CIMZIA (certolizumab pegol)
CIMZIA is indicated for the treatment of Crohn's Disease; Rheumatoid Arthritis; Polyarticular Juvenile Idiopathic Arthritis; Psoriatic Arthritis; Ankylosing Spondylitis; Axial Spondyloarthritis; Plaque Psoriasis.
How CIMZIA Works
Certolizumab pegol functions by selectively binding to and neutralizing human tumor necrosis factor alpha (TNFα), a key pro-inflammatory cytokine that plays a central role in inflammatory processes. The drug neutralizes both membrane-associated and soluble forms of TNFα, thereby inhibiting the production of other inflammatory mediators like IL-1β. Unlike complete antibodies, certolizumab pegol does not contain a fragment crystallizable (Fc) region, which prevents it from fixing complement or causing antibody-dependent cell-mediated cytotoxicity. This targeted action helps suppress the overactive immune response responsible for tissue inflammation in the approved indications.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2008-04-22
- Patent Cliff
- 2024
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
CIMZIA Approval History
What CIMZIA Treats
7 indicationsCIMZIA is approved for 7 conditions since its original approval in 2008. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Crohn's Disease
- Rheumatoid Arthritis
- Polyarticular Juvenile Idiopathic Arthritis
- Psoriatic Arthritis
- Ankylosing Spondylitis
- Axial Spondyloarthritis
- Plaque Psoriasis
CIMZIA Boxed Warning
SERIOUS INFECTIONS and MALIGNANCY SERIOUS INFECTIONS Patients treated with CIMZIA are at increased risk for developing serious infections that may lead to hospitalization or death [see Warnings and Precautions (5.1) and Adverse Reactions (6.1) ] . Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. CIMZIA should be discontinued if a patient develops a serious infection or sepsis. Reported infections include: Active tube...
WARNING: SERIOUS INFECTIONS and MALIGNANCY SERIOUS INFECTIONS Patients treated with CIMZIA are at increased risk for developing serious infections that may lead to hospitalization or death [see Warnings and Precautions (5.1) and Adverse Reactions (6.1) ] . Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. CIMZIA should be discontinued if a patient develops a serious infection or sepsis. Reported infections include: Active tuberculosis, including reactivation of latent tuberculosis. Patients with tuberculosis have frequently presented with disseminated or extrapulmonary disease. Patients should be tested for latent tuberculosis before CIMZIA use and during therapy. Treatment for latent infection should be initiated prior to CIMZIA use. Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Empiric anti-fungal therapy should be considered in patients at risk for invasive fungal infections who develop severe systemic illness. Bacterial, viral and other infections due to opportunistic pathogens, including Legionella and Listeria. The risks and benefits of treatment with CIMZIA should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection. Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with CIMZIA, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy. [see Warnings and Precautions (5.1) and Adverse Reactions (6.1) ]. MALIGNANCY Lymphoma and other malignancies, some fatal, have been
CIMZIA Target & Pathway
ProTarget
A pro-inflammatory cytokine that plays a central role in immune responses and inflammation. Excess TNF contributes to autoimmune diseases like rheumatoid arthritis, psoriasis, and inflammatory bowel disease. Blocking TNF reduces inflammation and prevents tissue damage.
CIMZIA Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in CIMZIA's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications CIMZIA treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to CIMZIA
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
42 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04123795 CIMcare | PS0007 | Ph 3 | active not recruiting | A Study to Evaluate the Pharmacokinetics, Safety, and Effectiveness of Certolizumab Pegol in Children With Moderate to Severe Chronic Plaque Psoriasis |
| NCT03152058 | 94818 | Ph 2 | recruiting | IMPACT Study: IMProve Pregnancy in APS With Certolizumab Therapy |
| NCT04740814 results posted | RA0138 | Ph 1 | completed | A Study to Assess the Pharmacokinetics of Certolizumab Pegol in Adults With Active Rheumatoid Arthritis |
| NCT03215277 results posted | AS0013 2017-000957-37 | Ph 2 | completed | A Study to Test the Efficacy and Safety of Bimekizumab and Certolizumab Pegol in Patients With Active Ankylosing Spondylitis |
| NCT03100253 RAFTING | IRFMN-RA-6453 | Ph 4 | terminated | Rheumatoid Arthritis Treatment After First Anti-TNF INvestiGation |
| NCT02552212 C-AXSPAND results posted | AS0006 2015-001894-41 | Ph 3 | completed | Multicenter Study Evaluating Certolizumab Pegol Compared to Placebo in Subjects With axSpA Without X-ray Evidence of AS |
| NCT01197066 | 101-KOA-0802i | Ph 3 | completed | Open-label, Extension Study of CDP870 in Patients With Rheumatoid Arthritis |
| NCT03051217 results posted | PS0017 | Ph 2, Ph 3 | completed | A Study to Test the Efficacy and Safety of Certolizumab Pegol in Japanese Subjects With Moderate to Severe Chronic Psoriasis |
| NCT01090154 UC CIMZIA | 37823 CZP-UC-001 | Ph 2 | completed | Study of Cimzia for the Treatment of Ulcerative Colitis |
| NCT02346240 CIMPACT results posted | PS0003 2014-003492-36 | Ph 3 | completed | Efficacy and Safety Study of Certolizumab Pegol (CZP) Versus Active Comparator and Placebo in Subjects With Plaque Psoriasis (PSO) |
| NCT04643483 | CD0003 | Ph 3 | withdrawn | A Study to Test Efficacy, Safety, and Pharmacokinetics of Certolizumab Pegol in Children and Adolescents With Moderately to Severely Active Crohn's Disease |
| NCT03020992 C-VIEW results posted | AS0007 2016-000343-14 | Ph 4 | completed | A Study to Assess the Effects of Certolizumab Pegol on the Reduction of Anterior Uveitis (AU) Flares in Axial Spondyloarthritis Subjects With a Documented History of AU |
| NCT02505542 C-OPTIMISE results posted | AS0005 2015-000339-34 | Ph 3 | completed | Study to Evaluate Maintenance of Sustained Remission of axSpA With CZP Compared to Placebo |
| NCT01190410 results posted | CR0012 | Ph 2 | completed | Extension Study to Assess Long Term Safety in Children and Adolescents With Crohn's Disease Receiving Certolizumab Pegol |
| NCT01864265 PreCePRA | PreCePRA | Ph 3 | completed | Prediction of Response to Certolizumab Pegol Treatment by Functional MRI of the Brain |
| NCT02326298 CIMPASI-1 results posted | PS0005 2014-003513-28 | Ph 3 | completed | An Efficacy and Safety Study of Two Dose Levels of Certolizumab Pegol (CZP) in Subjects With Plaque Psoriasis (PSO) |
| NCT02326272 CIMPASI-2 results posted | PS0002 2014-003486-14 | Ph 3 | completed | A Study to Evaluate the Efficacy and Safety of Two Dose Levels of Certolizumab Pegol (CZP) in Subjects With Plaque Psoriasis (PSO) |
| NCT02019602 CRIB results posted | UP0017 2013-003812-30 | Ph 1 | completed | A Multicener, Postmarketing Study Evaluating the Transfer of Cimzia From the Mother to the Infant Via the Placenta |
| NCT02319642 RAPID-C OLE results posted | RA0078 CTR20140412 | Ph 3 | completed | An Open-label Extension Study of Certolizumab Pegol in Chinese Patients With Rheumatoid Arthritis Who Enrolled in RA0044 |
| NCT00552344 results posted | C87088 2007-002716-26 | Ph 3 | completed | A Study to Evaluate Safety of Long Term Therapy of Certolizumab Pegol Patients With Crohn's Disease |
| NCT00899678 NURTURE results posted | C87035 2014-004381-24 | Ph 2 | terminated | The Use of Certolizumab Pegol for Treatment of Active Crohn's Disease in Children and Adolescents |
| NCT02293590 RICE | EKSG13/104/2B | Ph 2 | completed | RICE: Remission by Intra-articular Injection Plus CErtolizumab |
| NCT00753454 Dose Flex II results posted | C87084 2007-005267-10 | Ph 3 | completed | Open Label Extension for Patients Coming From the Dosing Flexibility Study in Patients With Rheumatoid Arthritis (RA) |
| NCT01292265 SWIFT results posted | RA0033 | Ph 3 | terminated | A 12 Week Study to Assess Changes in Joint Inflammation Using Ultrasonography in Patients With Rheumatoid Arthritis (RA) |
| NCT00993668 results posted | RA0017 | Ph 4 | completed | Assessing the Use of Certolizumab Pegol in Adult Subjects With Rheumatoid Arthritis on the Antibody Response When Receiving Influenza Virus and Pneumococcal Vaccines |
| NCT01519791 C-early results posted | RA0055 Period 1 2011-001729-25 | Ph 3 | completed | A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Certolizumab Pegol in Combination With Methotrexate in the Treatment of Disease Modifying Antirheumatic Drugs (DMARD)-naïve Adults With Early Active Rheumatoid Arthritis |
| NCT02151851 RAPID-C results posted | RA0044 | Ph 3 | completed | A Study of Certolizumab Pegol as Additional Therapy in Chinese Patients With Active Rheumatoid Arthritis |
| NCT02497976 results posted | IC-201 | Ph 3 | completed | Pilot Study Evaluating the Efficacy of Certolizumab Pegol for Interstitial Cystitis |
| NCT02154425 CRADLE results posted | UP0016 2013-004126-28 | Ph 1 | completed | A Multicenter, Postmarketing Study Evaluating the Concentration of Cimzia® in Mature Breast Milk of Lactating Mothers |
| NCT01696942 results posted | 36497 | Ph 4 | terminated | Cimzia Versus Mesalamine for Crohn's Recurrence |
| NCT01213017 PICS | OMRF-UCB-5-16-2010 | Ph 3 | completed | The Effect of Certolizumab Pegol on MRI Synovitis and Bone Edema in Rheumatoid Arthritis Patients |
| NCT01443364 SPEED results posted | RA0069 2011-000385-35 | Ph 4 | completed | Open Label Study to Assess the Predictability of Early Response to Certolizumab Pegol in Patients With Rheumatoid Arthritis |
| NCT02430909 | RA0123 2014-003307-30 | Ph 2 | completed | Multiple Dose Study of UCB4940 as add-on to Certolizumab Pegol in Subjects With Rheumatoid Arthritis |
| NCT01295151 SWITCH | RR10/9589 2010-023880-17 | Ph 4 | completed | SWITCH Clinical Trial for Patients With Rheumatoid Arthritis Who Have Failed an Initial TNF-blocking Drug. |
| NCT02365948 | RA0045 | Ph 1 | completed | A Study of Certolizumab Pegol to Evaluate Pharmacokinetics and Safety in Adult Healthy Chinese Subjects |
| NCT00850343 results posted | CDP870-275-08-004 JapicCTI-090701 | Ph 3 | completed | Long-term Treatment Study of Certolizumab Pegol Without Coadministration of Methotrexate in Japanese Rheumatoid Arthritis (RA) Patients |
| NCT00851318 results posted | CDP870-275-08-002 JapicCTI-090700 | Ph 3 | completed | Long-term Treatment Study of Certolizumab Pegol (CDP870) as Add-on Medication to Methotrexate in Japanese Rheumatoid Arthritis (RA) Patients |
| NCT01147341 results posted | CERT-001 | Ph 4 | completed | Can TNF-Alpha Incomplete Secondary Responders Attain a Safe and Efficacious Response Switching to Cimzia |
| NCT00843778 CERTAIN 2 results posted | C87080 2007-000830-38 | Ph 3 | completed | Follow-up of Rheumatoid Arthritis (RA) Moderate to Low Disease Activity Study |
| NCT00813774 | RA0003 Eudract no. 2007-006344-22 | Ph 1 | completed | Bio-availability Comparison of Three Formulations of Certolizumab Pegol in Healthy Volunteers |
| NCT00674362 CERTAIN results posted | C87076 2007-000828-40 | Ph 3 | completed | Rheumatoid Arthritis (RA) Moderate to Low Disease Activity Study |
| NCT01091220 | CR0001 2009-015216-17 | Ph 1 | completed | Evaluation of the Effects of Certolizumab Pegol on Semen Quality in Healthy Male Volunteers |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
CIMZIA FDA Label Details
Indications & Usage
FDA Label (PDF)CIMZIA is indicated for the treatment of Crohn's Disease; Rheumatoid Arthritis; Polyarticular Juvenile Idiopathic Arthritis; Psoriatic Arthritis; Ankylosing Spondylitis; Axial Spondyloarthritis; Plaque Psoriasis.
WARNING: SERIOUS INFECTIONS and MALIGNANCY SERIOUS INFECTIONS Patients treated with CIMZIA are at increased risk for developing serious infections that may lead to hospitalization or death [see Warnings and Precautions (5.1) and Adverse Reactions (6.1) ] . Most patients who developed these infection...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment