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 · 12 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (10) | 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 98 · 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 15 trials | ||||||
| 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 | ||||||
| Phase 2 | NCT07588568 | Jul 2026 → Feb 2030 expected | eosinophilic esophagitis | University of North Carolina, Chapel Hill | Not yet 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 | NCT07492251 | Jun 2026 → Feb 2028 expected | lichen planus | Centre Hospitalier Universitaire de Nice | 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 | No outcome recorded |
| 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 | No outcome recorded |
| Phase 2 | NCT03178487 | Oct 2017 → Jan 2019 | ankylosing spondylitis | AbbVie | Completed | No outcome recorded |
| Phase 2 | NCT02925117 | Oct 2016 → Aug 2017 | atopic eczema | AbbVie | Completed | No outcome recorded |
| 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 | No outcome recorded |
| 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 | No outcome recorded |
| Phase 2/32 trials | ||||||
| Phase 2/3 | NCT02819635 | Sep 2016 → Dec 2021 | ulcerative colitis | AbbVie | Completed | No outcome recorded |
| Phase 2/3 | NCT02720523 | Mar 2016 → Aug 2017 | rheumatoid arthritis | AbbVie | Completed | No outcome recorded |
| Phase 345 trials | ||||||
| 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 | NCT06928272 | Sep 2025 → Dec 2026 expected | long COVID-19 | Douglas D. Fraser | 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 expected | 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 |
| Phase 3 | NCT06118411 | Dec 2023 → Mar 2028 expected | vitiligo | AbbVie | Active not recruiting | No outcome recorded |
| 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 | No outcome recorded |
| 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 |
| 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 | No outcome recorded |
| Phase 3 | NCT03738397 | Feb 2019 → Aug 2020 | atopic eczema | AbbVie | Completed | No outcome recorded |
| 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 | No outcome recorded |
| 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 | No outcome recorded |
| Phase 3 | NCT03568318 | Aug 2018 → Feb 2021 overdue | atopic eczema | AbbVie | Active not recruiting | No outcome recorded |
| Phase 3 | NCT03607422 | Jul 2018 → Mar 2021 | atopic eczema | AbbVie | Completed | No outcome recorded |
| Phase 3 | NCT03345823 | Mar 2018 → Sep 2027 expected | Crohn disease | AbbVie | Active not recruiting | No outcome recorded |
| Phase 3 | NCT02955212 | Jan 2018 → Aug 2019 | rheumatoid arthritis | AbbVie | Completed | No outcome recorded |
| Phase 3 | NCT03345849 | Dec 2017 → Oct 2021 | Crohn disease | AbbVie | Completed | No outcome recorded |
| Phase 3 | NCT03345836 | Nov 2017 → Aug 2021 | Crohn disease | AbbVie | Completed | No outcome recorded |
| Phase 3 | NCT03086343 | May 2017 → Jun 2019 | rheumatoid arthritis | AbbVie | Completed | No outcome recorded |
| Phase 3 | NCT03104374 | May 2017 → Jul 2019 | psoriatic arthritis | AbbVie | Completed | No outcome recorded |
| Phase 3 | NCT03104400 | Apr 2017 → Sep 2019 | psoriatic arthritis | AbbVie | Completed | No outcome recorded |
| 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 | No outcome recorded |
| Phase 3 | NCT02706847 | Mar 2016 → Apr 2017 | rheumatoid arthritis | AbbVie | Completed | No outcome recorded |
| Phase 3 | NCT02706873 | Feb 2016 → Mar 2018 | rheumatoid arthritis | AbbVie | Completed | No outcome recorded |
| Phase 3 | NCT02675426 | Dec 2015 → Apr 2017 | rheumatoid arthritis | AbbVie | Completed | No outcome recorded |
| Phase 3 | NCT02629159 | Dec 2015 → Oct 2017 overdue | rheumatoid arthritis | AbbVie | Active not recruiting | No outcome recorded |
| Phase 419 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 | 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 | NCT07502339 | Jul 2026 → Aug 2028 expected | ulcerative colitis | University of California, San Francisco | 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 |
| 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 | ||||||
| — | 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 | No outcome recorded |
| — | 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 |
Also used as a comparator or background therapy in 7 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT06379958 Comparator | Apr → Sep 2024 overdue | — | Modern Biosciences Ltd | Recruiting | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT07670156 Comparator | Aug 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 21 trial | ||||||
