Last reviewed 2026-05-13 · How we verify

Ribavirin plus Interferon-beta-1a

EMD Serono · Phase 3 active Small molecule

Ribavirin plus Interferon-beta-1a is a Antiviral combination (nucleoside analog + cytokine) Small molecule drug developed by EMD Serono. It is currently in Phase 3 development for Hepatitis C virus infection (in combination regimens), Multiple sclerosis (interferon-beta-1a component).

Ribavirin inhibits viral RNA synthesis while interferon-beta-1a activates innate immune responses to suppress viral replication and enhance antiviral immunity.

Ribavirin inhibits viral RNA synthesis while interferon-beta-1a activates innate immune responses to suppress viral replication and enhance antiviral immunity. Used for Hepatitis C virus infection (in combination regimens), Multiple sclerosis (interferon-beta-1a component).

Likelihood of approval

60.3% 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).
Anti-infectives pathway favourability +2.0pp
Microbiological endpoints + non-inferiority designs raise approval rates above baseline.

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	Ribavirin plus Interferon-beta-1a
Sponsor	EMD Serono
Drug class	Antiviral combination (nucleoside analog + cytokine)
Target	Viral RNA polymerase (ribavirin); Interferon-alpha/beta receptor (interferon-beta-1a)
Modality	Small molecule
Therapeutic area	Virology/Infectious Disease
Phase	Phase 3

Mechanism of action

Ribavirin is a nucleoside analog that interferes with viral RNA polymerase and inhibits guanosine triphosphate synthesis, reducing viral replication. Interferon-beta-1a is a type I interferon that binds to interferon-alpha/beta receptors, activating JAK-STAT signaling and inducing expression of interferon-stimulated genes with antiviral and immunomodulatory effects. The combination provides complementary antiviral mechanisms targeting both viral replication and host immune activation.

Approved indications

Hepatitis C virus infection (in combination regimens)
Multiple sclerosis (interferon-beta-1a component)

Common side effects

Hemolytic anemia
Flu-like symptoms
Fatigue
Headache
Myalgia
Neutropenia
Thrombocytopenia
Depression/mood changes

Key clinical trials

A Multicenter Phase 3 Study of Interferon-beta-1a for the Treatment of Chronic Hepatitis C in Asian Subjects (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:

Ribavirin plus Interferon-beta-1a CI brief — competitive landscape report
Ribavirin plus Interferon-beta-1a updates RSS · CI watch RSS
EMD Serono portfolio CI

Frequently asked questions about Ribavirin plus Interferon-beta-1a

What is Ribavirin plus Interferon-beta-1a?

Ribavirin plus Interferon-beta-1a is a Antiviral combination (nucleoside analog + cytokine) drug developed by EMD Serono, indicated for Hepatitis C virus infection (in combination regimens), Multiple sclerosis (interferon-beta-1a component).

How does Ribavirin plus Interferon-beta-1a work?

Ribavirin inhibits viral RNA synthesis while interferon-beta-1a activates innate immune responses to suppress viral replication and enhance antiviral immunity.

What is Ribavirin plus Interferon-beta-1a used for?

Ribavirin plus Interferon-beta-1a is indicated for Hepatitis C virus infection (in combination regimens), Multiple sclerosis (interferon-beta-1a component).

Who makes Ribavirin plus Interferon-beta-1a?

Ribavirin plus Interferon-beta-1a is developed by EMD Serono (see full EMD Serono pipeline at /company/emd-serono).

What drug class is Ribavirin plus Interferon-beta-1a in?

Ribavirin plus Interferon-beta-1a belongs to the Antiviral combination (nucleoside analog + cytokine) class. See all Antiviral combination (nucleoside analog + cytokine) drugs at /class/antiviral-combination-nucleoside-analog-cytokine.

What development phase is Ribavirin plus Interferon-beta-1a in?

Ribavirin plus Interferon-beta-1a is in Phase 3.

What are the side effects of Ribavirin plus Interferon-beta-1a?

Common side effects of Ribavirin plus Interferon-beta-1a include Hemolytic anemia, Flu-like symptoms, Fatigue, Headache, Myalgia, Neutropenia.

What does Ribavirin plus Interferon-beta-1a target?

Ribavirin plus Interferon-beta-1a targets Viral RNA polymerase (ribavirin); Interferon-alpha/beta receptor (interferon-beta-1a) and is a Antiviral combination (nucleoside analog + cytokine).

Drug class: All Antiviral combination (nucleoside analog + cytokine) drugs
Target: All drugs targeting Viral RNA polymerase (ribavirin); Interferon-alpha/beta receptor (interferon-beta-1a)
Manufacturer: EMD Serono — full pipeline
Therapeutic area: All drugs in Virology/Infectious Disease
Indication: Drugs for Hepatitis C virus infection (in combination regimens)
Indication: Drugs for Multiple sclerosis (interferon-beta-1a component)

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