Last reviewed · How we verify
ravidasvir and sofosbuvir
ravidasvir and sofosbuvir is a Small molecule drug developed by Ascletis Pharmaceuticals Co., Ltd.. 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 | ravidasvir and sofosbuvir |
|---|---|
| Sponsor | Ascletis Pharmaceuticals Co., Ltd. |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- 8- Versus 12-week of Sofosbuvir-ravidasvir Treatment of Chronic Hepatitis C (PHASE2, PHASE3)
- Strategic Transformation of the Market of HCV Treatments (PHASE2, PHASE3)
- A Study of the Relative Bioavailability of ASC18 Tablets vs Reference Tablets in Healthy Volunteers (PHASE1)
- A Study of the Efficacy and Safety of PPI-668 (NS5A Inhibitor) Plus Sofosbuvir, With or Without Ribavirin, in Patients With Chronic Hepatitis C Genotype-4 (PHASE2, 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:
- ravidasvir and sofosbuvir CI brief — competitive landscape report
- ravidasvir and sofosbuvir updates RSS · CI watch RSS
- Ascletis Pharmaceuticals Co., Ltd. portfolio CI
Frequently asked questions about ravidasvir and sofosbuvir
What is ravidasvir and sofosbuvir?
Who makes ravidasvir and sofosbuvir?
What development phase is ravidasvir and sofosbuvir in?
Related
- Manufacturer: Ascletis Pharmaceuticals Co., Ltd. — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing