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Drug

Risankizumab

Approved · FDA / EMA
Emerging researchLate-stage development

Also known as Skyrizi.

RxNorm2166040UNII90ZX3Q3FR7
1
Research papers
18
Active clinical trials
28
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Phase 3b, Multicenter, Randomized, Open-Label Study of Risankizumab Compared to Vedolizumab for the Treatment of Adult Subjects With Moderate to Severe Ulcerative Colitis Who Are Naïve to Targeted Therapies

Clinical trial2026-08-03Results expected Q3 2027 · ClinicalTrials.gov

A Phase 3, Randomized, Double-Blind Study Comparing Risankizumab to Placebo in Subjects With Active Psoriatic Arthritis Including Those Who Have a History of Inadequate Response or Intolerance to Biologic Therapy(Ies) (KEEPsAKE 2)

Clinical trial2026-07-20Status changed to Completed · ClinicalTrials.gov

A Phase 3, Parallel-group, Randomized, Double-blind, 4-arm, Placebo-controlled, Multicenter Study With Risankizumab as Active Reference Arm, to Investigate the Efficacy and Safety of Subcutaneous Sonelokimab in Male and Female Participants Aged 18 Years and Over With Active Psoriatic Arthritis and Previous Inadequate Response or Intolerance to Tumor Necrosis Factor-α Inhibitors

Clinical trial2026-07-13Results expected Q1 2027 · ClinicalTrials.gov

Immunosuppressant Management in Rheumatology Patients Undergoing Elective Total Shoulder Arthroplasty

Clinical trial2026-07-09Results expected Q1 2028 · ClinicalTrials.gov

A Phase 3b, Multicenter, Randomized, Open-Label, Active-Controlled Study to Compare the Efficacy and Safety of Guselkumab Versus Risankizumab in the Treatment of Participants With Moderately to Severely Active Crohn's Disease

Clinical trial2026-07-06Results expected Q4 2028 · ClinicalTrials.gov

A Phase 1 Study in Healthy Subjects to Assess Pharmacokinetics Following Intravenous and Subcutaneous Administration of Risankizumab

Clinical trial2026-07-01Results expected Q1 2027 · ClinicalTrials.gov

Indication expansion: RISANKIZUMAB-RZAA (BLA761105)

Regulatory2026-06-26FDA

Label change: RISANKIZUMAB-RZAA (BLA761262)

Regulatory2026-06-26FDA

Indication expansion: RISANKIZUMAB-RZAA (BLA761105)

Regulatory2026-06-12FDA

Label change: RISANKIZUMAB-RZAA (BLA761262)

Regulatory2026-06-12FDA

AbbVie’s Skyrizi narrowly slides ahead of J&J’s Tremfya in May drug ad spending rankings

Industry2026-06-09Fierce Pharma

Comparative Effectiveness of Bimekizumab and Risankizumab in Patients with Psoriatic Arthritis at 52 Weeks Assessed Using a Matching-Adjusted Indirect Comparison.

Research2024-08-09Rheumatology and therapy

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Risankizumab
Aliases & brands
Skyrizi
RxNorm CUI
2166040
UNII
90ZX3Q3FR7
Regulatory jurisdictions
emafda

Regulatory timeline

28 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Approval / market entry confirmed across FDA and EMA (2019-04-23 → 2021-04-26)
Earliest approval
2019-04-23
Latest approval
2026-06-26
Authorities
FDA · EMA
Total events
28
fdaU.S. Food and Drug Administration· 27 events
2026-06-26Indication expansion
Indication expansion: RISANKIZUMAB-RZAA (BLA761105)
Evidence ↗
2026-06-26Label change
Label change: RISANKIZUMAB-RZAA (BLA761262)
Evidence ↗
2026-06-12Indication expansion
Indication expansion: RISANKIZUMAB-RZAA (BLA761105)
Evidence ↗
emaEuropean Medicines Agency· 1 event
2019-04-26ApprovalMulti-authority
Approval: Skyrizi (EMA)
Indication: 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… Show full indication

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.

Evidence ↗

Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

71 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
71
registered trials across all phases
LATEST COMPLETION 2026
18
Active studies
12
Recruiting
40
Late-stage (III+)
52
Completed
1
Discontinued
PHASE DISTRIBUTIONn = 71
Phase 116Phase 215Phase 2 / 31Phase 332Phase 46Phase N / A1

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Utilization of a Cutaneous Therapy In Situ Microdevice

Not yet recruitingPH IVUniversity of California, San Franciscon=102030

A Phase 4 Multicenter, Randomized, Open-label, Efficacy Assessor Blinded Study of Risankizumab Compared to Deucravacitinib for the Treatment of Adult Subjects With Moderate Plaque Psoriasis Who Are Candidates for Systemic Therapy

CompletedPH IVAbbVien=3932026

A Phase 4, Open-Label, Milk-Only Lactation Study to Assess Concentration of Risankizumab in Breast Milk of Lactating Women With Inflammatory Bowel Disease Who Are Receiving Risankizumab Therapeutically

CompletedPH IVAbbVien=102026

A Phase 4 Multicenter, Randomized, Double-Blind Study of Risankizumab for the Treatment of Adult Subjects With Moderate to Severe Genital Psoriasis or Moderate to Severe Scalp Psoriasis

CompletedPH IVAbbVien=2142025

Dose Reduction of the New Generation Biologicals (IL17 and IL23 Inhibitors) in Psoriasis: A Pragmatic, Multicentre, Randomized, Controlled, Non-inferiority Study - BeNeBio Study

CompletedPH IVRadboud University Medical Centern=2442025

Recent completions

Trials that read out recently, adding to the completed evidence base.

A Phase 3, Randomized, Double-Blind Study Comparing Risankizumab to Placebo in Subjects With Active Psoriatic Arthritis Including Those Who Have a History of Inadequate Response or Intolerance to Biologic Therapy(Ies) (KEEPsAKE 2)

CompletedPH IIIAbbVien=4442026

A Multicenter, Randomized, Double-Blind, Risankizumab-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Study Participants With Active Psoriatic Arthritis

CompletedPH IIIUCB Biopharma SRLn=6842026

A Phase 4 Multicenter, Randomized, Open-label, Efficacy Assessor Blinded Study of Risankizumab Compared to Deucravacitinib for the Treatment of Adult Subjects With Moderate Plaque Psoriasis Who Are Candidates for Systemic Therapy

CompletedPH IVAbbVien=3932026

A Phase 4, Open-Label, Milk-Only Lactation Study to Assess Concentration of Risankizumab in Breast Milk of Lactating Women With Inflammatory Bowel Disease Who Are Receiving Risankizumab Therapeutically

CompletedPH IVAbbVien=102026

A Phase 1 Pharmacokinetic Study in Healthy Subjects to Evaluate the Bioavailability of Risankizumab Subcutaneous Administration With On-Body Injector Relative to Prefilled Syringe

CompletedPH IAbbVien=2602026

A Phase 4 Multicenter, Randomized, Double-Blind Study of Risankizumab for the Treatment of Adult Subjects With Moderate to Severe Genital Psoriasis or Moderate to Severe Scalp Psoriasis

CompletedPH IVAbbVien=2142025

Research activity

1 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Journals, researchers & institutions
Top journals
  • Rheumatology and therapy1
Leading researchers
  • Eells J1
  • Grouin JM1
  • Lyris N1
  • McInnes IB1
  • Mease PJ1
  • Nash P1
  • Taieb V1
  • Warren RB1
Leading institutions
free-text, unnormalised
  • College of Medical Veterinary and Life Sciences1
  • Dermatology Centre1
  • School of Medicine1
  • Swedish Medical Center/Providence St. Joseph Health and University of Washington1
  • University of Rouen1

Related drugs

1 matches

Drugs sharing diseases, protein targets and literature with this one. Ranked by graph evidence (shared targets + diseases weighted above co-mentions).

Bimekizumab

Frequently co-studied with Risankizumab in the research literature.

1 shared paper
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.