Drugs / Risankizumab
Risankizumab
also known as
RZB · Skyrizi · BI 655066 · ABBV-066 · RISA · Risakizumab · risankizumab-800CW · risankizumab-rzaa
Regulatory milestones approvals, filings & regulatory actions · 18 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed Crohn jejunoileitis 4 milestones | |||||
| Filed | EU (EMA) | SKYRIZI | Crohn jejunoileitis | 2026-08-27 | “has submitted an application to the European Medicines Agency (EMA) seeking approval for SKYRIZI® (risankizumab) for subcutaneous (SC) induction” abbvie.com ↗ |
| Filed | EU (EMA) | SKYRIZI | Crohn jejunoileitis | 2022-02-02 | “submitted an application to the EMA seeking approval for Skyrizi (600 mg intravenous induction and 360 mg subcutaneous maintenance therapy)” abbvie.com ↗ |
| Filed | EU (EMA) | SKYRIZI | Crohn jejunoileitis | 2021-11-30 | “submitted an application to the European Medicines Agency (EMA) seeking approval for risankizumab” abbvie.com ↗ |
| Filed | US (FDA) | SKYRIZI | Crohn jejunoileitis | 2021-09-20 | “submitted an application to the U.S. Food and Drug Administration (FDA) seeking approval for risankizumab-rzaa” abbvie.com ↗ “AbbVie announced that it submitted an application to the FDA seeking approval for Skyrizi” abbvie.com ↗ |
| Filed psoriasis 2 milestones | |||||
| Filed | EU (EMA) | SKYRIZI | psoriasis | 2018-05-01 | “marketing authorization application (MAA) for SKYRIZI for the treatment of patients with moderate to severe plaque psoriasis was submitted to the European Medicines Agency” abbvie.com ↗ “AbbVie submitted a Biologics License Application (BLA) to the FDA and a marketing authorization application (MAA) to the European Medicines Agency (EMA) for risankizumab” abbvie.com ↗ “announced that it has submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) for risankizumab” abbvie.com ↗ |
| Filed | US (FDA) | — | psoriasis | 2018-04-25 | “AbbVie submitted a Biologics License Application (BLA) to the FDA and a marketing authorization application (MAA) to the European Medicines Agency (EMA) for risankizumab” abbvie.com ↗ “announced that it has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration for risankizumab” abbvie.com ↗ “AbbVie submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for risankizumab” abbvie.com ↗ |
| Filed psoriatic arthritis 2 milestones | |||||
| Filed | US (FDA) | SKYRIZI | psoriatic arthritis | 2021-04-07 | “AbbVie announced that it submitted applications to the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) seeking approval for Skyrizi” abbvie.com ↗ |
| Filed | EU (EMA) | SKYRIZI | psoriatic arthritis | 2021-04-07 | “AbbVie announced that it submitted applications to the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) seeking approval for Skyrizi” abbvie.com ↗ |
| Approved Indication not stated 3 milestones | |||||
| Label expansions (8) | US (FDA) | SKYRIZI | — | 2021-04-26 – 2026-06-12 | fda.gov ↗ |
| Approved | EU (EMA) | Skyrizi | — | 2019-04-26 | europa.eu ↗ |
| Approved | US (FDA) | SKYRIZI | — | 2019-04-23 | fda.gov ↗ |
Trials 80 · started per year
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US approved 2019
EU approved 2019
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 119 trials | ||||||
| Phase 1 | NCT07466550 | Jun 2026 → Jan 2027 expected | — | AbbVie | Recruiting | No outcome recorded |
| Phase 1 | NCT07007091 | Jun 2025 → Jan 2026 | — | AbbVie | Completed | No outcome recorded |
| Phase 1 | NCT06946524 | May → Nov 2025 | — | AbbVie | Completed | No outcome recorded |
| Phase 1 | NCT06937619 | Apr → Nov 2025 | — | AbbVie | Completed | No outcome recorded |
| Phase 1 | NCT06571266 | Sep 2024 → Apr 2025 | — | AbbVie | Completed | No outcome recorded |
| Phase 1 | NCT06487572 | Jul 2024 → Feb 2025 | — | AbbVie | Completed | No outcome recorded |
| Phase 1 | NCT06054425 | Nov 2023 → May 2024 | — | AbbVie | Completed | No outcome recorded |
| Phase 1 | NCT05567029 | Sep 2022 → Apr 2023 | — | AbbVie | Completed | No outcome recorded |
| Phase 1 | NCT05083078 | Nov 2021 → Jul 2022 | psoriatic arthritis | Janssen Research & Development, LLC | Terminated | No outcome recorded |
| Phase 1 | NCT05274087 | Sep 2020 → Apr 2021 | — | AbbVie | Completed | No outcome recorded |
| Phase 1 | NCT05274100 | Sep 2020 → Jul 2021 | — | AbbVie | Completed | No outcome recorded |
| Phase 1 | NCT04254783 | May 2020 → Oct 2022 | Crohn disease, ulcerative colitis | AbbVie | Completed | No outcome recorded |
| Phase 1 | NCT05268068 | Jun 2019 → Apr 2020 | — | AbbVie | Completed | No outcome recorded |
| Phase 1 | NCT05283681 | Apr → Nov 2019 | — | AbbVie | Completed | No outcome recorded |
| Phase 1 | NCT05305222 | Oct 2017 → Jun 2018 | — | AbbVie | Completed | No outcome recorded |
| Phase 1 | NCT05283694 | Sep 2017 → Jun 2018 | — | AbbVie | Completed | No outcome recorded |
| Phase 1 | NCT02772601 | Sep 2016 → Jun 2017 | psoriasis | AbbVie | Completed | No outcome recorded |
| Phase 1 | NCT02596217 | Aug 2015 → Jun 2017 | — | AbbVie | Completed | No outcome recorded |
