First FDA-Approved Treatment for Chronic Hepatitis D

Who this is for

Next clinical step

Health Canada and the US Food and Drug Administration (FDA) have approved this medicine. In Canada, the United States and the European Union, ask your doctor or a specialist whether it suits you. They can write a prescription. Insurance or public drug plan coverage is not guaranteed.

Ways to access this treatment

• United States · Prescription

  US prescription (FDA-labelled)

  https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=12391cc2-38c2-4cf5-86d3-2be9370127fc

• Canada · Prescription

  Canada prescription (Health Canada NOC, DIN 02560178)

  https://health-products.canada.ca/api/drug/drugproduct/?din=02560178

• European Union · Prescription

  EU prescription (EC marketing authorisation)

  https://www.ema.europa.eu/en/medicines/human/EPAR/hepcludex

• European Union · Recruiting clinical trial

  A Trial Evaluating Brelovitug (BJT-778) vs Bulevirtide for the Treatment of Chronic Hepatitis Delta Infection (AZURE-2)

  Combination or different setting. Bulevirtide is the comparator arm; the trial tests brelovitug (phase 3).

  https://clinicaltrials.gov/study/NCT07200908

Search all trials on ClinicalTrials.gov: https://clinicaltrials.gov/search?cond=hepatitis%20D&intr=bulevirtide&aggFilters=status:rec

General resources for further research

• Canadian Clinical Trial Search Portal (Health Canada)

  Health Canada's public search of the drug and biologic clinical trials it has authorised in Canada (phase 1 to 3, since April 2013). Search by condition, drug, or trial status and see where trials are running. It replaced the Health Canada Clinical Trials Database in July 2026. A listing is not enrolment, and Health Canada does not recruit patients: ask your clinician and contact the trial sponsor.

  https://clinical-trials-search.canada.ca/en/home

• ClinicalTrials.gov

  US National Library of Medicine registry of clinical studies. Search by condition, drug, NCT number, and location. A listing is not enrolment, eligibility, or funding. Talk with the trial contact and a clinician before assuming a slot exists.

  https://clinicaltrials.gov/

• CTIS (EU Clinical Trials Information System)

  European Union public portal for clinical trials submitted under the Clinical Trials Regulation. Search by medicine, condition, and member state. A CTIS record is not an EMA marketing authorisation and is not enrolment.

  https://euclinicaltrials.eu/