Last reviewed 2026-04-23 · How we verify

PEG-Interferon a-2b + Ribavirin

Hepatitis Resource Network · Phase 3 active Small molecule

PEG-Interferon a-2b + Ribavirin is a Antiviral combination therapy Small molecule drug developed by Hepatitis Resource Network. It is currently in Phase 3 development for Chronic hepatitis C virus infection.

PEG-Interferon alfa-2b activates innate immune responses against hepatitis C virus, while ribavirin inhibits viral replication through multiple mechanisms including nucleotide synthesis disruption.

PEG-Interferon alfa-2b activates innate immune responses against hepatitis C virus, while ribavirin inhibits viral replication through multiple mechanisms including nucleotide synthesis disruption. Used for Chronic hepatitis C virus infection.

Likelihood of approval

58.3% vs 58.3% industry baseline

If approved by FDA: likely 2028–2030

Steps remaining: NDA/BLA submission

Confidence: High

Why this estimate

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).

Predicted approval windows by jurisdiction (conditional on FDA approval)

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 a-2b + Ribavirin
Sponsor	Hepatitis Resource Network
Drug class	Antiviral combination therapy
Target	Interferon-alpha receptor (IFNAR); HCV RNA-dependent RNA polymerase
Modality	Small molecule
Therapeutic area	Virology/Hepatology
Phase	Phase 3

Mechanism of action

PEG-Interferon alfa-2b is a pegylated form of interferon that binds to interferon-alpha receptors on immune cells, triggering antiviral and immunomodulatory responses including upregulation of MHC molecules and activation of natural killer cells. Ribavirin is a nucleoside analog that inhibits viral RNA-dependent RNA polymerase and depletes guanosine pools, reducing hepatitis C virus replication. The combination has synergistic antiviral activity against HCV.

Approved indications

Chronic hepatitis C virus infection

Common side effects

Flu-like symptoms (fever, fatigue, myalgia)
Hemolytic anemia
Neutropenia
Thrombocytopenia
Depression/mood changes
Headache
Insomnia
Nausea
Alopecia

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:

PEG-Interferon a-2b + Ribavirin CI brief — competitive landscape report
PEG-Interferon a-2b + Ribavirin updates RSS · CI watch RSS
Hepatitis Resource Network portfolio CI

Frequently asked questions about PEG-Interferon a-2b + Ribavirin

What is PEG-Interferon a-2b + Ribavirin?

PEG-Interferon a-2b + Ribavirin is a Antiviral combination therapy drug developed by Hepatitis Resource Network, indicated for Chronic hepatitis C virus infection.

How does PEG-Interferon a-2b + Ribavirin work?

PEG-Interferon alfa-2b activates innate immune responses against hepatitis C virus, while ribavirin inhibits viral replication through multiple mechanisms including nucleotide synthesis disruption.

What is PEG-Interferon a-2b + Ribavirin used for?

PEG-Interferon a-2b + Ribavirin is indicated for Chronic hepatitis C virus infection.

Who makes PEG-Interferon a-2b + Ribavirin?

PEG-Interferon a-2b + Ribavirin is developed by Hepatitis Resource Network (see full Hepatitis Resource Network pipeline at /company/hepatitis-resource-network).

What drug class is PEG-Interferon a-2b + Ribavirin in?

PEG-Interferon a-2b + Ribavirin belongs to the Antiviral combination therapy class. See all Antiviral combination therapy drugs at /class/antiviral-combination-therapy.

What development phase is PEG-Interferon a-2b + Ribavirin in?

PEG-Interferon a-2b + Ribavirin is in Phase 3.

What are the side effects of PEG-Interferon a-2b + Ribavirin?

Common side effects of PEG-Interferon a-2b + Ribavirin include Flu-like symptoms (fever, fatigue, myalgia), Hemolytic anemia, Neutropenia, Thrombocytopenia, Depression/mood changes, Headache.

What does PEG-Interferon a-2b + Ribavirin target?

PEG-Interferon a-2b + Ribavirin targets Interferon-alpha receptor (IFNAR); HCV RNA-dependent RNA polymerase and is a Antiviral combination therapy.

Drug class: All Antiviral combination therapy drugs
Target: All drugs targeting Interferon-alpha receptor (IFNAR); HCV RNA-dependent RNA polymerase
Manufacturer: Hepatitis Resource Network — full pipeline
Therapeutic area: All drugs in Virology/Hepatology
Indication: Drugs for Chronic hepatitis C virus infection

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing