Bulevirtide clinical trials
Bulevirtide is named as an intervention in 10 current clinical trials in our Germany, Italy, UK, France, Spain, Austria, Czechia, Sweden, USA, Israel, Belgium, Switzerland, Turkey, Canada, Australia, Taiwan and Netherlands registers. 5 are recruiting patients now. The most common phase is Observational. The sponsor with the most trials is Mirum Pharmaceuticals, Inc (4). The most-studied condition is Chronic Hepatitis D Infection.
Where Bulevirtide is approved
All regulators →Of the three regulators tracked here, the first to approve Bulevirtide was the EU, on 31 Jul 2020. 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.
Bulevirtide patents and exclusivity
Expiry tracker →Protections still running for marketed products containing Bulevirtide, as listed by the regulators. Expired patents and exclusivities, and discontinued products, are not shown.
- Hepcludex for treatment of hepatitis delta virus infection: until 5 Aug 2032 (includes 24 months' paediatric extension). Union Register
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.
How Bulevirtide works
All drug targets →- Bile acid transporter inhibitor InhibitorTarget: SLC10A1 solute carrier family 10 member 1✓ In ChEMBL and the Guide to Pharmacology
- Hepatitis B virus infectionPhase 2
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL4297711, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 12775, 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 Bulevirtide
All NICE appraisals →NICE, which decides whether the NHS in England should fund new medicines, has published 1 technology appraisal of Bulevirtide. 1 is current, and 1 of it recommends it for at least some patients.
| Appraisal | NICE recommendation | Published | Status |
|---|---|---|---|
| Bulevirtide for treating chronic hepatitis D NICE TA896 | Optimised | 7 Jun 2023 | 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 Bulevirtide
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: HepcludexEMA 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 Bulevirtide
- ChEMBL
- CHEMBL4297711
- DrugBank
- DB15248
- CAS number
- 2012558-47-1
- FDA UNII
- WKM56H3TLB
- Wikidata
- Q98139660
- Wikipedia
- Bulevirtide
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 Bulevirtide
10 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.
Bulevirtide 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 Bulevirtide on the HPRA medicines list.
- HEPCLUDEX 2 mg powder for solution for injectionGilead Sciences Ireland UC · EU/1/20/1446/001
Supply shortages
No entry for Bulevirtide in the EMA, FDA or German BfArM shortage lists we track.
Conditions studied with Bulevirtide
7 conditionsSponsors
lead sponsor per trial| Lead sponsor | Trials |
|---|---|
| Mirum Pharmaceuticals, Inc | 4 |
| Vir Biotechnology, Inc | 2 |
| Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico | 2 |
| Hannover Medical School | 1 |
| Karolinska University Hospital | 1 |
By country register
A trial with sites in more than one country appears in each of those registers.
Related compounds
Questions about Bulevirtide trials
How many clinical trials are testing Bulevirtide?
10 current trials in our Germany, Italy, UK, France, Spain, Austria, Czechia, Sweden, USA, Israel, Belgium, Switzerland, Turkey, Canada, Australia, Taiwan and Netherlands registers name Bulevirtide (also registered as BJT-778) as a drug or biological intervention, as of the registry sync on 9 November 2026. Completed and withdrawn studies are not counted.
Are Bulevirtide trials recruiting patients?
Yes. 5 of the 10 trials are recruiting: 2 with sites in Germany, 4 with sites in Italy, 2 with sites in UK, 2 with sites in France, 2 with sites in Spain, 2 with sites in Austria, 2 with sites in Czechia, 2 with sites in Sweden and 1 with sites in Switzerland. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Who sponsors Bulevirtide clinical trials?
Mirum Pharmaceuticals, Inc (4), Vir Biotechnology, Inc (2), Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico (2) and Hannover Medical School (1), among 5 lead sponsors in total. The number in brackets is how many trials each organisation leads.
Is Bulevirtide licensed in Ireland?
Yes. The HPRA medicines list includes 1 single-substance product containing Bulevirtide, for example HEPCLUDEX 2 mg powder for solution for injection (Gilead Sciences Ireland UC). A licence does not mean a product is currently marketed or reimbursed; see each product's record.
Is there a Bulevirtide shortage?
Not in the lists we track: Bulevirtide 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 Bulevirtide 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 Bulevirtide 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 Bulevirtide (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.