FDA Approves Hepcludex (bulevirtide) for Chronic Hepatitis Delta Virus InfectionFDA approves new drug Hepcludex for chronic hepatitis delta infection.

FDA Published May 28, 2026 DOI ↗ Editorial oversight: Dr. Amelia Tan, PhD · Internal Medicine & Chronic Disease

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Key Takeaway

Consider Hepcludex for chronic HDV infection in adults without cirrhosis or with compensated cirrhosis; confirmatory trials are pending.

The FDA has approved Hepcludex (bulevirtide) for the treatment of chronic hepatitis delta virus (HDV) infection in adults without cirrhosis or with compensated cirrhosis. This is the first HDV attachment inhibitor targeting the sodium taurocholate co-transporting polypeptide (NTCP) receptor. The approval is under accelerated approval based on a decrease in HDV RNA and ALT normalization; improvement in clinical outcomes has not been established. Clinicians should note that continued approval may depend on confirmatory trials. The recommended dose is 8.5 mg once daily by subcutaneous injection.

＋ Clinical Details (Mechanism · Dosing · Trial Data · Warnings)

Mechanism of Action

Hepcludex is a sodium taurocholate co-transporting polypeptide (NTCP)-directed HDV attachment inhibitor.

Indication & Patient Population

Hepcludex is indicated for the treatment of chronic hepatitis delta virus (HDV) infection in adults without cirrhosis or with compensated cirrhosis. This indication is approved under accelerated approval based on a decrease in HDV RNA and alanine aminotransferase (ALT) normalization. An improvement in disease-related clinical outcomes has not been established.

Dosing & Administration

The recommended dosage in adults is Hepcludex 8.5 mg once daily administered by subcutaneous injection. Hepcludex should be continued as long as it is associated with a response to treatment. The optimal treatment duration is unknown. Manage underlying HBV infection as clinically appropriate. If a dose is missed, take it as soon as possible; if almost time for next dose, skip the missed dose. Reconstitute lyophilized powder with 1 mL Sterile Water for Injection and administer immediately. Inject into upper thigh, lower abdomen, or back of upper arm (if given by caregiver).

Key Clinical Trial Data

Efficacy was evaluated in Trial MYR301 (NCT03852719), a Phase 3 open-label trial in 100 participants with chronic HDV infection without cirrhosis or with compensated cirrhosis. Participants received Hepcludex 8.5 mg once daily (protocol specified 10 mg; dose recovery showed 8.5 mg) for 144 weeks or delayed treatment (48-week observation then 96 weeks of Hepcludex). At week 48, combined response (undetectable HDV RNA or ≥2 log10 decline and ALT normalization) was 48% with Hepcludex vs 2% with delayed treatment (p<0.0001). Virologic response was 76% vs 4%, and ALT normalization was 56% vs 12%. Undetectable HDV RNA (<50 IU/mL) was 20% vs 0%.

Warnings & Contraindications

Not reported in label.

Place in Therapy

Hepcludex is a first-in-class HDV attachment inhibitor for chronic HDV infection. It is approved under accelerated approval; clinical benefit has not been established. It should be used in patients without cirrhosis or with compensated cirrhosis. Management of underlying HBV infection is recommended.

The FDA has approved a new drug called Hepcludex (bulevirtide) for adults with chronic hepatitis delta virus (HDV) infection. This is the first treatment that works by blocking the virus from entering liver cells. It is for patients who do not have cirrhosis or who have compensated cirrhosis (where the liver still works well).

The approval is based on studies showing that the drug lowered HDV levels in the blood and helped normalize liver enzyme levels (ALT). However, it has not yet been proven that Hepcludex improves how patients feel or prevents long-term liver damage. The FDA granted accelerated approval, which means the drug is available now but the company must do more studies to confirm its benefits.

Hepcludex is given as a shot under the skin once a day. The recommended dose is 8.5 mg. Common side effects may include injection site reactions, headache, and fatigue. If you have chronic hepatitis delta, talk to your doctor about whether this new option is right for you. This is a promising step, but it is important to understand what is known and what is still being studied.

What this means for you:

Hepcludex is a new daily shot for chronic hepatitis delta, but its long-term benefits are still being studied.

Study Details

Study typeFda approval

PublishedMay 2026

View Original Abstract ↓

1 INDICATIONS AND USAGE HEPCLUDEX is indicated for the treatment of chronic hepatitis delta virus (HDV) infection in adults without cirrhosis or with compensated cirrhosis. This indication is approved under accelerated approval based on a decrease in HDV RNA and alanine aminotransferase (ALT) normalization [see Clinical Studies (14) ] . An improvement in disease-related clinical outcomes has not been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). HEPCLUDEX is a sodium taurocholate co-transporting polypeptide (NTCP)-directed HDV attachment inhibitor indicated for the treatment of chronic HDV infection in adults without cirrhosis or with compensated cirrhosis. This indication is approved under accelerated approval based on participants who achieved a decrease in HDV RNA and alanine aminotransferase (ALT) normalization. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). ( 1 , 14 )

FDA Approves Hepcludex (bulevirtide) for Chronic Hepatitis Delta Virus InfectionFDA approves new drug Hepcludex for chronic hepatitis delta infection.

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FDA Approves Hepcludex (bulevirtide) for Chronic Hepatitis Delta Virus InfectionFDA approves new drug Hepcludex for chronic hepatitis delta infection.

Study Details

Intrawound tobramycin plus vancomycin did not reduce deep infection risk compared with vancomycin alone in high-risk tibial fractures

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Clinical research that matters. Delivered to your inbox.

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