Risankizumab
Highest phase reached
Approved
Drug type
Antibody
First approval year
2019
- First approval year
- 2019
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Antibody
- Drug name
- Risankizumab
- skyrizi
- Skyrizi
- 655066 01
- 655066-01
- abbv 066
- ABBV-066
- bi 655066
- BI 655066
- BI 655066 (high i.v. dose)
- BI 655066 (high medium i.v. dose)
- BI 655066 (high s.c. dose)
- BI 655066 (low i.v. dose)
- BI 655066 (low medium i.v. dose)
- BI 655066 (low s.c. dose)
- BI 655066 (very high i.v. dose)
- BI 655066 (very low i.v. dose)
- Bi-655066
- bi655066
- BI655066
- immunoglobulin g1 kappa anti homo sapiens il23a interleukin 23 subunit alpha il 23a il23 subunit p19 il23p19 humanized monoclonal antibody
- IMMUNOGLOBULIN G1-KAPPA, ANTI-(HOMO SAPIENS IL23A (INTERLEUKIN 23 SUBUNIT ALPHA, IL-23A, IL23 SUBUNIT P19, IL23P19)), HUMANIZED MONOCLONAL ANTIBODY
- risankizumab
- Risankizumab
- Risankizumab (RISA)
- risankizumab [INN]
- RISANKIZUMAB [JAN]
- RISANKIZUMAB [MI]
And 17 more, listed on the interactive page.
- ATC classification codes
- L04AC18
Sources for recorded values
- CAS registry numbers
- 1612838-76-2
- ChEMBL ID
- CHEMBL3990029
- FDA ingredient codes (UNII)
- 90ZX3Q3FR7
- 2166040
- 2166132
- Applicant
- ABBVIE INC
- Approval date
- 23 Apr 2019
- Application number
- BLA761105
- Status
- Authorised
- Status date
- 26 Apr 2019
- Authorisation date
- 26 Apr 2019
- Approved indications
- Adult plaque psoriasis Skyrizi is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. Paediatric plaque psoriasis Skyrizi 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 Arthritis Skyrizi, alone or in combination with methotrexate (MTX), is indicated for the treatment of active psoriatic arthritis in adults who have had an inadequate response or who have been intolerant to one or more disease-modifying antirheumatic drugs (DMARDs). Crohn’s disease Skyrizi is indicated for the treatment of adult patients with moderately to severely active Crohn's disease who have had an inadequate response to, lost response to, or were intolerant to conventional therapy or a biologic therapy. Ulcerative colitis Skyrizi is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to, lost response to, or were intolerant to conventional therapy or a biologic therapy.
- Product number
- EMEA/H/C/004759
- Authorisation holder
- AbbVie Deutschland GmbH & Co. KG
- 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, Psoriatic
- Colitis, Ulcerative
- Crohn Disease
- Psoriasis
European medicines record
- 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
- Availability
- Prescription only
- Pharmacology name
- risankizumab
- Type
- Antibody
- Drug name stem
- -mab; -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
- 10.37
- 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
- Colitis, Ulcerative
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000729
- Subject identifier
- D003093
- Condition
- Arthritis, Psoriatic
- Highest recorded phase
- 4
- Condition identifier
- EFO:0003778
- Subject identifier
- D015535
- Condition
- Spondylitis, Ankylosing
- Highest recorded phase
- 2
- Condition identifier
- EFO:0003898
- Subject identifier
- D013167
- Condition
- Arthritis, Juvenile
- Highest recorded phase
- 3
- Condition identifier
- EFO:0009733
- Subject identifier
- D001171
- Condition
- Hidradenitis Suppurativa
- Highest recorded phase
- 2
- Condition identifier
- EFO:1000710
- Subject identifier
- D017497
- Condition
- Dermatitis
- Highest recorded phase
- 2
- Condition identifier
- MONDO:0002406
- Subject identifier
- D003872
- Condition
- Asthma
- Highest recorded phase
- 2
- Condition identifier
- MONDO:0004979
- Subject identifier
- D001249
- Condition
- Psoriasis
- Highest recorded phase
- 4
- Condition identifier
- MONDO:0015597
- Subject identifier
- D011565
- Condition
- Severe Acute Respiratory Syndrome
- Highest recorded phase
- 2
- Condition identifier
- MONDO:0100096
- Subject identifier
- D045169
- Condition identifier
- EFO_0000384
- Condition identifier
- EFO_0000540
- Condition identifier
- EFO_0000676
- Condition identifier
- EFO_0000729
- Condition identifier
- EFO_0003778
- Condition identifier
- EFO_0003898
- Highest recorded phase
- 2
- Condition identifier
- EFO_1000710
- Highest recorded phase
- 2
- Condition identifier
- EFO_1001494
- Condition identifier
- EFO_1001494
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0002406
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0004565
- Highest recorded phase
- 3
- Condition identifier
- MONDO_0004979
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0004980
- Highest recorded phase
- 2
- 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_0005101
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0005306
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0006559
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0011849
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0015597
- Highest recorded phase
- 3
- Condition identifier
- MONDO_0019436
- Highest recorded phase
- 3
- Condition identifier
- MONDO_0022205
- Condition identifier
- MONDO_0022205
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0100096
- Highest recorded phase
- 2
And 1 more, listed on the interactive page.
- Event
- botryomycosis
- Reports
- 4
- Reporting signal score
- 23.8979
- Event
- covid-19
- Reports
- 24
- Reporting signal score
- 26.4465
- Event
- cutaneous t-cell lymphoma
- Reports
- 7
- Reporting signal score
- 26.8674
- Event
- dermatitis exfoliative generalised
- Reports
- 26
- Reporting signal score
- 91.4655
- Event
- feeling of despair
- Reports
- 6
- Reporting signal score
- 15.7021
- Event
- paternal exposure during pregnancy
- Reports
- 5
- Reporting signal score
- 20.7231
- Event
- pityriasis rubra pilaris
- Reports
- 5
- Reporting signal score
- 23.4822
- Event
- psoriasis
- Reports
- 137
- Reporting signal score
- 256.456
- Event
- skin plaque
- Reports
- 14
- Reporting signal score
- 31.3122
- Event
- therapeutic product effect decreased
- Reports
- 17
- Reporting signal score
- 22.4087
- Event
- therapeutic product effect incomplete
- Reports
- 18
- Reporting signal score
- 19.7375
- Event
- therapeutic response shortened
- Reports
- 19
- Reporting signal score
- 41.9273
- NCT02031276
- NCT02513459
- NCT03104413
- NCT03105102
- NCT03105128
- NCT04254783
- NCT04524611
- NCT05995353
- NCT06063967
- NCT02047110
- NCT02203851
- NCT02672852
- NCT02684357
- NCT02684370
- NCT02694523
- NCT02772601
- NCT03000075
- NCT03022045
- NCT03047395
- NCT03219437
- NCT03255382
- NCT03478787
- NCT03518047
- NCT03875482
- NCT03875508
And 23 more, listed on the interactive page.
- Dose
- 150 mg
- Route
- Subcutaneous
- How often
- At Week 0, Week 4, and every 12 weeks thereafter
Conditions of use
- Inject subcutaneously
- Prodrug
- No
- Chirality
- Single enantiomer
- Inorganic
- No
- Natural product
- No
- Component
- Glycosylation sites (N)
- Sequence
- Asn-300$Asn-300''''
- Component
- Disulfide bridges location
- Sequence
- 22-96$22''-96''$23'-88'$23'''-88'''$134'-194'$134'''-194'''$147-203$147''-203''$232-232''$264-324$264''-324''$370-428$370''-428''$214'-223$214'''-223''$229-229''
- Component
- Light chain
- Type
- Protein
- Sequence
- DIQMTQSPSSLSASVGDRVTITCKASRDVAIAVAWYQQKPGKVPKLLIYWASTRHTGVPSRFSGSGSRTDFTLTISSLQPEDVADYFCHQYSSYPFTFGSGTKLEIKRTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC
- Component
- Heavy chain
- Type
- Protein
- Sequence
- QVQLVQSGAEVKKPGSSVKVSCKASGYTFTDQTIHWMRQAPGQGLEWIGYIYPRDDSPKYNENFKGKVTITADKSTSTAYMELSSLRSEDTAVYYCAIPDRSGYAWFIYWGQGTLVTVSSASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKRVEPKSCDKTHTCPPCPAPEAAGGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYNSTYRVVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSREEMTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRWQQGNVFSCSVMHEALHNHYTQKSLSLSPG
- Component
- Glycosylation sites (N)
- Sequence
- Asn-300$Asn-300''
- 0074-1050
- 0074-1065
- 0074-1070
- 0074-2100
- 0074-4059
- 0074-5015
- 0074-7040
- 0074-7042
- 0074-8300
- 0074-8350
Related records
Trials (88)
- A Global Study Comparing Risankizumab to Placebo in Adult Participants With Moderate to Severe Hidradenitis Suppurativa
- A Long Term Extension Trial of BI 655066/ABBV-066 (Risankizumab), in Patients With Moderately to Severely Active Crohn's Disease
- A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Ulcerative Colitis
- A Study Comparing Risankizumab to Placebo in Participants With Active Psoriatic Arthritis (PsA) Who Have a History of Inadequate Response to or Intolerance to at Least One Disease Modifying Anti-Rheumatic Drug (DMARD) Therapy
- A Study Comparing Risankizumab to Placebo in Participants With Active Psoriatic Arthritis Including Those Who Have a History of Inadequate Response or Intolerance to Biologic Therapy(Ies)
- A Study Comparing the Safety and Efficacy of Risankizumab to Methotrexate in Subjects With Moderate to Severe Plaque Psoriasis
- A Study in Healthy Japanese and Caucasian Subjects to Assess the Pharmacokinetics, Safety and Tolerability of Risankizumab
- A Study of Guselkumab and Risankizumab in Healthy Participants and Participants With Psoriatic Arthritis
- A Study of Guselkumab Versus Risankizumab in Participants With Moderately to Severely Active Crohn's Disease
- A Study of Intravenously (IV) Infused or Subcutaneously (SC) Injected Risankizumab in Healthy Adult Participants in China
- A Study of Subcutaneous Risankizumab Injection for Pediatric Participants With Moderate to Severe Plaque Psoriasis to Assess Change in Disease Symptoms
- A Study of the Efficacy and Safety of Risankizumab in Participants With Crohn's Disease
- A Study of the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Crohn's Disease
- A Study of the Safety and Efficacy of Risankizumab in Adult Participants With Plaque Psoriasis Who Have Had a Suboptimal Response to Secukinumab or Ixekizumab
- A Study to Assess Adverse Events and Change in Disease Activity of Risankizumab Subcutaneous Induction Treatment for Moderately to Severely Active Crohn's Disease.
- A Study to Assess Adverse Events, Change in Disease Activity, and How Intravenous and Subcutaneous Risankizumab Moves Through the Body of Pediatric Participants With Moderately to Severely Active Crohn's Disease
- A Study to Assess Adverse Events, Change in Disease Activity, and How the Drug Moves Through the Body in Children With Juvenile Psoriatic Arthritis (jPsA) Receiving Subcutaneously Injected Risankizumab or Adalimumab
- A Study to Assess Efficacy and Safety of Two Different Dose Regimens of Risankizumab Administered Subcutaneously in Japanese Subjects With Generalized Pustular Psoriasis or Erythrodermic Psoriasis
- A Study to Assess How Intravenous and Subcutaneous Administrations of Risankizumab Moves Through the Body of Healthy Adult Participants
- A Study to Assess Pharmacokinetic Exposures Following Intravenous and Subcutaneous Administration of Risankizumab in Healthy Participants
Approved for (4)
- Immune system disorder
- Palmoplantar pustulosis
- Psoriasis
- Psoriatic arthritis
In development for (8)
- Ankylosing spondylitis Phase 2
- Asthma Phase 2
- COVID-19 Phase 2
- Crohn disease Phase 3
- Dermatitis Phase 2
- Hidradenitis suppurativa Phase 2
- Psoriasis-related juvenile idiopathic arthritis Phase 3
- Ulcerative colitis Phase 3
Other linked conditions (1)
- Pustular psoriasis