Cimzia

(Certolizumab Pegol)

ApprovedMonoclonal antibody

This drug is used to treat inflammatory conditions like rheumatoid arthritis, Crohn's disease, and psoriasis by reducing the immune system's inflammatory response. It helps decrease pain, swelling, and other symptoms caused by these conditions.[2] Cimzia is currently approved and in use across 16 indications[4].[1]

Cimzia is one of 322 biologic programs targeting Arthritis. It is currently in Approved.

Indications

Total Trials

Active Trials

321

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

ArthritisActive, not recruiting

Anterior UveitisActive, not recruiting

Psoriasis VulgarisActive, not recruiting

Immune System DiseaseUnknown

Takayasu ArteritisActive, not recruiting

Interstitial CystitisActive, not recruiting

Juvenile Idiopathic ArthritisActive, not recruiting

Rheumatoid ArthritisUnknown

PsoriasisActive, not recruiting

Crohn's DiseaseUnknown

ArthritisPreclinical

Active, not recruiting

Anterior UveitisApproved

Active, not recruiting

Psoriasis VulgarisPhase 3

Active, not recruiting

Immune System DiseasePreclinical

Unknown

Takayasu ArteritisPreclinical

Active, not recruiting

Interstitial CystitisPhase 3

Active, not recruiting

Juvenile Idiopathic ArthritisPhase 3

Active, not recruiting

Rheumatoid ArthritisPreclinical

Unknown

PsoriasisPhase 3

Active, not recruiting

Crohn's DiseasePreclinical

Unknown

Showing 10 of 16 indications

Competition

Competitive Landscape

791 competitors in Rheumatoid Arthritis

#DrugCompanyPhaseTrials

Cimzia

UCB

Approved

30 2

Rituxan

Roche

Preclinical

61 3

Orencia

Bristol-Myers Squibb

Preclinical

47 4

Enbrel

IImmunex

Preclinical

64 5

Arcoxia

Novartis

Preclinical

4 6

Ilaris

Novartis

Preclinical

3 7

Actos

Takeda

Preclinical

2 8

Zelhou

Jiangsu Simcere Pharmaceutical Co., Ltd.

Preclinical

7 9

Kineret

SSwedish Orphan Biovitrum

Preclinical

6 10

Cataflam

Novartis

Preclinical

—

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 2Recruiting

Pregnancy

NCT03152058

Q4 2027

N/ARecruiting

Takayasu Arteritis

NCT07491913

Clinical

Trials by Indication[1]

Rheumatoid Arthritis30 trials

Long-term Treatment Study of Certolizumab Pegol (CDP870) as Add-on Medication to Methotrexate in Japanese Rheumatoid Arthritis (RA) Patients

Completed· Astellas logo

Astellas·Phase 3·NCT00851318·285 enrolled

RABIOPRED - a Validation Study of Theranostic Test to PREDict Treatment Response of Anti-TNFα BIologicals in Rheumatoid Arthritis

Terminated·TTcLand Expression S.A.··NCT03016260·250 enrolled

Open Label Extension for Patients Coming From the Dosing Flexibility Study in Patients With Rheumatoid Arthritis (RA)

Completed· UCB logo

UCB·Phase 3·NCT00753454·168 enrolled

Show 27 more trials

A 12 Week Study to Assess Changes in Joint Inflammation Using Ultrasonography in Patients With Rheumatoid Arthritis (RA)

Terminated· UCB logo

UCB·Phase 3·NCT01292265·3 enrolled

Assessing the Use of Certolizumab Pegol in Adult Subjects With Rheumatoid Arthritis on the Antibody Response When Receiving Influenza Virus and Pneumococcal Vaccines

Completed· UCB logo

UCB·Phase 4·NCT00993668·224 enrolled

Open Label Long-Term Safety Study of Certolizumab Pegol (CZP) for Patients With Rheumatoid Arthritis

Completed· UCB logo

UCB·Phase 3·NCT00160693·402 enrolled

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

Completed· UCB logo

UCB·Phase 3·NCT01521923·359 enrolled

Dosing Flexibility Study in Patients With Rheumatoid Arthritis

Completed· UCB logo

UCB·Phase 4·NCT00580840·333 enrolled

A Study of the Safety and Effectiveness of Lyophilized Certolizumab Pegol in the Treatment of Signs and Symptoms of Rheumatoid Arthritis and in Prevention of Joint Damage in Patients With Active Rheumatoid Arthritis

