Drug

hepatitis B immune globulin

Established medicine

ClassSurface antigen (HBsAg) binding agentResearchOngoing clinical research

Also known as Bayhep B, HBIG, HUMAN HEPATITIS B VIRUS IMMUNE GLOBULIN, HepaGam B+13 more

Bayhep B, HBIG, HUMAN HEPATITIS B VIRUS IMMUNE GLOBULIN, HepaGam B, Hepatitis B immune globulin intravenous (human), Hepatitis B immunoglobulin (human), Hepatitis B surface antigen immunoglobulin, Human hepatitis B immunoglobulin, Human hepatitis-B immunoglobulin, Hyperhep B, Nabi-HB, Nabi-HB Novaplus, HEPATITIS B IMMUNE GLOBULIN,HUMAN, Hepatitis B Immune Globulin (Human), Hepatitis B immune globulin human, hepatitis B immunoglobin, hepatitis B immunoglobulin.

RxNorm26744 ChEMBLCHEMBL2108512 ATCJ06BB04UNIIXII270YC6M

Active clinical trials

Surface antigen (HBsAg)

Primary target

Regulatory events

Latest activity

beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Study on Novel Immunomodulatory Therapeutic Regimens for Clinical Cure of Chronic Hepatitis B and Efficacy Prediction

Clinical trial2026-01-09Results expected Q4 2028 · ClinicalTrials.gov

Lung Transplantation Using Hepatitis B Positive Donors to Hepatitis B Negative Recipients Using Ex-Vivo Treatment of Organs: A Safety Trial

Clinical trial2025-11-17Results expected Q3 2027 · ClinicalTrials.gov

Use of Hepatitis B Immune Globulin (HBIg) to Restore Immune Control in Patients With Chronic Hepatitis B

Clinical trial2022-03-29Withdrawn · ClinicalTrials.gov

Comparative Study of the Immunogenicity and Protective Efficacy of GlaxoSmithKline Biologicals' Rec-DNA Hepatitis B Vaccine With or Without Hepatitis B Immunoglobulins (HBIg) in Newborns of HBeAg+ Mothers.

Clinical trial2016-12-07Results posted · ClinicalTrials.gov

Efficacy and Safety of Niuliva® for the Prevention of Hepatitis B Virus Recurrence in Newly Orthotopic Liver Transplant Recipients.

Clinical trial2016-02-25Results posted · ClinicalTrials.gov

HBIG for Prevention of Mother-to-infant HBV Transmission

Clinical trial2014-08-01Completed · ClinicalTrials.gov

A Phase 2, Open-Label Randomized Study to Evaluate the Efficacy and Safety of the Combination Product, Emtricitabine/Tenofovir Disoproxil Fumarate in the Presence or Absence of Hepatitis B Immunoglobulin (HBIg) in Preventing Recurrence of Chronic Hepatitis B (CHB) Post-Orthotopic Liver Transplant (OLT)

Clinical trial2014-03-14Results posted · ClinicalTrials.gov

Evaluation of HepaGam B® in Combination With Antiviral Treatment in Hepatitis B Liver Transplant Patients

Clinical trial2013-10-01Completed · ClinicalTrials.gov

A Phase 3, Multicenter, Open Label Study to Assess the Safety and Efficacy of Nabi-HB Administered Subcutaneously in Patients With Hepatitis B Virus Associated Liver Disease Who Underwent Liver Transplantation

Clinical trial2010-09-01Withdrawn · ClinicalTrials.gov

Approval: Zutectra (EMA)

Regulatory2009-11-30EMA

A Phase II, Multicenter, Randomized, Open-Label, Dose-Ranging, Parallel Group Study to Compare the Anti-Viral Effects, Pharmacokinetics and Safety of HepeX-Bä, a Mixture of Two Monoclonal Antibodies, as Compared to Hepatitis B Immune Globulin in Patients Who Have Received Hepatic Allografts for Treatment of End-Stage Liver Disease Due to Hepatitis B Virus Infection

Clinical trial2005-08-01Terminated · ClinicalTrials.gov

Study to Assess the Pharmacokinetics of Intravenous Nabi 5% Hepatitis B Immune Globulin Used in Combination With Lamivudine

Clinical trial2002-02-01Completed · ClinicalTrials.gov

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name

hepatitis B immune globulin

Aliases & brands

Bayhep BHBIGHUMAN HEPATITIS B VIRUS IMMUNE GLOBULINHepaGam BHepatitis B immune globulin intravenous (human)Hepatitis B immunoglobulin (human)Hepatitis B surface antigen immunoglobulinHuman hepatitis B immunoglobulinHuman hepatitis-B immunoglobulinHyperhep BNabi-HBNabi-HB NovaplusHEPATITIS B IMMUNE GLOBULIN,HUMANHepatitis B Immune Globulin (Human)Hepatitis B immune globulin humanhepatitis B immunoglobinhepatitis B immunoglobulin

RxNorm CUI

26744

ChEMBL ID

CHEMBL2108512

ATC codes

J06BB04

UNII

XII270YC6M

Primary mechanism

Surface antigen (HBsAg) binding agent

Regulatory jurisdictions

ema

Pharmacology & targets

1 target

Known molecular targets and mechanisms supported by curated pharmacology databases.

Surface antigen (HBsAg)

Q81158

BINDING AGENTSurface antigen (HBsAg) binding agent

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval

2009-11-30

Latest approval

2009-11-30

Authorities

EMA

Total events

emaEuropean Medicines Agency· 1 event

2009-11-30Approval

Approval: Zutectra (EMA)

Indication: Prevention of hepatitis B virus (HBV) re-infection in HBsAg and HBV-DNA negative adult patients at least one week after liver transplantation for hepatitis B induced liver… Show full indication

Prevention of hepatitis B virus (HBV) re-infection in HBsAg and HBV-DNA negative adult patients at least one week after liver transplantation for hepatitis B induced liver failure. HBV-DNA negative status should be confirmed within the last 3 months prior to OLT. Patients should be HBsAg negative before treatment start. The concomitant use of adequate virostatic agents should be considered as standard of hepatitis B re-infection prophylaxis.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.