Ustekinumab

Highest phase reached

Approved

www.ebi.ac.uk

Drug type

Antibody

www.ebi.ac.uk

First approval year

2009

www.ebi.ac.uk

First approval year: 2009
www.ebi.ac.uk

Listing at source: Listed

Highest phase reached: Approved
www.ebi.ac.uk

Drug type: Antibody
www.ebi.ac.uk

Drug name: Ustekinumab
www.ebi.ac.uk

stelara
Stelara
stelera
Stelera
uzpruvo
Uzpruvo
wezenla
Wezenla

abp 654
ABP 654
ABP 654 [WHO-DD]
abp 654 who dd
ABP-654
abp654
ABP654
cnto 1275
CNTO 1275
CNTO 1275 45 mg
CNTO 1275 63 mg
CNTO 1275 90 mg
CNTO-1275
fyb 202
FYB-202
fyb202
FYB202
FYB202 (Proposed ustekinumab biosimilar)
immunoglobulin g1 anti human interleukin 12 p40 subunit human monoclonal cnto 1275 γ1 chain disulfide with human monoclonal cnto 1275 κ chain dimer
immunoglobulin g1 anti human interleukin 12 subunit beta il 12b clmf p40 nksf2 human monoclonal cnto 1275 γ1 chain disulfide with human monoclonal cnto 1275 κ chain dimer
Immunoglobulin G1, anti-(human interleukin 12 p40 subunit) (human monoclonal CNTO 1275 γ1-chain), disulfide with human monoclonal CNTO 1275 κ-chain, dimer
Immunoglobulin G1, anti-(human interleukin-12 subunit beta (IL-12B, CLMF p40, NKSF2)) (human monoclonal CNTO 1275 γ1-chain), disulfide with human monoclonal CNTO 1275 κ-chain, dimer
imuldosa
IMULDOSA
otulfi

And 92 more, listed on the interactive page.

ATC classification codes

L04AC05

Sources for recorded values

www.ebi.ac.uk

CAS registry numbers

815610-63-0

ChEMBL ID: CHEMBL1201835
www.ebi.ac.uk

FDA ingredient codes (UNII)

FU77B4U5Z0

847083
2705377

Applicant: CENTOCOR ORTHO BIOTECH INC
Approval date: 25 Sept 2009
Application number: BLA125261

Status: Authorised
Status date: 16 Jan 2009
Authorisation date: 16 Jan 2009
Approved indications: Adult Crohn’s Disease Stelara is indicated for the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a TNFα antagonist. Paediatric Crohn's Disease Stelara is indicated for the treatment of moderately to severely active Crohn’s disease in paediatric patients from the age of 2 years and older, who have had an inadequate response to, or were intolerant to either conventional or biologic therapy. Adult ulcerative colitis Stelara is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic. Paediatric ulcerative colitis Stelara is indicated for the treatment of moderately to severely active ulcerative colitis in paediatric patients from the age of 2 years and older, who have had an inadequate response to, or were intolerant to either conventional therapy or a biologic. Plaque psoriasis Stelara is indicated for the treatment of moderate to severe plaque psoriasis in adults who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate (MTX) or PUVA (psoralen and ultraviolet A) (see section 5.1). Paediatric plaque psoriasis Stelara is indicated for the treatment of moderate to severe plaque psoriasis in children and adolescent patients from the age of 6 years and older, who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies. Psoriatic arthritis (PsA) Stelara, alone or in combination with MTX, is indicated for the treatment of active psoriatic arthritis in adult patients when the response to previous non-biological disease modifying anti rheumatic drug (DMARD) therapy has been inadequate (see section 5.1).
Product number: EMEA/H/C/000958
Authorisation holder: Janssen-Cilag International NV
Priority medicines scheme: No
Generic: No
Biosimilar: No
Generic medicines: 0
Biosimilar medicines: 11
Advanced therapy: No
Conditional approval: No
Additional monitoring: No
Accelerated assessment: No
Exceptional circumstances: No

Therapeutic areas

Arthritis, Psoriatic
Colitis, Ulcerative
Crohn Disease
Psoriasis

European medicines record

www.ema.europa.eu

Patents: 0
Designations: 2
Earliest recorded loss of exclusivity: 30 Apr 2025
First in class: Yes
Fast track: No
Breakthrough designation: No
Orphan designation: No
Priority review: No
Orphan exclusivity: No
Accelerated approval: No
Availability: Prescription only

Pharmacology name: ustekinumab
Type: Antibody
Drug name stem: -mab
Approval recorded by Guide to Pharmacology: Yes

Administration routes

Parenteral

Action
Binding
Action type
Binding
Target
IL-12B
Gene symbol
IL-12B
Median affinity
11.15
Affinity units
pKd
Primary target
Yes
Mechanism
Interleukin-12 inhibitor
Action type
Inhibitor
Target
Interleukin-12
Protein identifier
P29459
Mechanism
Interleukin-12 inhibitor
Action type
Inhibitor
Target
Interleukin-12
Protein identifier
P29460
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

Mechanism
Interleukin-12 inhibitor
Action type
Inhibitor
Target
Interleukin-12
Mechanism
Interleukin-23 inhibitor
Action type
Inhibitor
Target
Interleukin-23

Condition
Dermatitis, Atopic
Highest recorded phase
2
Condition identifier
EFO:0000274
Subject identifier
D003876
Condition
Crohn Disease
Highest recorded phase
4
Condition identifier
EFO:0000384
Subject identifier
D003424
Condition
Dermatomyositis
Highest recorded phase
3
Condition identifier
EFO:0000398
Subject identifier
D003882
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
Sjogren's Syndrome
Highest recorded phase
1
Condition identifier
EFO:0000699
Subject identifier
D012859
Condition
Colitis, Ulcerative
Highest recorded phase
4
Condition identifier
EFO:0000729
Subject identifier
D003093
Condition
Arthritis, Juvenile
Highest recorded phase
3
Condition identifier
EFO:0002609
Subject identifier
D001171
Condition
Polymyositis
Highest recorded phase
3
Condition identifier
EFO:0003063
Subject identifier
D017285
Condition
Inflammatory Bowel Diseases
Highest recorded phase
3
Condition identifier
EFO:0003767
Subject identifier
D015212
Condition
Arthritis, Psoriatic
Highest recorded phase
4
Condition identifier
EFO:0003778
Subject identifier
D015535
Condition
Behcet Syndrome
Highest recorded phase
2
Condition identifier
EFO:0003780
Subject identifier
D001528
Condition
Colitis
Highest recorded phase
3
Condition identifier
EFO:0003872
Subject identifier
D003092
Condition
Spondylitis, Ankylosing
Highest recorded phase
3
Condition identifier
EFO:0003898
Subject identifier
D013167
Condition
Pouchitis
Highest recorded phase
3
Condition identifier
EFO:0003921
Subject identifier
D019449
Condition
Hematologic Diseases
Highest recorded phase
2
Condition identifier
EFO:0005803
Subject identifier
D006402
Condition
Pemphigoid, Bullous
Highest recorded phase
2
Condition identifier
EFO:0007187
Subject identifier
D010391
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
Uveitis
Highest recorded phase
2
Condition identifier
EFO:1001231
Subject identifier
D014605
Condition
Liver Cirrhosis, Biliary
Highest recorded phase
2
Condition identifier
EFO:1001486
Subject identifier
D008105
Condition
Psoriasis
Highest recorded phase
4
Condition identifier
EFO:1001494
Subject identifier
D011565
Condition
Takayasu Arteritis
Highest recorded phase
3
Condition identifier
EFO:1001857
Subject identifier
D013625
Condition
Hematologic Neoplasms
Highest recorded phase
2
Condition identifier
MONDO:0002334
Subject identifier
D019337

And 6 more, listed on the interactive page.

Condition identifier
EFO_0000274
Highest recorded phase
2
Condition identifier
EFO_0000384
Condition identifier
EFO_0000398
Highest recorded phase
3
Condition identifier
EFO_0000540
Condition identifier
EFO_0000676
Condition identifier
EFO_0000685
Highest recorded phase
2
Condition identifier
EFO_0000699
Highest recorded phase
1
Condition identifier
EFO_0000729
Condition identifier
EFO_0001068
Condition identifier
EFO_0002609
Highest recorded phase
3
Condition identifier
EFO_0003063
Highest recorded phase
3
Condition identifier
EFO_0003767
Highest recorded phase
3
Condition identifier
EFO_0003778
Condition identifier
EFO_0003780
Highest recorded phase
2
Condition identifier
EFO_0003872
Highest recorded phase
3
Condition identifier
EFO_0003898
Highest recorded phase
3
Condition identifier
EFO_0003921
Highest recorded phase
3
Condition identifier
EFO_0005803
Highest recorded phase
2
Condition identifier
EFO_0007187
Highest recorded phase
2
Condition identifier
EFO_1000710
Highest recorded phase
2
Condition identifier
EFO_1001231
Highest recorded phase
2
Condition identifier
EFO_1001486
Highest recorded phase
2
Condition identifier
EFO_1001494
Condition identifier
EFO_1001494
Highest recorded phase
4
Condition identifier
EFO_1001857
Highest recorded phase
3

And 51 more, listed on the interactive page.

Event
abdominal discomfort
Reports
632
Reporting signal score
345.018
Event
alopecia
Reports
751
Reporting signal score
498.794
Event
anti-cyclic citrullinated peptide antibody positive
Reports
527
Reporting signal score
1,674.86
Event
arthropathy
Reports
618
Reporting signal score
683.149
Event
basal cell carcinoma
Reports
320
Reporting signal score
413.588
Event
crohn's disease
Reports
1,298
Reporting signal score
2,256.99
Event
discomfort
Reports
538
Reporting signal score
712.173
Event
drug intolerance
Reports
938
Reporting signal score
758.967
Event
duodenal ulcer perforation
Reports
198
Reporting signal score
477.399
Event
enthesopathy
Reports
135
Reporting signal score
376.632
Event
general physical health deterioration
Reports
553
Reporting signal score
355.424
Event
glossodynia
Reports
532
Reporting signal score
1,098.4
Event
hand deformity
Reports
538
Reporting signal score
1,329.95
Event
helicobacter infection
Reports
228
Reporting signal score
464.49
Event
hepatic enzyme increased
Reports
747
Reporting signal score
752.952
Event
hypersensitivity
Reports
997
Reporting signal score
593.327
Event
infusion related reaction
Reports
847
Reporting signal score
912.833
Event
intestinal resection
Reports
202
Reporting signal score
463.288
Event
joint swelling
Reports
718
Reporting signal score
486.107
Event
lower respiratory tract infection
Reports
618
Reporting signal score
835.132
Event
pemphigus
Reports
544
Reporting signal score
1,305.63
Event
pericarditis
Reports
502
Reporting signal score
988.29
Event
pneumonia
Reports
1,374
Reporting signal score
596.645
Event
product dose omission issue
Reports
730
Reporting signal score
820.622
Event
psoriasis
Reports
1,795
Reporting signal score
2,180.69

And 11 more, listed on the interactive page.

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And 87 more, listed on the interactive page.

Dose: 45 mg
Route: Subcutaneous
How often: Every 12 weeks

Prodrug: No
Chirality: Single enantiomer
Inorganic: No
Natural product: No

0143-9168
0143-9169
0143-9170
0143-9171
51759-413
51759-414
51759-505
51759-607
51759-708
51759-709
51759-710
57894-054
57894-060
57894-061
57894-440
57894-441
57894-444
61314-651
61314-652
61314-654
65219-822
65219-824
65219-826
65219-828
65219-862

And 22 more, listed on the interactive page.

Related records

Trials (232)

A Direct Head-to-head Comparison of Ustekinumab with Infliximab for the Treatment of Ulcerative Colitis
A Double-blind Study to Compare the Efficacy, Safety, and Immunogenicity of the Proposed Biosimilar Ustekinumab FYB202 to Stelara® in Patients With Moderate-to-Severe Plaque Psoriasis
A Long-term Extension Study of Ustekinumab in Pediatric Participants
A Multicenter Phase 2 Single-arm Proof-of-concept Trial to Assess the Efficacy and Safety of Ustekinumab in Association With Prednisone for the Treatment of Non-infectious Severe Uveitis (NISU)
A Multicentered Prospective Cohort Study of Chinese IBD Patients
A Pharmacokinetic Study Comparing EG12014 and Herceptin (Trastuzumab) in Healthy Male Volunteers
A Pharmacokinetic Study of Single-Dose Intravenous Ustekinumab Delivered in 2 Different Liquid in Vial Formulations
A Pharmacokinetic Study of Ustekinumab in Pediatric Subjects With Moderately to Severely Active Crohn's Disease
A Phase 2a, Efficacy and Safety Study of Ustekinumab in Systemic Lupus Erythematosus
A Phase 3 Trial to Look at the Safety and Effectiveness of Ustekinumab in Korean and Taiwanese Subjects With Moderate to Severe Plaque-type Psoriasis
A Phase I Study to Compare Abcertin and EU-sourced Cerezyme® in Healthy Volunteers
A Proof of Concept Study to Evaluate the Effectiveness of Ustekinumab in Hidradenitis Suppurativa
A QT/QTc Evaluation Study of TS-172 in Healthy Adult Subjects
A Randomized Phase 3 Study to Evaluate Two Formulations of Romosozumab in Postmenopausal Women With Osteoporosis
A Retrospective Observational Study of Ustekinumab Among Bio-naive Participants With Crohn's Disease in China
A Safety and Effectiveness Study of CNTO 1275 in Patients With Moderate to Severe Plaque-type Psoriasis
A Safety and Efficacy Study of CNTO1275 in Patients With Multiple Sclerosis
A Safety and Efficacy Study of Ustekinumab in Patients With Plaque Psoriasis Who Have Had an Inadequate Response to Methotrexate
A Safety and Pharmacokinetics Study of Ustekinumab Biosimilar GNR-068 and Stelara® in Healthy Volunteers
A Safety Study of Ustekinumab in the Treatment of Pediatric Participants Aged 6 Years and Older With Moderate to Severe Plaque Psoriasis

Approved for (6)

In development for (26)

Ankylosing spondylitis Phase 3
Atopic eczema Phase 2
Behcet disease Phase 2
Bullous pemphigoid Phase 2
Cancer Phase 2
Colitis Phase 3
Dermatomyositis Phase 3
Graft versus host disease Phase 2
Hematologic disorder Phase 2
Hematopoietic and lymphoid system neoplasm Phase 2
Hidradenitis suppurativa Phase 2
Ichthyosis Early phase 1
Inflammatory bowel disease Phase 3
Juvenile idiopathic arthritis Phase 3
Multiple sclerosis Phase 2
Polymyositis Phase 3
Pouchitis Phase 3
Primary biliary cholangitis Phase 2
Rheumatoid arthritis Phase 2
Sarcoidosis Phase 2

Targets (3)

IL12A Interleukin-12 inhibitor
IL12B Interleukin-12 inhibitor
IL23A Interleukin-23 inhibitor

Ustekinumab

Development status

Names and chemistry

Brand names (8)

Other names (117)

Identifiers

RxNorm IDs (RxCUI) (2)

Regulatory information

United States

European Union

Therapeutic areas

Other regulatory facts

Pharmacology

Drug classification

Administration routes

Mechanisms of action (5)

Open Targets mechanisms (2)

Investigated indications (31)

Open Targets indications (76)

Reported adverse events (36)

Trial references (112)

Dosing

Chemical properties

National Drug Codes

Related records

Trials (232)

Approved for (6)

In development for (26)

Other linked conditions (3)

Targets (3)