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Peg Interferon alpha2b + Ribavirin
Peg Interferon alpha2b + Ribavirin is a Antiviral combination therapy Small molecule drug developed by Casa Sollievo della Sofferenza IRCCS. It is currently in Phase 3 development for Chronic hepatitis C virus infection. Also known as: variable.
Pegylated interferon alpha-2b activates innate immunity to suppress viral replication, while ribavirin inhibits viral RNA synthesis through multiple mechanisms.
Pegylated interferon alpha-2b activates innate immunity to suppress viral replication, while ribavirin inhibits viral RNA synthesis through multiple mechanisms. Used for Chronic hepatitis C virus infection.
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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 | Peg Interferon alpha2b + Ribavirin |
|---|---|
| Also known as | variable |
| Sponsor | Casa Sollievo della Sofferenza IRCCS |
| Drug class | Antiviral combination therapy |
| Target | Interferon-alpha receptor (IFNAR); viral RNA-dependent RNA polymerase |
| Modality | Small molecule |
| Therapeutic area | Virology/Hepatology |
| Phase | Phase 3 |
Mechanism of action
Peg interferon alpha-2b is a long-acting form of interferon that binds to interferon-alpha receptors on immune cells, triggering antiviral and immunomodulatory responses including activation of natural killer cells and upregulation of MHC molecules. Ribavirin is a nucleoside analog that inhibits viral RNA-dependent RNA polymerase and depletes cellular guanosine pools, reducing viral replication. Together, they provide synergistic antiviral activity against hepatitis C virus.
Approved indications
- Chronic hepatitis C virus infection
Common side effects
- Flu-like symptoms (fever, fatigue, myalgia)
- Hemolytic anemia
- Neutropenia
- Thrombocytopenia
- Depression/psychiatric effects
- Thyroid dysfunction
- Headache
- Nausea
Key clinical trials
- Efficacy and Safety of MP-424, Peginterferon Alfa-2b and Ribavirin in Relapser Genotype 2 Hepatitis C Infected Patients (PHASE3)
- A Phase 1 Study of MP-424, Peginterferon Alfa 2b, and Ribavirin in Hepatitis C (PHASE1)
- Efficacy and Safety of MP-424, Peginterferon Alfa-2b, and Ribavirin in Patients With Chronic Hepatitis C Who Relapsed After Previous Interferon Based Therapy (PHASE3)
- Efficacy and Safety of MP-424/Peginterferon Alfa-2b/Ribavirin Combination in Treatment-Naïve Patients With Chronic Hepatitis C (PHASE3)
- Efficacy and Safety of MP-424, Peginterferon Alfa-2b and Ribavirin in Chronic Hepatitis C Who Have Not Achieved an Undetectable HCV RNA Level With Previous Interferon Based Therapy (PHASE3)
- Efficacy and Safety of MP-424, Peginterferon Alfa-2b and Ribavirin in Non-responder Genotype 2 Hepatitis C Infected Patients (PHASE3)
- HIV Patients With Chronic Hepatitis C Genotype 1 Infection Who Failed Previously to Peginterferon /Ribavirin (PHASE3)
- Evaluating Safety and Efficacy In Hepatitis C Patients After PegIntron Pen Treatment (Study P04896)
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:
- Peg Interferon alpha2b + Ribavirin CI brief — competitive landscape report
- Peg Interferon alpha2b + Ribavirin updates RSS · CI watch RSS
- Casa Sollievo della Sofferenza IRCCS portfolio CI
Frequently asked questions about Peg Interferon alpha2b + Ribavirin
What is Peg Interferon alpha2b + Ribavirin?
How does Peg Interferon alpha2b + Ribavirin work?
What is Peg Interferon alpha2b + Ribavirin used for?
Who makes Peg Interferon alpha2b + Ribavirin?
Is Peg Interferon alpha2b + Ribavirin also known as anything else?
What drug class is Peg Interferon alpha2b + Ribavirin in?
What development phase is Peg Interferon alpha2b + Ribavirin in?
What are the side effects of Peg Interferon alpha2b + Ribavirin?
What does Peg Interferon alpha2b + Ribavirin target?
Related
- Drug class: All Antiviral combination therapy drugs
- Target: All drugs targeting Interferon-alpha receptor (IFNAR); viral RNA-dependent RNA polymerase
- Manufacturer: Casa Sollievo della Sofferenza IRCCS — full pipeline
- Therapeutic area: All drugs in Virology/Hepatology
- Indication: Drugs for Chronic hepatitis C virus infection
- Also known as: variable
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing