Last reviewed 2026-04-23 · How we verify

Peg-interferon alpha 2a and ribavin

Hospices Civils de Lyon · Phase 3 active Small molecule

Peg-interferon alpha 2a and ribavin is a Antiviral combination therapy Small molecule drug developed by Hospices Civils de Lyon. It is currently in Phase 3 development for Chronic hepatitis C infection.

Peg-interferon alpha-2a activates innate immune responses against viral infection, while ribavirin inhibits viral RNA synthesis, together targeting hepatitis C virus replication.

Peg-interferon alpha-2a activates innate immune responses against viral infection, while ribavirin inhibits viral RNA synthesis, together targeting hepatitis C virus replication. Used for Chronic hepatitis C 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 alpha 2a and ribavin
Sponsor	Hospices Civils de Lyon
Drug class	Antiviral combination therapy
Target	Interferon-alpha receptor; HCV RNA-dependent RNA polymerase
Modality	Small molecule
Therapeutic area	Virology/Hepatology
Phase	Phase 3

Mechanism of action

Peg-interferon alpha-2a is a pegylated form of interferon-alpha that binds to interferon-alpha receptors on immune cells, triggering antiviral and immunomodulatory responses including activation of natural killer cells and T cells. Ribavirin is a nucleoside analog that inhibits viral RNA-dependent RNA polymerase and reduces hepatitis C virus replication. The combination has synergistic antiviral activity against HCV.

Approved indications

Chronic hepatitis C infection

Common side effects

Flu-like symptoms (fever, fatigue, myalgia)
Anemia
Neutropenia
Thrombocytopenia
Depression/mood changes
Headache
Nausea
Injection site reactions

Key clinical trials

RIBAJUSTE Clinical Trial Investigating the Efficacy and Safety of Dose Adaptation of Ribavirin (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:

Peg-interferon alpha 2a and ribavin CI brief — competitive landscape report
Peg-interferon alpha 2a and ribavin updates RSS · CI watch RSS
Hospices Civils de Lyon portfolio CI

Frequently asked questions about Peg-interferon alpha 2a and ribavin

What is Peg-interferon alpha 2a and ribavin?

Peg-interferon alpha 2a and ribavin is a Antiviral combination therapy drug developed by Hospices Civils de Lyon, indicated for Chronic hepatitis C infection.

How does Peg-interferon alpha 2a and ribavin work?

Peg-interferon alpha-2a activates innate immune responses against viral infection, while ribavirin inhibits viral RNA synthesis, together targeting hepatitis C virus replication.

What is Peg-interferon alpha 2a and ribavin used for?

Peg-interferon alpha 2a and ribavin is indicated for Chronic hepatitis C infection.

Who makes Peg-interferon alpha 2a and ribavin?

Peg-interferon alpha 2a and ribavin is developed by Hospices Civils de Lyon (see full Hospices Civils de Lyon pipeline at /company/hospices-civils-de-lyon).

What drug class is Peg-interferon alpha 2a and ribavin in?

Peg-interferon alpha 2a and ribavin belongs to the Antiviral combination therapy class. See all Antiviral combination therapy drugs at /class/antiviral-combination-therapy.

What development phase is Peg-interferon alpha 2a and ribavin in?

Peg-interferon alpha 2a and ribavin is in Phase 3.

What are the side effects of Peg-interferon alpha 2a and ribavin?

Common side effects of Peg-interferon alpha 2a and ribavin include Flu-like symptoms (fever, fatigue, myalgia), Anemia, Neutropenia, Thrombocytopenia, Depression/mood changes, Headache.

What does Peg-interferon alpha 2a and ribavin target?

Peg-interferon alpha 2a and ribavin targets Interferon-alpha receptor; 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; HCV RNA-dependent RNA polymerase
Manufacturer: Hospices Civils de Lyon — full pipeline
Therapeutic area: All drugs in Virology/Hepatology
Indication: Drugs for Chronic hepatitis C infection

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