Drugs / Certolizumab
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | Japan (PMDA) | Cimzia® | rheumatoid arthritis | — | “UCB filed certolizumab pegol for marketing authorisation with the Japanese Ministry of Health, Labour and Welfare” astellas.com ↗ |
Trials 14
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials · 1 met primary | ||||||
| Phase 1 | NCT03293784 | Oct 2017 → Dec 2019 | melanoma | Institut Claudius Regaud | Completed | Met primary |
| Phase 1 | NCT02120807 | Apr 2014 → Jan 2023 | lung adenocarcinoma | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
| Phase 23 trials · 1 missed | ||||||
| Phase 2 | NCT07138898 | Dec 2025 → Jan 2028 expected | rheumatic disorder | NYU Langone Health | Recruiting | No outcome recorded |
| Phase 2 | NCT06028438 | Aug 2023 → Aug 2024 | rheumatoid arthritis | Janssen Research & Development, LLC | Completed | Missed primary |
| Phase 2 | NCT04991025 | Oct 2022 → Oct 2026 expected | lung carcinoma | Memorial Sloan Kettering Cancer Center | Recruiting | No outcome recorded |
| Phase 33 trials | ||||||
| Phase 3 | NCT05930613 | Nov 2023 → Apr 2029 expected | infertility disorder | Assistance Publique - Hôpitaux de Paris | Recruiting | No outcome recorded |
| Phase 3 | NCT05379322 | Mar 2023 | rheumatoid arthritis | Abu Dhabi Stem Cells Center | Withdrawn | No outcome recorded |
| Phase 3 | NCT02779114 | Jan 2009 → Dec 2017 | rheumatoid arthritis | University of Erlangen-Nürnberg Medical School | Unknown | No outcome recorded |
| Phase 45 trials | ||||||
| Phase 4 | NCT07352566 | Aug 2026 → Jun 2030 expected | atopic eczema, psoriasis | University of California, San Francisco | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT05080218 | Nov 2021 → Apr 2024 | psoriatic arthritis, spondyloarthropathy | Jeffrey Curtis | Completed | No outcome recorded |
| Phase 4 | NCT02714634 | Mar 2016 → Mar 2029 expected | rheumatoid arthritis | University Hospital, Strasbourg, France | Recruiting | No outcome recorded |
| Phase 4 | NCT02132234 | Jun 2013 → Jul 2014 | ankylosing spondylitis, hypertensive disorder, psoriatic arthritis | Jagiellonian University | Unknown | No outcome recorded |
| Phase 4 | NCT01602302 | Jun 2012 → Nov 2020 | rheumatoid arthritis | Medical University of Graz | Terminated | No outcome recorded Stop: Enrollment |
| Phase not applicable1 trial | ||||||
| — | NCT05305066 | Feb 2023 → Dec 2028 expected | rheumatoid arthritis | Marie Hudson, MD | Recruiting | No outcome recorded |
| Comparator or background therapy4 trials | ||||||
| Phase 2 | NCT02862574 Background | Dec 2016 → Jun 2017 | rheumatoid arthritis | Gilead Sciences | Terminated | No outcome recorded |
| Phase 3 | NCT03414502 Comparator | Dec 2007 → Mar 2028 expected | rheumatoid arthritis | University of Nebraska | Recruiting | No outcome recorded |
| Phase 4 | NCT03445845 Comparator | Dec 2018 → Sep 2024 | spondyloarthropathy | University Hospital of Saint-Etienne | Completed | No outcome recorded |
| Phase 4 | NCT02242474 Comparator | Jul 2015 → Oct 2019 | rheumatoid arthritis | CHU de Quebec-Universite Laval | Unknown | No outcome recorded |
News releases announcing trial results or a regulatory action · 13
| Date | Issuer | Release |
|---|---|---|
| 2026-09-09 | UCB Pharma | Regulatory UCB receives U.S. FDA Breakthrough Therapy Designation for CIMZIA[®] (certolizumab pegol) in pregnant women with antiphospholipid syndrome (APS) ucb.com ↗
UCB, a global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) to CIMZIA® (certolizumab pegol) for the prevention of placenta-mediated adverse pregnancy outcomes in pregnant women who have antiphospholipid syndrome (APS) and are positive for lupus anticoagulant (LA). |
| 2026-06-05 | UCB Pharma | Results New EULAR 2026 data show CIMZIA[®] (certolizumab pegol) delivered consistent effect in rheumatoid arthritis, regardless of rheumatoid factor (RF) levels ucb.com ↗
In contrast, RF did not bind to Fc free certolizumab pegol, and no immune complex formation or cytokine induction was observed. |
| 2024-06-13 | UCB Pharma | Results New data support the value of CIMZIA[®] for women living with chronic rheumatic diseases throughout pregnancy and post-partum, and for people living with RA and high rheumatoid factor levels ucb.com ↗
Conversely, the RFs were unable to interact with certolizumab pegol, due to its lack of Fc domain, and no complexes with RF were formed. |
| 2023-11-11 | UCB Pharma | Results Post hoc analysis showed meaningful efficacy of certolizumab pegol for RA patients with high Rheumatoid Factor (RF) levels ucb.com ↗
A post hoc analysis from the EXXELERATE trial shows that 65.7 percent of certolizumab pegol-treated patients, and 48.3 percent of adalimumab-treated patients, with rheumatoid arthritis (RA) and high rheumatoid factor (RF) levels achieved low disease activity at Week 104 |
| 2021-06-01 | UCB Pharma | Results EULAR 2021: New Data from UCB’s Rheumatology Portfolio Demonstrates Real World Value for Patients with axSpA, PsA, and Women of Childbearing Age ucb.com ↗
