BETASERON (interferon beta-1b)
BETASERON is indicated for the treatment of Multiple Sclerosis.
How BETASERON Works
The precise mechanism of action of BETASERON in patients with multiple sclerosis is currently unknown. While the drug is classified as an interferon beta-1b, the specific biological targets or pathways it interacts with to produce a therapeutic effect have not been established. Consequently, the exact process by which it impacts the progression or symptoms of multiple sclerosis remains unidentified.
Development Insights
Details
- Status
- Prescription
- First Approved
- 1993-07-23
- Routes
- SUBCUTANEOUS
- Dosage Forms
- VIAL
BETASERON Approval History
What BETASERON Treats
1 indicationsBETASERON is approved for 1 conditions since its original approval in 1993. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Multiple Sclerosis
BETASERON Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in BETASERON's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications BETASERON treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to BETASERON
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
6 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03177083 PLENO | PRT-PEG-15-10880 2016-000434-21 | Ph 4 | completed | Evaluate Safety/Tolerability in Portuguese Participants With RRMS Transitioning From Current Therapy |
| NCT04350281 | UW 20-211 | Ph 2 | completed | Double Therapy With IFN-beta 1b and Hydroxychloroquine |
| NCT04343768 COVIFERON | Different Interferons in COVID | Ph 2 | completed | 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 |
| NCT04276688 | UW-20-074 | Ph 2 | completed | Lopinavir/ Ritonavir, Ribavirin and IFN-beta Combination for nCoV Treatment |
| NCT01144052 results posted | EOC.NC.09.01 | Ph 4 | completed | Natalizumab De-escalation With Interferon Beta-1b |
| NCT01701856 | EOC.NSI.11.01 | Ph 4 | terminated | Natalizumab De-escalation to Interferon-beta-1b in Patients With Relapsing-remitting Multiple Sclerosis |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
BETASERON FDA Label Details
Indications & Usage
FDA Label (PDF)BETASERON is indicated for the treatment of Multiple Sclerosis.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment