PLEGRIDY (peginterferon beta-1a)
PLEGRIDY is indicated for the treatment of Multiple Sclerosis; Clinically Isolated Syndrome; Relapsing-Remitting Disease; Secondary Progressive Disease.
How PLEGRIDY Works
PLEGRIDY is classified as an interferon beta. The specific mechanism by which the drug exerts its therapeutic effects in patients with multiple sclerosis is currently unknown. Consequently, the precise biological targets and the exact pathways through which the medication produces its clinical effect have not been established.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2014-08-15
- Revenue
- $55M (Q4-2025)
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
PLEGRIDY Approval History
What PLEGRIDY Treats
4 indicationsPLEGRIDY is approved for 4 conditions since its original approval in 2014. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Multiple Sclerosis
- Clinically Isolated Syndrome
- Relapsing-Remitting Disease
- Secondary Progressive Disease
PLEGRIDY 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 PLEGRIDY's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications PLEGRIDY treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to PLEGRIDY
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
9 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04183491 results posted | SCR-008 | Ph 1 | completed | Pharmacodynamic Biomarkers to Support Biosimilar Development: Interferon Beta-1A Products |
| NCT02587065 PLATINUM results posted | ITA-PEG-14-10779 2015-002201-11 | Ph 4 | completed | Plegridy Satisfaction Study in Participants |
| NCT03870763 results posted | 800MS301 2018-000516-22 | Ph 3 | terminated | Study to Evaluate the Efficacy and Safety of Dimethyl Fumarate (Tecfidera) and Peginterferon Beta-1a (Plegridy) for the Treatment of Relapsing-Remitting Multiple Sclerosis in Pediatric Participants |
| NCT04552379 ConCorD-19 | 200703013 | Ph 3 | completed | The Containing Coronavirus Disease 19 (COVID-19) Trial |
| NCT03177083 PLENO | PRT-PEG-15-10880 2016-000434-21 | Ph 4 | completed | Evaluate Safety/Tolerability in Portuguese Participants With RRMS Transitioning From Current Therapy |
| NCT01332019 ATTAIN results posted | 105MS302 2010-024477-39 | Ph 3 | completed | Long-Term Safety and Efficacy Study of Peginterferon Beta-1a |
| NCT02568111 BRITE | NLD-PEG-14-10784 2015-002159-89 | Ph 4 | withdrawn | Brimonidine Tartrate for the Treatment of Injection Related Erythema |
| NCT02269930 | 105HV105 | Ph 1 | completed | Study to Evaluate the Pharmacokinetic Profiles of BIIB017 (Peginterferon Beta-1a) and Rebif® (Interferon Beta-1a) in Healthy Volunteers |
| NCT01978652 | 105HV104 2013-002912-28 | Ph 1 | completed | Pharmacokinetic Study of Peginterferon Beta-1a in Japanese and Caucasian Adult Healthy Participants. |
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.
PLEGRIDY FDA Label Details
Indications & Usage
FDA Label (PDF)PLEGRIDY is indicated for the treatment of Multiple Sclerosis; Clinically Isolated Syndrome; Relapsing-Remitting Disease; Secondary Progressive Disease.
Pro Intelligence Preview
Deep insights for PLEGRIDY
Revenue Insights
- • Q4-2025: $55M
- • Historical trend analysis
Patent Timeline
- • Patent expiration dates
- • Generic/biosimilar risk
Trial Analysis
- • 11 total trials
- • Stage: Declining
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
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