Patients with axial spondyloarthritis (axSpA), who achieve sustained remission, benefit from continued CIMZIA[®] (certolizumab pegol) treatment either at the full or reduced maintenance dose, a post-hoc analysis of the C-OPTIMISE study confirms |
| 2015-04-23 | Astellas Pharma Inc | Results The Results of Japanese Clinical Trials of Anti-TNF-alpha Antibody Certolizumab Pegol were Announced at Leading Rheumatology Meeting 2015 in Japan astellas.com ↗
The additional analyses of C-OPERA, and long-term safety and efficacy over 4 years in J-RAPID and HIKARI studies were reported at the Annual General Assembly and Scientific Meeting of the Japan College of Rheumatology, April 23–25, 2015 in Nagoya, Japan. |
| 2014-11-19 | Astellas Pharma Inc | Results The results of Japanese Clinical Trials of Anti-TNF-alpha Antibody Certolizumab Pegol including new sub-group Analyses focusing on baseline patient characteristics were Announced at 2014 meeting of leading rheumatology meeting astellas.com ↗
In contrast, CZP + MTX co-therapy inhibited joint destruction even in patients with these characteristics compared to MTX monotherapy. |
| 2014-06-25 | Astellas Pharma Inc | Regulatory Announcement of an Application for the Additional Indication for the Anti-TNF-α Antibody Certolizumab Pegol (Generic Name) astellas.com ↗
they have filed an application for the additional indication. |
| 2012-12-25 | Astellas Pharma Inc | Regulatory Astellas and UCB announce approval of Cimzia®(certolizumab pegol) in Japan for the treatment of adult patients with rheumatoid arthritis astellas.com ↗
today announced that UCB Japan has received marketing approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) for Cimzia® (INN;certolizumab pegol). |
| 2011-11-08 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Results Results of two trials show a rapid and sustained response with certolizumab pegol for treatment of rheumatoid arthritis (J-RAPID and HIKARI Studies) released at 2011 meeting of American College of Rheumatology (ACR) otsuka.co.jp ↗
Results of the two Japanese clinical trials, phase II/III J-RAPID Study and phase III HIKARI Study, showed treatment with certolizumab pegol was associated with a rapid and sustained reduction in RA signs and symptoms and inhibition of joint damage progression. |
| 2009-05-14 | Nektar Therapeutics | Regulatory Nektar Announces UCB's Cimzia(R) Approved by U.S. FDA for Adult Patients Suffering From Moderate to Severe Rheumatoid Arthritis nektar.com ↗
Nektar Therapeutics (Nasdaq: NKTR) confirmed today UCB's announcement that the US Food and Drug Administration (FDA) has approved Cimzia(R) (certolizumab pegol), the only PEGylated anti-TNFa (Tumor Necrosis Factor alpha), for the treatment of adult patients with moderately to severely active rheumatoid arthritis. |
| 2009-05-14 | XOMA (US) LLC | Regulatory XOMA Royalties On CIMZIA(r) Expected to Increase Due to FDA Approval for Moderate to Severe Rheumatoid Arthritis in Adults xoma.com ↗ |
| 2008-04-23 | Nektar Therapeutics | Regulatory FDA Approval of Cimzia(R) for Crohn's Disease Represents Latest Milestone for Nektar's PEGylation Technology Platform nektar.com ↗
The U.S. Food and Drug Administration (FDA) approved UCB's Cimzia(R) (certolizumab pegol) for reducing the signs and symptoms of Crohn's disease and maintaining clinical response in adult patients with moderate to severe active disease who have an inadequate response to conventional therapy. |
All press releases naming this drug 25 releases
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 18 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Certolizumab | “certolizumab (pegylated fragment of a monoclonal antibody) 400 mg sc at week 0, 2 and 4, and then 200 mg sc every 2 weeks or 400 mg sc every 4 weeks” NCT05305066 ↗17“An approved stable subcutaneous formulation of one of the following TNF inhibitors may include adalimumab, certolizumab, etanercept, or golimumab.” NCT02862574 ↗ “certolizumab: 400mg every other week 3 times, and then 200mg every other week or 400mg per month in subcutaneous injections” NCT03445845 ↗ “Adalimumab, etanercept, certolizumab, or golimumab” NCT05379322 ↗ “Methotrexate or leflunomide + certolizumab or” NCT02714634 ↗ “Certolizumab (Cimzia®)” NCT02779114 ↗ “Certolizumab” NCT02242474 ↗ “Certolizumab” NCT05080218 ↗ |
| Known as | Cimzia | “Certolizumab (CIMZIA® ; TNF-α antagonist)” NCT05930613 ↗1“Certolizumab (Cimzia®)” NCT02779114 ↗ |
| Action | Inhibit | “Nivolumab+Ipilimumab administered in combination with the anti-TNF-α either Infliximab or Certolizumab” NCT03293784 ↗ |
| Modality | Protein / enzyme biologic | “Certolizumab is a fusion between a fab fragment targeting TNF and a Peg fraction” NCT03445845 ↗ |
| Route | Subcutaneous | “* certolizumab 400 mg s.c. every 2 weeks for 4 weeks, then 200mg every 2 weeks” NCT02132234 ↗ |
| Target | TNF | “Nivolumab+Ipilimumab administered in combination with the anti-TNF-α either Infliximab or Certolizumab” NCT03293784 ↗ |