Skyrizi

(Risankizumab)

ApprovedMonoclonal antibody

Risankizumab is used to treat moderate to severe plaque psoriasis, a skin condition that causes red, scaly patches. It works by blocking a protein in the body that causes inflammation.[2] Skyrizi is currently approved and in use across 15 indications[4].[1]

Skyrizi is one of 315 monoclonal antibody programs targeting Psoriasis. It is currently in Approved.

Indications

Total Trials

Active Trials

314

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

PsoriasisActive, not recruiting

Pustular PsoriasisUnknown

Immune System DiseaseUnknown

Psoriasis VulgarisUnknown

Juvenile Psoriatic ArthritisRecruiting

Crohn DiseaseRecruiting

Rheumatic DiseaseRecruiting

AutoimmunityUnknown status

Psoriatic ArthritisActive, not recruiting

Crohn's DiseaseRecruiting

PsoriasisApproved

Active, not recruiting

Pustular PsoriasisPreclinical

Unknown

Immune System DiseasePreclinical

Unknown

Psoriasis VulgarisPreclinical

Unknown

Juvenile Psoriatic ArthritisPhase 3

Recruiting

Crohn DiseasePhase 3

Recruiting

Rheumatic DiseasePhase 2

Recruiting

AutoimmunityApproved

Unknown status

Psoriatic ArthritisPhase 3

Active, not recruiting

Crohn's DiseasePhase 3

Recruiting

Showing 10 of 15 indications

Competition

Competitive Landscape

127 competitors in Atopic Dermatitis

#DrugCompanyPhaseTrials

Skyrizi

AbbVie

Approved

2 2

Cytosar

Teva

Phase 3

1 3

Fludara

Sanofi

Phase 3

1 4

Adtralza

LEO Pharma

Phase 3

16 5

Amlitelimab

Sanofi

Phase 3

2 6

DUPIXENT

Regeneron

Phase 3

1 7

Certolizumab

Johnson & Johnson

Phase 3

1 8

Jaktinib

SSuzhou Zelgen Biopharmaceuticals Co.,Ltd

Phase 3

4 9

ICP-332

BBeijing InnoCare Pharma Tech Co., Ltd.

Phase 3

2 10

VC005

JJiangsu vcare pharmaceutical technology co., LTD

Phase 3

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q3 2026

Phase 3Active, not recruiting

Psoriatic Arthritis

NCT03675308

Phase 1Recruiting

Immunogenicity

NCT07258745

Q4 2026

N/ARecruiting

Crohn's Disease

NCT06298188

Active, not recruiting

Crohn's Disease

NCT06249555

Q1 2027

Phase 1Recruiting

Study completion

NCT07466550

Phase 3Recruiting

Arthritis, Psoriatic

NCT06641089

Clinical

Trials by Indication[1]

Psoriasis23 trials

High Dose Risankizumab for Psoriasis

Completed·—·Phase 2·NCT05283135·20 enrolled

Dose Reduction of IL17 and IL23 Inhibitors in Psoriasis

Completed·RRadboud University Medical Center·Phase 4·NCT04340076·244 enrolled

A Study to Assess the Safety and Efficacy of Risankizumab for Maintenance in Moderate to Severe Plaque Type Psoriasis ( LIMMITLESS )

Completed· AbbVie logo

AbbVie·Phase 3·NCT03047395·2,170 enrolled

Show 20 more trials

A Study to Assess the Efficacy of Risankizumab Compared to FUMADERM® in Subjects With Moderate to Severe Plaque Psoriasis Who Are Naïve to and Candidates for Systemic Therapy

Completed· AbbVie logo

AbbVie·Phase 3·NCT03255382·120 enrolled

Study to Assess the Safety and Efficacy of Subcutaneously Injected Risankizumab in Adult Participants With Genital or Scalp Psoriasis

Completed· AbbVie logo

AbbVie·Phase 4·NCT05969223·214 enrolled

BI 655066 (Risankizumab) Compared to Placebo and Active Comparator (Ustekinumab) in Patients With Moderate to Severe Chronic Plaque Psoriasis

Completed· AbbVie logo

AbbVie·Phase 3·NCT02684370·560 enrolled

Study of Subcutaneous (Injected Under the Skin) Risankizumab to Assess Change in Disease Symptoms in Adult Participants With Moderate to Severe Plaque Psoriasis With Palmoplantar Involvement

Completed· AbbVie logo

AbbVie·Phase 3·NCT04713592·174 enrolled

A Study to Assess Safety and Efficacy of Risankizumab Using a New Formulation in Participants With Moderate to Severe Plaque Psoriasis

Completed· AbbVie logo

AbbVie·Phase 3·NCT03875482·157 enrolled

A Study of Subcutaneous Risankizumab Injection for Pediatric Participants With Moderate to Severe Plaque Psoriasis to Assess Change in Disease Symptoms

Completed· AbbVie logo

AbbVie·Phase 3·NCT04435600·139 enrolled

Extension Trial Assessing the Safety and Efficacy of BI 655066/ABBV-066/Risankizumab in Patients With Moderate to Severe Chronic Plaque Psoriasis

Completed· AbbVie logo

AbbVie·Phase 2·NCT02203851·110 enrolled

Study to Evaluate Adverse Events and Change in Disease Activity in Participants Between 6 and 17 Years With Moderate to Severe Plaque Psoriasis Treated With Subcutaneous (SC) Injection of Risankizumab Who Have Completed Participation in Study M19-977

Active, not recruiting· AbbVie logo

AbbVie·Phase 3·NCT04862286·132 enrolled

BI 655066/ABBV-066 (Risankizumab) Compared to Active Comparator (Adalimumab) in Patients With Moderate to Severe Chronic Plaque Psoriasis

Completed· AbbVie logo

AbbVie·Phase 3·NCT02694523·684 enrolled

Risankizumab Versus Secukinumab for Participants With Moderate to Severe Plaque Psoriasis

Completed· AbbVie logo

AbbVie·Phase 3·NCT03478787·327 enrolled

BI 655066 Versus Placebo & Active Comparator (Ustekinumab) in Patients With Moderate to Severe Chronic Plaque Psoriasis

Completed· AbbVie logo

AbbVie·Phase 3·NCT02684357·577 enrolled

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

Completed· AbbVie logo

AbbVie·Phase 3·NCT04102007·244 enrolled

BI 655066 (Risankizumab) Compared to Placebo in Japanese Patients With Moderate to Severe Chronic Plaque Psoriasis

Completed· AbbVie logo

AbbVie·Phase 2·NCT03000075·182 enrolled

A Study to Assess Usability of Risankizumab Autoinjector Combination Product in Participants With Moderate to Severe Plaque Psoriasis

Completed· AbbVie logo

AbbVie·Phase 3·NCT03875508·108 enrolled

A Study Comparing the Safety and Efficacy of Risankizumab to Methotrexate in Subjects With Moderate to Severe Plaque Psoriasis

Completed· AbbVie logo

AbbVie·Phase 3·NCT03219437·104 enrolled

A Study to Learn How Safe and Effective Risankizumab is When Compared to Deucravacitinib to Treat Participants With Moderate Plaque Psoriasis and Who Need to Try Systemic Treatment (Works Throughout the Whole Body)

Active, not recruiting· AbbVie logo

AbbVie·Phase 4·NCT06333860·393 enrolled

Study of Subcutaneous Risankizumab Injection Compared to Oral Apremilast Tablets to Assess Change in Disease Activity And Adverse Events in Adult Participants With Moderate Plaque Psoriasis Who Are Candidates for Systemic Therapy

Completed· AbbVie logo

AbbVie·Phase 4·NCT04908475·352 enrolled

Risankizumab Therapy Versus Placebo for Subjects With Psoriasis in the Russian Federation

Completed· AbbVie logo

AbbVie·Phase 3·NCT03518047·50 enrolled

Study to Assess Adverse Events When Subcutaneous Risankizumab Injection is Given to Adult Participants With Psoriasis in Real World Setting

Withdrawn· AbbVie logo

AbbVie··NCT04799990

BI 655066 / ABBV-066 (Risankizumab) in Moderate to Severe Plaque Psoriasis With Randomized Withdrawal and Re-treatment

Completed· AbbVie logo

AbbVie·Phase 3·NCT02672852·507 enrolled

Crohn's Disease9 trials

Risankizumab in Children With Crohn's Disease (RisaKids)

Recruiting·SShaare Zedek Medical Center·N/A·NCT06298188·90 enrolled

Efficacy, Safety and Pharmacokinetics of BI 655066/ABBV-066 (Risankizumab) in Patients With Active, Moderate-to-severe Crohn's Disease.

