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Drug

Risankizumab

Approved medicine
ClassInterleukin-23 inhibitorResearchActive indication expansion

Also known as Skyrizi.

RxNorm2166040ChEMBLCHEMBL3990029ATCL04AC18UNII90ZX3Q3FR7
1
Research papers
18
Active clinical trials
2
Protein targets
30
Regulatory events
Latest activity
beta

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

Risankizumab in Children With Crohn's Disease (RisaKids): A Multi-center PORTO Group Prospective Study

Clinical trial2026-10-31Primary completion · ClinicalTrials.gov

Supplements and Liver Injury; New Skyrizi Approval in Crohn's; Preventing C. Diff

Regulatory2026-10-29Regulatory news · MedPage Today — Gastroenterology

The FDA has expanded its approval of Skyrizi to include subcutaneous induction for adults with moderately to severely active Crohn’s disease.

Regulatory2026-10-23Regulatory news · Healio Gastroenterology

Indication expansion: RISANKIZUMAB-RZAA (BLA761105)

Regulatory2026-10-23FDA

Label change: RISANKIZUMAB-RZAA (BLA761262)

Regulatory2026-10-23FDA

AbbVie’s Skyrizi combo beats Skyrizi alone in mid-stage Crohn’s trial

Clinical trial2026-10-19Trial news · Endpoints News

Subcutaneous Risankizumab Induction Improved Outcomes in Crohn's Disease

Industry2026-10-16MedPage Today — Gastroenterology

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 trial2026-10-09Status changed to Active, not recruiting · ClinicalTrials.gov

Open-label, Randomized, Assessor-blinded, Efficacy, Safety, Tolerability, and Pharmacokinetics Study of Subcutaneous Risankizumab With an Adalimumab Reference Arm in Children With Active Juvenile Psoriatic Arthritis

Clinical trial2026-09-30Primary completion · 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 trial2026-09-25Results expected Q4 2028 · ClinicalTrials.gov

Indication expansion: RISANKIZUMAB-RZAA (BLA761105)

Regulatory2026-06-26FDA

Label change: RISANKIZUMAB-RZAA (BLA761262)

Regulatory2026-06-26FDA

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
ChEMBL ID
CHEMBL3990029
ATC codes
L04AC18
UNII
90ZX3Q3FR7
Primary mechanism
Interleukin-23 inhibitor
Regulatory jurisdictions
fdaema

Pharmacology & targets

2 targets

Known molecular targets and mechanisms supported by curated pharmacology databases.

Interleukin-12 subunit beta
IL12B · P29460
INHIBITORInterleukin-23 inhibitor
Interleukin-23 subunit alpha
IL23A · Q9NPF7
INHIBITORInterleukin-23 inhibitor

Regulatory timeline

30 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
2026-10-23
Authorities
FDA · EMA
Total events
30
fdaU.S. Food and Drug Administration· 29 events
2026-10-23Label change
Label change: RISANKIZUMAB-RZAA (BLA761262)
Evidence ↗
2026-10-23Indication expansion
Indication expansion: RISANKIZUMAB-RZAA (BLA761105)
Evidence ↗
2026-06-26Indication expansion
Indication expansion: RISANKIZUMAB-RZAA (BLA761105)
Evidence ↗
emaEuropean Medicines Agency· 1 event
2019-04-26Original application approvalMulti-authority
Marketing authorisation: 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
11
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 paper

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
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.