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EMA-approvedaka Betaseron, Extavia

Interferon beta-1b — Complete Research Guide (2026)

Last updated 2026-06-30

TL;DR

Interferon beta-1b (also known as Betaseron) is a peptide catalogued under Immune (IFN-β). Neutral reference entry; EU status: EU-approved prescription medicine.

What is Interferon beta-1b?

Interferon beta-1b is a recombinant non-glycosylated interferon-beta protein marketed as Betaseron (US), Betaferon (EU) and Extavia. It was the first disease-modifying therapy approved for multiple sclerosis and is FDA- and EMA-approved for relapsing forms of MS, including clinically isolated syndrome.

Its evidence base is human and robust, anchored by the pivotal IFNB Multiple Sclerosis Study Group randomized trial (1993) and its long-term follow-up.

How does Interferon beta-1b work?

Like other beta interferons, it binds type I interferon receptors to produce immunomodulatory effects that reduce pro-inflammatory cytokine activity, T-cell activation and lymphocyte trafficking into the central nervous system.

This lessens the inflammatory attacks underlying MS relapses.

What does the research say about Interferon beta-1b?

  • Subcutaneous interferon beta-1b significantly reduced the annual relapse rate in relapsing-remitting MS in the pivotal placebo-controlled trial. [1]
  • In the same program, interferon beta-1b reduced accumulation of MRI-detected lesion burden versus placebo. [2]
  • Given at a first clinical demyelinating event, interferon beta-1b delayed conversion to clinically definite MS (BENEFIT). [4]

Clinical research & studies

The references below are the primary sources cited throughout this guide. Each links directly to PubMed or the regulator. Where evidence is preclinical (animal or in-vitro), that is stated rather than implied.

  • [1] Interferon beta-1b is effective in relapsing-remitting multiple sclerosis. I. Clinical results of a multicenter, randomized, double-blind, placebo-controlled trial. The IFNB Multiple Sclerosis Study Group — IFNB Multiple Sclerosis Study Group, Neurology 1993. (Randomized controlled trial (pivotal))
  • [2] Interferon beta-1b is effective in relapsing-remitting multiple sclerosis. II. MRI analysis results of a multicenter, randomized, double-blind, placebo-controlled trial. UBC MS/MRI Study Group and the IFNB Multiple Sclerosis Study Group — Paty DW et al., Neurology 1993. (Randomized controlled trial (MRI analysis))
  • [3] Interferon beta-1b in the treatment of multiple sclerosis: final outcome of the randomized controlled trial. The IFNB Multiple Sclerosis Study Group and The University of British Columbia MS/MRI Analysis Group — IFNB Multiple Sclerosis Study Group, Neurology 1995. (Randomized controlled trial (final outcome))
  • [4] Treatment with interferon beta-1b delays conversion to clinically definite and McDonald MS in patients with clinically isolated syndromes — Kappos L et al., Neurology 2006. (Randomized controlled trial (BENEFIT))
  • [5] 250 microg or 500 microg interferon beta-1b versus 20 mg glatiramer acetate in relapsing-remitting multiple sclerosis: a prospective, randomised, multicentre study — O'Connor P et al., Lancet Neurology 2009. (Randomized controlled trial (BEYOND))

Dosing context

This is not medical advice or a usage recommendation. Dosing figures are reported research context only, cited from the published literature.

For context only: interferon beta-1b is administered as a subcutaneous injection every other day, usually with gradual dose escalation to reduce flu-like effects.

Exact dosing, titration and safety monitoring are decided and supervised by a treating neurologist.

Side effects & safety profile

Interferon beta-1b frequently causes flu-like symptoms (fever, chills, myalgia) and injection-site reactions, including rare injection-site necrosis, plus headache and fatigue that often ease over time.

Labeling warns of hepatic injury, depression and suicidality, low blood counts and thrombotic microangiopathy; neutralizing antibodies can develop and may blunt efficacy.

It does not carry the interferon-alfa boxed warning, but liver function, blood counts and mood require monitoring. It is a specialist-prescribed biologic for multiple sclerosis only.

Stacking & combinations

Interferon beta-1b is used as monotherapy and is not intended to be combined with other agents outside physician-directed care.

Finding Interferon beta-1b vendors

Finding Interferon beta-1b vendors

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Frequently asked questions

Yes. It was the first FDA-approved disease-modifying therapy for multiple sclerosis and is approved by the FDA and EMA for relapsing forms of MS; brands include Betaseron/Betaferon and Extavia.

References

  1. [1] Interferon beta-1b is effective in relapsing-remitting multiple sclerosis. I. Clinical results of a multicenter, randomized, double-blind, placebo-controlled trial. The IFNB Multiple Sclerosis Study Group — IFNB Multiple Sclerosis Study Group, Neurology 1993. PMID: 8469318. View sourceStudy: Randomized controlled trial (pivotal)Interferon beta-1b significantly reduced relapse frequency in relapsing-remitting MS, the first DMT proven effective for the disease.
  2. [2] Interferon beta-1b is effective in relapsing-remitting multiple sclerosis. II. MRI analysis results of a multicenter, randomized, double-blind, placebo-controlled trial. UBC MS/MRI Study Group and the IFNB Multiple Sclerosis Study Group — Paty DW et al., Neurology 1993. PMID: 8469319. View sourceStudy: Randomized controlled trial (MRI analysis)Interferon beta-1b reduced MRI disease activity and accumulation of lesion burden versus placebo.
  3. [3] Interferon beta-1b in the treatment of multiple sclerosis: final outcome of the randomized controlled trial. The IFNB Multiple Sclerosis Study Group and The University of British Columbia MS/MRI Analysis Group — IFNB Multiple Sclerosis Study Group, Neurology 1995. PMID: 7617182. View sourceStudy: Randomized controlled trial (final outcome)The clinical and MRI benefit of interferon beta-1b was sustained over the full trial, with neutralizing antibodies noted in a subset of patients.
  4. [4] Treatment with interferon beta-1b delays conversion to clinically definite and McDonald MS in patients with clinically isolated syndromes — Kappos L et al., Neurology 2006. PMID: 16914693. View sourceStudy: Randomized controlled trial (BENEFIT)Early interferon beta-1b after a first clinical event delayed conversion to clinically definite and McDonald-criteria MS.
  5. [5] 250 microg or 500 microg interferon beta-1b versus 20 mg glatiramer acetate in relapsing-remitting multiple sclerosis: a prospective, randomised, multicentre study — O'Connor P et al., Lancet Neurology 2009. PMID: 19729344. View sourceStudy: Randomized controlled trial (BEYOND)Standard-dose interferon beta-1b was comparable to glatiramer acetate, and a doubled dose provided no additional clinical benefit.
This article is for educational and research purposes only. Peptides discussed here are not approved for human consumption by the FDA, EMA, or equivalent regulators outside of specific clinical contexts. Always consult a licensed medical professional before any therapeutic use.