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Evidence: HighPeptideFDA ApprovedHBV and HDV entry inhibitorFDA-approved 2026 · HepcludexChronic hepatitis D

Bulevirtide

A first-in-class peptide that blocks the receptor hepatitis B and D viruses use to enter liver cells

A peptide that blocks NTCP, the liver-cell receptor hepatitis B and D viruses use to get in. Approved in Europe and, since May 22, 2026, in the US as Hepcludex for chronic hepatitis D.

At a Glance Read Research →
Overview

What is it?

Hepatitis D occurs as a coinfection with hepatitis B and speeds up the liver disease it causes. Both viruses enter liver cells through NTCP, the sodium taurocholate co-transporting polypeptide. Bulevirtide, developed as myrcludex B, binds that receptor and blocks entry; before it, interferon used off-label was the only option.

In MYR301, the phase 3 trial, 150 people took 2 mg or 10 mg a day or waited 48 weeks. The combined response (HDV RNA undetectable or down at least 2 log, plus a normal ALT) occurred in 45% and 48% against 2%. Two years after 144 weeks of treatment ended, it was 24% in every group.

The US label, effective May 22, 2026, sets the adult dose at 8.5 mg once a day and carries a boxed warning that hepatitis D and B can flare severely after treatment stops.

Structured data

At a Glance

Every value in this table is printed from the Grey Peptides dataset, the same record the compound explorer and comparison tool read, so the three can never disagree.

ClassA first-in-class peptide entry inhibitor that blocks NTCP, the receptor hepatitis B and D viruses use to enter liver cells; FDA-approved as Hepcludex on May 22, 2026, for chronic hepatitis D.
FormulaC248H355N65O72
Molecular weight5399 g/mol
Half-lifeabout 3 hours (range 2 to 6) after subcutaneous injection
Label dose8.5 mg (once daily, subcutaneous)
US statusFDA Approved
Evidence levelHigh
Last reviewed2026-10-02

Educational information, not medical advice. The doses on this page come from approved labels, published studies and, where no study exists, amounts reported by users. None is a recommendation for you. An unapproved compound has no established safe or effective human dose, and products sold for “research use only” are not made or tested for people. Talk to a doctor before acting on anything on this site, including before you start, stop or change any medicine or dose. Full medical disclaimer.

Interactive

Half-Life: How Much Remains

The dataset records a half-life of about 3 hours (range 2 to 6) after subcutaneous injection for Bulevirtide. After each half-life, half of what was in the circulation is gone, so about 3% remains after five. Real clearance varies with the person, the dose, the route and kidney or liver function; this is arithmetic on a published figure, not a dosing tool.

Time since a single dose
ElapsedTimeRemaining
1 half-life3 h50% remaining
2 half-lives6 h25% remaining
3 half-lives9 h12.5% remaining
4 half-lives12 h6.25% remaining
5 half-lives15 h3.125% remaining
Evidence

Published Research

The studies behind bulevirtide, read from their PubMed abstracts.

Human2016

First patients: myrcludex B, peginterferon or both, 24 patients

Twenty-four people with chronic hepatitis D took myrcludex B, peginterferon or both for 24 weeks. HDV RNA fell in all groups and became undetectable in 2, 2 and 5 patients; no serious adverse events occurred.

PMID: 27132170
Human2023

MYR301: phase 3, 150 patients, week 48

Combined response at 48 weeks: 45% on 2 mg, 48% on 10 mg, 2% untreated. HDV RNA was undetectable in 12% and 20% of the dose groups, and ALT normalized in 51% and 56% against 12%.

PMID: 37345876
Human2024

MYR301 at week 96

143 of 150 patients completed 96 weeks. Responses held or improved; 43% of week-24 non-responders and 82% of partial responders reached a virologic response by week 96.

PMID: 38734383
Human2026

MYR301 final: 144 weeks, then two years off treatment

Combined response was 57%, 54% and 56% at the end of treatment and 24% in every group two years later. Serious liver events after stopping occurred in 14% and resolved in 85% of them.

PMID: 41966308
Human2024

MYR204: adding peginterferon, phase 2b, 174 patients

Twenty-four weeks after treatment ended, HDV RNA was undetectable in 46% on bulevirtide 10 mg plus peginterferon, 12% on 10 mg alone, 32% on 2 mg plus peginterferon and 17% on peginterferon alone.

PMID: 38842520
Human2025

Pooled safety: three trials, 269 patients at week 48

Raised total bile acids (20% and 17% on 2 mg and 10 mg), injection-site reactions (16% and 20%) and headache (16% and 17%) were more common than in untreated controls. No serious adverse event was related to bulevirtide.

PMID: 39648559
Safety

Side Effects & Contraindications

Reported Side Effects

From the studies above.

● Raised total bile acids in about one in five treated patients (pooled data)
● Injection-site reactions and headache in roughly one in six
● Serious liver flares after stopping in 14% of MYR301 patients, most of which resolved

Contraindications & Cautions

From the Hepcludex label (DailyMed, effective May 22, 2026).

● Boxed warning: severe flares of hepatitis D and B after treatment stops, especially with cirrhosis
● Hypersensitivity reactions, including anaphylaxis
● Not evaluated in end-stage kidney disease or dialysis
● Tested athletes — see the Sport (WADA) row below
Questions

Frequently Asked Questions

?What is bulevirtide?

A first-in-class peptide that blocks NTCP, the receptor hepatitis B and D viruses use to enter liver cells. It is sold as Hepcludex for chronic hepatitis D.

?Is bulevirtide FDA-approved?

Yes. The FDA approved Hepcludex on May 22, 2026, for adults with chronic hepatitis D without cirrhosis or with compensated cirrhosis. It was already approved in Europe.

?Does it cure hepatitis D?

Not reliably. In MYR301 the combined response was 54% to 57% at the end of 144 weeks of treatment but fell to 24% two years after stopping, and the label warns of severe flares after stopping.

Bibliography

References

  1. [fda] US FDA, Drugs@FDA (openFDA): HEPCLUDEX (bulevirtide), BLA 761468, original approval May 22, 2026, prescription. Read October 2, 2026.
  2. [fda-pi] FDA. Hepcludex (bulevirtide) US prescribing information (DailyMed set 12391cc2-38c2-4cf5-86d3-2be9370127fc, effective May 22, 2026). Read October 2, 2026.
  3. [clinical-trial] Bogomolov P, et al. "Treatment of chronic hepatitis D with the entry inhibitor myrcludex B: First results of a phase Ib/IIa study." J Hepatol, 2016;65(3):490-8. PMID: 27132170.
  4. [clinical-trial] Wedemeyer H, et al. "A Phase 3, Randomized Trial of Bulevirtide in Chronic Hepatitis D." N Engl J Med, 2023;389(1):22-32. PMID: 37345876.
  5. [clinical-trial] Wedemeyer H, et al. "Bulevirtide monotherapy in patients with chronic HDV: Efficacy and safety results through week 96 from a phase III randomized trial." J Hepatol, 2024;81(4):621-629. PMID: 38734383.
  6. [clinical-trial] Wedemeyer H, et al. "144 Weeks of bulevirtide monotherapy for chronic hepatitis D: Final and post-treatment results from a phase III randomized trial." J Hepatol, 2026;85(3):493-503. PMID: 41966308.
  7. [clinical-trial] Asselah T, et al. "Bulevirtide Combined with Pegylated Interferon for Chronic Hepatitis D." N Engl J Med, 2024;391(2):133-143. PMID: 38842520.
  8. [pubmed] Asselah T, et al. "Bulevirtide Monotherapy Is Safe and Well Tolerated in Chronic Hepatitis Delta: An Integrated Safety Analysis of Bulevirtide Clinical Trials at Week 48." Liver Int, 2025;45(4):e16174. PMID: 39648559.

Sources & Citations

Studies were read from their PubMed records; regulatory sources are listed below, read October 2, 2026.

Medical Disclaimer: This content is for educational and informational purposes only. It is not medical advice, and nothing here is an instruction to obtain or use any compound. Consult a licensed healthcare provider before making health decisions.

Last reviewed: 2026-10-02