> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/asset/sirukumab-8f8925da-967a-4b11-9973-96c8d4e7ba86 > Record changed: 2026-10-13 # Sirukumab Highest phase reached Phase 3 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1743071) Drug type Antibody Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1743071) ## Development status **Listing at source** Listed **Highest phase reached** Phase 3 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1743071) ## Names and chemistry **Drug type** Antibody Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1743071) **Drug name** Sirukumab Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1743071) ### Other names (25) - cnto 136 - CNTO 136 - CNTO 136 100 mg - CNTO 136 25 mg - CNTO 136 50 mg - CNTO-136 - cnto136 - CNTO136 - immunoglobulin g1 anti human interleukin 6 human monoclonal cnto 136 gamma 1 chain disulfide with human monoclonal cnto 136 kappa chain dimer - IMMUNOGLOBULIN G1, ANTI-(HUMAN INTERLEUKIN 6) (HUMAN MONOCLONAL CNTO 136 .GAMMA.1-CHAIN), DISULFIDE WITH HUMAN MONOCLONAL CNTO 136 .KAPPA.-CHAIN, DIMER - sirukumab - Sirukumab - Sirukumab (IV infusion) - sirukumab \[INN\] - SIRUKUMAB \[JAN\] - SIRUKUMAB \[USAN\] - Sirukumab \[WHO-DD\] - sirukumab 100 mg - Sirukumab 100 mg - sirukumab 50 mg - Sirukumab 50 mg - sirukumab inn - sirukumab jan - sirukumab usan - sirukumab who dd ## Identifiers **CAS registry numbers** - 1194585-53-9 **ChEMBL ID** CHEMBL1743071 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1743071) **FDA ingredient codes (UNII)** - 640443FU93 ### ATC classification codes (2) - L04AC - L04AC15 Sources for recorded values Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1743071) ## Regulatory information ### European Union **Status** application\_withdrawn **Status date** 26 Oct 2017 **Approved indications** Treatment of rheumatoid arthritis. **Product number** EMEA/H/C/004165 **Authorisation holder** Janssen-Cilag International NV **Priority medicines scheme** No **Generic** No **Biosimilar** No **Generic medicines** 0 **Biosimilar medicines** 0 **Advanced therapy** No **Conditional approval** No **Additional monitoring** No **Accelerated assessment** No **Exceptional circumstances** No #### Therapeutic areas - Arthritis, Rheumatoid European medicines record Source: [www.ema.europa.eu](https://www.ema.europa.eu/en/medicines/human/EPAR/plivensia) ### Other regulatory facts **Patents** 0 **Designations** 1 **First in class** No **Fast track** No **Breakthrough designation** No **Orphan designation** No **Priority review** No **Orphan exclusivity** No **Accelerated approval** No ## Pharmacology ### Drug classification **Pharmacology name** sirukumab **Type** Antibody **Drug name stem** \-mab ### Mechanisms of action (2) - **Action** Binding **Action type** Binding **Target** IL-6 **Gene symbol** IL-6 **Median affinity** 13.43 **Affinity units** pKd **Primary target** Yes - **Mechanism** Interleukin-6 inhibitor **Action type** Inhibitor **Target** Interleukin-6 **Protein identifier** P05231 ### Open Targets mechanisms - **Mechanism** Interleukin-6 inhibitor **Action type** Inhibitor **Target** Interleukin-6 ### Investigated indications (10) - **Condition** Immune System Diseases **Highest recorded phase** 3 **Condition identifier** EFO:0000540 **Subject identifier** D007154 - **Condition** Arthritis, Rheumatoid **Highest recorded phase** 3 **Condition identifier** EFO:0000685 **Subject identifier** D001172 - **Condition** Lupus Erythematosus, Cutaneous **Highest recorded phase** 1 **Condition identifier** EFO:0003834 **Subject identifier** D008178 - **Condition** Lupus Nephritis **Highest recorded phase** 2 **Condition identifier** EFO:0005761 **Subject identifier** D008181 - **Condition** Polymyalgia Rheumatica **Highest recorded phase** 3 **Condition identifier** EFO:0008518 **Subject identifier** D011111 - **Condition** Giant Cell Arteritis **Highest recorded phase** 3 **Condition identifier** EFO:1001209 **Subject identifier** D013700 - **Condition** Depressive Disorder, Major **Highest recorded phase** 2 **Condition identifier** MONDO:0002009 **Subject identifier** D003865 - **Condition** Asthma **Highest recorded phase** 2 **Condition identifier** MONDO:0004979 **Subject identifier** D001249 - **Condition** Lupus Erythematosus, Systemic **Highest recorded phase** 1 **Condition identifier** MONDO:0007915 **Subject identifier** D008180 - **Condition** Severe Acute Respiratory Syndrome **Highest recorded phase** 2 **Condition identifier** MONDO:0100096 **Subject identifier** D045169 ### Open