Bulevirtide (Hepcludex)_Dosage, benefits & legal status
Also known as Hepcludex, Myrcludex B, MyrB, bulevirtide-gmod, bulevirtide acetate
A 47-residue lipopeptide that locks the receptor hepatitis B and D use to get into the liver. EU-approved since 2020, US since May 2026.
Common vial size is what vendors typically sell, not a recommendation. Enter your own vial in the calculator.
What is Bulevirtide (Hepcludex)?
Plain language first. The technical label stays, but it never stands alone.Overview
Hepatitis delta is the most severe form of chronic viral hepatitis and only infects people who also carry hepatitis B. Daily injections cut the virus and normalised liver enzymes in about half of patients in the phase 3, against 2% without treatment, but the virus often returns after stopping. The EU approved it in 2020 at 2 mg; the FDA gave accelerated approval in May 2026 at 8.5 mg.
Bulevirtide is a 47-residue copy of the preS1 region of the hepatitis B virus envelope, with a myristoyl fatty acid on its first residue and an amide at its end. It binds NTCP, the liver's bile-acid transporter that hepatitis B and D use as their entry receptor, so the virus cannot get into new liver cells. Stephan Urban's group at Heidelberg University Hospital invented it; MYR GmbH developed it, and Gilead bought MYR in 2021.
What it's used for
A prescription daily injection for chronic hepatitis delta in adults with compensated liver disease (and in the EU, children from age 3 and 10 kg).
How does Bulevirtide (Hepcludex) work?
What it does in the body, and where.Bulevirtide copies the part of the hepatitis B envelope that docks onto liver cells, and gets there first.
- 01The virus's doorHepatitis delta borrows hepatitis B's envelope. The fatty-tailed preS1 region of that envelope docks onto NTCP, a bile-acid pump on liver cells, to get inside.
- 02Blocking the doorBulevirtide is a copy of that region with its own myristoyl tail anchoring it to cell membranes. In liver-cell tests it blocks infection at about 0.4 to 0.5 nanomolar, so new liver cells cannot be infected. It does not clear virus from cells already infected.
- 03The bile acid trade-offNTCP also moves bile acids into the liver, so blocking it raises blood bile acids in everyone treated. No resistance has been found in cell culture or trials.
A schematic of the compound's mechanism, not a diagnostic image.
What else is it used for?
Each group carries its own evidence level.Approved means regulators have cleared it for that purpose. Investigational means it is in trials. Early research means it is being studied and is not established.
Phase 3 MYR301
FDA-approved- Human trialCombined response at week 48: 45% (2 mg) and 48% (higher dose) against 2%; normal liver enzymes 51% and 56% against 12%.
- Human trialVirus undetectable in 20% at week 48, 36% at week 96 and 50% at week 144 on the higher dose.
- No dataThe trial was open-label, and no patient cleared hepatitis B surface antigen.
With peginterferon
Investigational- Human trialMYR204, 174 adults: undetectable virus 24 weeks after a fixed course in 46% on the higher dose with peginterferon, against 17% on peginterferon alone.
'Not approved in the US' is out of date: the FDA granted accelerated approval on 22 May 2026, after a 2022 rejection over manufacturing. The dose is not universal: 2 mg in the EU, UK, Australia and Canada, 8.5 mg in the US. The trial's '10 mg' arm actually received about 8.5 mg. The half-life is 3 hours in the US label and 4 to 7 hours in the EU label. 'PreS1 residues 2 to 48' is correct only in genotype D numbering. The US approval rests on virus and liver enzyme falls; benefit on cirrhosis, cancer or survival has not been shown. Gilead's deal is quoted as EUR 1.15 billion, EUR 1.45 billion or $1.4 billion depending on whether the approval milestone is counted.
The published record
Papers and trials about Bulevirtide (Hepcludex)
240 papers tagged human · 125 not reviews or lab · 15 clinical trial publications
28 registered trials · 8 with posted results
Furthest stage reached: Approved in the US
Counted from Europe PMC indexing, not read by a person; a human tag can land on reviews, commentary or lab papers; clinical trial publications is the narrower count.
At a glance
Four things to know about Bulevirtide (Hepcludex)
Evidence
FDA-approved
Category
Immune support
Common vial
Varies
Half-life
About 3 hours (US label; EU label says 4 to 7)
How much, and do you cycle it?
The range, and whether you take breaks.8.5 mg daily (US label); 2 mg daily (EU label), once daily. Continuous, open-ended FDA label
Taken daily for as long as it works. The virus often returns after stopping, 93% of relapses within 24 weeks, so stopping needs monitoring.
How long does it stay in the body?
The half-life, and where the figure comes from.About 3 hours (US label; EU label says 4 to 7)FDA label
Peak about 3 hours after injection; 57% of the dose is absorbed. More than 99% is bound to plasma proteins, and exposure rises more than in proportion to dose because the drug is held by its target. Broken down by peptidases.
Source: Hepcludex US prescribing information section 12.3; EU SmPC section 5.2
You can compare this against the whole library to see where it sits.
How do I dose and price it?
Enter your vial and your dose. Pick a mix. We show the draw and the cost.The vial holds a fixed amount of drug. Adding more water does not make more drug, it just spreads it thinner, so you draw a bigger number on the syringe for the same dose.
Choose your mix
Measuring the water1 mL = one full 100-unit syringe.
How do you store it?
Before mixing, and after.Dry powder in the freezer or fridge. Once mixed, fridge, and use within about a month.
Unmixed lyophilized Bulevirtide (Hepcludex) keeps for a long time cold. Once you add water the clock starts: most reconstituted vials hold up for roughly 28 to 30 days at fridge temperature. Keep it out of light, and do not freeze it after mixing.
What are the side effects and cautions?
Known cautions and warnings for this compound.Solubility, computed: 21% charged residues, 45% hydrophobic. Base may help.
A first-pass rule from peptide manufacturers' guidance. It does not account for disulfide bridges, salt form or how the powder was dried, and it predicts what should be easy rather than what will happen in your vial.
Who should avoid it
- Decompensated cirrhosis: not studied for the US label and not recommended in the EU
- Allergy to bulevirtide or its ingredients (the EU label's contraindication); anaphylaxis has been reported
- End-stage kidney disease (creatinine clearance under 15 mL/min) or moderate to severe liver impairment, not studied; no dose change is needed for mild, moderate or severe kidney impairment
- Pregnancy, where human data are too limited to judge
Stop and get help
- Swelling of the face or throat, hives or trouble breathing
- Do not stop it on your own: severe hepatitis flares can follow, and the label requires liver and virus monitoring for at least 6 months after stopping
- Yellow skin or eyes, dark urine or severe tiredness, possible hepatitis flare
Common effects
- Injection-site reactions in 30%, headache in 20% and abdominal pain in 18%, against 0%, 0% and 2% without treatment
- Tiredness in 14% and itching in 14%, against 2% and 0%
- Blood bile acids rose in every treated patient, more with cirrhosis, and returned to normal after stopping
- Raised eosinophils in 33%, all mild
- Antibodies against the drug in 66% by week 96, with no effect on response or safety
Where this page says nothing is established, that means nobody has studied it, not that a compound is safe.
Is Bulevirtide (Hepcludex) approved?
And where the numbers on this page come from.Yes. Bulevirtide (Hepcludex) is FDA approved and available on prescription in the United States. It is also approved in the European Union, the United Kingdom, Russia, Switzerland, Australia, and Canada.
- Approval statusFDA-approved
- RouteUnder the skin (subcutaneous)
- Checked14 October 2026
- Approved outside the USEuropean Union, United Kingdom, Russia, Switzerland, Australia, Canada: EU conditional approval 31 July 2020, full approval 18 July 2023 (2 mg daily; children from age 3 added later). Russia November 2019, Great Britain August 2021, Switzerland February 2024, Australia July 2024, Canada August 2025. Also approved in the US.This does not change the United States position above.
- DoseFrom the drug label. The manufacturer tested this range and a regulator reviewed it.
- Vial sizeFrom what vendors typically list; not a recommendation.
