Last reviewed · How we verify
Seraprevir
Seraprevir is a Small molecule drug developed by Ginkgopharma CO., LTD. It is currently in Phase 3 development. Also known as: GP205.
Seraprevir is a medication used in combination with Sofosbuvir to treat chronic Hepatitis C Virus Infection, specifically in patients with genotype 2, 3, or 6. It is being investigated in a Phase IIa clinical trial to assess its efficacy and safety in this patient population.
-
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 | Seraprevir |
|---|---|
| Also known as | GP205 |
| Sponsor | Ginkgopharma CO., LTD |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 3 |
Approved indications
Common side effects
Key clinical trials
- Study of Seraprevir in Combination With Sofosbuvir in Chronic Genotype 2,3,6 Hepatitis C Virus Infection Patients (PHASE2)
- Study of Seraprevir in Combination With Sofosbuvir in Chronic Genotype 1 Hepatitis C Virus Infection Patients (PHASE3)
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:
- Seraprevir CI brief — competitive landscape report
- Seraprevir updates RSS · CI watch RSS
- Ginkgopharma CO., LTD portfolio CI
Frequently asked questions about Seraprevir
What is Seraprevir?
Who makes Seraprevir?
Is Seraprevir also known as anything else?
What development phase is Seraprevir in?
Related
- Manufacturer: Ginkgopharma CO., LTD — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: GP205
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing