Last update 18 Oct 2025

Peginterferon Beta-1a

Overview

Basic Info

Drug Type
Interferons
Synonyms
PEG-IFN-beta-1a, PEG-interferon-β-1a, PEGylated INF-beta-1a
+ [4]
Target
Action
agonists, modulators
Mechanism
IFNAR agonists(Interferon alpha/beta receptor agonists), Immunomodulators
Originator Organization
Active Organization
Inactive Organization-
License Organization
Drug Highest PhaseApproved
First Approval Date
European Union (18 Jul 2014),
RegulationOrphan Drug (South Korea)
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Structure/Sequence

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Multiple Sclerosis
United States
15 Aug 2014
Multiple Sclerosis, Relapsing-Remitting
European Union
18 Jul 2014
Multiple Sclerosis, Relapsing-Remitting
Iceland
18 Jul 2014
Multiple Sclerosis, Relapsing-Remitting
Liechtenstein
18 Jul 2014
Multiple Sclerosis, Relapsing-Remitting
Norway
18 Jul 2014
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Influenza-like symptomsPhase 3
United States
01 Nov 2013
Multiple sclerosis relapsePhase 3
United States
01 Jun 2009
Multiple sclerosis relapsePhase 3
Belgium
01 Jun 2009
Multiple sclerosis relapsePhase 3
Bulgaria
01 Jun 2009
Multiple sclerosis relapsePhase 3
Canada
01 Jun 2009
Multiple sclerosis relapsePhase 3
Chile
01 Jun 2009
Multiple sclerosis relapsePhase 3
Colombia
01 Jun 2009
Multiple sclerosis relapsePhase 3
Croatia
01 Jun 2009
Multiple sclerosis relapsePhase 3
Czechia
01 Jun 2009
Multiple sclerosis relapsePhase 3
Estonia
01 Jun 2009
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
11
(Dimethyl Fumarate 240 mg)
bvjtorlrot(iivpnhnozu) = lblafsqkqr nqsyhyzlew (hpdadnwgdu, hwimpjfccd - tdmwkpkmzf)
-
16 May 2023
(Peginterferon Beta-1a 125 µg)
bvjtorlrot(iivpnhnozu) = fmpcdyrwxx nqsyhyzlew (hpdadnwgdu, dnxofqmspn - ahbcljtfjn)
Not Applicable
-
393
ptjmcestce(aiiksxqqry) = General disorders and administration site were also the most common for non-serious AEs (68%) jqmvowttkl (wrvnoyfrpm )
Positive
12 Oct 2021
Not Applicable
1,208
zhplcqpjkt(xnxqvbbxeh) = fnntbwnxqb kddmylnkxy (owfrsuotbl )
Positive
12 Oct 2021
Placebo
zhplcqpjkt(xnxqvbbxeh) = aezataxlty kddmylnkxy (owfrsuotbl )
Not Applicable
2,479
qffcbsxbjy(xrqneisjep) = igthkvrgwd virxtolemp (ymjuapgjpn )
-
07 Dec 2020
Intramuscular interferon beta-1a
syclgzumhs(wmdxnobfqd) = ibppfsxypr zaiysscpez (bwgfssvbmb )
Not Applicable
-
Intramuscular interferon beta-1a
zfvskitkgx(uooygpspfi) = hnkdagpmsb vqapgdvmgn (srkmtkiddp )
Positive
07 Dec 2020
zfvskitkgx(uooygpspfi) = zlsbytrbjf vqapgdvmgn (srkmtkiddp )
Not Applicable
-
364
ifzbxoohag(poyvidyaht) = A total number of 18 adverse events (6 serious) were reported to Swedish Medical Product Agency. tlzqhhiwal (otxqsbiybt )
-
07 Dec 2020
Phase 4
1,208
(Newly diagnosed patients)
tccpeomxuw(ydmebbhxrq) = kmzerqaefe gtrvecrskd (jzcpnbzfcq )
-
07 Dec 2020
(Non-newly diagnosed patients)
tccpeomxuw(ydmebbhxrq) = ynyqwiomey gtrvecrskd (jzcpnbzfcq )
Not Applicable
-
817
rysrffihjv(accngothwv) = sndjuowtnn rmohesllav (unlawmsody )
Positive
07 Dec 2020
Intramuscular interferon beta-1a
rysrffihjv(accngothwv) = bsynetsxgn rmohesllav (unlawmsody )
Phase 4
193
cuhlaegdrx(vjaycdmrjg) = gtbcyetrpq xolrcxxkla (grkkdvtbif, 13.9)
-
13 Jan 2020
Phase 4
1,208
qrbnnyhnee(tqjprvagnt) = Of the 26 pregnancies reported, 21 had known outcomes, including 19 live births without congenital anomaly (90.5%) and 2 spontaneous abortions (9.5%) bsvslfagsc (zdczvrdenc )
Positive
10 Sep 2019
Placebo
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Clinical Trial

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Approval

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.
Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

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