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Drug

Peginterferon beta-1a

Established medicine
ClassInterferon alpha/beta receptor agonistResearchOngoing clinical research

Also known as PEG IFN-beta-1a, Plegridy, Polyethylene glycol-interferon beta-1a.

RxNorm1546168ChEMBLCHEMBL2108677ATCL03AB13UNIII8309403R0
2
Protein targets
1
Regulatory events
Latest activity
beta

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

Pharmacodynamic Biomarkers to Support Biosimilar Development: Clinical Study 3 - Interferon Beta-1A and Peginterferon Beta-1A

Clinical trial2024-04-22Results posted · ClinicalTrials.gov

Multicenter Interventional Phase IV Study for the Assessment of the Effects on Patient's Satisfaction of Plegridy (Pre-filled Pen) in Subjects With Relapsing-remitting Multiple Sclerosis Unsatisfied With Other Injectable Subcutaneous Interferons (PLATINUM)

Clinical trial2023-08-31Results posted · ClinicalTrials.gov

A Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, 3-Arm, Parallel Group Study in Pediatric Subjects Aged 10 Through 17 Years to Evaluate the Efficacy and Safety of BG00012 and BIIB017 for the Treatment of Relapsing-Remitting Multiple Sclerosis

Clinical trial2022-07-21Terminated · ClinicalTrials.gov

A Cluster Randomised Trial of Interferon Versus Standard of Care in the Reduction of Transmission of SARS-Cov-2. The Containing Coronavirus Disease 19 Trial (ConCorD-19)

Clinical trial2021-06-30Completed · 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

A Trial of Prednisone and Acetaminophen Versus Acetaminophen Alone in Minimizing Flu-like Symptoms From Pegylated Interferon Beta-1a

Clinical trial2020-05-01Primary completion · ClinicalTrials.gov

A Dose-Frequency Blinded, Multicenter, Extension Study to Determine the Long-Term Safety and Efficacy of PEGylated Interferon Beta-1a (BIIB017) in Subjects With Relapsing Multiple Sclerosis

Clinical trial2017-01-13Results posted · ClinicalTrials.gov

Brimonidine Tartrate for the Treatment of Injection Related Erythema Associated With Sub-cutaneous Administration of Peginterferon Beta-1a (BRITE)

Clinical trial2016-08-01Withdrawn · ClinicalTrials.gov

An Open-label Crossover Phase 1 Study to Evaluate the Pharmacokinetic Profiles of BIIB017 (Peginterferon Beta-1a) and Rebif® (Interferon Beta-1a) in Healthy Volunteers

Clinical trial2014-12-01Completed · ClinicalTrials.gov

Approval: Plegridy (EMA)

Regulatory2014-07-18EMA

A Two-Arm, Open-Label, Single-Dose, Phase 1 Study of the Pharmacokinetics, Safety, and Tolerability of Peginterferon Beta-1a (BIIB017) in Japanese and Caucasian Adult Healthy Subjects

Clinical trial2014-02-01Completed · ClinicalTrials.gov

Profile

Identifiers & mechanism

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

Canonical name
Peginterferon beta-1a
Aliases & brands
PEG IFN-beta-1aPlegridyPolyethylene glycol-interferon beta-1a
RxNorm CUI
1546168
ChEMBL ID
CHEMBL2108677
ATC codes
L03AB13
UNII
I8309403R0
Primary mechanism
Interferon alpha/beta receptor agonist
Regulatory jurisdictions
ema

Pharmacology & targets

2 targets

Known molecular targets and mechanisms supported by curated pharmacology databases.

Interferon alpha/beta receptor 1
IFNAR1 · P17181
AGONISTInterferon alpha/beta receptor agonist
Interferon alpha/beta receptor 2
IFNAR2 · P48551
AGONISTInterferon alpha/beta receptor agonist

Regulatory timeline

1 event

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
2014-07-18
Latest approval
2014-07-18
Authorities
EMA
Total events
1
emaEuropean Medicines Agency· 1 event
2014-07-18Approval
Approval: Plegridy (EMA)

Indication: Treatment of relapsing remitting multiple sclerosis in adult patients.

Evidence ↗

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

Clinical trials

10 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
10
registered trials across all phases
LATEST COMPLETION 2021
7
Late-stage (III+)
7
Completed
3
Discontinued
PHASE DISTRIBUTIONn = 10
Phase 13Phase 33Phase 44

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

A Trial of Prednisone and Acetaminophen Versus Acetaminophen Alone in Minimizing Flu-like Symptoms From Pegylated Interferon Beta-1a

Unknown statusPH IVHoly Name Medical Center, Inc.n=502020

Multicenter Interventional Phase IV Study for the Assessment of the Effects on Patient's Satisfaction of Plegridy (Pre-filled Pen) in Subjects With Relapsing-remitting Multiple Sclerosis Unsatisfied With Other Injectable Subcutaneous Interferons (PLATINUM)

CompletedPH IVBiogenn=1932017

Brimonidine Tartrate for the Treatment of Injection Related Erythema Associated With Sub-cutaneous Administration of Peginterferon Beta-1a (BRITE)

WithdrawnPH IVBiogen2016

A Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, 3-Arm, Parallel Group Study in Pediatric Subjects Aged 10 Through 17 Years to Evaluate the Efficacy and Safety of BG00012 and BIIB017 for the Treatment of Relapsing-Remitting Multiple Sclerosis

TerminatedPH IIIBiogenn=112022

Recent completions

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

A Cluster Randomised Trial of Interferon Versus Standard of Care in the Reduction of Transmission of SARS-Cov-2. The Containing Coronavirus Disease 19 Trial (ConCorD-19)

CompletedPH IIIKey trialPontificia Universidad Catolica de Chilen=1,1732021

Pharmacodynamic Biomarkers to Support Biosimilar Development: Clinical Study 3 - Interferon Beta-1A and Peginterferon Beta-1A

CompletedPH IFood and Drug Administration (FDA)n=842021

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

Multicenter Interventional Phase IV Study for the Assessment of the Effects on Patient's Satisfaction of Plegridy (Pre-filled Pen) in Subjects With Relapsing-remitting Multiple Sclerosis Unsatisfied With Other Injectable Subcutaneous Interferons (PLATINUM)

CompletedPH IVBiogenn=1932017

A Dose-Frequency Blinded, Multicenter, Extension Study to Determine the Long-Term Safety and Efficacy of PEGylated Interferon Beta-1a (BIIB017) in Subjects With Relapsing Multiple Sclerosis

CompletedPH IIIKey trialBiogenn=1,0772015

An Open-label Crossover Phase 1 Study to Evaluate the Pharmacokinetic Profiles of BIIB017 (Peginterferon Beta-1a) and Rebif® (Interferon Beta-1a) in Healthy Volunteers

CompletedPH IBiogenn=302014
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.