| Phase 1 | NCT01577550 | Apr 2012 → Oct 2013 | psoriasis | AbbVie | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT07258641 | Jan 2026 → Dec 2027 expected | Crohn disease, ulcerative colitis | University Medical Center Groningen | Not yet recruiting | No outcome recorded |
| Phase 217 trials · 3 met primary · 5 missed | ||||||
| Phase 2 | NCT07697456 | Jul 2026 → Oct 2031 expected | Crohn disease, ulcerative colitis | AbbVie | Recruiting | No outcome recorded |
| Phase 2 | NCT07138898 | Dec 2025 → Jan 2028 expected | rheumatic disorder | NYU Langone Health | Recruiting | No outcome recorded |
| Phase 2 | NCT06865105 | Apr 2025 → Dec 2027 expected | psoriatic arthritis | AbbVie | Recruiting | No outcome recorded |
| Phase 2 | NCT06548542 | Sep 2024 → Jan 2030 expected | Crohn disease | AbbVie | Recruiting | No outcome recorded |
| Phase 2 | NCT05283135 | Mar 2022 → Aug 2023 | psoriasis | Oregon Medical Research Center | Completed | No outcome recorded |
| Phase 2 | NCT04583956 | Oct 2020 → Sep 2021 | COVID-19 | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | Missed primary |
| Phase 2 | NCT03926169 | Jun 2019 → Feb 2021 | hidradenitis suppurativa | AbbVie | Completed | Missed primary |
| Phase 2 | NCT03706040 | Dec 2018 → Oct 2020 | atopic eczema | AbbVie | Completed | Missed primary |
| Phase 2 | NCT02986373 | Dec 2016 → Jul 2018 | psoriatic arthritis | AbbVie | Completed | No outcome recorded |
| Phase 2 | NCT03000075 | Dec 2016 → Sep 2017 | psoriasis | AbbVie | Completed | Met primary |
| Phase 2 | NCT02719171 | Apr 2016 → May 2017 | psoriatic arthritis | AbbVie | Completed | Met primary |
| Phase 2 | NCT02513459 | Sep 2015 → Jun 2019 | Crohn disease | AbbVie | Completed | No outcome recorded |
| Phase 2 | NCT02443298 | Jun 2015 → Oct 2017 | asthma | AbbVie | Completed | Missed primary |
| Phase 2 | NCT02203851 | Nov 2014 → Sep 2018 | psoriasis | AbbVie | Completed | No outcome recorded |
| Phase 2 | NCT02031276 | Feb 2014 → Dec 2015 | Crohn disease | AbbVie | Completed | No outcome recorded |
| Phase 2 | NCT02054481 | Feb → Nov 2014 | psoriasis | Boehringer Ingelheim | Completed | Met primary |
| Phase 2 | NCT02047110 | Jan 2014 → Mar 2015 | ankylosing spondylitis | AbbVie | Completed | Missed primary |
| Phase 2/31 trial · 1 met primary | ||||||
| Phase 2/3 | NCT03398148 | Mar 2018 → Nov 2022 | ulcerative colitis | AbbVie | Completed | Met primary |
| Phase 330 trials · 17 met primary | ||||||
| Phase 3 | NCT07499232 | Apr 2026 → Nov 2028 expected | Crohn disease | Janssen Research & Development, LLC | Recruiting | No outcome recorded |
| Phase 3 | NCT07177118 | Oct 2025 → Jun 2028 expected | Crohn disease | First Affiliated Hospital of Wenzhou Medical University | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT07071519 | Jul 2025 → Jul 2034 expected | ulcerative colitis | AbbVie | Recruiting | No outcome recorded |
| Phase 3 | NCT06100744 | Jul 2024 → Sep 2026 overdue | psoriasis-related juvenile idiopathic arthritis | AbbVie | Recruiting | No outcome recorded |
| Phase 3 | NCT05995353 | Dec 2023 → Apr 2029 expected | Crohn disease | AbbVie | Recruiting | No outcome recorded |
| Phase 3 | NCT06063967 | Nov 2023 → Mar 2027 expected | Crohn disease | AbbVie | Active not recruiting | Met primary |
| Phase 3 | NCT04862286 | Jul 2021 → Apr 2028 expected | psoriasis | AbbVie | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04713592 | Feb 2021 → Apr 2023 | psoriasis | AbbVie | Completed | Met primary |
| Phase 3 | NCT04524611 | Sep 2020 → Feb 2028 expected | Crohn disease | AbbVie | Active not recruiting | Met primary |
| Phase 3 | NCT04451720 | Jul 2020 → Nov 2022 | palmoplantar pustulosis | AbbVie | Completed | No outcome recorded |
| Phase 3 | NCT04435600 | Jul 2020 → Feb 2024 | psoriasis | AbbVie | Completed | No outcome recorded |
| Phase 3 | NCT04102007 | Nov 2019 → Jan 2022 | psoriasis | AbbVie | Completed | Met primary |
| Phase 3 | NCT03875508 | Jun 2019 → Apr 2020 | psoriasis | AbbVie | Completed | No outcome recorded |
| Phase 3 | NCT03875482 | May 2019 → Feb 2020 | psoriasis | AbbVie | Completed | Met primary |
| Phase 3 | NCT03675308 | Mar 2019 → Oct 2020 overdue | psoriatic arthritis | AbbVie | Active not recruiting | Met primary |
| Phase 3 | NCT03671148 | Mar 2019 → Jun 2020 | psoriatic arthritis | AbbVie | Completed | Met primary |
| Phase 3 | NCT03398135 | Aug 2018 → Sep 2028 expected | ulcerative colitis | AbbVie | Active not recruiting | Met primary |
| Phase 3 | NCT03219437 | Jul 2018 → Nov 2021 | psoriasis | AbbVie | Completed | No outcome recorded |
| Phase 3 | NCT03518047 | Jul 2018 → Feb 2020 | psoriasis | AbbVie | Completed | Met primary |
| Phase 3 | NCT03478787 | May 2018 → Jul 2020 | psoriasis | AbbVie | Completed | Met primary |
| Phase 3 | NCT03105102 | Apr 2018 → May 2026 overdue | Crohn disease | AbbVie | Active not recruiting | No outcome recorded |
| Phase 3 | NCT03104413 | Dec 2017 → Nov 2020 | Crohn disease | AbbVie | Completed | Met primary |
| Phase 3 | NCT03255382 | Aug 2017 → Jul 2018 | psoriasis | AbbVie | Completed | Met primary |
| Phase 3 | NCT03105128 | May 2017 → Nov 2020 | Crohn disease | AbbVie | Completed | Met primary |
| Phase 3 | NCT03047395 | Feb 2017 → Nov 2023 | psoriasis | AbbVie | Completed | No outcome recorded |
| Phase 3 | NCT03022045 | Jan → Sep 2017 | psoriasis | AbbVie | Completed | No outcome recorded |
| Phase 3 | NCT02684357 | Mar → Dec 2016 | psoriasis | AbbVie | Completed | Met primary |
| Phase 3 | NCT02694523 | Mar 2016 → Aug 2017 | psoriasis | AbbVie | Completed | Met primary |
| Phase 3 | NCT02672852 | Feb 2016 → Aug 2017 | psoriasis | AbbVie | Completed | Met primary |
| Phase 3 | NCT02684370 | Feb → Dec 2016 | psoriasis | AbbVie | Completed | Met primary |
| Phase 411 trials · 3 met primary | ||||||
| Phase 4 | NCT07352566 | Aug 2026 → Jun 2030 expected | atopic eczema, psoriasis | University of California, San Francisco | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07149792 | Jul 2025 → Dec 2026 expected | psoriasis, psoriatic arthritis | Taichung Veterans General Hospital | Recruiting | No outcome recorded |
| Phase 4 | NCT06333860 | May 2024 → Mar 2026 | psoriasis | AbbVie | Completed | Met primary |
| Phase 4 | NCT06346288 | Apr 2024 → Feb 2026 | inflammatory bowel disease | AbbVie | Completed | No outcome recorded |
| Phase 4 | NCT05969223 | Aug 2023 → Jan 2025 | psoriasis | AbbVie | Completed | Met primary |
| Phase 4 | NCT05270733 | Nov 2022 → Dec 2026 expected | psoriasis | University Hospitals Cleveland Medical Center | Recruiting | No outcome recorded |
| Phase 4 | NCT05169593 | Sep 2022 → Oct 2027 expected | Crohn disease | Universitaire Ziekenhuizen KU Leuven | Recruiting | No outcome recorded |
| Phase 4 | NCT04908475 | Jun 2021 → Apr 2023 | psoriasis | AbbVie | Completed | Met primary |
| Phase 4 | NCT04630652 | Apr 2021 → May 2025 | psoriasis | Jaehwan Kim | Completed | No outcome recorded |
| Phase 4 | NCT04722640 | Jan 2021 → Jan 2022 | psoriasis | Istituto Clinico Humanitas | Unknown | No outcome recorded |
| Phase 4 | NCT04340076 | Aug 2020 → Jan 2025 | psoriasis | Radboud University Medical Center | Completed | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT06298188 | Oct 2024 → Oct 2026 expected | Crohn disease | Shaare Zedek Medical Center | Recruiting | No outcome recorded |
| Comparator or background therapy8 trials | ||||||
| Phase 1 | NCT07258745 Comparator | Nov 2025 → Sep 2026 overdue | psoriasis | Chong Kun Dang Pharmaceutical | Recruiting | No outcome recorded |
| Phase 3 | NCT06880744 Comparator | Jun 2025 → Aug 2027 expected | ulcerative colitis | AbbVie | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06624228 Comparator | Oct 2024 → Feb 2026 | psoriatic arthritis | UCB Biopharma SRL | Completed | Met primary |
| Phase 3 | NCT06641089 Comparator | Oct 2024 → Jan 2027 expected | psoriatic arthritis | MoonLake Immunotherapeutics AG | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06274554 Background | Oct 2024 → Dec 2028 expected | Crohn disease | Weill Medical College of Cornell University | Recruiting | No outcome recorded |
| Phase 3 | NCT04505410 Comparator | Sep 2020 → Dec 2023 | ulcerative colitis | University of Miami | Completed | No outcome recorded |
| Phase 4 | NCT05928039 Comparator | Oct 2023 → Jul 2027 expected | Crohn disease | University of Calgary | Recruiting | No outcome recorded |
| — | NCT03914261 Background | — | Crohn disease, ulcerative colitis | AbbVie | No longer available | No outcome recorded |
News releases announcing trial results or a regulatory action · 57
| Date | Issuer | Release |
|---|---|---|
| 2026-08-27 | AbbVie | Regulatory AbbVie Submits Regulatory Application to EMA for SKYRIZI® (risankizumab) Subcutaneous Induction for Adults with Moderately to Severely Active Crohn's Disease abbvie.com ↗
AbbVie (NYSE: ABBV) today announced that it has submitted an application to the European Medicines Agency (EMA) seeking approval for SKYRIZI® (risankizumab) for subcutaneous (SC) induction for the treatment of adult patients with moderately to severely active Crohn's disease (CD). |
| 2026-06-26 | AbbVie | Regulatory SKYRIZI® (risankizumab-rzaa) Now FDA Approved for Pediatric Use in Psoriatic Disease abbvie.com ↗
SKYRIZI (risankizumab-rzaa) is now approved for patients six years of age and older with moderate-to-severe plaque psoriasis or active psoriatic arthritis |
| 2026-06-23 | AbbVie | Regulatory AbbVie Announces European Commission Approval of SKYRIZI® (risankizumab) for the Treatment of Pediatric Patients with Moderate to Severe Plaque Psoriasis abbvie.com ↗
AbbVie (NYSE: ABBV) today announced that the European Commission (EC) has approved SKYRIZI ® (risankizumab) for the treatment of children and adolescents six years of age and older with moderate to severe plaque psoriasis who are candidates for systemic therapy. |
| 2026-05-19 | UCB Pharma | Results BIMZELX[®](bimekizumab) demonstrates superior efficacy over SKYRIZI[®] (risankizumab) in psoriatic arthritis: BE BOLD Week 16 data ucb.com ↗
UCB, a global biopharmaceutical company, today announced Week 16 data from the BE BOLD trial demonstrating superior ACR50 joint outcomes at Week 16 for BIMZELX ® (bimekizumab) versus SKYRIZI®(risankizumab) in adults living with active psoriatic arthritis (PsA). |
| 2026-05-05 | AbbVie | Results AbbVie Highlights New Long-Term Data Advancing Treatment Standards in Inflammatory Bowel Diseases (IBD) at 2026 Digestive Disease Week® abbvie.com ↗
It found the switch rate was 14% for risankizumab, compared with 21% for ustekinumab, 30% for vedolizumab, 33% for infliximab, and 36% for adalimumab. |
| 2026-04-27 | AbbVie | Regulatory AbbVie Submits Regulatory Application to FDA for SKYRIZI® (risankizumab-rzaa) Subcutaneous Induction for Adults with Moderately to Severely Active Crohn's Disease abbvie.com ↗ |
| 2026-03-27 | AbbVie | Results AbbVie to Highlight New Clinical and Real-World Evidence Advancing Standards of Care in Immune-Mediated Skin Diseases at the 2026 AAD Annual Meeting abbvie.com ↗
Results demonstrated that patients with higher levels of skin clearance (PASI 90 [RZB 57.3% vs DEU 22.9%] and PASI 100 [RZB 27.5% vs DEU 6.5%]), had greater resolution of psoriasis symptoms and quality of life (Psoriasis Symptom Scale 0/1 [RZB 58.0% vs DEU 26.3%] and DLQI 0/1 [RZB 64.1% vs DEU 30.5%]). |
| 2026-03-11 | UCB Pharma | Results BIMZELX[®]▼(bimekizumab) superior to SKYRIZI[®] (risankizumab) in BE BOLD: first head-to-head study in active psoriatic arthritis (PsA) to demonstrate superiority in ACR50 ucb.com ↗
Bimekizumab achieved statistically significant superiority over risankizumab in reducing disease activity, as measured by the stringent ACR50 endpoint, at Week 16 in adults living with active psoriatic arthritis |
| 2026-03-02 | AbbVie | Results AbbVie Announces Positive Topline Results from Phase 3 AFFIRM Study Evaluating SKYRIZI® (Risankizumab) Subcutaneous Induction in Patients with Crohn's Disease abbvie.com ↗
AbbVie (NYSE: ABBV) today announced positive topline results from the Phase 3, randomized, placebo-controlled, double-blind AFFIRM study evaluating the efficacy and safety of risankizumab (SKYRIZI ® ) subcutaneous (SC) induction treatment versus placebo in adult patients with moderately to severely active Crohn's disease (CD). |
| 2024-07-26 | AbbVie | Regulatory AbbVie Announces European Commission Approval of SKYRIZI® (risankizumab) for the Treatment of Adults with Moderately to Severely Active Ulcerative Colitis abbvie.com ↗
The marketing authorization for SKYRIZI ® (risankizumab) marks its fourth approved indication in the European Union |
| 2024-06-18 | AbbVie | Regulatory U.S. FDA Approves SKYRIZI® (risankizumab-rzaa) for Ulcerative Colitis, Expanding AbbVie's Portfolio Across Inflammatory Bowel Disease abbvie.com ↗
SKYRIZI is now approved for four indications across immune-mediated inflammatory diseases. |
| 2024-05-31 | AbbVie | Regulatory AbbVie Receives Positive CHMP Opinion for Risankizumab (SKYRIZI®) for the Treatment of Adults with Moderately to Severely Active Ulcerative Colitis abbvie.com ↗ |
| 2024-03-06 | AbbVie | Results AbbVie and Allergan Aesthetics to Present New Data at 2024 Annual AAD Meeting Showcasing Depth and Strength Across Dermatology and Aesthetics Portfolios abbvie.com ↗
Achievement of High NPF Treatment Targets After 52 Weeks in Psoriasis Patients Switching to Risankizumab After Suboptimal Response to Secukinumab or Ixekizumab |
| 2023-10-15 | AbbVie | Results AbbVie's SKYRIZI® (risankizumab) Versus STELARA® (ustekinumab) Head-to-Head Study in Crohn's Disease Meets All Primary and Secondary Endpoints abbvie.com ↗ |
| 2023-09-12 | AbbVie | Results AbbVie's SKYRIZI® (risankizumab) Met All Primary and Secondary Endpoints Versus Stelara® (ustekinumab) in Head-to-Head Study in Crohn's Disease abbvie.com ↗
Risankizumab met both primary endpoints of non-inferiority for clinical remission (Crohn's Disease Activity Index [CDAI]) at week 24 and superiority of endoscopic remission at week 48 versus ustekinumab |
| 2023-08-28 | AbbVie | Regulatory AbbVie Submits Regulatory Applications to FDA and EMA for Risankizumab (SKYRIZI®) in Ulcerative Colitis abbvie.com ↗
AbbVie (NYSE: ABBV) today announced that it has submitted applications for a new indication to the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) for risankizumab (SKYRIZI ® , 1200 mg intravenous [IV] [induction dose] and 180 mg and 360 mg subcutaneous [SC] [maintenance dose]) for the treatment of adult patients with moderately to severely active ulcerative colitis. |
| 2023-07-26 | AbbVie | Results SKYRIZI® (risankizumab) Achieved Superiority Versus Apremilast for Co-Primary Endpoints Among Adult Patients with Moderate Plaque Psoriasis in Phase 4 Head-to-Head Study abbvie.com ↗
