Guselkumab
Highest phase reached
Approved
Drug type
Antibody
First approval year
2017
- First approval year
- 2017
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Antibody
- Drug name
- Guselkumab
- tremfya
- Tremfya
- 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.
- CAS registry numbers
- 1350289-85-8
- ChEMBL ID
- CHEMBL2364648
- RxNorm IDs (RxCUI)
- 1928588
- FDA ingredient codes (UNII)
- 089658A12D
- L04AC
- L04AC16
Sources for recorded values
- Applicant
- JANSSEN BIOTECH
- Approval date
- 13 Jul 2017
- Application number
- BLA761061
- 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
- First in class
- Yes
- Orphan designation
- No
- Availability
- Prescription only
- Pharmacology name
- guselkumab
- Type
- Antibody
- Drug name stem
- -mab
- Approval recorded by Guide to Pharmacology
- Yes
Administration routes
- Parenteral
- 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
- 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
- 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.
- 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
- NCT00925574
- NCT01483599
- NCT01484587
- NCT01845987
- NCT02203032
- NCT02207231
- NCT02207244
- NCT02325219
- NCT02397382
- NCT02905331
- NCT02951533
- NCT03090100
- NCT03451851
- NCT03573323
- NCT03818035
- NCT03998683
- NCT04340076
- NCT04533737
- NCT04645355
- NCT04914429
- NCT05004727
- NCT05125679
- NCT05272150
- NCT05858632
- NCT01645280
And 37 more, listed on the interactive page.
- Dose
- 100 mg
- Route
- Subcutaneous
- How often
- Every 8 weeks
- Prodrug
- No
- Chirality
- Single enantiomer
- Inorganic
- No
- Natural product
- No
- Component
- Light chain
- Type
- Protein
- Sequence
- QSVLTQPPSVSGAPGQRVTISCTGSSSNIGSGYDVHWYQQLPGTAPKLLIYGNSKRPSGVPDRFSGSKSGTSASLAITGLQSEDEADYYCASWTDGLSLVVFGGGTKLTVLGQPKAAPSVTLFPPSSEELQANKATLVCLISDFYPGAVTVAWKADSSPVKAGVETTTPSKQSNNKYAASSYLSLTPEQWKSHRSYSCQVTHEGSTVEKTVAPTECS
- Component
- Heavy chain
- Type
- Protein
- Sequence
- EVQLVQSGAEVKKPGESLKISCKGSGYSFSNYWIGWVRQMPGKGLEWMGIIDPSNSYTRYSPSFQGQVTISADKSISTAYLQWSSLKASDTAMYYCARWYYKPFDVWGQGTLVTVSSASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPKSCDKTHTCPPCPAPELLGGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYNSTYRVVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSRDELTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRWQQGNVFSCSVMHEALHNHYTQKSLSLSPG
- 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
- A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis
- 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
- Palmoplantar pustulosis
- Psoriasis
- Psoriatic arthritis
In development for (14)
- Alcoholic liver disease Phase 1
- Asthma Phase 3
- Celiac disease Phase 1
- Classic familial adenomatous polyposis Phase 1
- Crohn disease Phase 3
- Hailey-Hailey disease Phase 2
- Hidradenitis suppurativa Phase 2
- Juvenile idiopathic arthritis Phase 3
- Lupus nephritis Phase 2
- Pityriasis rubra pilaris Phase 2
- Rheumatoid arthritis Phase 2
- Systemic sclerosis Phase 2
- Temporal arteritis Phase 2
- Ulcerative colitis Phase 3
Other linked conditions (1)
- Pustular psoriasis