Last reviewed 2026-06-01 · How we verify

Comparator: ENGERIX-B™

Merck Sharp & Dohme LLC · Phase 3 active Biologic ✓ Verified Jun 2026

Comparator: ENGERIX-B™ is a Recombinant 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 recombinant hepatitis B vaccine that stimulates the immune system to produce antibodies against hepatitis B surface antigen (HBsAg), providing protection against hepatitis B virus infection.

ENGERIX-B is a hepatitis B vaccine used as a comparator in clinical trials, specifically for Hepatitis B Vaccines, Hepatitis B, Hepatitis A, and Hepatitis B Virus Infection studies. It is compared to other hepatitis B vaccines, including RECOMBIVAX HB and a modified process hepatitis B vaccine, in clinical trials such as NCT03408730.

Likelihood of approval

62.3% vs 58.3% industry baseline

If approved by FDA: likely 2028–2030

Steps remaining: NDA/BLA submission

Confidence: High

Why this estimate

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.

Predicted approval windows by jurisdiction (conditional on FDA approval)

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: ENGERIX-B™
Sponsor	Merck Sharp & Dohme LLC
Drug class	Recombinant vaccine
Target	Hepatitis B surface antigen (HBsAg)
Modality	Biologic
Therapeutic area	Immunology / Infectious Disease
Phase	Phase 3

Mechanism of action

The vaccine 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 immunological memory provides long-term protection against hepatitis B 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
Fever
Myalgia

Key clinical trials

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: ENGERIX-B™ CI brief — competitive landscape report
Comparator: ENGERIX-B™ updates RSS · CI watch RSS
Merck Sharp & Dohme LLC portfolio CI

Frequently asked questions about Comparator: ENGERIX-B™

What is Comparator: ENGERIX-B™?

Comparator: ENGERIX-B™ is a Recombinant vaccine drug developed by Merck Sharp & Dohme LLC, indicated for Prevention of hepatitis B infection in infants, children, and adults, Post-exposure prophylaxis for hepatitis B.

How does Comparator: ENGERIX-B™ work?

What is Comparator: ENGERIX-B™ used for?

Comparator: ENGERIX-B™ is indicated for Prevention of hepatitis B infection in infants, children, and adults, Post-exposure prophylaxis for hepatitis B.

Who makes Comparator: ENGERIX-B™?

Comparator: ENGERIX-B™ is developed by Merck Sharp & Dohme LLC (see full Merck Sharp & Dohme LLC pipeline at /company/merck).

What drug class is Comparator: ENGERIX-B™ in?

Comparator: ENGERIX-B™ belongs to the Recombinant vaccine class. See all Recombinant vaccine drugs at /class/recombinant-vaccine.

What development phase is Comparator: ENGERIX-B™ in?

Comparator: ENGERIX-B™ is in Phase 3.

What are the side effects of Comparator: ENGERIX-B™?

Common side effects of Comparator: ENGERIX-B™ include Injection site soreness or swelling, Fatigue, Headache, Fever, Myalgia.

What does Comparator: ENGERIX-B™ target?

Comparator: ENGERIX-B™ targets Hepatitis B surface antigen (HBsAg) and is a Recombinant vaccine.

Drug class: All Recombinant 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