Interferon beta-1b
How it works: The first medicines: interferon beta and glatiramer acetate →
Betaferon
EU: Approved in the EU since 1995US: FDA approved 1993
- Molecule type
- Protein
- Mechanism (ChEMBL)
- Interferon alpha/beta receptor agonist
- Targets
- Interferon alpha/beta receptor
- Availability
- Authorised in all EU and EEA countries. Reimbursement is decided by each country.
Approvals
Other regulatory events
- Withdrawn · Extavia25 April 2025 Source
Safety communications
None recorded.
Most-reported side effects (FDA reports)
Reports to the FDA's adverse event system (FAERS) show what people and doctors reported while taking the medicine. They do not prove the medicine caused it, and they are not rates.
19,800 reports in total, 11,320 marked serious.
- Influenza like illness1,429
- Multiple sclerosis relapse1,423
- Fatigue1,234
- Injection site pain1,217
- Multiple sclerosis1,204
- Drug ineffective998
- Injection site erythema993
- Pain884
- Headache883
- Injection site reaction853
Trials
Key trials
Large trials with a reported result on their main goal.
- Open Label Study to Evaluate Effect, Safety and Tolerability of Betafe
Completed · Phase 3 · Relapsing and progressive · Met its main goal
- BEYOND: Betaferon/Betaseron Efficacy Yielding Outcomes of a New Dose i
Completed · Phase 3 · Relapsing MS · Missed its main goal
- BENEFIT Study (Betaferon® / Betaseron® in Newly Emerging Multiple Scle
Completed · Phase 3 · Early (CIS/RIS) · Met its main goal
Running now
- Disease Modifying Therapies Withdrawal in Inactive Relapsing-remitting
Not yet recruiting · Phase 3 · Relapsing MS · Still running
- An Observational Study to Learn About the Interferon-beta Exposure of
Running, not recruiting · MS (type not specified) · Still running
- Disease Modifying Therapies Withdrawal in Inactive Secondary Progressi
Running, not recruiting · Phase 3 · Progressive MS · Still running
- Determining the Effectiveness of earLy Intensive Versus Escalation App
Running, not recruiting · Phase 4 · Relapsing MS · Still running
Other trials (57)
Completed small trials, dose-finding studies and trials in other diseases.
- US PROmyBETAapp2.0: A Study to Learn More About the Medication Usage a
Completed · MS (type not specified) · No results found
- PROmyBETAappGame: a Study to Learn More About the Medication Usage & P
Completed · MS (type not specified) · No results found
- A Post-Authorization Safety Study of Interferon Beta Therapy in Partic
Completed · Relapsing MS · No results found
- Medication Usage and Patient Reported Outcomes Evaluation Via myBETAap
Completed · Relapsing and progressive · Paper found, not read
- Evaluate Safety/Tolerability in Portuguese Participants With RRMS Tran
Completed · Phase 4 · Relapsing MS · No results found
- EPID Multiple Sclerosis Pregnancy Study
Completed · MS (type not specified) · No results found
- Impact of the BETACONNECT Auto-injector on BETASERON Therapy Adherence
Completed · Relapsing MS · No results found
- Evaluation of Potential Predictors of Adherence by Investigating a Rep
Completed · Relapsing MS · Paper found, not read
- Comparison Study of PF530 and Betaferon in Healthy Subjects
Completed · Phase 1 · MS (type not specified) · No results found
- BETAEVAL Global - The New BETACONNECT Auto-injector : Adherence and EV
Completed · Relapsing MS · No results found
Trials where it is given as background therapy
- Atorvastatin 40 mg in Patients With Relapsing-Remitting Multiple Scler
Completed · Phase 2 · Relapsing MS · Missed its main goal
For information only, not medical advice. Talk to your neurologist before changing treatment.
Hypotheses involving this medicine
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Lab studies
Lab studies in animals or cells. Results in animals often do not hold in people, and these studies never change the status of an idea.
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