-studied condition is Atrial Fibrillation.
Where Dabigatran Etexilate is approved
All regulators →Of the three regulators tracked here, the first to approve Dabigatran Etexilate was the EU, on 17 Mar 2008. It is approved in 2 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.
Dabigatran Etexilate patents and exclusivity
Expiry tracker →Protections still running for marketed products containing Dabigatran Etexilate, as listed by the regulators. Expired patents and exclusivities, and discontinued products, are not shown.
- 1 listed patent; the last listed expires 20 Jul 2031 (US 9034822, including a 6-month paediatric extension).
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 Dabigatran Etexilate
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 Dabigatran Etexilate works
All drug targets →- Thrombin inhibitor InhibitorTarget: F2 coagulation factor II, thrombinChEMBL only
- Venous thrombosisPhase 3
- Stroke disorderPhase 3
- Coronary artery disorderPhase 2
- Thrombotic diseasePhase 2
- Chronic kidney diseasePhase 1
- Interstitial lung diseasePhase 1
- Pulmonary fibrosisPhase 1
- SclerodermaPhase 1
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL539697, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 6379, 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 Dabigatran Etexilate
All NICE appraisals →NICE, which decides whether the NHS in England should fund new medicines, has published 3 technology appraisals of Dabigatran Etexilate. 3 are current, and 3 of these recommend it for at least some patients.
| Appraisal | NICE recommendation | Published | Status |
|---|---|---|---|
| Dabigatran etexilate for the treatment and secondary prevention of deep vein thrombosis and/or pulmonary embolism NICE TA327 | Recommended | 17 Dec 2014 | Current |
| Dabigatran etexilate for the prevention of stroke and systemic embolism in atrial fibrillation NICE TA249 | Recommended | 15 Mar 2012 Updated 2 Jul 2021 | Current |
| Dabigatran etexilate for preventing venous thromboembolism after hip or knee replacement surgery NICE TA157 | Recommended | 24 Sep 2008 | 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 Dabigatran Etexilate
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 28 products on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- EUEuropean Union: Pradaxa, Dabigatran Etexilate Accord (generic), Dabigatran etexilate Teva (previously Dabigatran etexilate Leon Farma) (generic)EMA 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 Dabigatran Etexilate
- ATC code
- B01AE07
- ChEMBL
- CHEMBL539697
- DrugBank
- DB06695
- PubChem CID
- 135565674
- CAS number
- 211915-06-9
- FDA UNII
- 2E18WX195X
- Wikidata
- Q20078502
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 Dabigatran Etexilate
6 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.
Dabigatran Etexilate 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)
28 single-substance products containing Dabigatran Etexilate on the HPRA medicines list.
- Dabigatran Etexilate 110 mg hard capsulesClonmel Healthcare Ltd · PA0126/386/002 · Marketed
- Dabigatran Etexilate 150 mg hard capsulesClonmel Healthcare Ltd · PA0126/386/003 · Marketed
- Dabigatran Etexilate Krka 110 mg hard capsulesKRKA, d.d., Novo mesto · PA1347/110/002 · Marketed
- Dabigatran Etexilate Krka 150 mg hard capsulesKRKA, d.d., Novo mesto · PA1347/110/003 · Marketed
- Dabigatran etexilate Accord 110 mg hard capsulesAccord Healthcare S.L.U. · EU/1/22/1665/007-016
Supply shortages
No entry for Dabigatran Etexilate in the EMA, FDA or German BfArM shortage lists we track.
Conditions studied with Dabigatran Etexilate
10 conditionsSponsors
lead sponsor per trial| Lead sponsor | Trials |
|---|---|
| Herlev and Gentofte Hospital | 2 |
| Chiesi Farmaceutici S.p.A | 1 |
| BeOne Medicines | 1 |
| Bristol-Myers Squibb | 1 |
| Medical University of Gdansk | 1 |
By country register
| Register | Trials | Recruiting |
|---|---|---|
| Clinical trials in USA | 2 | 2 |
| Clinical trials in Denmark | 2 | 0 |
| Clinical trials in UK | 1 | 0 |
| Clinical trials in Poland | 1 | 1 |
A trial with sites in more than one country appears in each of those registers.
Related compounds
Questions about Dabigatran Etexilate trials
How many clinical trials are testing Dabigatran Etexilate?
6 current trials in our USA, Denmark, UK and Poland registers name Dabigatran Etexilate as a drug or biological intervention, as of the registry sync on 10 November 2026. Completed and withdrawn studies are not counted.
Are Dabigatran Etexilate trials recruiting patients?
Yes. 3 of the 6 trials are recruiting: 2 with sites in USA and 1 with sites in Poland. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Who sponsors Dabigatran Etexilate clinical trials?
Herlev and Gentofte Hospital (2), Chiesi Farmaceutici S.p.A (1), BeOne Medicines (1) and Bristol-Myers Squibb (1), among 5 lead sponsors in total. The number in brackets is how many trials each organisation leads.
Is Dabigatran Etexilate licensed in Ireland?
Yes. The HPRA medicines list includes 28 single-substance products containing Dabigatran Etexilate, for example Dabigatran Etexilate 110 mg hard capsules (Clonmel Healthcare Ltd). A licence does not mean a product is currently marketed or reimbursed; see each product's record.
Is there a Dabigatran Etexilate shortage?
Not in the lists we track: Dabigatran Etexilate 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 Dabigatran Etexilate 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 Dabigatran Etexilate 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 Dabigatran Etexilate (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 10 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.