Completed· UCB logo

UCB·Phase 3·NCT00175877·857 enrolled

A Study of Certolizumab Pegol as Additional Therapy in Chinese Patients With Active Rheumatoid Arthritis

Completed· UCB logo

UCB·Phase 3·NCT02151851·430 enrolled

A Study to Assess the Pharmacokinetics of Certolizumab Pegol in Adults With Active Rheumatoid Arthritis

Completed· UCB logo

UCB·Phase 1·NCT04740814·33 enrolled

Completed· UCB logo

UCB·Phase 3·NCT01519791·880 enrolled

Long-term Treatment Study of Certolizumab Pegol Without Coadministration of Methotrexate in Japanese Rheumatoid Arthritis (RA) Patients

Completed· Astellas logo

Astellas·Phase 3·NCT00850343·208 enrolled

An Open-label Extension Study of Certolizumab Pegol in Chinese Patients With Rheumatoid Arthritis Who Enrolled in RA0044

Completed· UCB logo

UCB·Phase 3·NCT02319642·347 enrolled

SWITCH Clinical Trial for Patients With Rheumatoid Arthritis Who Have Failed an Initial TNF-blocking Drug.

Completed·JJulia Brown·Phase 4·NCT01295151·122 enrolled

A Study of the Safety and Effectiveness of Liquid Certolizumab Pegol in the Treatment of Signs and Symptoms of Rheumatoid Arthritis and in Prevention of Joint Damage in Patients With Active Rheumatoid Arthritis

Completed· UCB logo

UCB·Phase 3·NCT00160641·567 enrolled

Rheumatoid Arthritis (RA) Moderate to Low Disease Activity Study

Completed· UCB logo

UCB·Phase 3·NCT00674362·194 enrolled

Study to Assess the Short- and Long-term Efficacy of Certolizumab Pegol Plus Methotrexate Compared to Adalimumab Plus Methotrexate in Subjects With Moderate to Severe Rheumatoid Arthritis (RA) Inadequately Responding to Methotrexate

Completed· UCB logo

UCB·Phase 4·NCT01500278·915 enrolled

Magnetic Resonance Image Verified Early Response to Certolizumab Pegol in Subjects With Active Rheumatoid Arthritis (RA)

Completed· UCB logo

UCB·Phase 3·NCT01235598·41 enrolled

Certolizumab Pegol for the Treatment of Patients With Active Rheumatoid Arthritis

Completed· UCB logo

UCB·Phase 3·NCT00717236·1,648 enrolled

A Placebo Controlled Study to Assess Efficacy and Safety of Certolizumab Pegol in the Treatment of Rheumatoid Arthritis

Completed· UCB logo

UCB·Phase 3·NCT00152386·950 enrolled

Rheumatoid Arthritis Treatment and Biopsy Study Assessing Certolizumab Pegol (Cimzia)

Completed·—·Phase 3·NCT01374971·12 enrolled

A Comparison of Two Assessment Tools in Predicting Treatment Success of Cimzia in Rheumatoid Arthritis Subjects

Completed· UCB logo

UCB·Phase 4·NCT01255761·736 enrolled

A Study of Liquid Certolizumab Pegol as Additional Medication to Methotrexate in the Treatment of Signs and Symptoms of Rheumatoid Arthritis and in Prevention of Joint Damage in Patients With Active Rheumatoid Arthritis

Completed· UCB logo

UCB·Phase 3·NCT00160602·590 enrolled

Open Label Study to Assess the Predictability of Early Response to Certolizumab Pegol in Patients With Rheumatoid Arthritis

Completed· UCB logo

UCB·Phase 4·NCT01443364·132 enrolled

The Effect of Certolizumab Pegol on MRI Synovitis and Bone Edema in Rheumatoid Arthritis Patients

Completed·OOklahoma Medical Research Foundation·Phase 3·NCT01213017·20 enrolled

Rheumatoid Arthritis Treatment After First Anti-TNF INvestiGation

Terminated· Mario Negri Institute for Pharmacological Research logo

Mario Negri Institute for Pharmacological Research·Phase 4·NCT03100253·208 enrolled

Follow-up of Rheumatoid Arthritis (RA) Moderate to Low Disease Activity Study

Completed· UCB logo

UCB·Phase 3·NCT00843778·131 enrolled

Multiple Dose Study of UCB4940 as add-on to Certolizumab Pegol in Subjects With Rheumatoid Arthritis

Completed· UCB logo

UCB·Phase 2·NCT02430909·159 enrolled

Open-label, Extension Study of CDP870 in Patients With Rheumatoid Arthritis

Completed·KKorea Otsuka Pharmaceutical Co., Ltd.·Phase 3·NCT01197066·110 enrolled

Crohn's Disease15 trials

A Study to Test Efficacy, Safety, and Pharmacokinetics of Certolizumab Pegol in Children and Adolescents With Moderately to Severely Active Crohn's Disease

Withdrawn· UCB logo

UCB·Phase 3·NCT04643483

Assessment of Small Bowel Healing in Crohn's Disease Patients Treated With Cimzia Using Wireless Capsule Endoscopy

Completed·SShafran Gastroenterology Center·N/A·NCT01053559·15 enrolled

A Trial Evaluating Safety of Chronic Therapy With Certolizumab Pegol in Crohn's Disease

Withdrawn· UCB logo

UCB·Phase 3·NCT00358683

Show 12 more trials

Clinical Study of CDP870/Certolizumab Pegol in Patients With Active Crohn's Disease

Completed· UCB logo

UCB·Phase 2·NCT00291668·94 enrolled

Extension Study to Assess Long Term Safety in Children and Adolescents With Crohn's Disease Receiving Certolizumab Pegol

Completed· UCB logo

UCB·Phase 2·NCT01190410·16 enrolled

The Use of Certolizumab Pegol for Treatment of Active Crohn's Disease in Children and Adolescents

Terminated· UCB logo

UCB·Phase 2·NCT00899678·99 enrolled

Examining the Long Term Safety, Efficacy, and Corticosteroid-sparing Effect of Certolizumab Pegol in Crohn's Disease

Completed· UCB logo

UCB·Phase 3·NCT00356408·106 enrolled

Follow-up to Welcome Study C87042 [NCT00308581] Examining Certolizumab Pegol (CDP870) in Subjects With Crohn's Disease

Completed· UCB logo

UCB·Phase 3·NCT00333788·233 enrolled

Corticosteroid Sparing Effect of Certolizumab in Crohn's Disease

Terminated· UCB logo

UCB·Phase 3·NCT00349752·174 enrolled

A Study to Test the Effect of CDP870 in the Treatment of Crohn's Disease Over 26 Weeks, Comparing CDP870 to a Dummy Drug (Placebo)

Completed· UCB logo

UCB·Phase 3·NCT00152490·604 enrolled

Study to Test the Effect of CDP870 in the Treatment of Crohn's Disease Over 26 Weeks, Comparing CDP870 to a Dummy Drug (Placebo), Following 3 Doses of Active Drug (CDP870).

Completed· UCB logo

UCB·Phase 3·NCT00152425·392 enrolled

A follow-on Safety Study in Subjects With Crohn's Disease Who Have Previously Been Withdrawn From the Double-blind Study CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425] Due to an Exacerbation of Crohn's Disease

Completed· UCB logo

UCB·Phase 3·NCT00160706·310 enrolled

Maintenance Study of Certolizumab Pegol (CZP) in Crohn's Disease

Completed· UCB logo

UCB·Phase 2·NCT00329550·40 enrolled

Certolizumab in Crohn's Disease Patients With Loss of Response or Intolerance to Infliximab

Completed· UCB logo

UCB·Phase 3·NCT00308581·539 enrolled

Cimzia Versus Cimzia Plus Azathioprine in the Treatment of Active Crohn's Disease

Unknown status·GGastroenterology Research of America·Phase 3·NCT01817972·65 enrolled

Psoriasis7 trials

A Study to Evaluate the Efficacy and Safety of Two Dose Levels of Certolizumab Pegol (CZP) in Subjects With Plaque Psoriasis (PSO)

Completed· UCB logo

UCB·Phase 3·NCT02326272·227 enrolled

A Study to Assess How Well Certolizumab Pegol Works in Patients With Moderate to Severe Plaque Psoriasis as Part of Routine Clinical Practice

Completed· UCB logo

UCB··NCT04053881·412 enrolled

Efficacy and Safety Study of Certolizumab Pegol (CZP) Versus Active Comparator and Placebo in Subjects With Plaque Psoriasis (PSO)

Completed· UCB logo

UCB·Phase 3·NCT02346240·559 enrolled

Show 4 more trials

An Efficacy and Safety Study of Two Dose Levels of Certolizumab Pegol (CZP) in Subjects With Plaque Psoriasis (PSO)

