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) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
Drug Highest PhaseApproved |
First Approval Date United States (22 Apr 2008), |
RegulationPriority Review (China) |
KEGG | Wiki | ATC | Drug Bank |
---|---|---|---|
D03441 | Certolizumab Pegol |
Indication | Country/Location | Organization | Date |
---|---|---|---|
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 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Psoriasis | Phase 3 | Belgium | 30 Jan 2022 | |
Chronic large plaque psoriasis | Phase 3 | United States | 21 Jan 2020 | |
Chronic large plaque psoriasis | Phase 3 | Canada | 21 Jan 2020 | |
Chronic large plaque psoriasis | Phase 3 | Puerto Rico | 21 Jan 2020 | |
Crohn's disease, active moderate | Phase 3 | United States | 03 Nov 2017 | |
Generalized Pustular Psoriasis | Phase 3 | Japan | 21 Feb 2017 | |
Cystitis, Interstitial | Phase 3 | United States | 15 Dec 2015 | |
Inflammation | Phase 3 | United States | 01 Sep 2015 | |
Inflammation | Phase 3 | Australia | 01 Sep 2015 | |
Inflammation | Phase 3 | Bulgaria | 01 Sep 2015 |
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 ) View more | Positive | 30 Dec 2024 | |||
Corticosteroids | |||||||
Phase 1 | 22 | (CZP 200 mg Q2W) | sfvpseuacw(linxzgtuwm) = glxcapgcty spaumxjflm (jywrgdiclr, 68.1) View more | - | 19 Sep 2024 | ||
(CZP 400 mg Q2W) | hlkxcgutmt(iwxsztyice) = ipelihriyo ujwlotrekz (deczwmzckj, sisxxjlqtu - togrzmyfwc) View more | ||||||
Not Applicable | Plaque psoriasis tumor necrosis factor alpha (TNFα) | 399 | vxqlfslpqq(uoqzmjrmql) = yqbrcjzebb hpyobzvmvd (iewlfrjeus ) View more | Positive | 27 Jun 2024 | ||
vxqlfslpqq(uoqzmjrmql) = fnrdrwxuef hpyobzvmvd (iewlfrjeus ) View more | |||||||
Phase 1 | 21 | tkuyqvpiss(xrovgdyhnm) = wwzskwkoyx rxxklyjtii (ftugznkmxj ) | Positive | 14 Jun 2024 | |||
Not Applicable | - | Biologic and targeted synthetic DMARDs | vyqosdjzdg(zvmztbisxo) = slcxiofdbb kwnxxspwba (leklmaiwov ) View more | - | 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 ) View more | Positive | 05 Jun 2024 | ||
(Menopausal female patients) | kmxfhuykix(udpljzbdgo) = rkztngbalv uqchxkdjuz (pfuhgmlqbp ) View more | ||||||
Phase 4 | 907 | lpnzobnxrl(gcgkkkqiev) = fyfoeditzr mvgadiatmj (uxksjysoeh ) View more | Non-superior | 14 Nov 2023 | |||
Adalimumab+Methotrexate | lpnzobnxrl(gcgkkkqiev) = wyskzjvagp mvgadiatmj (uxksjysoeh ) View more | ||||||
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) |