Last reviewed · How we verify
Comparator: Comparator: ENGERIX-B
Comparator: Comparator: ENGERIX-B is a Hepatitis B vaccine Biologic drug developed by Merck Sharp & Dohme LLC. It is currently in Phase 3 development for Prevention of hepatitis B infection in infants, children, and adults, Post-exposure prophylaxis for hepatitis B.
ENGERIX-B is a hepatitis B vaccine that stimulates the immune system to produce antibodies against hepatitis B surface antigen (HBsAg).
ENGERIX-B is a small molecule hepatitis B vaccine used as a comparator in clinical trials for conditions such as Hepatitis B Virus Infection and Hepatitis B. It is also used as a comparator in a study for patients with renal predialysis and dialysis, comparing it to a modified process hepatitis B vaccine.
-
Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Immunology slight uplift
+1.0pp
Mature endpoint landscape (ACR, DAS28, PASI) makes immunology approvals slightly more predictable. -
Big-pharma sponsor
+3.0pp
Merck Sharp & Dohme LLC is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Comparator: Comparator: ENGERIX-B |
|---|---|
| Sponsor | Merck Sharp & Dohme LLC |
| Drug class | Hepatitis B vaccine |
| Target | Hepatitis B surface antigen (HBsAg) |
| Modality | Biologic |
| Therapeutic area | Immunology / Infectious Disease |
| Phase | Phase 3 |
Mechanism of action
ENGERIX-B contains recombinant hepatitis B surface antigen produced in yeast cells. When administered, it triggers both humoral and cellular immune responses, leading to the production of protective antibodies (anti-HBs) and memory B cells. This provides immunity against hepatitis B virus infection.
Approved indications
- Prevention of hepatitis B infection in infants, children, and adults
- Post-exposure prophylaxis for hepatitis B
Common side effects
- Injection site soreness or swelling
- Fatigue
- Headache
- Myalgia
- Low-grade fever
Key clinical trials
- Safety and Immunogenicity of Pfs25M-EPA/AS01 and Pfs230D1M-EPA/AS01 Vaccines, Transmission Blocking Vaccines Against Plasmodium Falciparum, at Full and Fractional Dosing in Adults in Mali (PHASE1)
- Non Inferiority Trial of Locally Manufactured 'Hepa-B' Vaccine in Bangladesh. (PHASE2, PHASE3)
- Lot-to-lot Consistency of Sci-B-Vac™ in Adults (PHASE3)
- Evaluation of Immune Memory to Twinrix or Comparator by Challenge Dose Administration 4 Years After Primary Vaccination (PHASE4)
- Hepatitis B Vaccine Predialysis/Dialysis Study (V232-060) (PHASE3)
- Study of Recombinant Modified Process Hepatitis B Vaccine in Older Adults (V232-059)(COMPLETED) (PHASE3)
- Hepatitis B Vaccine Booster Study (V232-058)(COMPLETED) (PHASE3)
- Immunogenicity and Safety of the Hepatitis B Vaccine Hepavax-Gene TF and a Comparator Hepatitis B Vaccine in Newborns (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Comparator: Comparator: ENGERIX-B CI brief — competitive landscape report
- Comparator: Comparator: ENGERIX-B updates RSS · CI watch RSS
- Merck Sharp & Dohme LLC portfolio CI
Frequently asked questions about Comparator: Comparator: ENGERIX-B
What is Comparator: Comparator: ENGERIX-B?
How does Comparator: Comparator: ENGERIX-B work?
What is Comparator: Comparator: ENGERIX-B used for?
Who makes Comparator: Comparator: ENGERIX-B?
What drug class is Comparator: Comparator: ENGERIX-B in?
What development phase is Comparator: Comparator: ENGERIX-B in?
What are the side effects of Comparator: Comparator: ENGERIX-B?
What does Comparator: Comparator: ENGERIX-B target?
Related
- Drug class: All Hepatitis B vaccine drugs
- Target: All drugs targeting Hepatitis B surface antigen (HBsAg)
- Manufacturer: Merck Sharp & Dohme LLC — full pipeline
- Therapeutic area: All drugs in Immunology / Infectious Disease
- Indication: Drugs for Prevention of hepatitis B infection in infants, children, and adults
- Indication: Drugs for Post-exposure prophylaxis for hepatitis B
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing