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Drug

Interferon beta-1b

Approved · EMA
Emerging researchLate-stage development

Also known as Betaseron, Extavia, Interferon Beta-1b (E. coli), Interferon-beta-1b.

RxNorm72257UNIITTD90R31WZ
2
Research papers
2
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Market withdrawal: Extavia (EMA)

Regulatory2025-04-25EMA

An Open-label Randomised Controlled Trial on IFN Beta-1b and Ribavirin Combination, as Treatment for Covid-19 Infection

Clinical trial2022-07-01Primary completion · ClinicalTrials.gov

Phase IV, Rater-blinded, Randomized Study, Comparing 250 mg of Betaseron With 20 mg of Copaxone in Patients With the Relapsing-remitting(RR) or CIS Forms of ms Using 3 Tesla(3T) Magnetic Resonance Imaging (MRI) With Triple-dose Gadolinium

Clinical trial2021-11-16Results posted · ClinicalTrials.gov

An Open-label Randomized Controlled Trial on Interferon β-1b and Remdesivir Combination Versus Remdesivir as Treatment for COVID-19 Infection

Clinical trial2021-07-31Primary completion · ClinicalTrials.gov

An Open-label Randomised Controlled Trial on Dual Therapy With Interferon Beta-1b and Clofazimine Combination, as Treatment for COVID-19 Infection

Clinical trial2021-06-30Primary completion · ClinicalTrials.gov

Open-label, Randomized, 2-arm, Active Comparator Study to Evaluate Safety and Tolerability in Portuguese Patients With Relapsing Remitting Multiple Sclerosis (MS) Transitioning From Current Subcutaneous Interferon Therapy to Peginterferon Beta 1a (PLEGRIDY™)

Clinical trial2020-10-26Completed · ClinicalTrials.gov

An Open-label Randomized Controlled Trial on Interferon β-1b and Hydroxychloroquine Combination Versus Hydroxychloroquine Alone, as Treatment for COVID-19 Infection

Clinical trial2020-07-07Completed · ClinicalTrials.gov

An Investigation Into Beneficial Effects of Interferon Beta 1a, Compared to Interferon Beta 1b And The Base Therapeutic Regiment in Moderate to Severe COVID-19: A Randomized Clinical Trial

Clinical trial2020-04-27Completed · ClinicalTrials.gov

An Open-label Randomized Controlled Trial on Lopinavir/ Ritonavir, Ribavirin and Interferon Beta 1b Combination Versus Lopinavir/ Ritonavir Alone, as Treatment for 2019 Novel Coronavirus Infection

Clinical trial2020-03-31Completed · ClinicalTrials.gov

New acute and chronic black holes in patients with multiple sclerosis randomised to interferon beta-1b or glatiramer acetate.

Research2009-08-16Journal of neurology, neurosurgery, and psychiatry

Efficacy of treatment of MS with IFNbeta-1b or glatiramer acetate by monthly brain MRI in the BECOME study.

Research2009-03-11Neurology

Approval: Betaferon (EMA)

Regulatory1995-11-30EMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Interferon beta-1b
Aliases & brands
BetaseronExtaviaInterferon Beta-1b (E. coli)Interferon-beta-1b
RxNorm CUI
72257
UNII
TTD90R31WZ
Regulatory jurisdictions
ema

Regulatory timeline

2 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
1995-11-30
Latest approval
1995-11-30
Authorities
EMA
Total events
2
emaEuropean Medicines Agency· 2 events
2025-04-25Market withdrawalMarket
Market withdrawal: Extavia (EMA)
Indication: Extavia is indicated for the treatment of: patients with a single demyelinating event with an active inflammatory process, if it is severe enough to warrant treatment with… Show full indication

Extavia is indicated for the treatment of: patients with a single demyelinating event with an active inflammatory process, if it is severe enough to warrant treatment with intravenous corticosteroids, if alternative diagnoses have been excluded, and if they are determined to be at high risk of developing clinically definite multiple sclerosis; patients with relapsing-remitting multiple sclerosis and two or more relapses within the last two years; patients with secondary progressive multiple sclerosis with active disease, evidenced by relapses.

Evidence ↗
1995-11-30Approval
Approval: Betaferon (EMA)
Indication: Betaferon is indicated for the treatment of patients with a single demyelinating event with an active inflammatory process, if it is severe enough to warrant treatment with… Show full indication

Betaferon is indicated for the treatment of patients with a single demyelinating event with an active inflammatory process, if it is severe enough to warrant treatment with intravenous corticosteroids, if alternative diagnoses have been excluded, and if they are determined to be at high risk of developing clinically definite multiple sclerosis; patients with relapsing-remitting multiple sclerosis and two or more relapses within the last two years; patients with secondary progressive multiple sclerosis with active disease, evidenced by relapses.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

20 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
20
registered trials across all phases
LATEST COMPLETION 2020
10
Late-stage (III+)
15
Completed
5
Discontinued
PHASE DISTRIBUTIONn = 20
Phase 12Phase 28Phase 34Phase 45Phase N / A1

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Open-label, Randomized, 2-arm, Active Comparator Study to Evaluate Safety and Tolerability in Portuguese Patients With Relapsing Remitting Multiple Sclerosis (MS) Transitioning From Current Subcutaneous Interferon Therapy to Peginterferon Beta 1a (PLEGRIDY™)

CompletedPH IVBiogenn=802020

Natalizumab De-escalation to Interferon-beta-1b in Patients With Relapsing-remitting Multiple Sclerosis: A Swiss Multicenter Study Prospective, Controlled, Single-arm, Open-label, Multi-centre, Phase IV Study

TerminatedPH IVClaudio Gobbin=52013

De-escalation After Natalizumab Treatment With Interferon-beta-1b in Patients With Relapsing-remitting Multiple Sclerosis

CompletedPH IVClaudio Gobbin=192011

A Multi-Center, Randomized, Single-Blind, Parallel Group Study to Compare the Efficacy, Tolerability and Safety, of Copaxone® to That of High Dose Interferon (Betaseron® or Rebif®) in the Treatment of Relapsing Multiple Sclerosis Patients

TerminatedPH IVTeva Branded Pharmaceutical Products R&D, Inc.n=912007

Phase IV, Rater-blinded, Randomized Study, Comparing 250 mg of Betaseron With 20 mg of Copaxone in Patients With the Relapsing-remitting(RR) or CIS Forms of ms Using 3 Tesla(3T) Magnetic Resonance Imaging (MRI) With Triple-dose Gadolinium

CompletedPH IVUniversity of Medicine and Dentistry of New Jerseyn=752007

Recent completions

Trials that read out recently, adding to the completed evidence base.

Open-label, Randomized, 2-arm, Active Comparator Study to Evaluate Safety and Tolerability in Portuguese Patients With Relapsing Remitting Multiple Sclerosis (MS) Transitioning From Current Subcutaneous Interferon Therapy to Peginterferon Beta 1a (PLEGRIDY™)

CompletedPH IVBiogenn=802020

An Open-label Randomized Controlled Trial on Interferon β-1b and Hydroxychloroquine Combination Versus Hydroxychloroquine Alone, as Treatment for COVID-19 Infection

CompletedPH IIThe University of Hong Kongn=602020

An Investigation Into Beneficial Effects of Interferon Beta 1a, Compared to Interferon Beta 1b And The Base Therapeutic Regiment in Moderate to Severe COVID-19: A Randomized Clinical Trial

CompletedPH IIShahid Beheshti University of Medical Sciencesn=602020

An Open-label Randomized Controlled Trial on Lopinavir/ Ritonavir, Ribavirin and Interferon Beta 1b Combination Versus Lopinavir/ Ritonavir Alone, as Treatment for 2019 Novel Coronavirus Infection

CompletedPH IIThe University of Hong Kongn=1272020

A Phase 1 Double-Blind, Randomised, Two-Treatment Cross-over Study Comparing the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PF530 and Betaferon Administered by Subcutaneous Injection in Healthy Adult Volunteers

CompletedPH IPfenex, Incn=122015

De-escalation After Natalizumab Treatment With Interferon-beta-1b in Patients With Relapsing-remitting Multiple Sclerosis

CompletedPH IVClaudio Gobbin=192011

Research activity

2 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Journals, researchers & institutions
Top journals
  • Journal of neurology, neurosurgery, and psychiatry1
  • Neurology1
Leading researchers
  • Cadavid D2
  • Cheriyan J2
  • Cook SD2
  • Skurnick J2
  • Wolansky LJ2
  • Halper J1
  • Kamin SS1
  • Lincoln J1
Leading institutions
free-text, unnormalised
  • UMDNJ-New Jersey Medical School1
  • University of Medicine and Dentistry of New Jersey-New Jersey Medical School1
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.