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24-week Entecavir
24-week Entecavir is a Small molecule drug developed by National Taiwan University Hospital. It is currently in Phase 1 development. Also known as: Prophylaxis arm 1.
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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 | 24-week Entecavir |
|---|---|
| Also known as | Prophylaxis arm 1 |
| Sponsor | National Taiwan University Hospital |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
- Nausea
- Headache
- Pruritus
- Upper respiratory tract infection
- Vomiting
- Myalgia
- Dizziness
- Nasopharyngitis
- Diarrhoea
- Fatigue
- Eczema
- Dyspnoea
Key clinical trials
- Study of ARC-520 With or Without Other Drugs Used in the Treatment of Chronic Chronic Hepatitis B Virus (HBV) (PHASE2)
- A Clinical Trial to Evaluate the Efficacy and Safety of TQA3605 Tablets in Treatment-naive Chronic HBV-infected Subjects (PHASE2)
- The Safety and Efficacy of Sequential Treatment of Ropeginterferon Alfa-2b (P1101) and Anti-PD1 in Interferon-Naive Adults With Chronic Hepatitis B or D Infection (PHASE1)
- A Study to Assess Intrahepatic and Peripheral Changes of Immunologic and Virologic Markers in Chronic Hepatitis B Virus Infection (PHASE2)
- Peginterferon Treatment Study for Inactive Chronic Hepatitis B Patients (PHASE4)
- A Clinical Study of TQA3605 Tablets Monotherapy or in Combination With Nucleoside (Acid) Analogues in Treatment Naive and Treated Patients With Chronic Hepatitis B (PHASE1, PHASE2)
- A Clinical Trial to Evaluate the Efficacy and Safety of TQA3810 Tablets in Combination/Non Combination With Nucleoside (Acid) Analogues in Patients With Primary/Treated Chronic Hepatitis B (PHASE2)
- A Study of JNJ-73763989, Pegylated Interferon Alpha-2a and Nucleos(t)Ide Analogs in Participants With Chronic Hepatitis B Virus Infection (PHASE2)
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:
- 24-week Entecavir CI brief — competitive landscape report
- 24-week Entecavir updates RSS · CI watch RSS
- National Taiwan University Hospital portfolio CI
Frequently asked questions about 24-week Entecavir
What is 24-week Entecavir?
Who makes 24-week Entecavir?
Is 24-week Entecavir also known as anything else?
What development phase is 24-week Entecavir in?
What are the side effects of 24-week Entecavir?
Related
- Manufacturer: National Taiwan University Hospital — full pipeline
- Also known as: Prophylaxis arm 1
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing