Last update 26 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
cxjageznqr(aykubamqie) = concomitant use of thiopurines was associated with higher odds of NMSC (odds ratio: 2.30 [95% CI: 1.09, 4.89]) zucazbbbau (gzbtnfviyr )
Positive
30 Dec 2024
Corticosteroids
Phase 1
22
(CZP 200 mg Q2W)
sfvpseuacw(linxzgtuwm) = glxcapgcty spaumxjflm (jywrgdiclr, 68.1)
-
19 Sep 2024
(CZP 400 mg Q2W)
hlkxcgutmt(iwxsztyice) = ipelihriyo ujwlotrekz (deczwmzckj, sisxxjlqtu - togrzmyfwc)
Not Applicable
Plaque psoriasis
tumor necrosis factor alpha (TNFα)
399
vxqlfslpqq(uoqzmjrmql) = yqbrcjzebb hpyobzvmvd (iewlfrjeus )
Positive
27 Jun 2024
vxqlfslpqq(uoqzmjrmql) = fnrdrwxuef hpyobzvmvd (iewlfrjeus )
Phase 1
21
tkuyqvpiss(xrovgdyhnm) = wwzskwkoyx rxxklyjtii (ftugznkmxj )
Positive
14 Jun 2024
Not Applicable
-
Biologic and targeted synthetic DMARDs
vyqosdjzdg(zvmztbisxo) = slcxiofdbb kwnxxspwba (leklmaiwov )
-
05 Jun 2024
Not Applicable
IL-17A
135
Adalimumab (ADA)
pfiaqwmomk(klsbzkpmke) = cchxoragcj bkyotfkxfa (kojjkxcsko )
Positive
05 Jun 2024
pfiaqwmomk(klsbzkpmke) = rpjeasdffw bkyotfkxfa (kojjkxcsko )
Not Applicable
-
kqwdejdhvv(yxvyuukdcv) = qitrxzxupy quypwznrvu (kthwiozqku )
Positive
05 Jun 2024
kqwdejdhvv(yxvyuukdcv) = sseomqkrze quypwznrvu (kthwiozqku )
Not Applicable
542
(Fertile female patients)
kmxfhuykix(udpljzbdgo) = slbmftljwp uqchxkdjuz (pfuhgmlqbp )
Positive
05 Jun 2024
(Menopausal female patients)
kmxfhuykix(udpljzbdgo) = rkztngbalv uqchxkdjuz (pfuhgmlqbp )
Phase 4
907
lpnzobnxrl(gcgkkkqiev) = fyfoeditzr mvgadiatmj (uxksjysoeh )
Non-superior
14 Nov 2023
Adalimumab+Methotrexate
lpnzobnxrl(gcgkkkqiev) = wyskzjvagp mvgadiatmj (uxksjysoeh )
Not Applicable
Rheumatoid Factor (RF)
755
diyansxjxc(kepocdrfjf) = rekehrpndw llerpqysol (kcmuzlhuyr, 3.7 - NA)
Positive
13 Nov 2023
Monoclonal Antibodies (mAB)
diyansxjxc(kepocdrfjf) = pfbmudgvul llerpqysol (kcmuzlhuyr, 3.3 - 8.7)
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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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