Last reviewed · How we verify

rhIFN beta-1b

Nuron Biotech Inc. · Phase 3 active Biologic ✓ Verified May 2026

rhIFN beta-1b is a Interferon Biologic drug developed by Nuron Biotech Inc.. It is currently in Phase 3 development for Relapsing forms of multiple sclerosis.

rhIFN beta-1b is a recombinant form of interferon beta-1b that modulates the immune system to reduce inflammation in the central nervous system.

rhIFN beta-1b is used to treat Relapsing Remitting Multiple Sclerosis. It is a recombinant human interferon beta-1b, which is a type of protein that has been shown to have therapeutic effects in this condition.

Likelihood of approval
59.3% 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).
  • Immunology slight uplift +1.0pp
    Mature endpoint landscape (ACR, DAS28, PASI) makes immunology approvals slightly more predictable.
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 namerhIFN beta-1b
SponsorNuron Biotech Inc.
Drug classInterferon
TargetIFN-beta receptor
ModalityBiologic
Therapeutic areaImmunology
PhasePhase 3

Mechanism of action

Interferon beta-1b works by binding to the interferon beta receptor, which triggers a signaling cascade that reduces the production of pro-inflammatory cytokines and promotes the production of anti-inflammatory cytokines. This leads to a decrease in inflammation and a reduction in the severity of symptoms associated with multiple sclerosis.

Approved indications

Common side effects

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.

SourceUsed for
ClinicalTrials.govTrial 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:

Frequently asked questions about rhIFN beta-1b

What is rhIFN beta-1b?

rhIFN beta-1b is a Interferon drug developed by Nuron Biotech Inc., indicated for Relapsing forms of multiple sclerosis.

How does rhIFN beta-1b work?

rhIFN beta-1b is a recombinant form of interferon beta-1b that modulates the immune system to reduce inflammation in the central nervous system.

What is rhIFN beta-1b used for?

rhIFN beta-1b is indicated for Relapsing forms of multiple sclerosis.

Who makes rhIFN beta-1b?

rhIFN beta-1b is developed by Nuron Biotech Inc. (see full Nuron Biotech Inc. pipeline at /company/nuron-biotech-inc).

What drug class is rhIFN beta-1b in?

rhIFN beta-1b belongs to the Interferon class. See all Interferon drugs at /class/interferon.

What development phase is rhIFN beta-1b in?

rhIFN beta-1b is in Phase 3.

What are the side effects of rhIFN beta-1b?

Common side effects of rhIFN beta-1b include Flu-like symptoms, Injection site reactions, Fatigue, Headache, Nausea.

What does rhIFN beta-1b target?

rhIFN beta-1b targets IFN-beta receptor and is a Interferon.

Related

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