Completed· AbbVie logo

AbbVie·Phase 2·NCT02031276·121 enrolled

A Long Term Extension Trial of BI 655066/ABBV-066 (Risankizumab), in Patients With Moderately to Severely Active Crohn's Disease

Completed· AbbVie logo

AbbVie·Phase 2·NCT02513459·65 enrolled

Show 6 more trials

A Study to Assess Adverse Events and Change in Disease Activity of Risankizumab Subcutaneous Induction Treatment for Moderately to Severely Active Crohn's Disease.

Active, not recruiting· AbbVie logo

AbbVie·Phase 3·NCT06063967·289 enrolled

A Phase 2 Platform Basket Study Evaluating Advanced Therapies in Subjects With Moderately to Severely Active Crohn's Disease or Ulcerative Colitis

Recruiting· AbbVie logo

AbbVie·Phase 2·NCT07697456·2,000 enrolled

A Phase 3, Multi-Center Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of Risankizumab With Open-Label Induction, Randomized Double-Blind Maintenance, and Long-Term Extension Periods in Pediatric Subjects (2 to < 18 Years of Age) With Moderately to Severely Active Crohn's Disease

Recruiting· AbbVie logo

AbbVie·Phase 3·NCT05995353·110 enrolled

VOICE-Characterization of Early Response to Vedolizumab and IL-23 Antagonists in Participants With Crohn's Disease Using Patient-Reported Outcome Measures: A Prospective Observational Study

Active, not recruiting·AAlimentiv Inc.··NCT06249555·300 enrolled

A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects With Crohn's Disease

Active, not recruiting· AbbVie logo

AbbVie·Phase 3·NCT03105102·1,336 enrolled

A Phase 2a Multicenter, Randomized, Platform Study of Targeted Therapies for the Treatment of Adult Subjects With Moderate to Severe Crohn's Disease

Recruiting· AbbVie logo

AbbVie·Phase 2·NCT06548542·540 enrolled

Psoriatic Arthritis7 trials

BI 655066/ABBV-066/Risankizumab Compared to Placebo in Patients With Active Psoriatic Arthritis

Completed· AbbVie logo

AbbVie·Phase 2·NCT02719171·185 enrolled

A Study of Guselkumab and Risankizumab in Healthy Participants and Participants With Psoriatic Arthritis

Terminated· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT05083078·11 enrolled

This Study Tests the Effect of Risankizumab on the Metabolism in the Liver of Five Additional Drugs to Study Possible Drug Interactions in Patients With Psoriasis With or Without Psoriatic Arthritis

Completed· AbbVie logo

AbbVie·Phase 1·NCT02772601·21 enrolled

Show 4 more trials

Study of Targeted Therapies for the Treatment of Adult Participants With Active Psoriatic Arthritis

Recruiting· AbbVie logo

AbbVie·Phase 2·NCT06865105·120 enrolled

A Study to Investigate Safety With Risankizumab in Psoriatic Arthritis Subjects Who Have Completed Week 24 Visit of Study M16-002 (NCT02719171)

Completed· AbbVie logo

AbbVie·Phase 2·NCT02986373·145 enrolled

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

Active, not recruiting· AbbVie logo

AbbVie·Phase 3·NCT03675308·964 enrolled

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

Completed· UCB logo

UCB·Phase 3·NCT06624228·553 enrolled

Ulcerative Colitis6 trials

A Study to Assess the Efficacy and Safety of Risankizumab in Participants With Ulcerative Colitis

Active, not recruiting· AbbVie logo

AbbVie·Phase 3·NCT03398135·1,242 enrolled

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

Completed· AbbVie logo

AbbVie·Phase 2/3·NCT03398148·1,558 enrolled

A Study to Evaluate the Effect of Intravenous (IV) Infusions of Risankizumab on Pharmacokinetics of Cytochome P450 Substrates in Adult Participants With Moderately to Severely Active Ulcerative Colitis or Crohn's Disease

Completed· AbbVie logo

AbbVie·Phase 1·NCT04254783·20 enrolled

Show 3 more trials

A Phase 3, Multi-Center Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of Risankizumab With Open-Label Induction, Randomized Double-Blind Maintenance, and Open-Label Long-Term Extension Periods in Pediatric Subjects (2 to < 18 Years of Age) With Moderately to Severely Active Ulcerative Colitis

Recruiting· AbbVie logo

AbbVie·Phase 3·NCT07071519·120 enrolled

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

Active, not recruiting· AbbVie logo

AbbVie·Phase 3·NCT06880744·573 enrolled

LUMINANCE: Risankizumab in Ulcerative Colitis

Recruiting· AbbVie logo

AbbVie·Phase 3·NCT04524611·520 enrolled

Adult5 trials

A Study to Assess the Relative Bioavailability of Risankizumab Following Subcutaneous Administrations With a Pre-Filled Syringe or an On-Body Injector in Healthy Adult Participants

Completed· AbbVie logo

AbbVie·Phase 1·NCT07007091·260 enrolled

A Study to Assess the Relative Bioavailability of Risankizumab Following Subcutaneous Administration With On-Body Injector in Healthy Adult Participants

Completed· AbbVie logo

AbbVie·Phase 1·NCT06937619·263 enrolled

A Study to Evaluate the Bioavailability of Risankizumab in Pre-filled Syringe or Auto-injector in Healthy Adult Participants

Completed· AbbVie logo

AbbVie·Phase 1·NCT05283681·226 enrolled

Show 2 more trials

A Study to Assess the Relative Bioavailability of Two Formulations of Risankizumab Following Subcutaneous Administration With Prefilled Syringes in Healthy Adult Participants

Completed· AbbVie logo

AbbVie·Phase 1·NCT06571266·231 enrolled

A Study to Assess the Bioavailability of Risankizumab Following Subcutaneous Administration With Prefilled Pen Relative to a Prefilled Syringe in Healthy Adult Participants

Completed· AbbVie logo

AbbVie·Phase 1·NCT06946524·59 enrolled

28 more indications

Intravenous4 trials

Study of Intravenous and Subcutaneous Administration of Risankizumab in Healthy Participants

Completed· AbbVie logo

AbbVie·Phase 1·NCT05274100·394 enrolled

A Study to Compare the Bioavailability of Intravenously Infused Risankizumab Manufactured by Two Different Processes in Healthy Adults

Completed· AbbVie logo

AbbVie·Phase 1·NCT06054425·48 enrolled

A Study to Assess Pharmacokinetic Exposures Following Intravenous and Subcutaneous Administration of Risankizumab in Healthy Participants

Completed· AbbVie logo

AbbVie·Phase 1·NCT06487572·60 enrolled

Show 1 more trial

A Study of Intravenously (IV) Infused or Subcutaneously (SC) Injected Risankizumab in Healthy Adult Participants in China

Completed· AbbVie logo

AbbVie·Phase 1·NCT05268068·30 enrolled

Inflammatory Bowel Disease3 trials

A Study to Assess the Concentrations of Risankizumab in the Breast Milk of Adult Lactating Women With Inflammatory Bowel Disease

Completed· AbbVie logo

AbbVie·Phase 4·NCT06346288·10 enrolled

Fluorescence Imaging of Risankizumab-800CW in Inflammatory Bowel Disease

Recruiting·UUniversity Medical Center Groningen·Phase 1/2·NCT06606808·18 enrolled

Fluorescence Imaging of Adalimumab-680LT and Risankizumab-800CW in Inflammatory Bowel Disease

Not yet recruiting·UUniversity Medical Center Groningen·Phase 1/2·NCT07258641·30 enrolled

Atopic Dermatitis2 trials

A Study to Evaluate Risankizumab in Adults and Adolescents With Moderate to Severe Atopic Dermatitis

Completed· AbbVie logo

AbbVie·Phase 2·NCT03706040·172 enrolled

Utilization of a Microdevice for Psoriasis and Atopic Dermatitis

Not yet recruiting·UUniversity of California, San Francisco·Phase 4·NCT07352566·10 enrolled

Efficacy and Safety2 trials

A Study of the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Crohn's Disease

Completed· AbbVie logo

AbbVie·Phase 3·NCT03105128·931 enrolled

A Study to Assess the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment

Completed· AbbVie logo

AbbVie·Phase 3·NCT03104413·618 enrolled

Ankylosing Spondylitis1 trial

BI 655066 (Risankizumab) Proof of Concept Dose Finding Study in Ankylosing Spondylitis (AS)

Completed· AbbVie logo

AbbVie·Phase 2·NCT02047110·159 enrolled

ART1 trial

A Study to Evaluate the Bioavailability of Risankizumab Following Subcutaneous Dosing in Healthy Male Participants

Completed· AbbVie logo

AbbVie·Phase 1·NCT05283694·48 enrolled

Pregnancy1 trial

Study to Evaluate Pregnancy Outcomes in Risankizumab Exposed Pregnancies Relative to Those Non-risankizumab Exposed Pregnancies in Women With FDA Approved Indications

Recruiting· AbbVie logo

AbbVie··NCT04846959·818 enrolled

Generalized Pustular Psoriasis1 trial

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

Completed· AbbVie logo

AbbVie·Phase 3·NCT03022045·18 enrolled

Asthma1 trial

Efficacy and Safety of BI 655066/ABBV-066 (Risankizumab) in Patients With Severe Persistent Asthma

Completed· AbbVie logo

AbbVie·Phase 2·NCT02443298·214 enrolled

ESS1 trial

Expanded Access to Risankizumab

No longer available· AbbVie logo

AbbVie··NCT03914261

GIST1 trial

Costa Rican Registry of IL-23 Inhibitors in Psoriatic Disease

Not yet recruiting·CCaja Costarricense de Seguro Social··NCT07448402·50 enrolled

Hidradenitis Suppurativa1 trial

A Global Study Comparing Risankizumab to Placebo in Adult Participants With Moderate to Severe Hidradenitis Suppurativa

Completed· AbbVie logo

AbbVie·Phase 2·NCT03926169·243 enrolled

Pain1 trial

Study to Evaluate the Effect of Different Warm-Up Times of Risankizumab Autoinjector (AI) on the Injection Pain Experiences in Healthy Volunteers

Completed· AbbVie logo

AbbVie·Phase 1·NCT05274087·30 enrolled

Remission1 trial

Risankizumab Long-term Remission Study

Active, not recruiting·JJaehwan Kim·Phase 4·NCT04630652·20 enrolled

Drug1 trial

Study to Evaluate the Relative Bioavailability of Two Risankizumab Drug Product Presentations in Healthy Volunteers.

Completed· AbbVie logo

AbbVie·Phase 1·NCT05567029·198 enrolled

Autoimmunity1 trial

Exploring the Effects of IL-23 Inhibition by Risankizumab on Psoriasis Autoimmunity

Unknown status·IIstituto Clinico Humanitas·Phase 4·NCT04722640·240 enrolled

First-line Treatment1 trial

PATHFINDER: Evaluating the Optimal First-Line Treatment Strategy for Moderate-to-Severely Active Ileal-dominant Crohn's Disease

Recruiting·UUniversity of Calgary·Phase 4·NCT05928039·297 enrolled

Immunogenicity1 trial

Pharmacokinetic, Safety, Tolerability, and Immunogenicity Comparison of CKD-704 (Risankizumab Biosimilar), With EU-approved Skyrizi®, and US-licensed Skyrizi® in Healthy Adult Participants

Recruiting· Chong Kun Dang Pharmaceutical logo

Chong Kun Dang Pharmaceutical·Phase 1·NCT07258745·213 enrolled

Tics1 trial

A Study in Healthy Japanese and Caucasian Subjects to Assess the Pharmacokinetics, Safety and Tolerability of Risankizumab

Completed· AbbVie logo

AbbVie·Phase 1·NCT05305222·17 enrolled

COVID-191 trial

ACTIV-5 / Big Effect Trial (BET-A) for the Treatment of COVID-19

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT04583956·214 enrolled

Palmoplantar Pustulosis1 trial

Study of Subcutaneous Risankizumab Injection to Assess Change in Palmoplantar Pustulosis Area and Severity Index [PPPASI] in Adult Japanese Participants With Palmoplantar Pustulosis

Completed· AbbVie logo

AbbVie·Phase 3·NCT04451720·119 enrolled

Fibrostenotic Crohn's Disease1 trial

Risankizumab for Fibrostenotic Crohn's Disease Treatment

Not yet recruiting·FFirst Affiliated Hospital of Wenzhou Medical University·Phase 3·NCT07177118·260 enrolled

Arthritis, Psoriatic1 trial

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

Recruiting·MMoonLake Immunotherapeutics AG·Phase 3·NCT06641089·600 enrolled

Juvenile Psoriatic Arthritis1 trial

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

Recruiting· AbbVie logo

AbbVie·Phase 3·NCT06100744·40 enrolled

Crohn Disease1 trial

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

Recruiting· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT07499232·530 enrolled

Psoriatic Arthritis (PsA)1 trial

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)

Completed· AbbVie logo

AbbVie·Phase 3·NCT03671148·444 enrolled

Rheumatic Disease1 trial

Immunosuppressant Management in Rheumatology Patients Undergoing Elective Total Shoulder Arthroplasty

Recruiting·NNYU Langone Health·Phase 2·NCT07138898·80 enrolled

Unspecified1 trial

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

Recruiting· AbbVie logo

AbbVie·Phase 1·NCT07466550·60 enrolled

Regulatory

FDA Approval Timeline[5]

Apr 23, 2019

SKYRIZI

NDA BLA761105

Apr 23, 2019

Skyrizi

BLA 761105

Mar 20, 2020

SKYRIZI

NDA BLA761105

Apr 26, 2021

SKYRIZI

NDA BLA761105

Apr 26, 2021

SKYRIZI

NDA BLA761105

Jan 21, 2022

SKYRIZI

NDA BLA761105

Jun 16, 2022

SKYRIZI

NDA BLA761105

Sep 23, 2022

SKYRIZI

NDA BLA761262

Sep 23, 2022

SKYRIZI

NDA BLA761105

Jan 3, 2024

SKYRIZI

NDA BLA761262

Jan 3, 2024

SKYRIZI

NDA BLA761105

Mar 4, 2024

SKYRIZI

NDA BLA761262

Mar 4, 2024

SKYRIZI

NDA BLA761105

Jun 18, 2024

SKYRIZI

NDA BLA761105

Jun 18, 2024

SKYRIZI

NDA BLA761262

May 7, 2025

SKYRIZI

NDA BLA761105

May 7, 2025

SKYRIZI

NDA BLA761262

Sep 3, 2025

SKYRIZI

NDA BLA761105

Sep 3, 2025

SKYRIZI

NDA BLA761262

Mar 6, 2026

SKYRIZI

NDA BLA761262

Mar 6, 2026

SKYRIZI

NDA BLA761105

Mar 18, 2026

SKYRIZI

NDA BLA761105

Mar 18, 2026

SKYRIZI

NDA BLA761262

Jun 12, 2026

SKYRIZI

NDA BLA761105

Jun 12, 2026

SKYRIZI

NDA BLA761262

Jun 26, 2026

SKYRIZI

NDA BLA761262

Jun 26, 2026

SKYRIZI

NDA BLA761105

Sources

References

[1]
ClinicalTrials.gov — 85 trial records for Risankizumab. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Skyrizi drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Risankizumab compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Risankizumab. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA BLA761262). U.S. Food & Drug Administration.
[6]
PubMed — 1 publication indexed for Risankizumab. U.S. National Library of Medicine.
[7]
SEC EDGAR — AbbVie company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: IL-23 Inhibitor[3]
Modality: Monoclonal antibody[3]
Highest Phase: Approved[1]
Company: AbbVie

Key Publications[6]

Risankizumab Induction and Maintenance in Ulcerative Colitis: Phase 3

LancetJan 8, 2024DOI: 10.1016/S0140-6736(24)00018-5

Skyrizi

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q3 2026

Q4 2026

Q1 2027

Trials by Indication[1]

Psoriasis23 trials

Crohn's Disease9 trials

Psoriatic Arthritis7 trials

Ulcerative Colitis6 trials

Adult5 trials

Intravenous4 trials

Inflammatory Bowel Disease3 trials

Atopic Dermatitis2 trials

Efficacy and Safety2 trials

Ankylosing Spondylitis1 trial

ART1 trial

Pregnancy1 trial

Generalized Pustular Psoriasis1 trial

Asthma1 trial

ESS1 trial

GIST1 trial

Hidradenitis Suppurativa1 trial

Pain1 trial

Remission1 trial

Drug1 trial

Autoimmunity1 trial

First-line Treatment1 trial

Immunogenicity1 trial

Tics1 trial

COVID-191 trial

Palmoplantar Pustulosis1 trial

Fibrostenotic Crohn's Disease1 trial

Arthritis, Psoriatic1 trial

Juvenile Psoriatic Arthritis1 trial

Crohn Disease1 trial

Psoriatic Arthritis (PsA)1 trial

Rheumatic Disease1 trial

Unspecified1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Key Publications[6]

Related News