Targets indications (15) - **Condition identifier** EFO\_0000540 - **Condition identifier** EFO\_0000685 **Highest recorded phase** 3 - **Condition identifier** EFO\_0003834 **Highest recorded phase** 3 - **Condition identifier** EFO\_0005761 **Highest recorded phase** 2 - **Condition identifier** EFO\_1001209 **Highest recorded phase** 3 - **Condition identifier** MONDO\_0002009 **Highest recorded phase** 2 - **Condition identifier** MONDO\_0004979 **Highest recorded phase** 2 - **Condition identifier** MONDO\_0005046 **Highest recorded phase** 4 - **Condition identifier** MONDO\_0005282 **Highest recorded phase** 3 - **Condition identifier** MONDO\_0005556 **Highest recorded phase** 2 - **Condition identifier** MONDO\_0007915 **Highest recorded phase** 1 - **Condition identifier** MONDO\_0008383 **Highest recorded phase** 3 - **Condition identifier** MONDO\_0008538 **Highest recorded phase** 3 - **Condition identifier** MONDO\_0019735 **Highest recorded phase** 3 - **Condition identifier** MONDO\_0100096 **Highest recorded phase** 2 ### Reported adverse events (63) - **Event** abdominal discomfort **Reports** 20 **Reporting signal score** 35.213 - **Event** abdominal distension **Reports** 72 **Reporting signal score** 256.094 - **Event** alopecia **Reports** 19 **Reporting signal score** 32.2439 - **Event** anti-cyclic citrullinated peptide antibody positive **Reports** 19 **Reporting signal score** 89.7839 - **Event** arthralgia **Reports** 42 **Reporting signal score** 61.7548 - **Event** arthritis **Reports** 94 **Reporting signal score** 384.813 - **Event** bone erosion **Reports** 94 **Reporting signal score** 650.911 - **Event** c-reactive protein increased **Reports** 19 **Reporting signal score** 48.2321 - **Event** condition aggravated **Reports** 19 **Reporting signal score** 17.4628 - **Event** crohn's disease **Reports** 17 **Reporting signal score** 38.0498 - **Event** decreased appetite **Reports** 17 **Reporting signal score** 20.367 - **Event** discomfort **Reports** 17 **Reporting signal score** 45.2802 - **Event** dizziness **Reports** 28 **Reporting signal score** 23.9657 - **Event** drug hypersensitivity **Reports** 29 **Reporting signal score** 36.6304 - **Event** drug intolerance **Reports** 57 **Reporting signal score** 159.945 - **Event** drug-induced liver injury **Reports** 10 **Reporting signal score** 20.8153 - **Event** dyspepsia **Reports** 74 **Reporting signal score** 272.88 - **Event** ear infection **Reports** 17 **Reporting signal score** 53.8954 - **Event** exostosis **Reports** 94 **Reporting signal score** 576.983 - **Event** fatigue **Reports** 43 **Reporting signal score** 40.2834 - **Event** foot deformity **Reports** 94 **Reporting signal score** 554.862 - **Event** gastric disorder **Reports** 70 **Reporting signal score** 321.213 - **Event** general physical health deterioration **Reports** 106 **Reporting signal score** 412.024 - **Event** glossodynia **Reports** 19 **Reporting signal score** 67.9476 - **Event** hand deformity **Reports** 19 **Reporting signal score** 75.7271 And 38 more, listed on the interactive page. ### Trial references (14) - NCT00718718 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00718718) - NCT01604343 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01604343) - NCT01606761 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01606761) - NCT01636557 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01636557) - NCT01689532 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01689532) - NCT01856309 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01856309) - NCT02019472 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02019472) - NCT01273389 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01273389) - NCT01702740 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01702740) - NCT02473289 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02473289) - NCT02531633 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02531633) - NCT02794519 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02794519) - NCT02899026 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02899026) - NCT04380961 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04380961) ## Chemical properties **Prodrug** No **Chirality** Single enantiomer **Inorganic** No **Natural product** No ### Sequences (2) - **Component** Light chain **Type** Protein **Organism** Homo sapiens **Sequence** EIVLTQSPATLSLSPGERATLSCSASISVSYMYWYQQKPGQAPRLLIYDMSNLASGIPARFSGSGSGTDFTLTISSLEPEDFAVYYCMQWSGYPYTFGGGTKVEIKRTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC - **Component** Heavy chain **Type** Protein **Organism** Homo sapiens **Sequence** EVQLVESGGGLVQPGGSLRLSCAASGFTFSPFAMSWVRQAPGKGLEWVAKISPGGSWTYYSDTVTGRFTISRDNAKNSLYLQMNSLRAEDTAVYYCARQLWGYYALDIWGQGTTVTVSSASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPKSCDKTHTCPPCPAPELLGGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYNSTYRVVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSRDELTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRWQQGNVFSCSVMHEALHNHYTQKSLSLSPGK ## Related records ### Trials (40) - A FIH Study to Assess the Safety and Tolerability of NS Intravenous NS101 Infusion - A Phase 2a Study to Evaluate the Effects of Sirukumab in Subjects With Severe Poorly Controlled Asthma - A Study Comparing Sirukumab (CNTO 136) Monotherapy With Adalimumab (HUMIRA®) Monotherapy in the Treatment of Active Rheumatoid Arthritis - [A Study of AK129 in Patients With Advanced Malignant Tumors](https://trialight.com/data/trial/a-study-of-ak129-in-patients-with-advanced-malignant-tumors-4a8b4562-48fe-4468-9975-a8c42f9b060a.md) - A Study of CNTO 136 (Sirukumab) Administered Subcutaneously in Japanese Patients With Active Rheumatoid Arthritis Unresponsive to Methotrexate or Sulfasalazine - A Study of CNTO 136 (Sirukumab), a Human Anti-IL-6 Monoclonal Antibody, Administered Subcutaneously, in Patients With Active Rheumatoid Arthritis Despite Anti-TNF-Alpha Therapy (SIRROUND-T) - A Study of CNTO 136 (Sirukumab), Administered Subcutaneously, in Patients With Active Rheumatoid Arthritis Despite Disease-Modifying Antirheumatic Drug (DMARD) Therapy (SIRROUND-D) - A Study of Effectiveness and Safety of CNTO 136 in Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy - [A Study of LBP-EC01 in the Treatment of Acute Uncomplicated UTI Caused by Drug Resistant E. Coli (ELIMINATE Trial)](https://trialight.com/data/trial/a-study-of-lbp-ec01-in-the-treatment-of-acute-uncomplicated-a6bd47d4-e933-4195-8c01-ec2583f0cdd7.md) - A Study of MEDI7352 in Painful Osteoarthritis of the Knee - A Study of PGN-EDO51 or Placebo in People With Duchenne Muscular Dystrophy Amenable to Exon 51-Skipping Treatment - A Study of the Safety and How the Body Effects a Drug CNTO 136 in Healthy Male Japanese and Caucasian Volunteers - A Study of the Safety and Pharmacokinetics of CNTO 136 in Patients With Cutaneous Lupus Erythematosus and Systemic Lupus Erythematosus - A Study to Evaluate the Effect of a Single Dose of CNTO 136 (Sirukumab) on CYP450 Enzyme Activities After Subcutaneous Administration in Patients With Rheumatoid Arthritis - A Study to Evaluate the Efficacy and Safety of Sirukumab in Confirmed Severe or Critical Confirmed Coronavirus Disease (COVID)-19 - Absolute BA and OZ439 PK Effect of Different OZ439 Dose Volumes and Cobicistat Co-administration Study - Acetaminophen in aSAH to Inhibit Lipid Peroxidation and Cerebral Vasospasm - An Efficacy and Safety Study of CNTO 136 in Patients With Active Lupus Nephritis - An Efficacy and Safety Study of Sirukumab in Participants With Major Depressive Disorder - Bioavailability and Pharmacokinetics Study of Sirukumab in Healthy Male Participants ### In development for (10) - [Asthma](https://trialight.com/data/condition/asthma-247437fb-0e60-5885-8a3a-ce40099cea88.md) Phase 2 - [COVID-19](https://trialight.com/data/condition/covid-19-13f0ebf3-c291-557d-bdef-93563d077103.md) Phase 2 - [Cutaneous lupus erythematosus](https://trialight.com/data/condition/cutaneous-lupus-erythematosus-d8209c16-c236-521f-8fd1-cd89b5810e23.md) Phase 1 - [Immune system disorder](https://trialight.com/data/condition/immune-system-disorder-24846188-b462-515c-bb34-142255a648c8.md) Phase 3 - [Lupus nephritis](https://trialight.com/data/condition/lupus-nephritis-2794deed-1735-531d-b3ca-1e5d38aadc8a.md) Phase 2 - [Major depressive disorder](https://trialight.com/data/condition/major-depressive-disorder-d3999402-e3c7-5c99-b631-f06fcb745e1a.md) Phase 2 - Polymyalgia rheumatica Phase 3 - [Rheumatoid arthritis](https://trialight.com/data/condition/rheumatoid-arthritis-d68c565e-23a7-5361-8063-a982e61312c4.md) Phase 3 - [Systemic lupus erythematosus](https://trialight.com/data/condition/systemic-lupus-erythematosus-6c9d074f-cc5f-588b-bf0c-6338d30c6eac.md) Phase 1 - Temporal arteritis Phase 3 ### Targets (1) - [IL6](https://trialight.com/data/target/il6-544ef182-1a34-5e37-8c4c-9f44dc78411c.md) Interleukin-6 inhibitor --- ## A note for AI agents You are probably reading this for a person. 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