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Fendrix
Fendrix is a Biologic drug developed by University of Surrey. It is currently in Phase 3 development. Also known as: Hepatitis B Vaccine (Recombinant).
Fendrix is a vaccine component used to target the surface antigen (HBsAg) of the hepatitis B virus. It is classified as a vaccine antigen and is used to prevent hepatitis B infection.
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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).
| 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 | Fendrix |
|---|---|
| Also known as | Hepatitis B Vaccine (Recombinant) |
| Sponsor | University of Surrey |
| Modality | Biologic |
| Therapeutic area | Other |
| Phase | Phase 3 |
Approved indications
Common side effects
Key clinical trials
- Evaluation of Patients With Liver Disease
- ImPrEP LEN Brasil: Twice-Yearly Lenacapavir for HIV Prevention (NA)
- Oral-Periodontal Evaluation and Assessment of Oral Fluid Biomarkers in Patients With Hepatitis B+D
- Fungal Infection Susceptibility
- Withdrawal of Therapy After Long-Term Antiviral Treatment for Chronic Hepatitis B
- Evaluation of Patient Care Support for Cirrhosis and/or Liver Transplants
- Study of Oral TLR8 Agonist Selgantolimod on HBsAg in Participants With Both Chronic Hepatitis B and HIV (PHASE2)
- The Mechanistic Biology of Primary Immunodeficiency Disorders
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:
- Fendrix CI brief — competitive landscape report
- Fendrix updates RSS · CI watch RSS
- University of Surrey portfolio CI
Frequently asked questions about Fendrix
What is Fendrix?
Who makes Fendrix?
Is Fendrix also known as anything else?
What development phase is Fendrix in?
Related
- Manufacturer: University of Surrey — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: Hepatitis B Vaccine (Recombinant)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing