Drugs / Upadacitinib
Upadacitinib
also known as
ABT-494 · UPA · Rinvoq · ABT-494 TARTRATE TETRAHYDRATE · Rinvoq lq · Upadacitinib (as hemihydrate) · Upadacitinib anhydrous · Upadacitinib component of abbv-599 · +3 more
Small molecule targets JAK1, JAK2, JAK3, TYK2 via inhibition
Regulatory milestones approvals, filings & regulatory actions · 15 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed alopecia areata 1 milestone | |||||
| Filed | US (FDA) | RINVOQ | alopecia areata | 2026-04-28 | “submitted an application for a new indication to the U.S. Food and Drug Administration (FDA) for upadacitinib” abbvie.com ↗ |
| Filed ankylosing spondylitis 1 milestone | |||||
| Filed | EU (EMA) | Rinvoq | ankylosing spondylitis | 2020-10-30 | “submitted an application to the European Medicines Agency (EMA) for Rinvoq for the treatment of adult patients with active AS” abbvie.com ↗ |
| Filed juvenile ankylosing spondylitis 2 milestones | |||||
| Filed | EU (EMA) | RINVOQ | juvenile ankylosing spondylitis | 2022-01-07 | “submitted applications seeking approvals for upadacitinib (RINVOQ ® , 15 mg once daily) to the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA)” abbvie.com ↗ “submitted applications to the FDA and European Medicines Agency (EMA) seeking approval for Rinvoq” abbvie.com ↗ |
| Filed | US (FDA) | RINVOQ | juvenile ankylosing spondylitis | 2022-01-07 | “submitted applications seeking approvals for upadacitinib (RINVOQ ® , 15 mg once daily) to the U.S. Food and Drug Administration (FDA)” abbvie.com ↗ “submitted applications to the FDA and European Medicines Agency (EMA) seeking approval for Rinvoq” abbvie.com ↗ |
| Filed vitiligo 2 milestones | |||||
| Filed | EU (EMA) | RINVOQ | vitiligo | 2026-02-03 | “it has submitted applications for a new indication to the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA)” abbvie.com ↗ |
| Filed | US (FDA) | RINVOQ | vitiligo | 2026-02-03 | “it has submitted applications for a new indication to the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA)” abbvie.com ↗ |
| Approved Indication not stated 3 milestones | |||||
| Label expansions (7) | US (FDA) | RINVOQ | — | 2021-12-14 – 2025-10-10 | fda.gov ↗ |
| Approved | EU (EMA) | Rinvoq | — | 2019-12-16 | europa.eu ↗ |
| Approved | US (FDA) | RINVOQ | — | 2019-08-16 | fda.gov ↗ |
Trials 101 · started per year
today
US approved 2019
EU approved 2019
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT06684522 | Dec 2025 → Jun 2027 expected | dermatosis of eyelid | Northwestern University | Recruiting | No outcome recorded |
| Phase 16 trials | ||||||
| Phase 1 | NCT07843693 | Aug → Dec 2026 expected | — | AbbVie | Recruiting | No outcome recorded |
| Phase 1 | NCT07425899 | Feb → Aug 2026 overdue | — | AbbVie | Recruiting | No outcome recorded |
| Phase 1 | NCT06902987 | Jan 2024 → Dec 2025 overdue | Crohn disease, anal fistula | Sixth Affiliated Hospital, Sun Yat-sen University | Recruiting | No outcome recorded |
| Phase 1 | NCT03725007 | Jun 2019 → May 2027 expected | polyarticular juvenile idiopathic arthritis | AbbVie | Active not recruiting | No outcome recorded |
| Phase 1 | NCT03646604 | Jan 2019 → Aug 2024 | atopic eczema | AbbVie | Completed | No outcome recorded |
| Phase 1 | NCT01741493 | Nov 2012 → Dec 2013 | rheumatoid arthritis | AbbVie | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT06873100 | Nov 2024 → Aug 2026 overdue | relapsing polychondritis | Peking University People's Hospital | Recruiting | No outcome recorded |
| Phase 220 trials · 6 met primary | ||||||
| Phase 2 | NCT07492251 | Oct 2026 → May 2028 expected | lichen planus | Centre Hospitalier Universitaire de Nice | Recruiting | No outcome recorded |
| Phase 2 | NCT07588568 | Sep 2026 → Feb 2030 expected | eosinophilic esophagitis | University of North Carolina, Chapel Hill | Recruiting | No outcome recorded |
| Phase 2 | NCT07678645 | Jun 2026 → Nov 2027 expected | atopic eczema, primary biliary cholangitis, primary sclerosing cholangitis | RenJi Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07530224 | Mar → Dec 2026 expected | — | Shixiu Wu | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07138898 | Dec 2025 → Jan 2028 expected | rheumatic disorder | NYU Langone Health | Recruiting | No outcome recorded |
| Phase 2 | NCT07064889 | Jul 2025 → Jul 2027 expected | autoimmune thrombocytopenia | Peking University People's Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06862284 | Mar 2025 → Dec 2026 expected | Sjogren syndrome | Peking University People's Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07080346 | Jan → Dec 2024 | Behcet disease | Liu Tian | Completed | No outcome recorded |
| Phase 2 | NCT04927975 | Jun 2021 → Jan 2023 | vitiligo | AbbVie | Completed | Met primary |
| Phase 2 | NCT04451772 | Jul 2020 → Jan 2024 | systemic lupus erythematosus | AbbVie | Completed | No outcome recorded |
| Phase 2 | NCT04430855 | Jul 2020 → Apr 2021 | hidradenitis suppurativa | AbbVie | Completed | No outcome recorded |
| Phase 2 | NCT03978520 | Jul 2019 → Jan 2022 | systemic lupus erythematosus | AbbVie | Completed | No outcome recorded |
| Phase 2 | NCT03823378 | May 2019 → Sep 2020 | rheumatoid arthritis | AbbVie | Terminated | No outcome recorded |
| Phase 2 | NCT03682705 | Oct 2018 → Mar 2020 | rheumatoid arthritis | AbbVie | Completed | Met primary |
| Phase 2 | NCT03178487 | Oct 2017 → Jan 2019 | ankylosing spondylitis | AbbVie | Completed | Met primary |
| Phase 2 | NCT02925117 | Oct 2016 → Aug 2017 | atopic eczema | AbbVie | Completed | Met primary |
| Phase 2 | NCT02782663 | May 2016 → Jul 2025 | Crohn disease | AbbVie | Completed | No outcome recorded |
| Phase 2 | NCT02066389 | Mar 2014 → Jul 2015 | rheumatoid arthritis | AbbVie | Completed | Met primary |
| Phase 2 | NCT02049138 | Jan 2014 → Jul 2021 | rheumatoid arthritis | AbbVie | Completed | No outcome recorded |
| Phase 2 | NCT01960855 | Oct 2013 → Jul 2015 | rheumatoid arthritis | AbbVie | Completed | Met primary |
| Phase 2/32 trials · 2 met primary | ||||||
| Phase 2/3 | NCT02819635 | Sep 2016 → Dec 2021 | ulcerative colitis | AbbVie | Completed | Met primary |
| Phase 2/3 | NCT02720523 | Mar 2016 → Aug 2017 | rheumatoid arthritis | AbbVie | Completed | Met primary |
| Phase 346 trials · 20 met primary | ||||||
| Phase 3 | NCT07772492 | Aug 2026 → Mar 2032 expected | alopecia areata | AbbVie | Recruiting | No outcome recorded |
| Phase 3 | NCT06928272 | Sep 2025 → Dec 2026 expected | long COVID-19 | Douglas D. Fraser | Recruiting | No outcome recorded |
| Phase 3 | NCT07149467 | Sep 2025 → Dec 2026 expected | Crohn disease | Sixth Affiliated Hospital, Sun Yat-sen University | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT07023302 | Jun 2025 → Feb 2029 expected | alopecia areata | AbbVie | Recruiting | No outcome recorded |
| Phase 3 | NCT07008846 | May 2025 → Sep 2026 overdue | rheumatoid arthritis | Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06227910 | Jan 2025 → Jun 2027 expected | Crohn disease | Takeda | Recruiting | No outcome recorded |
| Phase 3 | NCT06701331 | Dec 2024 → Jan 2027 expected | atopic eczema | AbbVie | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06461897 | Aug 2024 → Jul 2030 expected | atopic eczema | AbbVie | Recruiting | No outcome recorded |
| Phase 3 | NCT06332534 | Aug 2024 → Jun 2027 expected | Crohn disease | AbbVie | Recruiting | No outcome recorded |
| Phase 3 | NCT06389136 | Jun 2024 → Aug 2026 overdue | atopic eczema | AbbVie | Recruiting | No outcome recorded |
| Phase 3 | NCT06390722 | May 2024 → Jan 2026 | atopic eczema, sleep disorder | AbbVie | Withdrawn | No outcome recorded Stop: Business |
| Phase 3 | NCT06118411 | Dec 2023 → Mar 2028 expected | vitiligo | AbbVie | Active not recruiting | Met primary |
| Phase 3 | NCT05782907 | Nov 2023 → Aug 2028 expected | ulcerative colitis | AbbVie | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06012240 | Oct 2023 → Apr 2030 expected | alopecia areata | AbbVie | Recruiting | No outcome recorded |
| Phase 3 | NCT05609630 | Oct 2023 → Jun 2029 expected | systemic-onset juvenile idiopathic arthritis | AbbVie | Recruiting | No outcome recorded |
| Phase 3 | NCT05843643 | Jul 2023 → Mar 2027 expected | systemic lupus erythematosus | AbbVie | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05889182 | Jun 2023 → Mar 2028 expected | hidradenitis suppurativa | AbbVie | Recruiting | No outcome recorded |
| Phase 3 | NCT05814627 | Jun 2023 → Jul 2026 overdue | rheumatoid arthritis | AbbVie | Active not recruiting | Met primary |
| Phase 3 | NCT05379322 | Mar 2023 | rheumatoid arthritis | Abu Dhabi Stem Cells Center | Withdrawn | No outcome recorded |
| Phase 3 | NCT06758947 | Jan 2023 → Jun 2024 | interstitial lung disease | Assiut University | Completed | No outcome recorded |
| Phase 3 | NCT05601882 | Nov 2022 → Mar 2024 | atopic eczema | AbbVie | Completed | No outcome recorded |
| Phase 3 | NCT05121298 | Jan 2021 → Nov 2023 | rheumatoid arthritis | Atsushi Kawakami | Unknown | No outcome recorded |
| Phase 3 | NCT04666675 | Dec 2020 → Mar 2021 | atopic eczema | AbbVie | Withdrawn | No outcome recorded Stop: Business |
| Phase 3 | NCT04161898 | Feb 2020 → Aug 2028 expected | Takayasu arteritis | AbbVie | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04195698 | Jan 2020 → Sep 2023 | atopic eczema | AbbVie | Completed | No outcome recorded |
| Phase 3 | NCT04169373 | Nov 2019 → Sep 2021 | spondyloarthropathy | AbbVie | Completed | Met primary |
| Phase 3 | NCT03738397 | Feb 2019 → Aug 2020 | atopic eczema | AbbVie | Completed | Met primary |
| Phase 3 | NCT03725202 | Jan 2019 → Feb 2024 | temporal arteritis | AbbVie | Completed | No outcome recorded |
| Phase 3 | NCT03653026 | Dec 2018 → Jan 2021 | ulcerative colitis | AbbVie | Completed | Met primary |
| Phase 3 | NCT03661138 | Oct 2018 → Aug 2022 | atopic eczema | AbbVie | Completed | No outcome recorded |
| Phase 3 | NCT03569293 | Aug 2018 → Jan 2021 | atopic eczema | AbbVie | Completed | Met primary |
| Phase 3 | NCT03568318 | Aug 2018 → Feb 2021 overdue | atopic eczema | AbbVie | Active not recruiting | Met primary |
| Phase 3 | NCT03607422 | Jul 2018 → Mar 2021 | atopic eczema | AbbVie | Completed | Met primary |
| Phase 3 | NCT03345823 | Mar 2018 → Sep 2027 expected | Crohn disease | AbbVie | Active not recruiting | Met primary |
| Phase 3 | NCT02955212 | Jan 2018 → Aug 2019 | rheumatoid arthritis | AbbVie | Completed | Met primary |
| Phase 3 | NCT03345849 | Dec 2017 → Oct 2021 | Crohn disease | AbbVie | Completed | Met primary |
| Phase 3 | NCT03345836 | Nov 2017 → Aug 2021 | Crohn disease | AbbVie | Completed | Met primary |
| Phase 3 | NCT03086343 | May 2017 → Jun 2019 | rheumatoid arthritis | AbbVie | Completed | Met primary |
| Phase 3 | NCT03104374 | May 2017 → Jul 2019 | psoriatic arthritis | AbbVie | Completed | Met primary |
| Phase 3 | NCT03104400 | Apr 2017 → Sep 2019 | psoriatic arthritis | AbbVie | Completed | Met primary |
| Phase 3 | NCT03006068 | Jan 2017 → Jul 2027 expected | ulcerative colitis | AbbVie | Active not recruiting | No outcome recorded |
| Phase 3 | NCT02706951 | Mar 2016 → Oct 2017 | rheumatoid arthritis | AbbVie | Completed | Met primary |
| Phase 3 | NCT02706847 | Mar 2016 → Apr 2017 | rheumatoid arthritis | AbbVie | Completed | Met primary |
| Phase 3 | NCT02706873 | Feb 2016 → Mar 2018 | rheumatoid arthritis | AbbVie | Completed | Met primary |
| Phase 3 | NCT02675426 | Dec 2015 → Apr 2017 | rheumatoid arthritis | AbbVie | Completed | Met primary |
| Phase 3 | NCT02629159 | Dec 2015 → Oct 2017 overdue | rheumatoid arthritis | AbbVie | Active not recruiting | Met primary |
| Phase 420 trials | ||||||
| Phase 4 | NCT07700446 | Nov 2026 → Nov 2029 expected | ulcerative colitis | Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07502339 | Oct 2026 → Dec 2028 expected | ulcerative colitis | University of California, San Francisco | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07770646 | Sep 2026 → Sep 2028 expected | spondyloarthropathy | The University of Texas Health Science Center, Houston | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07352566 | Aug 2026 → Jun 2030 expected | atopic eczema, psoriasis | University of California, San Francisco | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07636057 | Jul 2026 → Mar 2027 expected | rheumatoid arthritis | Sheikh Zayed Federal Postgraduate Medical Institute | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07018206 | May 2026 → May 2027 expected | spondyloarthropathy | CARE ARTHRITIS LTD. | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07550673 | Apr 2026 → Apr 2028 expected | ulcerative colitis | Xijing Hospital of Digestive Diseases | Recruiting | No outcome recorded |
| Phase 4 | NCT07546097 | Mar 2026 → Mar 2027 expected | ulcerative colitis | Yongquan Shi | Recruiting | No outcome recorded |
| Phase 4 | NCT07510191 | Mar 2026 → Dec 2028 expected | Crohn disease | Sixth Affiliated Hospital, Sun Yat-sen University | Recruiting | No outcome recorded |
| Phase 4 | NCT07258771 | Jan 2026 → Dec 2029 expected | ulcerative colitis | Berinstein, Jeffrey | Recruiting | No outcome recorded |
| Phase 4 | NCT07160231 | Sep 2025 → May 2028 expected | psoriatic arthritis, spondyloarthropathy | Sint Maartenskliniek | Recruiting | No outcome recorded |
| Phase 4 | NCT06454188 | Dec 2024 → Sep 2028 expected | psoriatic arthritis, spondyloarthropathy | CARE ARTHRITIS LTD. | Recruiting | No outcome recorded |
| Phase 4 | NCT06520397 | Jul 2024 → Dec 2026 expected | Crohn disease | Sixth Affiliated Hospital, Sun Yat-sen University | Recruiting | No outcome recorded |
| Phase 4 | NCT06773403 | Apr 2024 → Jun 2025 | prurigo nodularis | Psoriasis Treatment Center of Central New Jersey | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT05867329 | Sep 2023 → May 2026 overdue | ulcerative colitis | Berinstein, Jeffrey | Recruiting | No outcome recorded |
| Phase 4 | NCT06366932 | Sep 2023 → Sep 2025 | atopic eczema | Instituto de Investigación Hospital Universitario La Paz | Unknown | No outcome recorded |
| Phase 4 | NCT05507580 | May 2023 → Jul 2024 | atopic eczema | AbbVie | Completed | No outcome recorded |
| Phase 4 | NCT05153200 | Jan 2022 → Jun 2023 | rheumatoid arthritis | Ottawa Hospital Research Institute | Unknown | No outcome recorded |
| Phase 4 | NCT05080218 | Nov 2021 → Apr 2024 | psoriatic arthritis, spondyloarthropathy | Jeffrey Curtis | Completed | No outcome recorded |
| Phase 4 | NCT02714634 | Mar 2016 → Mar 2029 expected | rheumatoid arthritis | University Hospital, Strasbourg, France | Recruiting | No outcome recorded |
| Phase not applicable4 trials · 1 met primary | ||||||
| — | NCT07406932 | May 2026 → Jul 2027 expected | antisynthetase syndrome, interstitial lung disease | China-Japan Friendship Hospital | Recruiting | No outcome recorded |
| — | NCT06454461 | Dec 2024 → Jun 2026 overdue | vitiligo | Jilin University | Recruiting | No outcome recorded |
| — | NCT06095596 | Nov 2023 → Oct 2025 overdue | ulcerative colitis | Sixth Affiliated Hospital, Sun Yat-sen University | Recruiting | Met primary |
| — | NCT05305066 | Feb 2023 → Dec 2028 expected | rheumatoid arthritis | Marie Hudson, MD | Recruiting | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT04159597 | — | Crohn disease, atopic eczema, juvenile idiopathic arthritis, ulcerative colitis | AbbVie | Available | No outcome recorded |
| Comparator or background therapy7 trials | ||||||
| Phase 1 | NCT06379958 Comparator | Apr → Sep 2024 overdue | — | Modern Biosciences Ltd | Recruiting | No outcome recorded |
| Phase 1/2 | NCT07670156 Comparator | Oct 2026 → Aug 2028 expected | STAT3-related early-onset multisystem autoimmune disease, hyper-IgE syndrome, immunodeficiency 31B | Lisa Satter | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT02365649 Comparator | Mar 2015 → Nov 2016 | Crohn disease | AbbVie | Completed | No outcome recorded |
| Phase 3 | NCT06660693 Comparator | Apr 2025 → May 2027 expected | ulcerative colitis | McMaster University | Recruiting | No outcome recorded |
| Phase 3 | NCT04692493 Comparator | Sep 2021 → May 2029 expected | rheumatoid arthritis | University of Alabama at Birmingham | Recruiting | No outcome recorded |
| Phase 3 | NCT04505410 Comparator | Sep 2020 → Dec 2023 | ulcerative colitis | University of Miami | Completed | No outcome recorded |
| Phase 4 | NCT06687551 Comparator | Jan 2025 → Apr 2029 expected | rheumatoid arthritis | University Hospital, Toulouse | Not yet recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 109
| Date | Issuer | Release |
|---|---|---|
| 2026-10-01 | Vitae Pharmaceuticals, Inc. | Results AbbVie Presents Long-Term RINVOQ® (upadacitinib) Data Showing Continued Repigmentation in Non-Segmental Vitiligo abbvie.com ↗
AbbVie (NYSE: ABBV) today announced late-breaking results from the ongoing Phase 3 Viti-Up-1 and Viti-Up-2 studies of RINVOQ ® (upadacitinib; 15 mg once daily) in non-segmental vitiligo (NSV), showing continued facial and total body repigmentation through week 76. |
| 2026-09-22 | AbbVie | Regulatory AbbVie Announces European Commission Approval of RINVOQ® (upadacitinib) for the Treatment of Children with Active Polyarticular Juvenile Idiopathic Arthritis abbvie.com ↗
RINVOQ is now approved in the European Union for the treatment of active polyarticular juvenile idiopathic arthritis (pJIA) in patients two years of age and older who have responded inadequately to, or who are intolerant to, one or more DMARDs |
| 2026-07-29 | AbbVie | Regulatory AbbVie Announces European Commission Approval of RINVOQ® (upadacitinib) for the Treatment of Adults and Adolescents with Severe Alopecia Areata abbvie.com ↗
AbbVie (NYSE: ABBV) today announced that the European Commission (EC) has approved RINVOQ® (upadacitinib; 15 mg and 30 mg, once daily) for the treatment of adult and adolescent patients 12 years and older with severe alopecia areata (AA). |
| 2026-07-29 | AbbVie | Regulatory AbbVie Announces European Commission Approval of RINVOQ® (upadacitinib) for the Treatment of Adults and Adolescents with Non-Segmental Vitiligo abbvie.com ↗
AbbVie (NYSE: ABBV) today announced that the European Commission (EC) has approved RINVOQ ® (upadacitinib; 15 mg, once daily) for the treatment of adult and adolescent patients 12 years and older with non-segmental vitiligo (NSV) who are candidates for systemic therapy. |
| 2026-06-29 | AbbVie | Regulatory AbbVie Receives Positive CHMP Opinion for Upadacitinib (RINVOQ®) for the Treatment of Adults and Adolescents with Severe Alopecia Areata abbvie.com ↗ |
| 2026-06-29 | AbbVie | Regulatory AbbVie Receives Positive CHMP Opinion for Upadacitinib (RINVOQ®) for the Treatment of Adults and Adolescents with Non-segmental Vitiligo abbvie.com ↗
AbbVie (NYSE: ABBV) today announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the approval of upadacitinib (RINVOQ®; 15 mg, once daily) for the treatment of adult and adolescent patients with non-segmental vitiligo (NSV). |
| 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 ↗
Our research presented at DDW adds to the growing body of evidence demonstrating the sustained durability of clinical and endoscopic response, as well as the established safety profile, of risankizumab and upadacitinib for people living with IBD. |
| 2026-04-28 | AbbVie | Regulatory AbbVie Submits Application to FDA for Upadacitinib (RINVOQ®) for Adults and Adolescents with Severe Alopecia Areata abbvie.com ↗
AbbVie (NYSE: ABBV) today announced that it has submitted an application for a new indication to the U.S. Food and Drug Administration (FDA) for upadacitinib (RINVOQ ® ; 15 mg and 30 mg, once daily) for the treatment of adult and adolescent patients with severe alopecia areata (AA), based on results from the Phase 3 UP-AA clinical program. |
| 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 ↗
Additionally, in evaluating outcomes across body regions, more than half of patients achieved EASI-90 in the head and neck region after six months of upadacitinib treatment, with consistent responses regardless of prior biologic exposure. |
| 2026-02-04 | AbbVie | Regulatory AbbVie Reports Full-Year and Fourth-Quarter 2025 Financial Results abbvie.com ↗
AbbVie announced it submitted applications for a new indication to the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) for Rinvoq (upadacitinib) in the treatment of adult and adolescent patients living with non-segmental vitiligo. |
| 2026-02-03 | AbbVie | Regulatory AbbVie Submits Regulatory Applications to FDA and EMA for Upadacitinib (RINVOQ®) in Adults and Adolescents With Vitiligo abbvie.com ↗
The regulatory submissions to the FDA and EMA are supported by previously announced results from the Viti-Up studies evaluating the safety and efficacy of upadacitinib in patients with NSV. |
| 2025-10-29 | AbbVie | Results AbbVie Announces Positive Topline Results from Phase 3 Pivotal Studies Evaluating Upadacitinib (RINVOQ®) in Adults and Adolescents with Vitiligo abbvie.com ↗
AbbVie (NYSE: ABBV) today announced positive topline results from two replicate Phase 3 studies evaluating the safety and efficacy of upadacitinib (RINVOQ ® ;15 mg, once daily in adult and adolescent patients living with non-segmental vitiligo (NSV). |
| 2025-10-20 | AbbVie | Results RINVOQ® (upadacitinib) Demonstrated Superiority Versus HUMIRA® (adalimumab) for Primary Endpoint in a Head-to-Head Study in Rheumatoid Arthritis Patients Who Have Failed First TNF Inhibitor abbvie.com ↗
Upadacitinib demonstrated superiority versus adalimumab for primary endpoint of achieving low disease activity (DAS28-CRP≤3.2) and ranked secondary endpoint of remission ( DAS28-CRP < 2.6) at week 12 |
| 2025-10-13 | AbbVie | Regulatory U.S. Food and Drug Administration (FDA) Approves Updated Indication Statement for RINVOQ® (upadacitinib) for the Treatment of Inflammatory Bowel Disease abbvie.com ↗
The updated indication statement also allows the use of RINVOQ for patients after they have received at least one approved systemic therapy in the event TNF blockers are clinically inadvisable. |
| 2025-08-21 | AbbVie | Results AbbVie Announces Positive Topline Results from Second Phase 3 UP-AA Trial Evaluating Upadacitinib (RINVOQ®) for Alopecia Areata abbvie.com ↗ |
| 2025-07-30 | AbbVie | Results AbbVie Announces Positive Topline Results from Phase 3 UP-AA Trial Evaluating Upadacitinib (RINVOQ®) for Alopecia Areata abbvie.com ↗
Key secondary endpoints, including improvements in eyebrows and eyelashes, as well as the percentage of subjects with 90% or more scalp coverage (SALT ≤ 10) and complete scalp hair coverage (SALT=0) at week 24, were also met |
| 2025-04-29 | AbbVie | Regulatory RINVOQ® (upadacitinib) Receives U.S. FDA Approval for Giant Cell Arteritis (GCA) abbvie.com ↗
AbbVie (NYSE: ABBV) today announced the U.S. Food and Drug Administration (FDA) has approved RINVOQ ® (upadacitinib), 15 mg, once daily, for the treatment of adults with giant cell arteritis (GCA). |
| 2025-04-08 | AbbVie | Regulatory AbbVie Announces European Commission Approval of RINVOQ® (upadacitinib) for the Treatment of Adults with Giant Cell Arteritis abbvie.com ↗
AbbVie (NYSE: ABBV) today announced that the European Commission (EC) granted marketing authorization to RINVOQ ® (upadacitinib; 15 mg, once daily) for the treatment of giant cell arteritis (GCA) in adult patients. |
| 2025-02-28 | AbbVie | Regulatory AbbVie Receives Positive CHMP Opinion for Upadacitinib (RINVOQ®) for the Treatment of Adults with Giant Cell Arteritis abbvie.com ↗
AbbVie (NYSE: ABBV) today announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the approval of upadacitinib (RINVOQ ® ; 15 mg, once daily) for the treatment of adult patients with GCA. |
| 2024-09-25 | AbbVie | Results New Analysis Demonstrates the Efficacy of RINVOQ® (upadacitinib) in Atopic Dermatitis with Varying Degrees of Severity in Head and Neck Involvement abbvie.com ↗
AbbVie (NYSE: ABBV) today announced positive results from a new post-hoc analysis from the Measure Up 1 and Measure Up 2 Phase 3 studies. |
| 2024-07-12 | AbbVie | Regulatory AbbVie Submits Regulatory Applications to FDA and EMA for Upadacitinib (RINVOQ®) in Giant Cell Arteritis abbvie.com ↗ |
| 2024-06-04 | AbbVie | Regulatory RINVOQ® (upadacitinib) Now Available for Pediatric Patients Two Years and Older with Polyarticular Juvenile Idiopathic Arthritis and Psoriatic Arthritis abbvie.com ↗
RINVOQ is now approved for eight indications across immune-mediated inflammatory diseases |
| 2024-04-25 | AbbVie | Results New Data Show RINVOQ® (upadacitinib) Demonstrated Superiority Versus DUPIXENT® (dupilumab) Across Primary and All Secondary Endpoints in an Open-Label Head-to-Head Atopic Dermatitis Study abbvie.com ↗
Upadacitinib demonstrated superiority versus dupilumab in primary endpoint of simultaneous achievement of near complete skin clearance (EASI 90) and no to little itch (WP-NRS 0/1) at Week 16 |
| 2024-04-18 | AbbVie | Results Phase 3 SELECT-GCA Study of Upadacitinib (RINVOQ®) Showed Positive Results in Patients With Giant Cell Arteritis abbvie.com ↗
Results from the Phase 3 SELECT-GCA study showed 46 percent of patients with giant cell arteritis (GCA) who were treated with upadacitinib (RINVOQ ® ; 15 mg) with a 26-week steroid taper regimen achieved sustained remission from week 12 through week 52 compared to 29 percent of patients receiving placebo with a 52-week steroid taper regimen 1 |
| 2023-10-12 | AbbVie | Results AbbVie Announces Upadacitinib (RINVOQ®) Met the Primary Endpoint in Phase 2 Clinical Trial of Vitiligo as Program Advances to Phase 3 abbvie.com ↗
AbbVie (NYSE: ABBV) today announced that its Phase 2b study evaluating upadacitinib (RINVOQ ® ) in adults with non-segmental vitiligo (NSV) met the primary endpoint of percent change from baseline in the Facial Vitiligo Area Scoring Index (F-VASI) at week 24 with the 11 mg and 22 mg doses versus placebo. |
| 2023-10-11 | AbbVie | Results AbbVie Presents Long-Term Data Further Supporting the Efficacy and Safety Profile of RINVOQ (upadacitinib) in Adults and Adolescents with Moderate to Severe Atopic Dermatitis abbvie.com ↗
Three ongoing, randomized, double-blind, multicenter Phase 3 studies demonstrated the long-term efficacy and safety profile of RINVOQ ® (upadacitinib) in treating moderate to severe atopic dermatitis based on results across 140 weeks |
| 2023-05-31 | AbbVie | Results Phase 2 Study of Upadacitinib (RINVOQ®) Alone or as a Combination Therapy Meets Primary and Key Secondary Endpoints in Patients with Systemic Lupus Erythematosus abbvie.com ↗ |
| 2023-05-25 | AbbVie | Results New England Journal of Medicine Publishes Results from Phase 3 Induction and Maintenance Programs Evaluating Upadacitinib (RINVOQ®) in Crohn's Disease abbvie.com ↗
The publication reports the safety and efficacy results of oral upadacitinib versus placebo in two induction studies (U-EXCEL and U-EXCEED) and one maintenance study (U-ENDURE), evaluating the co-primary endpoints of clinical remission and endoscopic response. |
| 2023-05-18 | AbbVie | Regulatory U.S. FDA Approves RINVOQ® (upadacitinib) as a Once-Daily Pill for Moderately to Severely Active Crohn's Disease in Adults abbvie.com ↗
the U.S. Food and Drug Administration (FDA) has approved RINVOQ ® (upadacitinib) for the treatment of adults with moderately to severely active Crohn's disease who have had an inadequate response or intolerance to one or more TNF blockers. |
| 2023-04-17 | AbbVie | Regulatory AbbVie Announces European Commission Approval of RINVOQ® (upadacitinib) for the Treatment of Moderately to Severely Active Crohn's Disease abbvie.com ↗ |
| 2023-03-23 | AbbVie | Results AbbVie Advances Upadacitinib (RINVOQ®) to Phase 3 Clinical Trials in Systemic Lupus Erythematosus abbvie.com ↗
The SLEek study met the primary endpoint of SLE Responder Index (SRI-4) and steroid dose less than or equal to 10 mg prednisone equivalent once per day at week 24 in the upadacitinib 30 mg group. |
| 2023-02-27 | AbbVie | Regulatory AbbVie Receives Positive CHMP Opinion for Upadacitinib (RINVOQ®) for the Treatment of Adults with Moderate to Severe Crohn's Disease abbvie.com ↗
The positive CHMP opinion for upadacitinib is based on results from two induction studies and one maintenance study |
| 2022-11-11 | AbbVie | Regulatory CHMP Issues Opinion Related to Review of Medicines within the Janus Kinase (JAK) Inhibitor Class abbvie.com ↗
The CHMP did not recommend changes to current RINVOQ indication statements. |
| 2022-10-21 | AbbVie | Regulatory RINVOQ® (Upadacitinib) Receives Its Sixth U.S. FDA Approval abbvie.com ↗
AbbVie (NYSE: ABBV) today announces that the U.S. Food and Drug Administration (FDA) has approved RINVOQ ® (upadacitinib 15 mg, once daily), an oral therapy, for the treatment of adults with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation who have had an inadequate response or intolerance to tumor necrosis factor (TNF) blocker therapy. |
| 2022-07-29 | AbbVie | Regulatory RINVOQ® (upadacitinib) Approved by European Commission as an Oral Treatment for Adults with Active Non-Radiographic Axial Spondyloarthritis abbvie.com ↗
With this approval, RINVOQ ® (upadacitinib 15 mg, once daily) is the first and only Janus Kinase (JAK) inhibitor approved to treat patients across the spectrum of axial spondyloarthritis (nr-axSpA and ankylosing spondylitis) in the European Union (EU) |
| 2022-07-27 | AbbVie | Regulatory AbbVie Submits Regulatory Applications to FDA and EMA for Upadacitinib (RINVOQ®) in Crohn's Disease abbvie.com ↗ |
| 2022-07-26 | AbbVie | Regulatory European Commission Approves RINVOQ® (upadacitinib) for the Treatment of Adults With Moderate to Severe Ulcerative Colitis abbvie.com ↗
AbbVie (NYSE: ABBV) today announced the European Commission (EC) approved RINVOQ® (upadacitinib 45 mg [induction dose] and 15 mg and 30 mg [maintenance doses]) for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent. |
| 2022-06-27 | AbbVie | Regulatory CHMP Recommends Approval of Upadacitinib (RINVOQ®) for the Treatment of Adults with Active Non-Radiographic Axial Spondyloarthritis abbvie.com ↗
The CHMP's recommendation to approve upadacitinib for patients with nr-axSpA is an important milestone in providing a new treatment option to patients in need. |
| 2022-06-01 | AbbVie | Results AbbVie Presents Positive Results from Phase 3 SELECT-AXIS 2 Trials of Upadacitinib (RINVOQ®) in Patients with Axial Spondyloarthritis at EULAR 2022 abbvie.com ↗
AbbVie (NYSE: ABBV) today announced the presentation of full results from two studies from the Phase 3 SELECT-AXIS 2 program evaluating upadacitinib (RINVOQ ® ), an oral therapy, in adult patients with active non-radiographic axial spondyloarthritis (nr-axSpA) and patients with treatment-refractory active ankylosing spondylitis (AS) with an inadequate response (IR) to biologic disease-modifying antirheumatic drugs (bDMARDs). |
| 2022-05-27 | AbbVie | Results The Lancet Publishes Results from Phase 3 Induction and Maintenance Programs Evaluating Upadacitinib (RINVOQ®) in Ulcerative Colitis abbvie.com ↗
The publication reports the efficacy and safety results of the two induction studies and a maintenance study evaluating clinical remission and endoscopic improvement with oral upadacitinib versus placebo over 8 weeks and 52 weeks, respectively. |
| 2022-05-23 | AbbVie | Regulatory CHMP Recommends European Commission Approval of Upadacitinib (RINVOQ®) for the Treatment of Adults with Moderate to Severe Ulcerative Colitis abbvie.com ↗ |
| 2022-05-11 | AbbVie | Results Upadacitinib (RINVOQ®) Achieved Clinical Remission and Endoscopic Response at One Year in Phase 3 Maintenance Study in Patients with Crohn's Disease abbvie.com ↗
AbbVie today announced positive topline results from U-ENDURE, its Phase 3 maintenance study evaluating upadacitinib in adult patients with moderate to severe Crohn's disease who had an inadequate response or were intolerant to a conventional or biologic therapy. |
| 2022-04-29 | AbbVie | Regulatory RINVOQ® (upadacitinib) Approved by U.S. FDA as an Oral Treatment for Adults with Active Ankylosing Spondylitis abbvie.com ↗
FDA approval in AS marks the fifth indication for RINVOQ in chronic immune-mediated diseases |
| 2022-04-29 | AbbVie | Regulatory AbbVie Reports First-Quarter 2022 Financial Results abbvie.com ↗
The approval is supported by data from two Phase 3 induction studies and one maintenance study. |
| 2022-03-16 | AbbVie | Regulatory RINVOQ® (upadacitinib) Receives FDA Approval for the Treatment of Adults with Moderately to Severely Active Ulcerative Colitis abbvie.com ↗
This FDA approval is the first indication for RINVOQ in gastroenterology and is supported by efficacy and safety data from three Phase 3 randomized, double-blind, placebo-controlled clinical studies. |
| 2022-02-24 | AbbVie | Results Second Phase 3 Induction Study Confirms Upadacitinib (RINVOQ®) Improved Clinical and Endoscopic Outcomes in Patients with Crohn's Disease abbvie.com ↗
AbbVie (NYSE: ABBV) today announced positive top-line results from U-EXCEL, a Phase 3 induction study, showing upadacitinib (45 mg once daily) achieved both primary endpoints of clinical remission a,b and endoscopic response c at week 12. |
| 2022-01-14 | AbbVie | Regulatory U.S. FDA Approves RINVOQ® (upadacitinib) to Treat Adults and Children 12 Years and Older with Refractory, Moderate to Severe Atopic Dermatitis abbvie.com ↗
The FDA approval is supported by efficacy and safety data from one of the largest registrational Phase 3 programs for atopic dermatitis with more than 2,500 patients evaluated across three studies. |
| 2022-01-07 | AbbVie | Regulatory AbbVie Submits Applications for Upadacitinib (RINVOQ®) in Non-Radiographic Axial Spondyloarthritis to U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) abbvie.com ↗ |
| 2021-12-14 | AbbVie | Regulatory RINVOQ® (upadacitinib) Receives U.S. FDA Approval for Active Psoriatic Arthritis abbvie.com ↗ |
| 2021-12-06 | AbbVie | Results Upadacitinib (RINVOQ®) Achieved Primary and Key Secondary Endpoints in First Phase 3 Induction Study in Patients with Crohn's Disease abbvie.com ↗
AbbVie (NYSE: ABBV) today announced positive top-line results from U-EXCEED, a Phase 3 induction study, showing upadacitinib (45 mg once daily) achieved both primary endpoints of clinical remission a,b and endoscopic response c at week 12. |
| 2021-12-03 | AbbVie | Regulatory AbbVie Provides Update on RINVOQ® (upadacitinib) for the Treatment of Rheumatoid Arthritis in the U.S. abbvie.com ↗
Based on this class-wide update, the U.S. label for RINVOQ will now include additional information about the risks of malignancy and thrombosis, and the addition of mortality and MACE (defined as cardiovascular death, myocardial infarction and stroke) risks within the Boxed Warnings and Warnings and Precautions sections. |
| 2021-11-09 | AbbVie | Results AbbVie to Present New Long-term Analysis Evaluating the Sustainability of Response to RINVOQ® (Upadacitinib) Among Patients with Rheumatoid Arthritis abbvie.com ↗
Results showed that 34% of patients receiving RINVOQ and background csDMARDs achieved Clinical Disease Activity Index (CDAI) remission (CDAI ≤2.8) at first occurrence of response before week 60, while 79% achieved CDAI low disease activity (LDA) (CDAI ≤10). |
| 2021-11-09 | AbbVie | Results AbbVie Presents New Efficacy Data on Upadacitinib (RINVOQ®) in People with Active Psoriatic Arthritis and Axial Involvement at ACR Convergence 2021 abbvie.com ↗
At week 24, upadacitinib showed numerically greater responses than adalimumab across all BASDAI and Ankylosing Spondylitis Disease Activity Score (ASDAS) endpoints in SELECT-PsA 1. |
| 2021-10-07 | AbbVie | Results AbbVie's Upadacitinib (RINVOQ®) Met Primary and Most Ranked Secondary Endpoints in Phase 3 Study for Non-Radiographic Axial Spondyloarthritis abbvie.com ↗
AbbVie (NYSE: ABBV) today announced positive top-line results from Study 2 of the Phase 3 SELECT-AXIS 2 clinical trial in adults with active non-radiographic axial spondyloarthritis (nr-axSpA), showing upadacitinib (RINVOQ ® ; 15 mg, once daily) met the primary endpoint of Assessment in SpondyloArthritis International Society (ASAS) 40 response and the majority of ranked secondary endpoints at week 14. |
| 2021-10-07 | AbbVie | Results AbbVie's RINVOQ® (upadacitinib) Met Primary and All Ranked Secondary Endpoints in Phase 3 Study in Ankylosing Spondylitis abbvie.com ↗
In this study, RINVOQ met its primary endpoint of Assessment in SpondyloArthritis International Society (ASAS) 40 response and all ranked secondary endpoints at week 14. |
| 2021-10-02 | AbbVie | Results AbbVie to Showcase New Data at the United European Gastroenterology (UEG) Week Virtual 2021 abbvie.com ↗
During UEG Week Virtual 2021, results of the pivotal Phase 3 maintenance study, in which the primary endpoint of clinical remission (per Adapted Mayo Score) was met, will be disclosed as a late-breaking presentation . |
| 2021-09-30 | AbbVie | Results AbbVie Presents New Analyses Evaluating RINVOQ® (upadacitinib) in Atopic Dermatitis Across Patient Characteristics and Body Regions at EADV Virtual Congress abbvie.com ↗
An additional analysis showed more patients treated with RINVOQ 30 mg achieved EASI 75 at week 16 compared to dupilumab when measured in four body regions. |
| 2021-09-16 | AbbVie | Regulatory AbbVie Submits Regulatory Applications to FDA and EMA for Upadacitinib (RINVOQ®) for the Treatment of Adults with Moderately to Severely Active Ulcerative Colitis abbvie.com ↗
AbbVie (NYSE: ABBV) today announced that it has submitted applications seeking approval for upadacitinib (15 mg and 30 mg (maintenance dose) and 45 mg (induction dose)) for the treatment of adults with moderately to severely active ulcerative colitis to the U.S. Food and Drug Administration (FDA), and to the European Medicines Agency (EMA) for the treatment of adults with moderately to severely active ulcerative colitis, who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic agent. |
| 2021-08-24 | AbbVie | Regulatory European Commission Approves RINVOQ® (upadacitinib) as First JAK Inhibitor in the European Union for the Treatment of Both Adults and Adolescents with Moderate to Severe Atopic Dermatitis abbvie.com ↗
AbbVie (NYSE: ABBV) today announced the European Commission (EC) approved RINVOQ ® (upadacitinib), an oral, selective and reversible JAK inhibitor, for the treatment of moderate to severe atopic dermatitis in adults and adolescents 12 years and older who are candidates for systemic therapy. |
| 2021-08-04 | AbbVie | Results JAMA Dermatology Publishes Data Showing RINVOQ® (upadacitinib) Achieved Superiority Versus DUPIXENT® (dupilumab) for Primary and All Ranked Secondary Endpoints in Phase 3b Head-to-Head Study in Adults with Atopic Dermatitis abbvie.com ↗
Of those treated with upadacitinib, 71 percent achieved EASI 75 at week 16 compared to 61 percent of those treated with dupilumab. |
| 2021-07-16 | AbbVie | Regulatory AbbVie Provides Update Regarding RINVOQ® (upadacitinib) for the Treatment of Moderate to Severe Atopic Dermatitis in the U.S. abbvie.com ↗
AbbVie (NYSE: ABBV) today announced the U.S. Food and Drug Administration (FDA) did not meet the Prescription Drug User Fee Act (PDUFA) action date for the supplemental New Drug Application (sNDA) for RINVOQ ® (upadacitinib) for the treatment of adults and adolescents with moderate to severe atopic dermatitis. |
| 2021-06-29 | AbbVie | Results Upadacitinib (RINVOQ®) Met the Primary and All Secondary Endpoints in the 52-Week Phase 3 Maintenance Study in Ulcerative Colitis Patients abbvie.com ↗
Significantly more upadacitinib-treated patients achieved clinical remission at week 52 compared to placebo (15 mg: 42 percent and 30 mg: 52 percent versus placebo: 12 percent; p<0.001). |
| 2021-06-25 | AbbVie | Regulatory CHMP Recommends Approval of RINVOQ® (upadacitinib) for the Treatment of Atopic Dermatitis abbvie.com ↗ |
| 2021-06-25 | AbbVie | Regulatory AbbVie Provides Update Regarding RINVOQ® (upadacitinib) in Psoriatic Arthritis and Ankylosing Spondylitis in the U.S. abbvie.com ↗
AbbVie (NYSE: ABBV) today announced that the U.S. Food and Drug Administration (FDA) has informed the company that the FDA will not meet the Prescription Drug User Fee Act (PDUFA) action dates for the supplemental New Drug Applications (sNDAs) for RINVOQ ® (upadacitinib) for the treatment of adults with active psoriatic arthritis and adults with active ankylosing spondylitis. |
| 2021-06-02 | AbbVie | Results New Long-Term Efficacy and Safety Analyses Evaluating RINVOQ® (upadacitinib) in Patients with Rheumatoid Arthritis to be Presented at EULAR 2021 Virtual Congress abbvie.com ↗
In this study, a higher proportion of patients treated with RINVOQ 15 mg achieved and maintained clinical remission and low disease activity compared to those treated with HUMIRA, through three years. |
| 2021-06-02 | AbbVie | Results AbbVie to Present Analysis Evaluating Continuous RINVOQ® (upadacitinib) Treatment in Psoriatic Arthritis for More Than One Year at EULAR 2021 Virtual Congress abbvie.com ↗
At week 56, 29 percent of patients treated with continuous RINVOQ 15 mg achieved minimal disease activity a (MDA). |
| 2021-05-24 | AbbVie | Results The Lancet Publishes Results from Pivotal Global Phase 3 Program Evaluating RINVOQ® (upadacitinib) in Atopic Dermatitis abbvie.com ↗
Across all three studies, RINVOQ met all primary and secondary endpoints. |
| 2021-04-02 | AbbVie | Regulatory AbbVie Announces Extension of Review for Supplemental New Drug Application of Upadacitinib for the Treatment of Moderate to Severe Atopic Dermatitis abbvie.com ↗
The Prescription Drug User Fee Act (PDUFA) action date has been extended three months to early Q3 2021. |
| 2021-04-01 | AbbVie | Results New England Journal of Medicine Publishes 24-Week Results from Phase 3 Study Evaluating RINVOQ™ (upadacitinib) in Psoriatic Arthritis abbvie.com ↗ |
| 2021-03-17 | AbbVie | Regulatory AbbVie Announces Extension of Review for Supplemental New Drug Application of Upadacitinib for the Treatment of Adults with Active Psoriatic Arthritis abbvie.com ↗
AbbVie (NYSE:ABBV), a global research and development-based biopharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) has extended the review period for the supplemental New Drug Application (sNDA) for upadacitinib in the treatment of adult patients with active psoriatic arthritis. |
| 2021-02-22 | AbbVie | Results Second Phase 3 Induction Study Confirms Upadacitinib (RINVOQ™) Improved Clinical, Endoscopic and Histologic Outcomes in Ulcerative Colitis Patients abbvie.com ↗
AbbVie (NYSE: ABBV) today announced that upadacitinib (45 mg, once daily) met the primary endpoint of clinical remission (per Adapted Mayo Score) and all ranked secondary endpoints in the Phase 3 induction study, U-ACCOMPLISH. |
| 2021-01-25 | AbbVie | Regulatory European Commission Approves AbbVie's RINVOQ™ (Upadacitinib) for the Treatment of Psoriatic Arthritis and Ankylosing Spondylitis abbvie.com ↗
AbbVie (NYSE: ABBV), today announced that the European Commission (EC) has approved RINVOQTM (upadacitinib, 15 mg), an oral, once daily selective and reversible JAK inhibitor for the treatment of active psoriatic arthritis (PsA) in adult patients who have responded inadequately to, or who are intolerant to one or more DMARDs. |
| 2020-12-11 | AbbVie | Regulatory CHMP Recommends the Approvals of RINVOQ™ (Upadacitinib) for the Treatment of Adults with Active Psoriatic Arthritis and Ankylosing Spondylitis abbvie.com ↗
The CHMP's recommendations to approve RINVOQ in both psoriatic arthritis and ankylosing spondylitis mark an important milestone. |
| 2020-12-10 | AbbVie | Results RINVOQ™ (upadacitinib) Achieved Superiority Versus DUPIXENT® (dupilumab) For Primary and All Ranked Secondary Endpoints in Phase 3b Head-to-Head Study in Adults with Atopic Dermatitis abbvie.com ↗
AbbVie (NYSE: ABBV) today announced top-line results from the Phase 3b Heads Up study showing that upadacitinib (30 mg, once daily) achieved superiority to dupilumab (300 mg, every other week) for the primary endpoint, the proportion of patients with at least a 75 percent improvement in the Eczema Area Severity Index (EASI 75) at week 16, in adults with moderate to severe atopic dermatitis. |
| 2020-12-09 | AbbVie | Results Upadacitinib (RINVOQ™) Meets Primary and All Ranked Secondary Endpoints in First Phase 3 Induction Study in Ulcerative Colitis abbvie.com ↗
In the study, 26 percent of patients receiving upadacitinib achieved clinical remission compared to 5 percent of patients receiving placebo (p<0.001). |
| 2020-10-29 | AbbVie | Results AbbVie to Present New Analyses from Pivotal Phase 3 Studies for RINVOQ™ (upadacitinib) in Atopic Dermatitis abbvie.com ↗
Additionally, for both doses of upadacitinib, the proportion of patients achieving a clinically meaningful itch reduction was significantly higher than placebo at week 4 and maintained through week 16.1 |
| 2020-10-19 | AbbVie | Regulatory AbbVie Submits Regulatory Applications to FDA and EMA for RINVOQ™ (upadacitinib) in Atopic Dermatitis abbvie.com ↗
AbbVie (NYSE: ABBV) today announced that it has submitted applications to the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) seeking approval for RINVOQ™ (upadacitinib) for the treatment of adults (15 mg and 30 mg, once daily) and adolescents (15 mg, once daily) with moderate to severe atopic dermatitis. |
| 2020-08-25 | AbbVie | Regulatory AbbVie Submits Regulatory Application to FDA for RINVOQ™ (upadacitinib) for the Treatment of Adults with Active Ankylosing Spondylitis abbvie.com ↗ |
| 2020-07-28 | AbbVie | Results Third Pivotal Phase 3 Study Shows RINVOQ™ (upadacitinib) Plus Topical Corticosteroids Improves Skin and Itch Symptoms in Atopic Dermatitis Patients abbvie.com ↗
AbbVie (NYSE: ABBV) today announced upadacitinib (15 mg and 30 mg, once daily) plus topical corticosteroids (TCS) met the co-primary endpoints and all secondary endpoints in AD Up, the third pivotal Phase 3 study of RINVOQ in atopic dermatitis. |
| 2020-07-21 | AbbVie | Results RINVOQ™ (upadacitinib) Monotherapy Meets All Primary and Secondary Endpoints in Second Phase 3 Study for Atopic Dermatitis abbvie.com ↗
AbbVie (NYSE: ABBV) today announced upadacitinib (15 mg and 30 mg, once daily) monotherapy met both primary and all secondary endpoints in Measure Up 2, the second Phase 3 study in individuals with moderate to severe atopic dermatitis. |
| 2020-06-18 | AbbVie | Results RINVOQ™ (upadacitinib) Monotherapy Shows Improvement in Skin Clearance and Itch in First Phase 3 Study for Atopic Dermatitis abbvie.com ↗
In this study, patients receiving either 15 mg or 30 mg of upadacitinib monotherapy showed significant improvement in skin clearance. |
| 2020-06-06 | AbbVie | Results AbbVie Presents Data Showing RINVOQ™ (upadacitinib) Meets Primary and Key Secondary Endpoints in Phase 3 Head-to-Head Study Versus ORENCIA (abatacept) in Rheumatoid Arthritis Patients abbvie.com ↗
In addition, RINVOQ met the key secondary endpoints of superiority versus ORENCIA on change from baseline in DAS28-CRP at week 12 and proportion of patients achieving clinical remission at week 12 as measured by DAS28-CRP<2.6. |
| 2020-06-04 | AbbVie | Results New Long-term Data from RINVOQ™ (upadacitinib, 15 mg) Phase 3 Studies in Rheumatoid Arthritis Presented at 2020 Annual European E-Congress of Rheumatology (EULAR) abbvie.com ↗
Results of this Long-Term Extension (LTE) of the SELECT-COMPARE study show that RINVOQ plus MTX maintained higher levels of clinical response, including remission compared to adalimumab plus MTX, through week 72. |
| 2020-06-01 | AbbVie | Regulatory AbbVie Submits Regulatory Applications to FDA and EMA for RINVOQ™ (upadacitinib) for the Treatment of Adults with Active Psoriatic Arthritis abbvie.com ↗
AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, 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 RINVOQ™ (upadacitinib; 15 mg, once daily), a selective and reversible JAK inhibitor, for the treatment of adult patients with active psoriatic arthritis. |
| 2020-02-05 | AbbVie | Results RINVOQ™ (upadacitinib) Meets Primary and Key Secondary Endpoints in Phase 3 Study in Psoriatic Arthritis abbvie.com ↗
AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced positive top-line results from the Phase 3 SELECT-PsA 1 clinical trial. |
| 2019-12-18 | AbbVie | Regulatory AbbVie Receives European Commission Approval of RINVOQ™ (upadacitinib) for the Treatment of Adults with Moderate to Severe Active Rheumatoid Arthritis abbvie.com ↗
AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced that the European Commission (EC) has approved RINVOQ ™ (upadacitinib) for the treatment of adult patients with moderate to severe active rheumatoid arthritis who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs). |
| 2019-11-12 | AbbVie | Results New Positive Data for RINVOQ™ (upadacitinib) on Signs and Symptoms in Patients with Ankylosing Spondylitis Presented at 2019 ACR/ARP Annual Meeting abbvie.com ↗ |
| 2019-10-31 | AbbVie | Results RINVOQ™ (upadacitinib) Meets Primary and All Ranked Secondary Endpoints in Phase 3 Study in Psoriatic Arthritis abbvie.com ↗
In this study, both doses of RINVOQ™ (upadacitinib; 15 mg and 30 mg, once daily) met the primary endpoint of ACR20 response at week 12 versus placebo in adult patients with active psoriatic arthritis who have responded inadequately to one or more biologic disease modifying anti-rheumatic drugs (bDMARDs). |
| 2019-10-18 | AbbVie | Regulatory AbbVie Receives CHMP Positive Opinion for Upadacitinib (RINVOQ™) for the Treatment of Adults with Moderate to Severe Active Rheumatoid Arthritis abbvie.com ↗
AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for RINVOQ ™ (upadacitinib), a once-daily selective and reversible JAK inhibitor, for the treatment of adult patients with moderate to severe active rheumatoid arthritis who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs). |
| 2019-08-16 | AbbVie | Regulatory AbbVie Receives FDA Approval of RINVOQ™ (upadacitinib), an Oral JAK Inhibitor For The Treatment of Moderate to Severe Rheumatoid Arthritis abbvie.com ↗
The FDA approval of RINVOQ is supported by data from the SELECT program, one of the largest registrational Phase 3 programs in RA with approximately 4,400 patients evaluated across all treatment arms in five studies. |
| 2019-06-12 | AbbVie | Results New Long-Term Data from Upadacitinib Phase 3 Studies in Rheumatoid Arthritis Including Results on Clinical Remission at 48 Weeks Presented at EULAR abbvie.com ↗
Additionally, data from an integrated safety analysis across five Phase 3 SELECT clinical trials show that treatment with upadacitinib in patients with moderately to severely active rheumatoid arthritis demonstrates a consistent safety profile. |
| 2019-02-19 | AbbVie | Regulatory AbbVie Announces New Drug Application Accepted for Priority Review by U.S. FDA for Upadacitinib for Treatment of Moderate to Severe Rheumatoid Arthritis abbvie.com ↗
AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, has announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review its New Drug Application (NDA) for upadacitinib for the treatment of adult patients with moderate to severe rheumatoid arthritis. |
| 2018-12-20 | AbbVie | Regulatory AbbVie Submits New Drug Application to U.S. FDA and Marketing Authorization Application to EMA for Upadacitinib for Treatment of Adults with Moderate to Severe Rheumatoid Arthritis abbvie.com ↗ |
| 2018-10-23 | AbbVie | Results AbbVie's Upadacitinib Shows Significant Improvements in Physical Function, Pain and Quality of Life as a Monotherapy in Patients with Rheumatoid Arthritis in Phase 3 Patient-Reported Outcomes Data abbvie.com ↗
Improvements in physical function, health-related quality of life, pain and morning joint stiffness were reported after 14 weeks of treatment with upadacitinib monotherapy compared to patients continuing methotrexate. |
| 2018-10-22 | AbbVie | Results Positive Phase 2b Data for AbbVie's Upadacitinib Show Significant Induction of Clinical Remission and Response in Patients with Ulcerative Colitis abbvie.com ↗
After 8 weeks, upadacitinib (15/30/45 mg, once daily) met the primary endpoint of clinical remission (per Adapted Mayo Score) and all ranked secondary endpoints. |
| 2018-09-13 | AbbVie | Results AbbVie Presents Upadacitinib Longer-Term (32-Week) and Patient-Reported Outcomes Data from Phase 2b Atopic Dermatitis Study at 27th European Academy of Dermatology and Venereology (EADV) Congress abbvie.com ↗
Additionally, results from a further analysis of a subset of patients showed that upadacitinib improved patient-reported itch and impact on sleep due to atopic dermatitis in patients receiving upadacitinib (30 mg, once-daily) compared to placebo at week 16. |
| 2018-06-12 | AbbVie | Results AbbVie Presents Additional Outcomes Data from Three Upadacitinib Phase 3 Studies in Rheumatoid Arthritis at the Annual European Congress of Rheumatology (EULAR 2018) abbvie.com ↗
Improvements in pain, physical function and morning joint stiffness were reported after 12 weeks of treatment with upadacitinib (15 mg and 30 mg, once-daily) in SELECT-NEXT and SELECT-BEYOND and after 14 weeks of treatment in SELECT-MONOTHERAPY. |
| 2018-06-05 | AbbVie | Results Upadacitinib Monotherapy Meets All Primary and Ranked Secondary Endpoints Versus Methotrexate in a Phase 3 Study in Rheumatoid Arthritis abbvie.com ↗
AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced positive top-line results from SELECT-EARLY showing that both doses of upadacitinib monotherapy (15 mg and 30 mg) met the primary endpoints of ACR50 a at week 12 and clinical remission b at week 24 versus methotrexate (MTX). |
| 2018-04-25 | AbbVie | Results AbbVie's Upadacitinib Meets Primary and Key Efficacy Endpoints in Phase 2b/3 Rheumatoid Arthritis Study in Japanese Patients abbvie.com ↗
Certain key efficacy endpoints were also achieved versus placebo. |
| 2018-04-09 | AbbVie | Results Upadacitinib Meets All Primary and Ranked Secondary Endpoints Including Superiority Versus Adalimumab in Phase 3 Study in Rheumatoid Arthritis abbvie.com ↗
All ranked secondary endpoints were also achieved versus either placebo or adalimumab (40 mg every other week). |
| 2018-02-17 | AbbVie | Results AbbVie Presents New Late-Breaking Phase 2b Data on Upadacitinib in Atopic Dermatitis at the 2018 American Academy of Dermatology Annual Meeting abbvie.com ↗
AbbVie (NYSE: ABBV), a global research and development-based biopharmaceutical company, today presented new positive results from a Phase 2b dose-ranging study evaluating upadacitinib, an investigational, once-daily oral JAK1-selective inhibitor, in adult patients with moderate to severe atopic dermatitis. |
| 2018-02-16 | AbbVie | Results AbbVie Announces New Phase 2 Data for Upadacitinib Showing Clinical and Endoscopic Outcomes in Crohn's Disease at 52 Weeks abbvie.com ↗ |
| 2018-01-08 | AbbVie | Regulatory AbbVie's Upadacitinib Granted Breakthrough Therapy Designation from the U.S. Food and Drug Administration for Atopic Dermatitis abbvie.com ↗
AbbVie (NYSE: ABBV), a global research and development-based biopharmaceutical company, today announced the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for the investigational, once-daily oral JAK1-selective inhibitor upadacitinib (ABT-494) in adult patients with moderate to severe atopic dermatitis who are candidates for systemic therapy. |
| 2017-12-20 | AbbVie | Results AbbVie's Upadacitinib Shows Positive Results as Monotherapy in Phase 3 Rheumatoid Arthritis Study, Meeting All Primary and Key Secondary Endpoints abbvie.com ↗
Results showed that after 14 weeks of treatment, both once-daily doses of upadacitinib (15 mg and 30 mg) met the study's primary endpoints of ACR20** and low disease activity (LDA)*** versus continuing prior stable methotrexate therapy. |
| 2017-09-11 | AbbVie | Results AbbVie's Upadacitinib (ABT-494) Meets All Primary and Ranked Secondary Endpoints in Second Phase 3 Study in Rheumatoid Arthritis abbvie.com ↗
AbbVie (NYSE: ABBV), a global research and development based biopharmaceutical company, today announced positive top-line results from the Phase 3 SELECT-BEYOND clinical trial evaluating upadacitinib (ABT-494), an investigational oral JAK1-selective inhibitor, in patients with moderate to severe rheumatoid arthritis (RA) who did not adequately respond or were intolerant to treatment with biologic DMARDs (bDMARDs). |
| 2017-09-07 | AbbVie | Results AbbVie's Upadacitinib (ABT-494) Meets Primary Endpoint in Phase 2b Study in Atopic Dermatitis abbvie.com ↗
In this study, all upadacitinib dose groups (30/15/7.5 mg once-daily) met the primary endpoint (mean percent change in EASI at week 16 versus placebo). |
| 2017-06-07 | AbbVie | Results AbbVie's Upadacitinib (ABT-494) Meets All Primary and Ranked Secondary Endpoints in Phase 3 Study in Rheumatoid Arthritis abbvie.com ↗
Results showed that after 12 weeks of treatment, both doses of upadacitinib (15 mg and 30 mg) met the study's primary endpoints of ACR20 and low disease activity. |
| 2017-05-09 | AbbVie | Results AbbVie Announces Positive Phase 2 Study Results for Upadacitinib (ABT-494), an Investigational JAK1-Selective Inhibitor, in Crohn's Disease abbvie.com ↗
These positive results support advancement into Phase 3 to further explore a potential new treatment option that may address the unmet needs of patients living with this challenging disease. |
| 2015-09-25 | AbbVie | Results AbbVie's ABT-494 Meets Primary Endpoint in Two Phase 2 Studies in Rheumatoid Arthritis abbvie.com ↗
The clinical trials, BALANCE-I and BALANCE-II, achieved ACR20 at week 12 across all dose levels, except the lowest dose in BALANCE-II. |
All press releases naming this drug 115 releases
| Date | Issuer | Release |
|---|---|---|
| Show all 115 releases opens the full record — a long page | ||
Evidence & citations 17 cited values
Every value below carries the sentence it was read from. 116 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | upadacitinib | “Patients with moderate to severe atopic dermatitis refractory to topical medication, who also have previous experience with cyclosporine and an unsatisfactory response, or in...” NCT06366932 ↗104“Oral JAK inhibitors (tofacitinib 5 mg twice daily, or baricitinib 4 mg once daily, or upadacitinib 15 mg once daily) administered in combination with standard glucocorticoid...” NCT07406932 ↗ “Switching to a targeted synthetic DMARD (choice from targeted synthetic DMARDs; currently available are tofacitinib, baricitinib, upadacitinib) in people with active RA despite...” NCT04692493 ↗ “Upadacitinib is a Janus kinase (JAK) 1 inhibitor being developed for the treatment of rheumatoid arthritis (RA) and other inflammatory diseases.” PMID 29076110 ↗ Aug 2018 “new advanced therapy: Tofacitinib and Upadacitinib (JAK inhibitors), Infliximab (anti-TNF), Ustekinumab or Risankizumab (IL-23 inhibitors).” NCT04505410 ↗ “treated with JAK inhibitors (upadacitinib 15mg qd/tofacitinib 5mg bid)orally for 28 days” NCT07530224 ↗ “Methotrexate or leflunomide + upadacitinib or” NCT02714634 ↗ “upadacitinib 15 mg po qd (JAK1 inhibitor)” NCT05305066 ↗ “Tofacitinib, baricitinib, or upadacitinib” NCT05379322 ↗ “Upadacitinib 15 mg once daily” NCT07160231 ↗ |
| Known as | ABT-494 | “A Study to Evaluate the Long-Term Safety and Efficacy of Upadacitinib (ABT-494) in Participants With Ulcerative Colitis (UC)” NCT03006068 ↗ |
| Known as | ABT-494 TARTRATE TETRAHYDRATE | ChEMBL registry synonym — accepted as the source's own label CHEMBL3622821 ↗ |
| Known as | Rinvoq | “Upadacitinib(Rinvoq) 15 mg orally (po) daily” NCT05153200 ↗ |
| Known as | Rinvoq lq | ChEMBL registry synonym — accepted as the source's own label CHEMBL3622821 ↗ |
| Known as | UPA | “Exposure-response analyses of upadacitinib (UPA) key efficacy and safety end points (3,685 and 4,577 subjects for efficacy and safety, respectively) using data from phase II...” PMID 31610021 ↗ Nov 20195“OBJECTIVE: To assess the efficacy and safety of upadacitinib (UPA), an oral Janus kinase inhibitor, as monotherapy or in combination with non-biologic DMARDs (nbDMARDs) in...” PMID 34864911 ↗ Aug 2022 “Upadacitinib (UPA)-an oral, reversible selective Janus kinase inhibitor-has a favorable benefit-risk profile for patients with Crohn's disease (CD) and ulcerative colitis (UC).” PMID 41264726 ↗ Jan 2026 “Upadacitinib (UPA), an oral Janus kinase inhibitor, is approved to treat moderately to severely active Crohn's disease (CD).” PMID 38492903 ↗ Mar 2024 “ABBV-599 (ELS 60 mg and upadacitinib \[UPA\] 15 mg) in adults with active rheumatoid arthritis” NCT03823378 ↗ “Upadacitinib (UPA) is an oral, selective Janus kinase inhibitor” PMID 37199884 ↗ May 2023 |
| Known as | Upadacitinib (as hemihydrate) | ChEMBL registry synonym — accepted as the source's own label CHEMBL3622821 ↗ |
| Known as | Upadacitinib anhydrous | ChEMBL registry synonym — accepted as the source's own label CHEMBL3622821 ↗ |
| Known as | Upadacitinib component of abbv-599 | ChEMBL registry synonym — accepted as the source's own label CHEMBL3622821 ↗ |
| Known as | UPADACITINIB HEMIHYDRATE | ChEMBL registry synonym — accepted as the source's own label CHEMBL3622821 ↗ |
| Known as | Upadacitinib hydrate | ChEMBL registry synonym — accepted as the source's own label CHEMBL3622821 ↗ |
| Known as | UPADACITINIB TARTRATE | ChEMBL registry synonym — accepted as the source's own label CHEMBL3622821 ↗ |
| Action | Inhibit | “ABT-494 is a potent and selective Janus kinase (JAK) 1 inhibitor” PMID 27272171 ↗ Dec 20161“Tyrosine-protein kinase TYK2 inhibitor” CHEMBL3622821 ↗ |
| Modality | Small molecule | “Upadacitinib was the first small molecule drug approved for CD treatment in China on June 30, 2023.” NCT06902987 ↗ |
| Route | Oral | “Oral administration of ABT-494 capsules” NCT01741493 ↗ |
| Target | JAK1 | “ABT-494 is a potent and selective Janus kinase (JAK) 1 inhibitor” PMID 27272171 ↗ Dec 2016 |
| Target | TYK2 | “Tyrosine-protein kinase TYK2 inhibitor” CHEMBL3622821 ↗ |