Completed· UCB logo

UCB·Phase 3·NCT02326298·234 enrolled

Efficacy Study of CDP870 in Subjects With Chronic Plaque Psoriasis Who Are Candidate for Systemic Therapy and/or Phototherapy/Photochemotherapy

Completed· UCB logo

UCB·Phase 2·NCT00245765·176 enrolled

Efficacy of Re-treatment With Cimzia® in Subject With Chronic Plaque Psoriasis

Completed· UCB logo

UCB·Phase 2·NCT00329303·71 enrolled

A Study to Test the Efficacy and Safety of Certolizumab Pegol in Japanese Subjects With Moderate to Severe Chronic Psoriasis

Completed· UCB logo

UCB·Phase 2/3·NCT03051217·127 enrolled

Crohn's Disease (CD)3 trials

CUP Certolizumab Pegol (CDP-870) in Adults Suffering From Crohn's Disease (CD)

No longer available· UCB logo

UCB··NCT03559660

Mucosal Healing Study in Crohn's Disease (CD)

Completed· UCB logo

UCB·Phase 3·NCT00297648·89 enrolled

A follow-on Safety Study of CDP870 in Subjects With Crohn's Disease (CD) Who Have Completed a 26-week Double Blind Study CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425]

Completed· UCB logo

UCB·Phase 3·NCT00160524·596 enrolled

Remission2 trials

Study to Evaluate Maintenance of Sustained Remission of axSpA With CZP Compared to Placebo

Completed· UCB logo

UCB·Phase 3·NCT02505542·736 enrolled

RICE: Remission by Intra-articular Injection Plus CErtolizumab

Completed·RRüdiger B. Müller·Phase 2·NCT02293590·43 enrolled

19 more indications

Arthritis2 trials

Named Patient Program With Certolizumab Pegol in Adults Suffering From Rheumatoid Aarthritis (RA)

Available· UCB logo

UCB··NCT03559686

Pediatric Arthritis Study of Certolizumab Pegol

Completed· UCB logo

UCB·Phase 3·NCT01550003·193 enrolled

MPA2 trials

Comparison Bioequivalence Study: Pre-filled Syringe (Reference) Versus Auto-injection Device (Test)

Completed· UCB logo

UCB·Phase 1·NCT00845663·98 enrolled

Bio-availability Comparison of Three Formulations of Certolizumab Pegol in Healthy Volunteers

Completed· UCB logo

UCB·Phase 1·NCT00813774·149 enrolled

Adult1 trial

A Study of Certolizumab Pegol to Evaluate Pharmacokinetics and Safety in Adult Healthy Chinese Subjects

Completed· UCB logo

UCB·Phase 1·NCT02365948·36 enrolled

AxSpA1 trial

Multicenter Study Evaluating Certolizumab Pegol Compared to Placebo in Subjects With axSpA Without X-ray Evidence of AS

Completed· UCB logo

UCB·Phase 3·NCT02552212·317 enrolled

Treatment1 trial

Prediction of Response to Certolizumab Pegol Treatment by Functional MRI of the Brain

Completed·UUniversity of Erlangen-Nürnberg Medical School·Phase 3·NCT01864265·156 enrolled

Concentration1 trial

A Multicenter, Postmarketing Study Evaluating the Concentration of Cimzia® in Mature Breast Milk of Lactating Mothers

Completed· UCB logo

UCB·Phase 1·NCT02154425·17 enrolled

Interstitial Cystitis1 trial

Pilot Study Evaluating the Efficacy of Certolizumab Pegol for Interstitial Cystitis

Completed·IICStudy, LLC·Phase 3·NCT02497976·42 enrolled

Psoriatic Arthritis1 trial

Impact of Tapering Immunosuppressants on Maintaining Minimal Disease Activity in Adult Subjects With Psoriatic Arthritis

Unknown status·UUniversity of Erlangen-Nürnberg Medical School·Phase 3·NCT04610476·270 enrolled

Moderate to Severe Crohn's Disease1 trial

Certolizumab Pegol for Treatment of Adult Greek Patients With Moderate to Severe Crohn's Disease Who Failed Infliximab

Terminated· UCB logo

UCB·Phase 3·NCT00307931·16 enrolled

Induction Therapy1 trial

Maintenance Study Including Re-induction Therapy for Patients Who Did Not Show a Clinical Effect in Study C87037 (NCT00291668)

Completed· UCB logo

UCB·Phase 2·NCT00329420·46 enrolled

Efficacy and Safety1 trial

Study to Evaluate Efficacy and Safety of Certolizumab Pegol for Induction of Remission in Patients With Crohn's Disease

Completed· UCB logo

UCB·Phase 3·NCT00552058·439 enrolled

ESS1 trial

IL-7 and IL-7R Expression in RA Patients With Active vs. Inactive Disease Treated With DMARD or CIMZIA

Completed·UUniversity of Illinois at Chicago·Phase 4·NCT02451748·32 enrolled

Ankylosing Spondylitis1 trial

A Study to Test the Efficacy and Safety of Bimekizumab and Certolizumab Pegol in Patients With Active Ankylosing Spondylitis

Completed· UCB logo

UCB·Phase 2·NCT03215277·76 enrolled

Pregnancy1 trial

IMPACT Study: IMProve Pregnancy in APS With Certolizumab Therapy

Recruiting·DDavid Ware Branch·Phase 2·NCT03152058·55 enrolled

Takayasu arteritis1 trial

Biologic Treatment Withdrawal in Takayasu Arteritis Patients in Sustained Remission

Recruiting·MMarmara University·N/A·NCT07491913·40 enrolled

Efficacy1 trial

Evaluate Efficacy of Certolizumab in Crohn's Patients With Draining Fistulas

Withdrawn· UCB logo

UCB·Phase 3·NCT00354367

Axial Spondyloarthritis1 trial

Multicenter, Open-Label Study to Assess the Effects of Certolizumab Pegol on the Reduction of Anterior Uveitis Flares in Axial Spondyloarthritis Subjects With a History of Anterior Uveitis (C-VIEW)

Completed· UCB logo

UCB·Approved·NCT03020992·89 enrolled

Chronic Plaque Psoriasis1 trial

Multicenter, Open Label or Double-Blind, Placebo-Controlled Study to Evaluate the Pharmacokinetics, Safety, and Effectiveness of Certolizumab Pegol in Pediatric Study Participants With Moderate to Severe Chronic Plaque Psoriasis

Active, not recruiting· UCB logo

UCB·Phase 3·NCT04123795·49 enrolled

Unspecified4 trials

Optimizing Cimzia in Crohn's Patients

Unknown status·AAtlanta Gastroenterology Associates·Phase 4·NCT01024647·50 enrolled

Does Clinical Response Correlate With Serum Certolizumab Levels?

Unknown status·SShafran Gastroenterology Center·Phase 4·NCT02597829·20 enrolled

A Multicener, Postmarketing Study Evaluating the Transfer of Cimzia From the Mother to the Infant Via the Placenta

Completed· UCB logo

UCB·Phase 1·NCT02019602·37 enrolled

Show 1 more trial

Evaluation of the Effects of Certolizumab Pegol on Semen Quality in Healthy Male Volunteers

Completed· UCB logo

UCB·Phase 1·NCT01091220·20 enrolled

Regulatory

FDA Approval Timeline[5]

Apr 22, 2008

CIMZIA

BLA BLA125160

Sources

References

[1]
ClinicalTrials.gov — 81 trial records for Certolizumab Pegol. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Cimzia drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Certolizumab Pegol compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Certolizumab Pegol. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (BLA BLA125160). U.S. Food & Drug Administration.
[6]
SEC EDGAR — UCB company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: TNF-Alpha Inhibitor[3]
Modality: Monoclonal antibody[3]
Highest Phase: Approved[1]
Company: UCB

Cimzia

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q4 2027

Trials by Indication[1]

Rheumatoid Arthritis30 trials

Crohn's Disease15 trials

Psoriasis7 trials

Crohn's Disease (CD)3 trials

Remission2 trials

Arthritis2 trials

MPA2 trials

Adult1 trial

AxSpA1 trial

Treatment1 trial

Concentration1 trial

Interstitial Cystitis1 trial

Psoriatic Arthritis1 trial

Moderate to Severe Crohn's Disease1 trial

Induction Therapy1 trial

Efficacy and Safety1 trial

ESS1 trial

Ankylosing Spondylitis1 trial

Pregnancy1 trial

Takayasu arteritis1 trial

Efficacy1 trial

Axial Spondyloarthritis1 trial

Chronic Plaque Psoriasis1 trial

Unspecified4 trials

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

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