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GF-001001-00
GF-001001-00 is a NS5A inhibitor Small molecule drug developed by Ferrer Internacional S.A.. It is currently in Phase 2 development for Chronic hepatitis C, Hepatitis C virus infection.
GF-001001-00 is a small molecule that targets the HCV NS5A protein.
GF-001001-00 is a small molecule that targets the HCV NS5A protein. Used for Chronic hepatitis C, Hepatitis C virus infection.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% 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 | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +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 | GF-001001-00 |
|---|---|
| Sponsor | Ferrer Internacional S.A. |
| Drug class | NS5A inhibitor |
| Target | HCV NS5A |
| Modality | Small molecule |
| Therapeutic area | Infectious Diseases |
| Phase | Phase 2 |
Mechanism of action
GF-001001-00 works by binding to the NS5A protein of the hepatitis C virus, which is essential for viral replication. This binding inhibits the NS5A protein's function, ultimately leading to the reduction of viral load in infected cells.
Approved indications
- Chronic hepatitis C
- Hepatitis C virus infection
Common side effects
- Fatigue
- Headache
- Nausea
Key clinical trials
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:
- GF-001001-00 CI brief — competitive landscape report
- GF-001001-00 updates RSS · CI watch RSS
- Ferrer Internacional S.A. portfolio CI
Frequently asked questions about GF-001001-00
What is GF-001001-00?
How does GF-001001-00 work?
What is GF-001001-00 used for?
Who makes GF-001001-00?
What drug class is GF-001001-00 in?
What development phase is GF-001001-00 in?
What are the side effects of GF-001001-00?
What does GF-001001-00 target?
Related
- Drug class: All NS5A inhibitor drugs
- Target: All drugs targeting HCV NS5A
- Manufacturer: Ferrer Internacional S.A. — full pipeline
- Therapeutic area: All drugs in Infectious Diseases
- Indication: Drugs for Chronic hepatitis C
- Indication: Drugs for Hepatitis C virus infection
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing