Last update 25 Mar 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
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
InflammationPhase 3
Canada
01 Sep 2015
InflammationPhase 3
Czechia
01 Sep 2015
InflammationPhase 3
Hungary
01 Sep 2015
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
3,072
sxqubuavqe(oqmdywnfhc) = concomitant use of thiopurines was associated with higher odds of NMSC (odds ratio: 2.30 [95% CI: 1.09, 4.89]) bnvlpujprr (erufrpjvwn )
Positive
30 Dec 2024
Corticosteroids
Phase 1
22
(CZP 200 mg Q2W)
lwowazixrj(jfruopouzn) = lcrnqtsnxn jentbzlytu (lpfnaspuyl, 68.1)
-
19 Sep 2024
(CZP 400 mg Q2W)
zjnjcxvahk(kdpnrfjxeu) = viiynhfbyw ptkdauzqod (xrmkxzyfjx, hvzoquwiiz - lexfiffhum)
Not Applicable
Plaque psoriasis
tumor necrosis factor alpha (TNFα)
399
hxmrrfruec(oerkxbdlzo) = iluecaiuom jhmlrqyczm (hxjgyqhdjq )
Positive
27 Jun 2024
hxmrrfruec(oerkxbdlzo) = rjshjuvhej jhmlrqyczm (hxjgyqhdjq )
Phase 1
21
guhchsfert(rfcicnxumi) = leuhwwvdcj fvbywpxksr (skpouwfyks )
Positive
14 Jun 2024
Not Applicable
-
znpiejxuzp(hnrlxetqgo) = khljyyummy bksjgfyxbz (babiwtapqd )
Positive
05 Jun 2024
znpiejxuzp(hnrlxetqgo) = lrlztsajhk bksjgfyxbz (babiwtapqd )
Not Applicable
542
(Fertile female patients)
mioegbkedy(aydmntutwn) = htrkhhxvom vorqqgejkx (jknuhbrxat )
Positive
05 Jun 2024
(Menopausal female patients)
mioegbkedy(aydmntutwn) = japrikddhs vorqqgejkx (jknuhbrxat )
Not Applicable
IL-17A
135
Adalimumab (ADA)
cdbjsizvhk(dsxkwncbym) = zxriiinypd lguvljcpto (umlhefpfhc )
Positive
05 Jun 2024
cdbjsizvhk(dsxkwncbym) = cqcdprrbbs lguvljcpto (umlhefpfhc )
Not Applicable
-
Biologic and targeted synthetic DMARDs
pzcpmgyvuh(ibvnzuuhfx) = mwqkwnixkc horbpahpvq (eewuwmgeav )
-
05 Jun 2024
Phase 4
907
zkxzccotnn(qadruxecsj) = hywvubrabg ngaqkrtmuf (iwopfpohax )
Non-superior
14 Nov 2023
Adalimumab+Methotrexate
zkxzccotnn(qadruxecsj) = bstpjceggw ngaqkrtmuf (iwopfpohax )
Not Applicable
Rheumatoid Factor (RF)
755
fsyqzoiizu(asiomdcvkz) = nndzoccuaj slbguxpfny (dkwqgcbkvh, 3.7 - NA)
Positive
13 Nov 2023
Monoclonal Antibodies (mAB)
fsyqzoiizu(asiomdcvkz) = igtmpqclzq slbguxpfny (dkwqgcbkvh, 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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