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Fendrix or HBVAXPRO 40
Fendrix or HBVAXPRO 40 is a Biologic drug developed by Corporacion Parc Tauli. It is currently in Phase 1 development.
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Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +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 or HBVAXPRO 40 |
|---|---|
| Sponsor | Corporacion Parc Tauli |
| Modality | Biologic |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- A Platform Study to Evaluate Investigational Therapies in Chronic Hepatitis B Infection (PHASE1, PHASE2)
- The Effectiveness and Safety of TMF in the Treatment of Chronic Hepatitis B Patients With Normal ALT. (NA)
- A Study of Exercise and Pharmacologic Intervention on Systemic Inflammation (PHASE1)
- Treatment of Patients With Chronic Hepatitis B With Hepatitis B Immunoglobulins (PHASE2)
- Screening for Chronic Liver Diseases in General Population (NA)
- A Study to Assess Intrahepatic and Peripheral Changes of Immunologic and Virologic Markers in Chronic Hepatitis B Virus Infection (PHASE2)
- The HOPE Study: Characterizing Patients With Hepatitis B and C
- Effectiveness of TAF in Reducing Clinical Events in CHB Patients Beyond Treatment Indications by Current Guidelines (PHASE4)
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 or HBVAXPRO 40 CI brief — competitive landscape report
- Fendrix or HBVAXPRO 40 updates RSS · CI watch RSS
- Corporacion Parc Tauli portfolio CI
Frequently asked questions about Fendrix or HBVAXPRO 40
What is Fendrix or HBVAXPRO 40?
Who makes Fendrix or HBVAXPRO 40?
What development phase is Fendrix or HBVAXPRO 40 in?
Related
- Manufacturer: Corporacion Parc Tauli — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing