> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/asset/hepatitis-b-virus-hbsag-surface-protein-antigen-a0d15154-d06d-47ee-80fb-c09a6db24d99 > Record changed: 2026-10-13 # Hepatitis B virus hbsag surface protein antigen Highest phase reached Approved Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4297973) Drug type Vaccine component Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4297973) First approval year 1996 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4297973) ## Development status **First approval year** 1996 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4297973) **Listing at source** Listed **Highest phase reached** Approved Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4297973) ## Names and chemistry **Drug type** Vaccine component Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4297973) **Drug name** Hepatitis B virus hbsag surface protein antigen Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4297973) ### Brand names (36) - ambirix - Ambirix - fendrix - Fendrix - hbvaxpro - Hbvaxpro - hepatitis b virus hbsag surface protein antigen component of hexacima - Hepatitis b virus hbsag surface protein antigen component of hexacima - hepatitis b virus hbsag surface protein antigen component of hexavac - Hepatitis b virus hbsag surface protein antigen component of hexavac - hepatitis b virus hbsag surface protein antigen component of hexyon - Hepatitis b virus hbsag surface protein antigen component of hexyon - hepatitis b virus hbsag surface protein antigen component of infanrix hepb - Hepatitis b virus hbsag surface protein antigen component of infanrix hepb - hepatitis b virus hbsag surface protein antigen component of infanrix hexa - Hepatitis b virus hbsag surface protein antigen component of infanrix hexa - hepatitis b virus hbsag surface protein antigen component of infanrix penta - Hepatitis b virus hbsag surface protein antigen component of infanrix penta - hepatitis b virus hbsag surface protein antigen component of primavax - Hepatitis b virus hbsag surface protein antigen component of primavax - hepatitis b virus hbsag surface protein antigen component of quintanrix - Hepatitis b virus hbsag surface protein antigen component of quintanrix - hepatitis b virus hbsag surface protein antigen component of tritanrix hepb - Hepatitis b virus hbsag surface protein antigen component of tritanrix hepb - hepatitis b virus hbsag surface protein antigen component of vaxelis And 11 more, listed on the interactive page. ### Other names (64) - Adjuvanted Hepatitis B surface antigen (HBsAg) candidate vaccine GSK2231392A. - adjuvanted hepatitis b surface antigen hbsag candidate vaccine gsk2231392a - adsorbed hepatitis b vaccine - Adsorbed hepatitis b vaccine - ADSORBED HEPATITIS B VACCINE \[JAN\] - adsorbed hepatitis b vaccine jan - Fendrix - FENDRIX - Fendrix™ - GSK Biologicals' Engerix TM vaccine (Hepatitis B vaccine) - hbsag - Hbsag - HBsAg - HBsAg (Booster injection) - HBV (Hepatitis B vaccine) - HBVaxPro - HBVAXPRO - HBVAXPRO™ - hepatitis b antigen - Hepatitis b antigen - hepatitis b surface antigen - Hepatitis b surface antigen - Hepatitis b surface antigen (rdna) - HEPATITIS B SURFACE ANTIGEN (RDNA) \[EMA EPAR\] - HEPATITIS B SURFACE ANTIGEN \[VANDF\] And 39 more, listed on the interactive page. ## Identifiers **ChEMBL ID** CHEMBL4297973 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4297973) **FDA ingredient codes (UNII)** - IFJ010MNE4 ### RxNorm IDs (RxCUI) (2) - 797752 - 1427171 ## Regulatory information ### Other regulatory facts **Patents** 0 **Designations** 0 **Earliest recorded loss of exclusivity** 30 Nov 2033 **First in class** No **Fast track** No **Breakthrough designation** No **Orphan designation** No **Priority review** No **Orphan exclusivity** No **Accelerated approval** No ## Pharmacology ### Drug classification **Drug name stem** vir- ### Mechanisms of action - **Mechanism** Surface antigen (HBsAg) vaccine antigen **Action type** VACCINE\_ANTIGEN **Target** Surface antigen (HBsAg) **Protein identifier** Q81158 ### Open Targets mechanisms - **Mechanism** Surface antigen (HBsAg) vaccine antigen **Action type** VACCINE ANTIGEN **Target** Surface antigen (HBsAg) ### Investigated indications (23) - **Condition** Infections **Highest recorded phase** 3 **Condition identifier** EFO:0000544 **Subject identifier** D007239 - **Condition** Whooping Cough **Highest recorded phase** 4 **Condition identifier** EFO:0000650 **Subject identifier** D014917 - **Condition** HIV Infections **Highest recorded phase** 2 **Condition identifier** EFO:0000764 **Subject identifier** D015658 - **Condition** Malaria **Highest recorded phase** 1 **Condition identifier** EFO:0001068 **Subject identifier** D008288 - **Condition** Liver Cirrhosis **Highest recorded phase** 2 **Condition identifier** EFO:0001422 **Subject identifier** D008103 - **Condition** Pancreatic Neoplasms **Highest recorded phase** 1 **Condition identifier** EFO:0002618 **Subject identifier** D010190 - **Condition** Inflammatory Bowel Diseases **Highest recorded phase** 1 **Condition identifier** EFO:0003767 **Subject identifier** D015212 - **Condition** Hepatitis B **Highest recorded phase** 4 **Condition identifier** EFO:0004197 **Subject identifier** D006509 - **Condition** Hepatitis B, Chronic **Highest recorded phase** 4 **Condition identifier** EFO:0004197 **Subject identifier** D019694 - **Condition** Hepatitis B, Chronic **Highest recorded phase** 4 **Condition identifier** EFO:0004239 **Subject identifier** D019694 - **Condition** Meningococcal Infections **Highest recorded phase** 3 **Condition identifier** EFO:0004249 **Subject identifier** D008589 - **Condition** Vaccination **Highest recorded phase** 4 **Condition identifier** EFO:0004292 **Subject identifier** D014611 - **Condition** Diphtheria **Highest recorded phase** 4 **Condition identifier** EFO:0005549 **Subject identifier** D004165 - **Condition** Tetanus **Highest recorded phase** 4 **Condition identifier** EFO:0005593 **Subject identifier** D013742 - **Condition** Condylomata Acuminata **Highest recorded phase** 3 **Condition identifier** EFO:0007147 **Subject identifier** D003218 - **Condition** Hepatitis E **Highest recorded phase** 3 **Condition identifier** EFO:0007303 **Subject identifier** D016751 - **Condition** Hepatitis A **Highest recorded phase** 4 **Condition identifier** EFO:0007305 **Subject identifier** D006506 - **Condition** Hookworm Infections **Highest recorded phase** 1 **Condition identifier** EFO:0007314 **Subject identifier** D006725 - **Condition** Poliomyelitis **Highest recorded phase** 4 **Condition identifier** EFO:0007450 **Subject identifier** D011051 - **Condition** Warts **Highest recorded phase** 1 **Condition identifier** EFO:0009662 **Subject identifier** D014860 - **Condition** Meningitis, Haemophilus **Highest recorded phase** 4 **Condition identifier** EFO:1000955 **Subject identifier** D008583 - **Condition** Schistosomiasis **Highest recorded phase** 1 **Condition identifier** EFO:1001475 **Subject identifier** D012552 - **Condition** Streptococcal Infections **Highest recorded phase** 3 **Condition identifier** EFO:1001476 **Subject identifier** D013290 ### Open Targets indications (35) - **Condition identifier** EFO\_0000544 **Highest recorded phase** 3 - **Condition identifier** EFO\_0000650 - **Condition identifier** EFO\_0000764 **Highest recorded phase** 3 - **Condition identifier** EFO\_0001068 **Highest recorded phase** 1 - **Condition identifier** EFO\_0002618 **Highest recorded phase** 1 - **Condition identifier** EFO\_0003767 **Highest recorded phase** 1 - **Condition identifier** EFO\_0004197 - **Condition identifier** EFO\_0004239 **Highest recorded phase** 3 - **Condition identifier** EFO\_0004249 **Highest recorded phase** 3 - **Condition identifier** EFO\_0005549 - **Condition identifier** EFO\_0005593 - **Condition identifier** EFO\_0007147 **Highest recorded phase** 3 - **Condition identifier** EFO\_0007303 **Highest recorded phase** 3 - **Condition identifier** EFO\_0007305 - **Condition identifier** EFO\_0007314 **Highest recorded phase** 1 - **Condition identifier** EFO\_0007450 - **Condition identifier** EFO\_0009662 - **Condition identifier** EFO\_1000955 - **Condition identifier** EFO\_1001475 - **Condition identifier** HP\_0012115 **Highest recorded phase** 3 - **Condition identifier** MONDO\_0000889 **Highest recorded phase** 4 - **Condition identifier** MONDO\_0001209 **Highest recorded phase** 1 - **Condition identifier** MONDO\_0004986 **Highest recorded phase** 2 - **Condition identifier** MONDO\_0005077 **Highest recorded phase** 4 - **Condition identifier** MONDO\_0005109 **Highest recorded phase** 3 And 10 more, listed on the interactive page. ### Reported adverse events (108) - **Event** abdominal discomfort **Reports** 6 **Reporting signal score** 6.50919 - **Event** abdominal pain **Reports** 13 **Reporting signal score** 14.1647 - **Event** abdominal wall disorder **Reports** 4 **Reporting signal score** 25.3918 - **Event** abortion **Reports** 4 **Reporting signal score** 15.7 - **Event** alanine aminotransferase increased **Reports** 6 **Reporting signal score** 7.15957 - **Event** anaphylactic reaction **Reports** 11 **Reporting signal score** 21.7588 - **Event** antibody test abnormal **Reports** 2 **Reporting signal score** 9.67491 - **Event** appetite disorder **Reports** 8 **Reporting signal score** 36.1346 - **Event** areflexia **Reports** 2 **Reporting signal score** 6.52577 - **Event** arthralgia **Reports** 11 **Reporting signal score** 7.55666 - **Event** arthritis infective **Reports** 7 **Reporting signal score** 30.1429 - **Event** asthenia **Reports** 14 **Reporting signal score** 12.7455 - **Event** back pain **Reports** 10 **Reporting signal score** 10.9353 - **Event** bacterial disease carrier **Reports** 2 **Reporting signal score** 9.8234 - **Event** blister **Reports** 10 **Reporting signal score** 23.6316 - **Event** chills **Reports** 13 **Reporting signal score** 23.2953 - **Event** chlamydia serology positive **Reports** 1 **Reporting signal score** 7.59909 - **Event** cholangitis sclerosing **Reports** 2 **Reporting signal score** 7.3826 - **Event** chronic gastritis **Reports** 2 **Reporting signal score** 7.53729 - **Event** chronic hepatitis b **Reports** 2 **Reporting signal score** 10.6764 - **Event** coagulation time shortened **Reports** 2 **Reporting signal score** 10.288 - **Event** constipation **Reports** 8 **Reporting signal score** 7.458 - **Event** contusion **Reports** 8 **Reporting signal score** 13.6565 - **Event** dermatitis **Reports** 5 **Reporting signal score** 13.1992 - **Event** dermatitis exfoliative **Reports** 3 **Reporting signal score** 8.03284 And 83 more, listed on the interactive page. ### Trial references (68) - NCT00000633 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00000633) - NCT00000745 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00000745) - NCT00272493 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00272493) - NCT02109354 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02109354) - NCT00003434 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00003434) - NCT00120796 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00120796) - NCT00197158 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00197158) - NCT00329576 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00329576) - NCT00335881 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00335881) - NCT00356564 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00356564) - NCT00393523 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00393523) - NCT00414050 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00414050) - NCT00426712 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00426712) - NCT00440531 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00440531) - NCT00480116 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00480116) - NCT00489099 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00489099) - NCT00498212 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00498212) - NCT00501124 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00501124) - NCT00508833 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00508833) - NCT00697125 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00697125) - NCT00697242 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00697242) - NCT00697840 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00697840) - NCT00697931 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00697931) - NCT00697970 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00697970) - NCT00698087 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00698087) And 43 more, listed on the interactive page. ## Chemical properties **Prodrug** No **Chirality** Single enantiomer **Inorganic** No **Natural product** No ## Related records ### Trials (204) - A Controlled Study to Evaluate the Safety and Immunogenicity of StreptAnova™ in Healthy Adults - A Hepatitis B Vaccine Challenge Study After Previous Vaxelis® Vaccination (V419-013) - A Heterologous Protein Prime/MVA Boost Therapeutic Hepatitis B Vaccine Candidate - A Multicenter Study of AHB-137 Injection Combined With Other Hepatitis B Drugs - A Phase I Multicenter Clinical Trial to Evaluate the Safety and Immunogenicity of Immuno-AG Recombinant HIV gp160 in Asymptomatic HIV Seropositive Individuals - A Phase I Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety and Immunogenicity of HIV-1 Recombinant Envelope Glycoprotein gp160 - A Phase Ib Study of the Safety, Reactogenicity, and Immunogenicity of Sm-TSP-2/Alhydrogel)(R) With or Without AP 10-701 for Intestinal Schistosomiasis in Healthy Exposed Adults - A Phase Ib Trial of MSP 3 LSP in 1-2 Year Old Children in Burkina Faso - A Pilot Study Comparing the Immunogenicity of Fendrix vs. Double-dose Engerix B in HIV-infected Non-responders to Standard Hepatitis B Vaccination Courses - A Randomised Controlled Phase 1 Study of Vaccine Therapy for Control or Cure of Chronic Hepatitis B Virus Infection - A Randomized Phase I Study of a Hepatitis B Antigen Combined With IMP321 - A Randomized,Parallel-group Clinical Trial of Hepatitis B Vaccine With Different Dosages and Schedules in Healthy Adults - A Research Study to Test Safety, Tolerability, and Immunogenicity of a Recombinant Hepatitis B Vaccine Manufactured With an Upgrade to the Production Process (V232-054) - A Study of 2 Doses of a Hepatitis B Vaccine (V232 RECOMBIVAX HB) in Healthy Infants (V232-057) - A Study of a Quadrivalent Meningococcal Tetanus Protein Conjugate Vaccine in Infants and Toddlers - A Study on the Safety and Immune Response of AS37 Together With Hepatitis B Antigen in Adults Aged 18-45 Years - A Study to Assess the Anamnestic Immune Response in Healthy 4 to 7 Year-old Children After a Primary Vaccination Series With Either HEXAVAC® or INFANRIX®-HEXA - A Study to Characterise Immune Responses Following Immunisations With "Fendrix" or "Engerix B" Hepatitis B Vaccines - A Study to Compare the Immune Response and Safety Elicited by Henogen's Adjuvanted Hepatitis B Vaccine Compared to Aventis Pasteur MSD's Hepatitis B Vaccine in Pre-Dialysis and Dialysis Patients Who Responded to Previous Hepatitis B Vaccination But Lost Antibody. - A Study to Compare the Immune Response and Safety Elicited by Henogen's Adjuvanted Hepatitis B Vaccine Compared to GSK Biologicals Adjuvanted Hepatitis B Vaccine in Pre-Dialysis and Dialysis Patients Who Have Not Been Exposed to Hepatitis B. ### Approved for (8) - [Chronic hepatitis B virus infection](https://trialight.com/data/condition/chronic-hepatitis-b-virus-infection-f0c75c88-745f-5098-8240-0ee9c839439b.md) - [Diphtheria](https://trialight.com/data/condition/diphtheria-1a3815ca-3ad9-5b77-b86f-11d55e29e9fa.md) - Haemophilus meningitis - Hepatitis A virus infection - [Hepatitis B virus infection](https://trialight.com/data/condition/hepatitis-b-virus-infection-63cb6d13-50c4-5e97-86fd-ce5481d9d1c6.md) - [Pertussis](https://trialight.com/data/condition/pertussis-810232d3-8d41-590a-8f38-1061f23d3a9f.md) - [Poliomyelitis](https://trialight.com/data/condition/poliomyelitis-5f8120f0-b67f-5e12-862f-914f03ab5ac7.md) - [Tetanus](https://trialight.com/data/condition/tetanus-a589c209-81c5-56e6-8a55-6d96fedb2c61.md) ### In development for (12) - Anogenital human papillomavirus infection Phase 3 - [Cirrhosis of liver](https://trialight.com/data/condition/cirrhosis-of-liver-d90e4a84-9e82-54fc-a553-1e42086e8382.md) Phase 2 - Common wart Phase 1 - Exocrine pancreatic carcinoma Phase 1 - Hepatitis E virus infection Phase 3 - [HIV infectious disease](https://trialight.com/data/condition/hiv-infectious-disease-1260f28c-d667-55f9-b221-15d5017fde05.md) Phase 2 - [Hookworm infectious disease](https://trialight.com/data/condition/hookworm-infectious-disease-107a1301-397c-5b97-8f5c-c89fba1a9d8a.md) Phase 1 - [Inflammatory bowel disease](https://trialight.com/data/condition/inflammatory-bowel-disease-619080ac-2d43-5ad3-b078-9699e1241655.md) Phase 1 - [Malaria](https://trialight.com/data/condition/malaria-54828cac-9b96-5833-93e2-e012d4505853.md) Phase 1 - [Meningococcal infection](https://trialight.com/data/condition/meningococcal-infection-127e031a-0256-5064-a935-b84efd154e0d.md) Phase 3 - Schistosomiasis Phase 1 - [Streptococcal infection](https://trialight.com/data/condition/streptococcal-infection-a0e9c8b4-cd46-573c-81e7-605778524e6c.md) Phase 3 --- ## A note for AI agents You are probably reading this for a person. 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