AbbVie (NYSE: ABBV) today announced the British Journal of Dermatology published results from the head-to-head Phase 4 IMMpulse study that evaluated the efficacy and safety of SKYRIZI ® (risankizumab) compared to Otezla ® (apremilast) among adult patients with moderate plaque psoriasis eligible for systemic therapy. |
| 2023-06-15 | AbbVie | Results Risankizumab (SKYRIZI®) Met Primary and Key Secondary Endpoints in 52-Week Phase 3 Maintenance Study in Ulcerative Colitis Patients abbvie.com ↗
Key secondary endpoints were met, including endoscopic improvement b , histologic endoscopic mucosal improvement c and steroid-free remission d at one year |
| 2023-03-23 | AbbVie | Results Risankizumab (SKYRIZI®) Achieves Primary and All Secondary Endpoints in Phase 3 Induction Study in Patients With Ulcerative Colitis abbvie.com ↗
In the study, 20.3% of patients receiving risankizumab achieved clinical remission compared to 6.2% of patients receiving placebo (p<0.00001). |
| 2023-03-18 | AbbVie | Results AbbVie Announces Late-Breaking Results of Study Evaluating 52-Week Efficacy and Safety of SKYRIZI® (risankizumab) in Plaque Psoriasis Patients With a Prior Suboptimal Response to IL-17 Inhibitor Therapy abbvie.com ↗
AbbVie (NYSE: ABBV) today announced new 52-week data from an open-label, single-arm study demonstrating improved plaque psoriasis signs and symptoms among a difficult-to-treat patient population who received SKYRIZI ® (risankizumab), an IL-23 inhibitor. |
| 2023-03-03 | Janssen Research & Development, LLC | Results TREMFYA® (guselkumab) Demonstrates a Differentiated Binding Mechanism from Risankizumab in In Vitro Studies jnj.com ↗
Comparatively, risankizumab showed negligible binding to transfected cell lines expressing Fcγ receptors |
| 2022-11-23 | AbbVie | Regulatory AbbVie Announces European Commission Approval of SKYRIZI® (risankizumab) for the Treatment of Moderate to Severe Active Crohn's Disease abbvie.com ↗
AbbVie (NYSE: ABBV) announced the European Commission (EC) approved SKYRIZI ® (risankizumab, 600 mg intravenous [IV] induction and 360 mg subcutaneous [SC] maintenance therapy) as the first specific interleukin-23 (IL-23) inhibitor for the treatment of adults with moderately to severely active Crohn's disease who have had inadequate response, lost response or were intolerant to conventional or biologic therapy. |
| 2022-09-19 | AbbVie | Regulatory AbbVie Secures Positive CHMP Opinion for Risankizumab (SKYRIZI®) for the Treatment of Adults with Moderate to Severe Crohn's Disease abbvie.com ↗
CHMP positive opinion is based on results from three Phase 3 studies: two for induction and one for maintenance |
| 2022-09-10 | AbbVie | Results New Late-Breaking Results from Phase 3 Trials of SKYRIZI® (risankizumab) Evaluating Long-term Effect on Skin and Joint Symptoms in Patients with Psoriatic Arthritis at Week 100 abbvie.com ↗
Additionally, the data demonstrated no new observed safety signals through 100 weeks. |
| 2022-06-17 | AbbVie | Regulatory SKYRIZI® (risankizumab-rzaa) Receives FDA Approval as the First and Only Specific Interleukin-23 (IL-23) to Treat Moderately to Severely Active Crohn's Disease in Adults abbvie.com ↗
AbbVie (NYSE: ABBV) today announced that the U.S. Food and Drug Administration (FDA) has approved SKYRIZI ® (risankizumab-rzaa) as the first and only specific interleukin-23 (IL-23) inhibitor for the treatment of adults with moderately to severely active Crohn's disease (CD). |
| 2022-05-27 | AbbVie | Results The Lancet Publishes Results from Phase 3 Induction and Maintenance Programs Evaluating Risankizumab (SKYRIZI®) in Crohn's Disease abbvie.com ↗
The publication of ADVANCE and MOTIVATE reports the efficacy and safety results of the two induction studies evaluating clinical remission and endoscopic response with intravenous (IV) risankizumab versus placebo over 12 weeks. |
| 2022-04-29 | AbbVie | Regulatory AbbVie Reports First-Quarter 2022 Financial Results abbvie.com ↗
AbbVie announced that the FDA extended the review period for Skyrizi (risankizumab) for the treatment of moderate to severe CD by three months to review additional data submitted by AbbVie, including information about the on-body injector. |
| 2022-02-28 | AbbVie | Regulatory AbbVie Provides Update Regarding SKYRIZI® (risankizumab-rzaa) for the Treatment of Moderate to Severe Crohn's Disease in the U.S. abbvie.com ↗
The FDA has extended the Prescription Drug User Fee Act (PDUFA) action date by three months to review additional data submitted by AbbVie, including information about the on-body injector, for this new proposed indication. |
| 2022-01-21 | AbbVie | Regulatory U.S. FDA Approves Second Indication for SKYRIZI® (risankizumab-rzaa) to Treat Adults with Active Psoriatic Arthritis abbvie.com ↗
AbbVie (NYSE: ABBV) today announced the U.S. Food and Drug Administration (FDA) has approved SKYRIZI ® (risankizumab-rzaa) for the treatment of adults with active psoriatic arthritis (PsA), a systemic inflammatory disease that affects the skin and joints and impacts approximately 30 percent of patients with psoriasis. |
| 2021-11-30 | AbbVie | Regulatory AbbVie Submits Application for Risankizumab (SKYRIZI®) in Moderate to Severe Crohn's Disease to European Medicines Agency (EMA) abbvie.com ↗
AbbVie (NYSE:ABBV) today announced it has submitted an application to the European Medicines Agency (EMA) seeking approval for risankizumab |
| 2021-11-17 | AbbVie | Regulatory AbbVie Expands Immunology Portfolio in the European Union with the European Commission Approval of SKYRIZI® (risankizumab) for the Treatment of Adults with Active Psoriatic Arthritis abbvie.com ↗
We are excited by the EC approval of SKYRIZI for the treatment of adults with active psoriatic arthritis. |
| 2021-11-05 | AbbVie | Results AbbVie Presents Integrated Efficacy and Safety Data From Two Phase 3 Trials on Risankizumab (SKYRIZI®) in Psoriatic Arthritis at ACR Convergence 2021 abbvie.com ↗
The data showed that 24-weeks of treatment with risankizumab resulted in greater improvements in PsA signs and symptoms compared with placebo with no new safety signals. |
| 2021-10-15 | AbbVie | Regulatory AbbVie Receives CHMP Positive Opinion for Risankizumab (SKYRIZI®) for the Treatment of Adults with Active Psoriatic Arthritis in the European Union (EU) abbvie.com ↗
The CHMP positive opinion is a scientific recommendation for marketing authorization to the European Commission, which authorizes marketing approval in the European Union. |
| 2021-09-30 | AbbVie | Results AbbVie Presents Late-Breaking Data on Risankizumab (SKYRIZI®) in Psoriatic Arthritis at the 30th European Academy of Dermatology and Venereology (EADV) Congress abbvie.com ↗
AbbVie (NYSE: ABBV) today presented results from new Phase 3 data analyses of KEEPsAKE-1 and KEEPsAKE-2, evaluating risankizumab (SKYRIZI ® , 150 mg) in adults with active psoriatic arthritis for one year (52 weeks). |
| 2021-09-20 | AbbVie | Regulatory AbbVie Submits Regulatory Application to FDA for Risankizumab-rzaa (SKYRIZI®) for the Treatment of Patients 16 Years and Older with Moderate to Severe Crohn's Disease abbvie.com ↗ |
| 2021-06-02 | AbbVie | Results Phase 3 Maintenance Results Show Patients with Crohn's Disease Receiving Risankizumab (SKYRIZI®) Achieved Endoscopic Response and Clinical Remission at One Year abbvie.com ↗
AbbVie (NYSE: ABBV) today announced positive top-line results from the Phase 3 maintenance study, FORTIFY, showing risankizumab 360 mg (subcutaneous [SC]; administered every eight weeks) achieved the co-primary endpoints of endoscopic response and clinical remission at one year in adult patients with moderate to severe Crohn's disease. |
| 2021-05-24 | AbbVie | Results AbbVie Presents New Late-Breaking Data Analyses Showing Risankizumab (SKYRIZI®) Achieves Clinical Remission and Endoscopic Response at Week 12 in Patients with Moderate to Severe Crohn's Disease abbvie.com ↗
In the ADVANCE study, risankizumab showed efficacy regardless of prior treatment status by subgroup analysis in patients with moderate to severe Crohn's disease, and non-bio-IR patients had numerically higher rates of efficacy compared to bio-IR patients. |
| 2021-04-07 | AbbVie | Regulatory AbbVie Submits Regulatory Applications for SKYRIZI® (risankizumab) in Psoriatic Arthritis to FDA and EMA abbvie.com ↗
AbbVie (NYSE: ABBV) today announced that it has submitted applications seeking approval for SKYRIZI ® (risankizumab-rzaa, 150 mg) to the U.S. Food and Drug Administration (FDA) and for SKYRIZI ® (risankizumab, 150 mg) to the European Medicines Agency (EMA) for the treatment of adults with active psoriatic arthritis. |
| 2021-01-07 | AbbVie | Results Risankizumab (SKYRIZI®) Demonstrates Significant Improvements in Clinical Remission and Endoscopic Response in Two Phase 3 Induction Studies in Patients with Crohn's Disease abbvie.com ↗
In the ADVANCE study, a significantly greater proportion of patients treated with risankizumab 600 mg or 1200 mg achieved clinical remission per CDAI at week 12 (45 and 42 percent of patients, respectively, compared to 25 percent of patients receiving placebo; p<0.001). |
| 2021-01-05 | AbbVie | Results Risankizumab (SKYRIZI®) Phase 3 Results Demonstrate Improvements in Disease Activity Across Joint and Skin Symptoms Among Psoriatic Arthritis Patients abbvie.com ↗
In KEEPsAKE-1 and KEEPsAKE-2, 57 and 51 percent of patients receiving risankizumab achieved ACR20 response at week 24, respectively, versus 34 and 27 percent receiving placebo (p<0.001). |
| 2020-06-12 | AbbVie | Results AbbVie Presents New Late-Breaking Data Showing SKYRIZI® (risankizumab-rzaa) Achieves Superior Rates of Complete Skin Clearance Versus COSENTYX® (secukinumab) at 52 Weeks abbvie.com ↗
AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced new late-breaking Phase 3b head-to-head data showing superior rates of skin clearance for SKYRIZI ® (risankizumab-rzaa) to COSENTYX ® (secukinumab) at week 52. |
| 2020-01-14 | AbbVie | Results New Head-to-Head Phase 3 Data Show SKYRIZI™ (risankizumab) Superior to Cosentyx® (secukinumab) Across Primary and All Ranked Secondary Endpoints in Adults with Moderate to Severe Plaque Psoriasis at 52 Weeks abbvie.com ↗
AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced that SKYRIZI ™ met both primary and all ranked secondary endpoints, including superiority at week 52, versus Cosentyx ® in a head-to-head Phase 3 study. |
| 2019-06-11 | AbbVie | Results New Two-Year Data at the 24th World Congress of Dermatology Shows SKYRIZI™ (risankizumab) Maintains Complete Skin Clearance abbvie.com ↗
AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced new results showing a significant number of patients treated with SKYRIZI™ (risankizumab) experienced complete skin clearance at week 94. |
| 2019-04-30 | AbbVie | Regulatory European Commission Approves SKYRIZI™ (risankizumab) for the Treatment of Moderate to Severe Plaque Psoriasis abbvie.com ↗
AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced that the European Commission (EC) has approved SKYRIZI™ (risankizumab) for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy. |
| 2019-04-23 | AbbVie | Regulatory AbbVie Expands Immunology Portfolio in the U.S. with FDA Approval of SKYRIZI™ (risankizumab-rzaa) for Moderate to Severe Plaque Psoriasis abbvie.com ↗ |
| 2019-03-26 | AbbVie | Regulatory AbbVie Announces First Regulatory Approval of SKYRIZI™ (risankizumab) for the Treatment of Plaque Psoriasis, Generalized Pustular Psoriasis and Erythrodermic Psoriasis and Psoriatic Arthritis in Japan abbvie.com ↗
AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved SKYRIZI™ (risankizumab), an interleukin-23 (IL-23) inhibitor, for the treatment of plaque psoriasis, generalized pustular psoriasis, erythrodermic psoriasis and psoriatic arthritis in adult patients who have an inadequate response to conventional therapies. |
| 2019-03-01 | AbbVie | Regulatory AbbVie Receives CHMP Positive Opinion for Risankizumab (SKYRIZI™) for the Treatment of Moderate to Severe Plaque Psoriasis abbvie.com ↗
The CHMP positive opinion is supported by data from the global Phase 3 psoriasis program evaluating more than 2,000 patients with moderate to severe plaque psoriasis across four pivotal Phase 3 studies. |
| 2018-09-13 | AbbVie | Results AbbVie Announces Patient-Reported Outcomes Data from Three Pivotal Phase 3 Studies of Risankizumab, Showing Significant Improvements in Health-Related Quality of Life for Patients with Psoriasis abbvie.com ↗
Across all three trials, patients reported significant improvements in health-related quality of life, mental health and work productivity measures when treated with risankizumab. |
| 2018-05-01 | AbbVie | Regulatory AbbVie Submits Marketing Authorization Application to the European Medicines Agency for Investigational Treatment Risankizumab for Moderate to Severe Plaque Psoriasis abbvie.com ↗
AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, announced that it has submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) for risankizumab, an investigational interleukin-23 (IL-23) inhibitor, being evaluated for the treatment of patients with moderate to severe plaque psoriasis. |
| 2018-04-25 | AbbVie | Regulatory AbbVie Submits Biologics License Application to U.S. FDA for Investigational Treatment Risankizumab for Moderate to Severe Plaque Psoriasis abbvie.com ↗
AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, announced that it has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration for risankizumab, an investigational interleukin-23 (IL-23) inhibitor, being evaluated for treatment of patients with moderate to severe plaque psoriasis. |
| 2018-02-17 | AbbVie | Results AbbVie Presents New Positive Late-Breaking Data from Two Phase 3 Psoriasis Trials of Risankizumab at the 2018 American Academy of Dermatology Annual Meeting abbvie.com ↗
In today's presentation, additional ranked secondary endpoints showed significantly higher rates of skin clearance at week 16 and at one year of treatment, compared with ustekinumab, as measured by static Physician Global Assessment (sPGA 0). |
| 2017-12-04 | AbbVie | Results Risankizumab Meets All Primary Endpoints Reporting Positive Results in Fourth Pivotal Phase 3 Psoriasis Study abbvie.com ↗
AbbVie (NYSE: ABBV), a global research and development-based biopharmaceutical company, today announced positive top-line results from IMMhance, the fourth pivotal Phase 3 clinical trial evaluating risankizumab (150 mg) for the treatment of patients with moderate to severe plaque psoriasis. |
| 2017-10-26 | AbbVie | Results Risankizumab Meets All Co-Primary and Ranked Secondary Endpoints, Achieving Significantly Greater Efficacy Versus Standard Biologic Therapies in Three Pivotal Phase 3 Psoriasis Studies abbvie.com ↗
today announced positive top-line results from three pivotal Phase 3 clinical trials evaluating risankizumab, an investigational interleukin-23 (IL-23) inhibitor, compared to ustekinumab and adalimumab for the treatment of patients with moderate to severe chronic plaque psoriasis. |
| 2016-11-30 | AbbVie | Regulatory AbbVie Receives Orphan Drug Designation for Investigational IL-23 Inhibitor Risankizumab from the U.S. Food and Drug Administration for the Treatment of Pediatric Patients with Crohn's Disease abbvie.com ↗
AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to risankizumab (ABBV-066; formerly BI 655066) for the investigational treatment of Crohn's disease in pediatric patients. |
| 2016-05-24 | AbbVie | Results IL-23 Inhibitor Risankizumab Induces Remission in Phase II Study in Patients with Moderate-to-Severe Crohn's Disease abbvie.com ↗
After 12 weeks, 24% and 37% of patients achieved clinical remission (no symptoms or very mild symptoms of disease) with 200 mg and 600 mg risankizumab, respectively, compared with 15% of patients receiving placebo* 1 . |
| 2015-10-08 | Boehringer Ingelheim | Results Boehringer Ingelheim's investigational biologic cleared skin better, faster and for longer than ustekinumab in phase II psoriasis study prnewswire.com ↗
New results from a Phase II head-to-head psoriasis study showed superior efficacy of Boehringer Ingelheim's investigational biologic compound BI 655066*, over ustekinumab. |
| 2015-03-20 | Boehringer Ingelheim | Results Boehringer Ingelheim's Investigational Biologic Cleared Skin Better than Ustekinumab in Head-to-Head Phase II Psoriasis Study prnewswire.com ↗
Nearly double the percentage of patients with moderate-to-severe plaque psoriasis achieved clear or almost clear skin (described as PASI 90 ) after 12 weeks of treatment with BI 655066 compared to ustekinumab (77.1% versus 40% of patients). |
All press releases naming this drug 63 releases
Evidence & citations 12 cited values
Every value below carries the sentence it was read from. 95 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Risankizumab | “Patients will be treated with ustekinumab (90mg at week 0 and week 4 by subcutaneous injection) for 8 weeks followed by treatment with guselkumab (100mg at week 0 and week 4 by...” NCT05270733 ↗83“risankizumab (BI 655066), a humanized IgG1 monoclonal antibody that inhibits interleukin-23 by specifically targeting the p19 subunit and thus prevents interleukin-23 signaling” PMID 28423301 ↗ Apr 2017 “new advanced therapy: Tofacitinib and Upadacitinib (JAK inhibitors), Infliximab (anti-TNF), Ustekinumab or Risankizumab (IL-23 inhibitors).” NCT04505410 ↗ “Risankizumab: Induction with 600 mg IV at day 0, week 4 and week 8; maintenance with 360 mg SC at week 12 and every eight weeks thereafter.” NCT05169593 ↗ “IL-23 therapy may include ustekinumab (anti-interleukin-12/23), risankizumab (anti-interleukin-23), or guselkumab (anti-interleukin-23).” NCT06274554 ↗ “S. pyogenes + risankizumab (2 μg/mL)” NCT07149792 ↗ |
| Known as | ABBV-066 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02596217 ↗ |
| Known as | BI 655066 | “risankizumab (BI 655066), a humanized IgG1 monoclonal antibody that inhibits interleukin-23 by specifically targeting the p19 subunit and thus prevents interleukin-23 signaling” PMID 28423301 ↗ Apr 2017 |
| Known as | RISA | “Patients were classified into five cohorts on the basis of their treatment experience during the follow-up period: risankizumab (RISA) only, RISA followed by re-randomization...” PMID 34921669 ↗ Dec 2021 |
| Known as | Risakizumab | “Patients whose lymphocytes reacted with proliferation to LL37 or ADAMTSL5 will receive SKYRIZI (Risakizumab) at Day 1, week 4, 16, 28, 40.” NCT04722640 ↗ |
| Known as | risankizumab-800CW | “fluorescently labeled adalimumab (adalimumab-680LT) and risankizumab (risankizumab-800CW)” NCT07258641 ↗ |
| Known as | risankizumab-rzaa | “In this study, subjects with moderate-to-severe psoriasis will receive FDA-approved anti-IL-23p19 antibody (Generic name: Risankizumab, Product name: SKYRIZI™ or...” NCT04630652 ↗ |
| Known as | RZB | “OBJECTIVES: Determine the impact of 24-week risankizumab (RZB) versus placebo (PBO) on patient-reported outcomes (PROs) in patients with psoriatic arthritis (PsA) and...” PMID 35701011 ↗ Jun 20223“This post hoc analysis evaluated the corticosteroid-sparing effects of risankizumab (RZB) therapy in patients with moderate-to-severe ulcerative colitis in the phase 3...” PMID 40168091 ↗ Apr 2025 “Risankizumab (RZB) and deucravacitinib (DEU) are both approved for the treatment of moderate-to-severe psoriasis.” PMID 42143644 ↗ May 2026 “To evaluate the long-term efficacy and safety of risankizumab (RZB) for the treatment of psoriasis.” PMID 34157132 ↗ Sep 2021 |
| Known as | Skyrizi | “EU-approved Skyrizi®, and US-licensed Skyrizi®” NCT07258745 ↗ |
| Action | Inhibit | “Risankizumab, an IL-23 inhibitor, for ankylosing spondylitis” PMID 29945918 ↗ Jun 2018 |
| Modality | Monoclonal antibody | “anti-interleukin (IL)-23 monoclonal antibody” PMID 31054118 ↗ Oct 2019 |
| Route | Intravenous | “risankizumab administered by IV infusion” NCT02031276 ↗ |