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Ribavirin, PEG-Intron
Ribavirin, PEG-Intron is a Antiviral Small molecule drug developed by Weill Medical College of Cornell University. It is currently in Phase 3 development for Chronic hepatitis C, Respiratory syncytial virus infection.
Ribavirin is an antiviral medication that works by inhibiting viral RNA synthesis, while PEG-Intron is an interferon that stimulates the body's immune response to fight viral infections.
Ribavirin, in combination with PEG-Intron (Peginterferon alpha-2b), is used to treat Hepatitis C Infection. It is a small molecule that works as an antiviral agent.
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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). -
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 | 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 | Ribavirin, PEG-Intron |
|---|---|
| Sponsor | Weill Medical College of Cornell University |
| Drug class | Antiviral |
| Modality | Small molecule |
| Therapeutic area | Infectious Diseases |
| Phase | Phase 3 |
Mechanism of action
Ribavirin is a nucleoside analog that is incorporated into viral RNA, causing chain termination and preventing viral replication. PEG-Intron, on the other hand, is a long-acting form of interferon-alpha that helps to stimulate the body's immune response, including the activation of natural killer cells and the production of cytokines that help to fight viral infections.
Approved indications
- Chronic hepatitis C
- Respiratory syncytial virus infection
Common side effects
- Anemia
- Fatigue
- Neutropenia
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:
- Ribavirin, PEG-Intron CI brief — competitive landscape report
- Ribavirin, PEG-Intron updates RSS · CI watch RSS
- Weill Medical College of Cornell University portfolio CI
Frequently asked questions about Ribavirin, PEG-Intron
What is Ribavirin, PEG-Intron?
How does Ribavirin, PEG-Intron work?
What is Ribavirin, PEG-Intron used for?
Who makes Ribavirin, PEG-Intron?
What drug class is Ribavirin, PEG-Intron in?
What development phase is Ribavirin, PEG-Intron in?
What are the side effects of Ribavirin, PEG-Intron?
Related
- Drug class: All Antiviral drugs
- Manufacturer: Weill Medical College of Cornell University — full pipeline
- Therapeutic area: All drugs in Infectious Diseases
- Indication: Drugs for Chronic hepatitis C
- Indication: Drugs for Respiratory syncytial virus infection
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing