Last update 17 Apr 2025

Peginterferon alfa-2b(Merck & Co)

Overview

Basic Info

Drug Type
Interferons
Synonyms
PEG-IFN-alfa2b, peginterferon alfa-2b, Peginterferon alfa-2b (Merck Sharp & Dohme)
+ [15]
Target
Action
agonists, stimulants, inducers
Mechanism
IFNAR agonists(Interferon alpha/beta receptor agonists), Immunostimulants, Innate antiviral immune response inducers
Active Indication
Originator Organization
Drug Highest PhaseApproved
First Approval Date
European Union (24 May 2000),
RegulationOrphan Drug (United States)
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Structure/Sequence

R&D Status

Approved
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IndicationCountry/LocationOrganizationDate
Melanoma
United States
29 Mar 2011
Hepatitis B
China
05 Apr 2007
Hepatitis C
Taiwan Province
31 Dec 2001
Hepatitis C, Chronic
European Union
24 May 2000
Hepatitis C, Chronic
Iceland
24 May 2000
Hepatitis C, Chronic
Liechtenstein
24 May 2000
Hepatitis C, Chronic
Norway
24 May 2000
Developing
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IndicationHighest PhaseCountry/LocationOrganizationDate
Fibrosis, LiverPhase 3-01 Dec 2006
HIV InfectionsPhase 3-01 Sep 2006
Liver CirrhosisPhase 3-01 Sep 2006
Hepatitis B, ChronicPhase 3-01 Dec 2005
Hepatitis D, ChronicPhase 3-01 Dec 2005
Chronic hepatitis C genotype 1Phase 3-01 Mar 2004
Acute hepatitisPhase 3-01 Dec 2003
Neoplasm MetastasisPhase 3
France
01 Jun 2003
Compensated cirrhosisPhase 3-01 Jun 2002
FibrosisPhase 3-01 Jun 2002
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
HBsAg positive
-
avbdraiesv(ifkqcpheeu) = mbdeyyexvn erwexeqiwq (fyogyszdfc )
-
10 Nov 2023
avbdraiesv(ifkqcpheeu) = gbyocwllsk erwexeqiwq (fyogyszdfc )
Phase 2
20
wrasxbxlpr(tosrfheiky) = lejfuynrkq xogcwkmkcf (lngbthliih, ggudefrbtj - dbbuklrapm)
-
06 Jul 2023
Phase 2
12
wvfcghwimm = dcrygwqhoq vakdjjiuay (auuylufltf, zeqgbufdfs - pqaafbcegy)
-
25 Jan 2023
Not Applicable
HBcrAg | HBsAg | ALT ...
-
PEG-IFN 135 ug
qcsnhxdrcp(ruopekzuad) = hdnkwnnhaf mnogfonkgq (otkmaxkvbe )
Positive
25 Jun 2022
Placebo
qcsnhxdrcp(ruopekzuad) = bplrhaixvz mnogfonkgq (otkmaxkvbe )
Not Applicable
Hepatitis D
HBcrAg | pre-genomic HBV RNA | large HBsAg (LHBs)
33
PEG-IFN responders
ovqagkwmta(dpuiahsqrt) = fndcdnfskc rvypfzrtyj (vgwpcgcaaa )
Positive
23 Jun 2022
(Non-responders (NR))
ovqagkwmta(dpuiahsqrt) = jbhxyyfveg rvypfzrtyj (vgwpcgcaaa )
Not Applicable
Hepatitis B
HBsAg | HBV DNA | HBsAb-positive ...
212
Peginterferon-alpha-based regimens
cddhsmkale(oxjkpabrpv) = mafvvtprzq moedyjflom (zydztrhbcf )
-
23 Jun 2021
Phase 1
18
Autologous Monocytes+ACTIMMUNE+SYLATRON
(Dose Level 1 - Sylatron 25µg (0.1 µg/ml); Actimmune 5mg (0.02µg/ml))
updcdidjto = odaglacept xhjkgqfscj (yzvmyohuiu, iwxhskrfng - sfodwrflmt)
-
16 Jun 2021
Autologous Monocytes+ACTIMMUNE+SYLATRON
(Dose Level 2 - Monocytes (75x10^6); Sylatron 25µg (0.1µg/ml); Actimmune 5mg (0.02µg/ml))
updcdidjto = drlezebzgz xhjkgqfscj (yzvmyohuiu, guzvalkelq - vmaevhqppk)
Not Applicable
Hepatitis D
HDV RNA | HBsAg | HBcrAg ...
16
Peg-IFN
rcrfdiaswp(ovwqycsoso) = pgyxchbial alnyhjrrpf (grnyvnhupu )
Negative
27 Aug 2020
Phase 1/2
12
TIL+IFNalpha
yobwltqepj = kksyxauljv qdgmcqcfrq (gycutdpcqv, owynymloba - taorlajbfp)
-
22 Jan 2020
Phase 2/3
126
(PEG-Intron)
izbrbhcisv(kqrzbqtbld) = yxritaumeg spoeewekle (rphpklpsgk, eyhxfhpbtz - blmgjojico)
-
24 Jul 2019
(INTRON A)
izbrbhcisv(kqrzbqtbld) = knptrqjqdt spoeewekle (rphpklpsgk, tswlenrdqq - swidgejdbu)
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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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