Hepatitis B virus hbsag surface protein antigen
Highest phase reached
Approved
Drug type
Vaccine component
First approval year
1996
- First approval year
- 1996
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Vaccine component
- Drug name
- Hepatitis B virus hbsag surface protein antigen
- 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.
- 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.
- ChEMBL ID
- CHEMBL4297973
- FDA ingredient codes (UNII)
- IFJ010MNE4
- 797752
- 1427171
- 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
- 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)
- 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
- 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.
- 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.
- NCT00000633
- NCT00000745
- NCT00272493
- NCT02109354
- NCT00003434
- NCT00120796
- NCT00197158
- NCT00329576
- NCT00335881
- NCT00356564
- NCT00393523
- NCT00414050
- NCT00426712
- NCT00440531
- NCT00480116
- NCT00489099
- NCT00498212
- NCT00501124
- NCT00508833
- NCT00697125
- NCT00697242
- NCT00697840
- NCT00697931
- NCT00697970
- NCT00698087
And 43 more, listed on the interactive page.
- 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
- Diphtheria
- Haemophilus meningitis
- Hepatitis A virus infection
- Hepatitis B virus infection
- Pertussis
- Poliomyelitis
- Tetanus
In development for (12)
- Anogenital human papillomavirus infection Phase 3
- Cirrhosis of liver Phase 2
- Common wart Phase 1
- Exocrine pancreatic carcinoma Phase 1
- Hepatitis E virus infection Phase 3
- HIV infectious disease Phase 2
- Hookworm infectious disease Phase 1
- Inflammatory bowel disease Phase 1
- Malaria Phase 1
- Meningococcal infection Phase 3
- Schistosomiasis Phase 1
- Streptococcal infection Phase 3