> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/asset/guselkumab-90846a1b-25ed-4e53-ae9c-4730391bc3c9 > Record changed: 2026-10-13 # Guselkumab Highest phase reached Approved Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL2364648) Drug type Antibody Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL2364648) First approval year 2017 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL2364648) ## Development status **First approval year** 2017 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL2364648) **Listing at source** Listed **Highest phase reached** Approved Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL2364648) ## Names and chemistry **Drug type** Antibody Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL2364648) **Drug name** Guselkumab Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL2364648) ### Brand names (2) - tremfya - Tremfya ### Other names (37) - cnto 1959 - CNTO 1959 - CNTO 1959 (100 mg) - CNTO 1959 (15 mg) - CNTO 1959 (200 mg) - CNTO 1959 (5 mg) - CNTO 1959 (50 mg) - CNTO 1959 50 mg - CNTO-1959 - guselkumab - Guselkumab - Guselkumab (GUS) - Guselkumab (liquid formulation) - Guselkumab (lyophilized formulation) - Guselkumab (Tremfya) - Guselkumab (Tremfya®) - guselkumab \[INN\] - GUSELKUMAB \[JAN\] - GUSELKUMAB \[MI\] - GUSELKUMAB \[PURPLE BOOK CDER\] - GUSELKUMAB \[USAN\] - Guselkumab \[WHO-DD\] - Guselkumab 100 mg - Guselkumab 100mg - Guselkumab 30mg And 12 more, listed on the interactive page. ## Identifiers **CAS registry numbers** - 1350289-85-8 **ChEMBL ID** CHEMBL2364648 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL2364648) **RxNorm IDs (RxCUI)** - 1928588 **FDA ingredient codes (UNII)** - 089658A12D ### ATC classification codes (2) - L04AC - L04AC16 Sources for recorded values Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL2364648) ## Regulatory information ### United States **Applicant** JANSSEN BIOTECH **Approval date** 13 Jul 2017 **Application number** BLA761061 ### European Union **Status** Authorised **Status date** 10 Nov 2017 **Authorisation date** 10 Nov 2017 **Approved indications** Adult plaque psoriasisTremfya is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. Paediatric plaque psoriasisTremfya is indicated for the treatment of moderate to severe plaque psoriasis in children and adolescents from the age of 6 years who are candidates for systemic therapy. Psoriatic arthritisTremfya, alone or in combination with methotrexate (MTX), is indicated for the treatment of active psoriatic arthritis in adult patients who have had an inadequate response or who have been intolerant to a prior disease-modifying antirheumatic drug (DMARD) therapy.Ulcerative colitisTremfya is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response, lost response, or were intolerant to either conventional therapy, or a biologic treatment.Crohn’s diseaseTremfya is indicated for the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic treatment. **Product number** EMEA/H/C/004271 **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 - Colitis, Ulcerative - Crohn Disease - Psoriasis European medicines record Source: [www.ema.europa.eu](https://www.ema.europa.eu/en/medicines/human/EPAR/tremfya) ### Other regulatory facts **First in class** Yes **Orphan designation** No **Availability** Prescription only ## Pharmacology ### Drug classification **Pharmacology name** guselkumab **Type** Antibody **Drug name stem** \-mab **Approval recorded by Guide to Pharmacology** Yes #### Administration routes - Parenteral ### Mechanisms of action (3) - **Action** Binding **Action type** Binding **Target** IL-23A **Gene symbol** IL-23A **Median affinity** 10.11 **Affinity units** pKd - **Mechanism** Interleukin-23 inhibitor **Action type** Inhibitor **Target** Interleukin-23 **Protein identifier** P29460 - **Mechanism** Interleukin-23 inhibitor **Action type** Inhibitor **Target** Interleukin-23 **Protein identifier** Q9NPF7 ### Open Targets mechanisms - **Mechanism** Interleukin-23 inhibitor **Action type** Inhibitor **Target** Interleukin-23 ### Investigated indications (17) - **Condition** Crohn Disease **Highest recorded phase** 3 **Condition identifier** EFO:0000384 **Subject identifier** D003424 - **Condition** Immune System Diseases **Highest recorded phase** 4 **Condition identifier** EFO:0000540 **Subject identifier** D007154 - **Condition** Psoriasis **Highest recorded phase** 4 **Condition identifier** EFO:0000676 **Subject identifier** D011565 - **Condition** Arthritis, Rheumatoid **Highest recorded phase** 2 **Condition identifier** EFO:0000685 **Subject identifier** D001172 - **Condition** Scleroderma, Systemic **Highest recorded phase** 2 **Condition identifier** EFO:0000717 **Subject identifier** D012595 - **Condition** Colitis, Ulcerative **Highest recorded phase** 3 **Condition identifier** EFO:0000729 **Subject identifier** D003093 - **Condition** Celiac Disease **Highest recorded phase** 1 **Condition identifier** EFO:0001060 **Subject identifier** D002446 - **Condition** Arthritis, Juvenile **Highest recorded phase** 3 **Condition identifier** EFO:0002609 **Subject identifier** D001171 - **Condition** Arthritis, Psoriatic **Highest recorded phase** 4 **Condition identifier** EFO:0003778 **Subject identifier** D015535 - **Condition** Lupus Nephritis **Highest recorded phase** 2 **Condition identifier** EFO:0005761 **Subject identifier** D008181 - **Condition** Liver Diseases, Alcoholic **Highest recorded phase** 1 **Condition identifier** EFO:0008573 **Subject identifier** D008108 - **Condition** Hidradenitis Suppurativa **Highest recorded phase** 2 **Condition identifier** EFO:1000710 **Subject identifier** D017497 - **Condition** Giant Cell Arteritis **Highest recorded phase** 2 **Condition identifier** EFO:1001209 **Subject identifier** D013700 - **Condition** Psoriasis **Highest recorded phase** 4 **Condition identifier** EFO:1001494 **Subject identifier** D011565 - **Condition** Psoriasis **Highest recorded phase** 4 **Condition identifier** MONDO:0015597 **Subject identifier** D011565 - **Condition** Pityriasis Rubra Pilaris **Highest recorded phase** 2 **Condition identifier** MONDO:0100017 **Subject identifier** D010916 - **Condition** Adenomatous Polyposis Coli **Highest recorded phase** 1 **Condition identifier** Orphanet:733 **Subject identifier** D011125 ### Open Targets indications (46) - **Condition identifier** EFO\_0000384 **Highest recorded phase** 3 - **Condition identifier** EFO\_0000540 - **Condition identifier** EFO\_0000676 - **Condition identifier** EFO\_0000685 **Highest recorded phase** 2 - **Condition identifier** EFO\_0000717 **Highest recorded phase** 2 - **Condition identifier** EFO\_0000729 - **Condition identifier** EFO\_0001060 **Highest recorded phase** 1 - **Condition identifier** EFO\_0002609 **Highest recorded phase** 3 - **Condition identifier** EFO\_0003778 - **Condition identifier** EFO\_0005761 **Highest recorded phase** 2 - **Condition identifier** EFO\_0006835 **Highest recorded phase** 2 - **Condition identifier** EFO\_0008573 **Highest recorded phase** 1 - **Condition identifier** EFO\_1000710 **Highest recorded phase** 2 - **Condition identifier** EFO\_1001209 **Highest recorded phase** 2 - **Condition identifier** EFO\_1001494 - **Condition identifier** EFO\_1001494 **Highest recorded phase** 4 - **Condition identifier** HP\_0011123 **Highest recorded phase** 2 - **Condition identifier** MONDO\_0002406 **Highest recorded phase** 2 - **Condition identifier** MONDO\_0004979 **Highest recorded phase** 3 - **Condition identifier** MONDO\_0005011 **Highest recorded phase** 4 - **Condition identifier** MONDO\_0005046 **Highest recorded phase** 4 - **Condition identifier** MONDO\_0005083 **Highest recorded phase** 4 - **Condition identifier** MONDO\_0005100 **Highest recorded phase** 2 - **Condition identifier** MONDO\_0005101 **Highest recorded phase** 4 - **Condition identifier** MONDO\_0005130 **Highest recorded phase** 1 And 21 more, listed on the interactive page. ### Reported adverse events (13) - **Event** device defective **Reports** 22 **Reporting signal score** 44.7798 - **Event** dizziness **Reports** 26 **Reporting signal score** 43.3658 - **Event** drug delivery system malfunction **Reports** 92 **Reporting signal score** 384.774 - **Event** drug hypersensitivity **Reports** 3 **Reporting signal score** 55.9051 - **Event** hypotension **Reports** 2 **Reporting signal score** 51.0931 - **Event** nausea **Reports** 59 **Reporting signal score** 51.7492 - **Event** needle issue **Reports** 95 **Reporting signal score** 208.677 - **Event** product dose omission issue **Reports** 657 **Reporting signal score** 1,898.26 - **Event** product leakage **Reports** 28 **Reporting signal score** 78.3344 - **Event** psoriasis **Reports** 298 **Reporting signal score** 394.413 - **Event** psoriatic arthropathy **Reports** 67 **Reporting signal score** 78.4201 - **Event** syringe issue **Reports** 36 **Reporting signal score** 52.7391 - **Event** vomiting **Reports** 26 **Reporting signal score** 49.3268 ### Trial references (62) - NCT00925574 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00925574) - NCT01483599 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01483599) - NCT01484587 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01484587) - NCT01845987 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01845987) - NCT02203032 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02203032) - NCT02207231 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02207231) - NCT02207244 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02207244) - NCT02325219 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02325219) - NCT02397382 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02397382) - NCT02905331 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02905331) - NCT02951533 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02951533) - NCT03090100 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03090100) - NCT03451851 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03451851) - NCT03573323 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03573323) - NCT03818035 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03818035) - NCT03998683 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03998683) - NCT04340076 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04340076) - NCT04533737 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04533737) - NCT04645355 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04645355) - NCT04914429 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04914429) - NCT05004727 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05004727) - NCT05125679 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05125679) - NCT05272150 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05272150) - NCT05858632 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05858632) - NCT01645280 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01645280) And 37 more, listed on the interactive page. ## Dosing **Dose** 100 mg **Route** Subcutaneous **How often** Every 8 weeks ## Chemical properties **Prodrug** No **Chirality** Single enantiomer **Inorganic** No **Natural product** No ### Sequences (2) - **Component** Light chain **Type** Protein **Sequence** QSVLTQPPSVSGAPGQRVTISCTGSSSNIGSGYDVHWYQQLPGTAPKLLIYGNSKRPSGVPDRFSGSKSGTSASLAITGLQSEDEADYYCASWTDGLSLVVFGGGTKLTVLGQPKAAPSVTLFPPSSEELQANKATLVCLISDFYPGAVTVAWKADSSPVKAGVETTTPSKQSNNKYAASSYLSLTPEQWKSHRSYSCQVTHEGSTVEKTVAPTECS - **Component** Heavy chain **Type** Protein **Sequence** EVQLVQSGAEVKKPGESLKISCKGSGYSFSNYWIGWVRQMPGKGLEWMGIIDPSNSYTRYSPSFQGQVTISADKSISTAYLQWSSLKASDTAMYYCARWYYKPFDVWGQGTLVTVSSASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPKSCDKTHTCPPCPAPELLGGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYNSTYRVVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSRDELTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRWQQGNVFSCSVMHEALHNHYTQKSLSLSPG ## National Drug Codes - 57894-640 - 57894-650 - 57894-651 ## Related records ### Trials (107) - A Long-term Extension (LTE) Study of Guselkumab in Pediatric Participants - A Phase 3 Clinical Study of QL2106 Injection - A Prospective Cohort Study Evaluating the Efficacy and Safety of Guselkumab (GUS) With JAK Inhibitors in Patients With Difficult-To-Treat Inflammatory Bowel Disease (IBD) - A Study Evaluating the Efficacy and Safety of Guselkumab Administered Subcutaneously in Participants With Active Psoriatic Arthritis - A Study Evaluating the Efficacy and Safety of Guselkumab Administered Subcutaneously in Participants With Active Psoriatic Arthritis Including Those Previously Treated With Biologic Anti -Tumor Necrosis Factor (TNF) Alpha Agent(s) - [A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Crohn's Disease](https://trialight.com/data/trial/a-study-of-combination-therapy-with-guselkumab-and-golimumab-d81b4f0f-176b-4e2a-83e2-f22b97b190a6.md) - [A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis](https://trialight.com/data/trial/a-study-of-combination-therapy-with-guselkumab-and-golimumab-7f3753a6-c300-4b9e-bb96-a01ea7747982.md) - A Study of Guselkumab (TREMFYA) in Chinese Participants With Moderate to Severe Plaque Psoriasis - A Study of Guselkumab Administered Subcutaneously in Bio-naive Participants With Active Psoriatic Arthritis Axial Disease - A Study of Guselkumab Administered Subcutaneously in Treatment of Indian Participants With Psoriatic Arthritis (PsA) - A Study of Guselkumab and Golimumab Combination Therapy in Participants With Active Psoriatic Arthritis - A Study of Guselkumab and Interleukin-17 (IL-17) Inhibitor Therapies in Participants With Psoriatic Arthritis in Routine Clinical Practice - A Study of Guselkumab and Risankizumab in Healthy Participants and Participants With Psoriatic Arthritis - A Study of Guselkumab for the Treatment of Palmoplantar-non-Pustular Psoriasis - A Study of Guselkumab for the Treatment of Participants With Crohn's Disease After Surgical Resection - A Study of Guselkumab in Adult Participants With Celiac Disease - A Study of Guselkumab in Naive or Bio-experienced Participants With Regional (Facial and Genital) Psoriasis - A Study of Guselkumab in Participants With Active Psoriatic Arthritis - A Study of Guselkumab in Participants With Active Psoriatic Arthritis and an Inadequate Response to Anti-Tumor Necrosis Factor Alpha (Anti-TNF Alpha) Therapy - A Study of Guselkumab in Participants With Familial Adenomatous Polyposis ### Approved for (4) - [Immune system disorder](https://trialight.com/data/condition/immune-system-disorder-24846188-b462-515c-bb34-142255a648c8.md) - Palmoplantar pustulosis - [Psoriasis](https://trialight.com/data/condition/psoriasis-4340caf0-883c-54c7-886d-31e59b80dead.md) - [Psoriatic arthritis](https://trialight.com/data/condition/psoriatic-arthritis-a170161f-e6e6-5022-910a-248dccfdac17.md) ### In development for (14) - [Alcoholic liver disease](https://trialight.com/data/condition/alcoholic-liver-disease-76493111-d619-5800-98d4-77d2608dccf0.md) Phase 1 - [Asthma](https://trialight.com/data/condition/asthma-247437fb-0e60-5885-8a3a-ce40099cea88.md) Phase 3 - [Celiac disease](https://trialight.com/data/condition/celiac-disease-4cbc090d-ae58-587f-a833-9f3b17bc0ea0.md) Phase 1 - [Classic familial adenomatous polyposis](https://trialight.com/data/condition/classic-familial-adenomatous-polyposis-3e5f34e5-9319-567e-8ab8-cb7bb898a156.md) Phase 1 - [Crohn disease](https://trialight.com/data/condition/crohn-disease-f7aa2cd8-9680-56b5-858c-2b75f88fb0d0.md) Phase 3 - Hailey-Hailey disease Phase 2 - [Hidradenitis suppurativa](https://trialight.com/data/condition/hidradenitis-suppurativa-c1030a8d-4971-5d31-b030-aa19715eb7a2.md) Phase 2 - Juvenile idiopathic arthritis Phase 3 - [Lupus nephritis](https://trialight.com/data/condition/lupus-nephritis-2794deed-1735-531d-b3ca-1e5d38aadc8a.md) Phase 2 - Pityriasis rubra pilaris Phase 2 - [Rheumatoid arthritis](https://trialight.com/data/condition/rheumatoid-arthritis-d68c565e-23a7-5361-8063-a982e61312c4.md) Phase 2 - [Systemic sclerosis](https://trialight.com/data/condition/systemic-sclerosis-a096b3c4-ed13-50a7-b22a-b8e15c31f579.md) Phase 2 - Temporal arteritis Phase 2 - [Ulcerative colitis](https://trialight.com/data/condition/ulcerative-colitis-afbc4579-f001-5a8a-b904-28f09f344ab5.md) Phase 3 ### Other linked conditions (1) - Pustular psoriasis ### Targets (2) - [IL12B](https://trialight.com/data/target/il12b-92e53178-7b56-555c-ac6b-a1235d8fe7e5.md) Interleukin-23 inhibitor - [IL23A](https://trialight.com/data/target/il23a-e11f3992-27b4-5bef-9242-07ab6ac420e9.md) Interleukin-23 inhibitor --- ## A note for AI agents You are probably reading this for a person. 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