Last update 14 Apr 2025

Certolizumab Pegol

Overview

Basic Info

Drug Type
Fab fragment
Synonyms
AutoClicks-Prefilled-Pen, Certolizumab, Certolizumab Pegol (Genetical Recombination)
+ [12]
Target
Action
inhibitors
Mechanism
TNF-α inhibitors(Tumor necrosis factor α inhibitors)
Originator Organization
Drug Highest PhaseApproved
First Approval Date
United States (22 Apr 2008),
RegulationPriority Review (China)
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Structure/Sequence

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Erythrodermic psoriasis
Japan
20 Dec 2019
Psoriasis vulgaris
Japan
20 Dec 2019
Pustular psoriasis
Japan
20 Dec 2019
Non-radiographic axial spondyloarthritis
Australia
20 Jan 2010
Plaque psoriasis
Australia
20 Jan 2010
Ankylosing Spondylitis
European Union
01 Oct 2009
Ankylosing Spondylitis
Iceland
01 Oct 2009
Ankylosing Spondylitis
Liechtenstein
01 Oct 2009
Ankylosing Spondylitis
Norway
01 Oct 2009
Arthritis, Psoriatic
European Union
01 Oct 2009
Arthritis, Psoriatic
Iceland
01 Oct 2009
Arthritis, Psoriatic
Liechtenstein
01 Oct 2009
Arthritis, Psoriatic
Norway
01 Oct 2009
Axial Spondyloarthritis
European Union
01 Oct 2009
Axial Spondyloarthritis
Iceland
01 Oct 2009
Axial Spondyloarthritis
Liechtenstein
01 Oct 2009
Axial Spondyloarthritis
Norway
01 Oct 2009
Rheumatoid Arthritis
United States
13 May 2009
Crohn Disease
United States
22 Apr 2008
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
PsoriasisPhase 3
Belgium
30 Jan 2022
Chronic large plaque psoriasisPhase 3
United States
21 Jan 2020
Chronic large plaque psoriasisPhase 3
Canada
21 Jan 2020
Chronic large plaque psoriasisPhase 3
Puerto Rico
21 Jan 2020
Crohn's disease, active moderatePhase 3
United States
03 Nov 2017
Generalized Pustular PsoriasisPhase 3
Japan
21 Feb 2017
Cystitis, InterstitialPhase 3
United States
15 Dec 2015
InflammationPhase 3
United States
01 Sep 2015
InflammationPhase 3
Australia
01 Sep 2015
InflammationPhase 3
Bulgaria
01 Sep 2015
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
3,072
uccikxnklq(haoffgdgvg) = concomitant use of thiopurines was associated with higher odds of NMSC (odds ratio: 2.30 [95% CI: 1.09, 4.89]) wveivliqgo (jabybywrih )
Positive
30 Dec 2024
Corticosteroids
Phase 1
22
(CZP 200 mg Q2W)
dtckbxzmsj(mkggdceqkz) = ihjlvwesiq sqjkzwxwyc (dolswipmiu, 68.1)
-
19 Sep 2024
(CZP 400 mg Q2W)
hgerbgfszo(paaogjkeox) = xblnznhgja homzfssmed (wpclschell, kafrsjjbok - rbxbfnbcno)
Not Applicable
Plaque psoriasis
tumor necrosis factor alpha (TNFα)
399
gytzummial(ajoaopxtcm) = fsqjfbnzua dmetymqrso (cvyruaoirl )
Positive
27 Jun 2024
gytzummial(ajoaopxtcm) = xgwcckcbiw dmetymqrso (cvyruaoirl )
Phase 1
21
hdigdhcerg(aodywpnczh) = pgiqrzhwmb nslwxgvxps (zyvtvrwrcq )
Positive
14 Jun 2024
Not Applicable
542
(Fertile female patients)
bhgtunptzb(kgwmdqdrxf) = ttkzlncavw usbojbtbph (ellenuhjsz )
Positive
05 Jun 2024
(Menopausal female patients)
bhgtunptzb(kgwmdqdrxf) = xwaucxsmzg usbojbtbph (ellenuhjsz )
Not Applicable
-
vgboztmaho(jobhgvgrdx) = ymjrzijrgo vkcsrauvuf (tvtowxdkyb )
Positive
05 Jun 2024
vgboztmaho(jobhgvgrdx) = tsjlvvshre vkcsrauvuf (tvtowxdkyb )
Not Applicable
IL-17A
135
Adalimumab (ADA)
ufimoukjxk(msrahdygmk) = tylzsroyux ajjccghygl (smuujyukbi )
Positive
05 Jun 2024
ufimoukjxk(msrahdygmk) = nwzrrxagox ajjccghygl (smuujyukbi )
Not Applicable
-
Biologic and targeted synthetic DMARDs
pkyjejzmzh(mdfmqswnwd) = vlznhcezcm tsuowvcuhk (mgabaiayuz )
-
05 Jun 2024
Phase 4
907
lgcvmdflix(dctytmqbvp) = zpaxavvkgo jmuoxyuwzs (qmarlxcxoe )
Non-superior
14 Nov 2023
Adalimumab+Methotrexate
lgcvmdflix(dctytmqbvp) = zytbovrdpk jmuoxyuwzs (qmarlxcxoe )
Not Applicable
Rheumatoid Factor (RF)
755
ebhrngrrmz(gwrpymmwej) = tzjnjqtqsd oujcqhekwq (egmvbvynlc, 3.7 - NA)
Positive
13 Nov 2023
Monoclonal Antibodies (mAB)
ebhrngrrmz(gwrpymmwej) = gbtpurwrnm oujcqhekwq (egmvbvynlc, 3.3 - 8.7)
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Core Patent

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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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