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Sebivo
Sebivo is a Small molecule drug developed by Ziv Hospital. It is currently in Phase 1 development for Chronic type B viral hepatitis.
Sebivo is a small molecule drug that belongs to the class of inhibitors, specifically targeting DNA polymerase/reverse transcriptase. It is used to treat hepatitis B infection and has been shown to be more effective than lamivudine or adefovir in clinical trials.
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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). -
Anti-infectives pathway favourability
+2.0pp
Microbiological endpoints + non-inferiority designs raise approval rates above baseline.
| 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 | Sebivo |
|---|---|
| Sponsor | Ziv Hospital |
| Target | Capsid protein, Protein P |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | Phase 1 |
Approved indications
- Chronic type B viral hepatitis
Common side effects
Key clinical trials
- Entecavir Resistance-Associated Mutations in Chronic HBV Patients in Turkey (STREAM Study)
- Carvedilol for Prevention of Esophageal Varices Progression (NA)
- FLT-PET as an Imaging Biomarker With Temsirolimus, Topotecan, and Bortezomib (PHASE1)
- Treatment of Hepatitis B Virus (HBV) Before Beginning Anti-HIV Drugs in Patients With Both HBV and HIV (NA)
- Extension Study of Carvedilol RCT Study (NA)
- Safety, Tolerability and Antiviral Activity of Selgantolimod in Virally-Suppressed Participants With Chronic Hepatitis B (PHASE2)
- Real World Study About Anti-viral Regimen Adjustment on Achieving Complete Response in CHB Patients
- FLT-PET/CT vs FDG-PET/CT for Therapy Monitoring of Diffuse Large B-cell Lymphoma
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:
- Sebivo CI brief — competitive landscape report
- Sebivo updates RSS · CI watch RSS
- Ziv Hospital portfolio CI
Frequently asked questions about Sebivo
What is Sebivo?
What is Sebivo used for?
Who makes Sebivo?
What development phase is Sebivo in?
What does Sebivo target?
Related
- Target: All drugs targeting Capsid protein, Protein P
- Manufacturer: Ziv Hospital — full pipeline
- Therapeutic area: All drugs in Infectious Disease
- Indication: Drugs for Chronic type B viral hepatitis
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing