Hepatitis B
Recent clinical, regulatory, research and industry developments relating to this disease.
What's happening now
An analyst briefing on current research, clinical, regulatory and industry activity surrounding this disease.
- 3 clinical trials expected to report results, the earliest in Q4 2027.
- 12 industry developments reported.
- Q4 2027Tenofovir Alafenamide Versus Entecavir for the Treatment of Chronic Hepatitis B: An Open Label, Randomized Controlled Trial
- Q1 2028A Prospective, Multi-national, Multi-center, Open-label, Randomized, Active Controlled, Parallel Group, Operationally Seamless Phase II/III Clinical Study to Evaluate the Immunogenicity, Safety and Lot-to-lot Consistency of LBVD, a Fully Liquid Hexavalent Diphtheria-tetanus-whole Cell Pertussis-hepatitis B-poliovirus (Inactivated)-Haemophilus Influenzae Type b Conjugate (DTwP-HepB-IPV-Hib) Vaccine, Compared to Co-administration of DTwP-HepB-Hib Vaccine and IPV Vaccine in Healthy Infants at 6-, 10-, and 14-week of Age as Primary Series
- Q4 2030Sodium-glucose Co-transporter-2 Inhibitor (SGLT2i) to Prevent of Liver Complications in Patients With Chronic Hepatitis B and Diabetes Mellitus: a Double-blind, Randomised, Placebo-controlled Trial
Clinical MilestonesView all 9Hide
- 2026-09-03A Prospective, Multi-national, Multi-center, Open-label, Randomized, Active Controlled, Parallel Group, Operationally Seamless Phase II/III Clinical Study to Evaluate the Immunogenicity, Safety and Lot-to-lot Consistency of LBVD, a Fully Liquid Hexavalent Diphtheria-tetanus-whole Cell Pertussis-hepatitis B-poliovirus (Inactivated)-Haemophilus Influenzae Type b Conjugate (DTwP-HepB-IPV-Hib) Vaccine, Compared to Co-administration of DTwP-HepB-Hib Vaccine and IPV Vaccine in Healthy Infants at 6-, 10-, and 14-week of Age as Primary SeriesResults expected Q1 2028
- 2026-05-14Tenofovir Alafenamide Versus Entecavir for the Treatment of Chronic Hepatitis B: An Open Label, Randomized Controlled TrialResults expected Q4 2027
- 2026-03-18Sodium-glucose Co-transporter-2 Inhibitor (SGLT2i) to Prevent of Liver Complications in Patients With Chronic Hepatitis B and Diabetes Mellitus: a Double-blind, Randomised, Placebo-controlled TrialResults expected Q4 2030
- 2026-07-28A Single-Arm, Open-Label, Multicenter Phase III Clinical Trial to Evaluate the Safety of Hydronidone Capsules in Patients With Hepatic Fibrosis and Liver CirrhosisCompleted
- 2026-06-30A Multicenter Prospective Open-label Single Arm Trial to Safely Discontinue Antiviral Treatment in Patients With HBeAg-Negative Chronic Hepatitis B and Low HBsAg Concentrations (ADAPT)Completed
- 2026-04-20Therapeutic Efficacy of SB Flavon in the Treatment of Advanced (F3-F4) HBV-related Cirrhosis and Hepatocellular CarcinomaCompleted
- 2026-04-15Phase 3 Multicenter, Randomized, Double-Blind, Study to Assess the Efficacy and Safety of Treatment With Bepirovirsen in Nucleos(t)Ide Analogue-treated Participants With Chronic Hepatitis B Virus (B-Well 1)Completed
- 2026-02-20An Observer-blind, Randomized, Active-controlled, Multi-centric Phase III Study to Assess Immunogenicity and Safety of Hexavalent (DTwP-Hepatitis B-IPV-Hib) Vaccine Containing Reduced Dose IPV in Comparison With HEXASIIL®Completed
Industry & MarketView all 12Hide
- 2026-10-22A hepatitis B hold lifted and drug tabled; Ultomiris' accelerated approvalRegulatory news · Endpoints News
- 2026-10-21FDA OKs Hibsago as first antisense for chronic hepatitis BRegulatory news · Healio Gastroenterology
- 2026-10-21GSK, Ionis win US approval for first-of-its-kind hepatitis B drugRegulatory news · BioPharma Dive
- 2026-10-21FDA approves GSK’s Hibsago as first functional cure for hepatitis BRegulatory news · Pharmaceutical Technology
- 2026-10-20FDA Approves First-of-Its-Kind Chronic Hepatitis B TreatmentRegulatory news · FDA Press Releases
- 2026-12-01ClinicalComparison of Immunogenicity and Safety of DTP-HB-Hib Using New Hepatitis B Bulk (Bio Farma) With Pentabio® Vaccine Primed With Recombinant Hepatitis B at Birth Dose Using New Hepatitis B Bulk (Bio Farma), in Indonesian InfantsWithdrawn
- 2026-10-30IndustryLiver Cancer Awareness Month: The importance of universal hepatitis B vaccinationIndustry · Healio Gastroenterology
- 2026-10-22IndustryA hepatitis B hold lifted and drug tabled; Ultomiris' accelerated approvalRegulatory news · Endpoints News
- 2026-10-21IndustryFDA OKs Hibsago as first antisense for chronic hepatitis BRegulatory news · Healio Gastroenterology
- 2026-10-21IndustryGSK, Ionis win US approval for first-of-its-kind hepatitis B drugRegulatory news · BioPharma Dive
- 2026-10-21IndustryFDA approves GSK’s Hibsago as first functional cure for hepatitis BRegulatory news · Pharmaceutical Technology
- 2026-10-21IndustryGSK gets FDA approval for hepatitis B drug that offers functional cureRegulatory news · Endpoints News
- 2026-10-21IndustryNot Just Moms Who Put Unvaccinated Infants at Risk of Hepatitis B, Study ShowsResearch news · MedPage Today — Gastroenterology
- 2026-10-20IndustryFDA Approves First-of-Its-Kind Chronic Hepatitis B TreatmentRegulatory news · FDA Press Releases
- 2026-10-19IndustryStudy Warns of More Chronic Hepatitis B in the Years AheadResearch news · MedPage Today — Infectious Disease
Therapeutic landscape
Therapies with a regulatory footing for this condition, alongside the wider set of agents co-studied with it in the literature.
Generic approval — Eltrombopag Accord is indicated for the treatment of adult patients with primary immune t… (2025)
Product authorisation ended — Exviera is indicated in combination with other medicinal products for the treatment of ch… (2024)
Product authorisation ended — Rebetol is indicated in combination with other medicinal products for the treatment of ch… (2023)
Original application approval — Jayempi is indicated in combination with other immunosuppressive agents for the prophylax… (2021)
Original application approval — Hepcludex is indicated for the treatment of chronic hepatitis delta virus (HDV) infection… (2020)
Generic approval — Entecavir Accord is indicated for the treatment of chronic hepatitis B virus (HBV) infect… (2017)
Original application approval — Vemlidy is indicated for the treatment of chronic hepatitis B (CHB) in adults and paediat… (2017)
Generic approval — HIV-1 infection Tenofovir disoproxil 245 mg film-coated tablets are indicated in combinat… (2016)
Generic approval — HIV?1 infection Tenofovir disoproxil Zentiva is indicated in combination with other antir… (2016)
Clinical trials
The current development programme across all trial phases.
Regulatory timeline
Drug regulatory events matched to this condition by indication — EMA.
European Medicines Agency (CC BY 4.0). Events are matched to this condition by drug indication text — approvals/updates for drugs indicated for it, not disease-specific acts.
Research activity
Key research shaping understanding of this disease, combining the latest publications with the most influential evidence.
Major themes3
- Hepatitis B2
- Infectious Disease Transmission, Vertical1
- Liver Neoplasms1
Leading journals3
- The lancet. Gastroenterology & hepatology2
- Gastroenterology1
- Gut and liver1
Leading researchers5
- Blechacz B1
- Llovet JM1
- Nault JC1
- Villanueva A1
- Zucman-Rossi J1
Affiliations (unnormalised)3
- Institut Universitaire d'Hematologie1
- The University of Texas MD Anderson Cancer Center1
- Tisch Cancer Institute1
Associated genes
Genes associated with this disease in the canonical knowledge graph (Open Targets evidence). Number shows the association score.
Disease biology
Proteins whose encoding gene is associated with this disease, reached through the canonical gene→disease graph. Number shows the gene's association score.
Related conditions
Diseases frequently studied alongside this one. Number shows shared papers.
Reference
Authoritative identity, definition & identifiers.
INFLAMMATION of the LIVER in humans caused by a member of the ORTHOHEPADNAVIRUS genus, HEPATITIS B VIRUS. It is primarily transmitted by parenteral exposure, such as transfusion of contaminated blood or blood products, but can also be transmitted via sexual or intimate personal contact.
- Disease identity & definition — NLM Medical Subject Headings (MeSH), public domain
- Clinical trials — ClinicalTrials.gov (U.S. National Library of Medicine)
- Research activity — Europe PMC (EMBL-EBI) + OpenAlex-derived paper links
- Related entities are derived from literature co-mention (studied together) — associative, not causal.