- SourcesHepcludex US prescribing information (2026)FDA risk assessment and risk mitigation review, BLA 761468Drugs@FDA, BLA 761468EMA, Hepcludex EPARHepcludex EU summary of product characteristicsFDA GSRS substance record, bulevirtide (UNII WKM56H3TLB)Wedemeyer H et al., New England Journal of Medicine 2023;389:22-32 (MYR301)Gilead Medical Information, MYR301 overviewGilead, MYR204 published in NEJM (6 Jun 2024)Gilead, US accelerated approval (May 2026)TGA, Australian public assessment reportGilead completes acquisition of MYR GmbH (Mar 2021)
What has happened recently
First approved in Russia (November 2019). The EU granted conditional approval on 31 July 2020 and full approval on 18 July 2023, at 2 mg daily; later approvals followed in Great Britain (2021), Switzerland (2024), Australia (2024) and Canada (2025), and NICE recommended it in 2023. In the US the FDA issued a complete response letter in October 2022 over manufacturing and delivery problems, then gave accelerated approval on 22 May 2026 (BLA 761468, nonproprietary name bulevirtide-gmod) at 8.5 mg daily, based on falls in virus and liver enzymes; benefit on liver outcomes has not been established, and an observational study of liver outcomes with up to 5 years of follow-up is required. Gilead bought the developer, MYR GmbH, in March 2021 for about EUR 1.15 billion upfront. No generic exists.
You can compare this against the whole library, or read how to check a seller.
What else is like Bulevirtide (Hepcludex)?
Others in Immune support, side by side.If you're weighing Bulevirtide (Hepcludex), it's worth reading Daptomycin (Cubicin), Dynobactin A, and Enfuvirtide (Fuzeon) in the same class.
A 47-residue lipopeptide that locks the receptor hepatitis B and D use to get into the liver. EU-approved since 2020, US since May 2026.
- Dose
- 8.5 mg daily (US label); 2 mg daily (EU label)
- How often
- Once daily
An approved IV antibiotic that collapses bacterial membranes, and proof that an antimicrobial peptide can become a mainstream drug.
- Dose
- 4 to 6 mg/kg once daily (adults, label)
- How often
- Once daily
An experimental peptide antibiotic against Gram-negative bacteria, found by computer and tested only in mice.
- Dose
- No human dose; mouse dose not retrieved
- How often
- Not established
A pioneering anti-HIV peptide that stops the virus fusing with cells, now discontinued in the US.
- Dose
- 90 mg twice daily (label)
- How often
- Twice daily
Guides for this compound
- How to Reconstitute a Peptide
Mix peptide powder with bacteriostatic water, step by step.
- How to Read an Insulin Syringe
Read the units, convert to millilitres, and draw the exact dose.
- mcg vs mg: The Peptide Dosing Mistake to Avoid
Your vial says mg and your protocol says mcg. Here is the conversion and how to check it.
Sources
- Hepcludex US prescribing information (2026)(2026)8.5 mg daily; boxed warning on flares after stopping; injection-site reactions 30% against 0%; half-life 3 hours; 47-residue myristoylated amide; MYR301 week 48, 96 and 144 results.
- FDA risk assessment and risk mitigation review, BLA 761468(2026)First approval in Russia in November 2019; complete response letter 18 October 2022; dose-recovery data showing the '10 mg' arm received about 8.5 mg; approval timeline and postmarketing outcomes study.
- Drugs@FDA, BLA 761468(2026)Accelerated approval 22 May 2026 with orphan status.
- EMA, Hepcludex EPAR(2026)Conditional approval 31 July 2020, converted to full approval 18 July 2023; indication extended to children aged 3 and over.
- Hepcludex EU summary of product characteristics(2026)2 mg daily; paediatric weight bands; half-life 4 to 7 hours.
- FDA GSRS substance record, bulevirtide (UNII WKM56H3TLB)(2026)Recommended INN; CAS 2012558-47-1; 47-residue sequence.
- Wedemeyer H et al., New England Journal of Medicine 2023;389:22-32 (MYR301)(2023)150 adults: combined response at week 48 in 45% (2 mg) and 48% (10 mg) against 2% with delayed treatment; no loss of hepatitis B surface antigen.
- Gilead Medical Information, MYR301 overview(2026)Week 144 safety by arm and off-treatment follow-up: most relapses within 24 weeks of stopping.
- Gilead, MYR204 published in NEJM (6 Jun 2024)(2024)With peginterferon, undetectable virus 24 weeks after stopping in 32% (2 mg) and 46% (10 mg), against 17% on peginterferon alone and 12% on bulevirtide alone.
- Gilead, US accelerated approval (May 2026)(2026)First and only approved treatment for chronic hepatitis delta in the US.
- TGA, Australian public assessment report(2026)Australian approval in 2024; Great Britain 2021 and Switzerland 2024 approval dates.
- Gilead completes acquisition of MYR GmbH (Mar 2021)(2021)Acquisition closed 4 March 2021.
Beyond these, 329 records are indexed. Browse the records