Drugs / peginterferon beta-1a

Regulatory milestones approvals, filings & regulatory actions · 4 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Label expansions (2) US (FDA) PLEGRIDY 2020-03-27 – 2021-01-29 fda.gov
Approved US (FDA) PLEGRIDY 2014-08-15 fda.gov
Approved EU (EMA) Plegridy 2014-07-18 europa.eu

Trials 14 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 15 trials
Phase 1 NCT04183491 Feb 2020 → Jan 2021 Food and Drug Administration (FDA) Completed No outcome recorded
Phase 1 NCT02269930 Oct → Dec 2014 multiple sclerosis Biogen Completed No outcome recorded
Phase 1 NCT01978652 Dec 2013 → Feb 2014 Biogen Completed No outcome recorded
Phase 1 NCT01119781 May 2010 → Aug 2011 impaired renal function disease Biogen Completed No outcome recorded
Phase 1 NCT02125578 Mar → May 2008 Biogen Completed No outcome recorded
Phase 37 trials
Phase 3 NCT03958877 Oct 2019 → May 2027 expected relapsing-remitting multiple sclerosis Biogen Active not recruiting No outcome recorded
Phase 3 NCT03870763 Mar 2019 → Jul 2022 relapsing-remitting multiple sclerosis Biogen Terminated No outcome recorded
Phase 3 NCT05242133 Dec 2017 → Apr 2022 relapsing-remitting multiple sclerosis Cinnagen Completed No outcome recorded
Phase 3 NCT01939002 Nov 2013 → Oct 2015 multiple sclerosis Biogen Completed No outcome recorded
Phase 3 NCT01332019 Apr 2011 → Oct 2015 multiple sclerosis Biogen Completed No outcome recorded
Phase 3 NCT01337427 Aug 2010 → Aug 2013 relapsing-remitting multiple sclerosis Johns Hopkins University Withdrawn No outcome recorded
Phase 3 NCT00906399 Jun 2009 → Oct 2012 relapsing-remitting multiple sclerosis Biogen Completed No outcome recorded
Phase 42 trials
Phase 4 NCT02587065 Feb 2016 → Oct 2017 relapsing-remitting multiple sclerosis Biogen Completed No outcome recorded
Phase 4 NCT02234869 Oct 2014 → Feb 2017 multiple sclerosis Biogen Withdrawn No outcome recorded
Also used as a comparator or background therapy in 5 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 32 trials
Phase 3 NCT04788615 Comparator Jul 2021 → Nov 2025 multiple sclerosis Novartis Pharmaceuticals Completed No outcome recorded
Phase 3 NCT04552379 Comparator Dec 2020 → May 2021 COVID-19 Pontificia Universidad Catolica de Chile Completed No outcome recorded
Phase 43 trials
Phase 4 NCT03424733 Background Sep 2017 → May 2020 multiple sclerosis Holy Name Medical Center, Inc. Unknown No outcome recorded
Phase 4 NCT03177083 Comparator Jan 2017 → Oct 2020 relapsing-remitting multiple sclerosis Biogen Completed No outcome recorded
Phase 4 NCT02568111 Background Feb → Aug 2016 relapsing-remitting multiple sclerosis Biogen Withdrawn No outcome recorded

Evidence & citations 10 cited values

Every value below carries the sentence it was read from. 23 sources stand behind the page.

FieldValueCited text
Known as peginterferon beta-1a “Efficacy and safety of peginterferon beta-1a compared to interferon beta-1a in relapsing remitting multiple sclerosis patients” PMID 39217809 Aug 2024
14

“Peg-Interferon beta-1a minimum dose of 63µg or maximum dose of 125µg every 2 weeks (14 days)” NCT04788615

“Drug: BIIB017 (peginterferon beta-1a)” NCT03958877

NCT04183491

NCT02269930

NCT03870763

NCT02568111

NCT02234869

NCT01119781

NCT00906399

NCT01978652

NCT03177083

NCT04552379

NCT01332019

NCT02587065

Known as BIIB017 BIIB017 (peginterferon beta-1a)” NCT00906399
6

BIIB017 (Peginterferon beta-1a)” NCT02234869

BIIB017(peginterferon beta-1a)” NCT01119781

NCT02125578

NCT01337427

NCT03958877

NCT01939002

Known as PEG-IFN beta-1a “This study clinically evaluated a novel PEGylated form of interferon beta-1a (PEG-IFN beta-1a), a potential first-line treatment for relapsing multiple sclerosis, in healthy volunteers.” PMID 21680782 Jun 2011
Known as Peginterferon beta ChEMBL registry synonym — accepted as the source's own label CHEMBL2108677
Known as Peginterferon β-1a Peginterferon β-1a every 2 weeks increased achievement of no evidence of disease activity over 4 years in the ADVANCE and ATTAIN studies in patients with relapsing-remitting...” PMID 30181780 Aug 2018
1

“Single-use autoinjector for peginterferon-β1a treatment of relapsing-remitting multiple sclerosis: safety, tolerability and patient evaluation data from the Phase IIIb ATTAIN study.” PMID 25073663 Jul 2014

Known as PEGylated Interferon Beta-1a “BIIB017 (PEGylated Interferon Beta-1a)” NCT02125578
Known as pegylated interferon-β1a “a pegylated interferon-β1a in clinical development” PMID 25073663 Jul 2014
Known as Plegridy ClinicalTrials.gov intervention name — accepted as the source's own label NCT03424733
Modality Protein / enzyme biologic “PEGylated Interferon Beta-1a (BIIB017)” NCT01119781
Route Subcutaneous “self-administered by subcutaneous injection” NCT00906399