| Phase 2 | NCT02365649 Comparator | Mar 2015 → Nov 2016 | Crohn disease | AbbVie | Completed | No outcome recorded |
| Phase 33 trials | ||||||
| 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 41 trial | ||||||
| Phase 4 | NCT06687551 Comparator | Jan 2025 → Apr 2029 expected | rheumatoid arthritis | University Hospital, Toulouse | Not yet recruiting | No outcome recorded |
Press releases naming this drug 107 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-07-29 | AbbVie | AbbVie Announces European Commission Approval of RINVOQ® (upadacitinib) for the Treatment of Adults and Adolescents with Severe Alopecia Areata abbvie.com ↗ |
| 2026-07-29 | AbbVie | AbbVie Announces European Commission Approval of RINVOQ® (upadacitinib) for the Treatment of Adults and Adolescents with Non-Segmental Vitiligo abbvie.com ↗ |
| 2026-06-29 | AbbVie | 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 | AbbVie Receives Positive CHMP Opinion for Upadacitinib (RINVOQ®) for the Treatment of Adults and Adolescents with Non-segmental Vitiligo abbvie.com ↗ |
| 2026-04-28 | AbbVie | AbbVie Submits Application to FDA for Upadacitinib (RINVOQ®) for Adults and Adolescents with Severe Alopecia Areata abbvie.com ↗ |
| 2026-02-03 | AbbVie | AbbVie Submits Regulatory Applications to FDA and EMA for Upadacitinib (RINVOQ®) in Adults and Adolescents With Vitiligo abbvie.com ↗ |
| 2025-10-29 | AbbVie | AbbVie Announces Positive Topline Results from Phase 3 Pivotal Studies Evaluating Upadacitinib (RINVOQ®) in Adults and Adolescents with Vitiligo abbvie.com ↗ |
| 2025-10-20 | AbbVie | 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 ↗ |
| 2025-10-13 | AbbVie | U.S. Food and Drug Administration (FDA) Approves Updated Indication Statement for RINVOQ® (upadacitinib) for the Treatment of Inflammatory Bowel Disease abbvie.com ↗ |
| 2025-08-21 | AbbVie | AbbVie Announces Positive Topline Results from Second Phase 3 UP-AA Trial Evaluating Upadacitinib (RINVOQ®) for Alopecia Areata abbvie.com ↗ |
| 2025-07-30 | AbbVie | AbbVie Announces Positive Topline Results from Phase 3 UP-AA Trial Evaluating Upadacitinib (RINVOQ®) for Alopecia Areata abbvie.com ↗ |
| 2025-04-29 | AbbVie | RINVOQ® (upadacitinib) Receives U.S. FDA Approval for Giant Cell Arteritis (GCA) abbvie.com ↗ |
| 2025-04-08 | AbbVie | AbbVie Announces European Commission Approval of RINVOQ® (upadacitinib) for the Treatment of Adults with Giant Cell Arteritis abbvie.com ↗ |
| 2025-02-28 | AbbVie | AbbVie Receives Positive CHMP Opinion for Upadacitinib (RINVOQ®) for the Treatment of Adults with Giant Cell Arteritis abbvie.com ↗ |
| 2024-09-25 | AbbVie | New Analysis Demonstrates the Efficacy of RINVOQ® (upadacitinib) in Atopic Dermatitis with Varying Degrees of Severity in Head and Neck Involvement abbvie.com ↗ |
| 2024-07-12 | AbbVie | AbbVie Submits Regulatory Applications to FDA and EMA for Upadacitinib (RINVOQ®) in Giant Cell Arteritis abbvie.com ↗ |
| 2024-06-04 | AbbVie | RINVOQ® (upadacitinib) Now Available for Pediatric Patients Two Years and Older with Polyarticular Juvenile Idiopathic Arthritis and Psoriatic Arthritis abbvie.com ↗ |
| 2024-04-25 | AbbVie | 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 ↗ |
| 2024-04-18 | AbbVie | Phase 3 SELECT-GCA Study of Upadacitinib (RINVOQ®) Showed Positive Results in Patients With Giant Cell Arteritis abbvie.com ↗ |
| 2023-10-12 | AbbVie | AbbVie Announces Upadacitinib (RINVOQ®) Met the Primary Endpoint in Phase 2 Clinical Trial of Vitiligo as Program Advances to Phase 3 abbvie.com ↗ |
| 2023-10-11 | AbbVie | 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 ↗ |
| 2023-07-24 | AbbVie | AbbVie Advances Immunology Pipeline with First Patient Dosed in Global Phase 3 Trial of Upadacitinib (RINVOQ®) in Hidradenitis Suppurativa abbvie.com ↗ |
| 2023-05-31 | AbbVie | 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 | New England Journal of Medicine Publishes Results from Phase 3 Induction and Maintenance Programs Evaluating Upadacitinib (RINVOQ®) in Crohn's Disease abbvie.com ↗ |
| 2023-05-24 | AbbVie | AbbVie Presents Long-Term Data Further Supporting the Efficacy and Safety Profile of RINVOQ® (upadacitinib) Across Multiple Rheumatic Diseases at the EULAR 2023 Congress abbvie.com ↗ |
| 2023-05-18 | AbbVie | U.S. FDA Approves RINVOQ® (upadacitinib) as a Once-Daily Pill for Moderately to Severely Active Crohn's Disease in Adults abbvie.com ↗ |
| 2023-04-17 | AbbVie | 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 | AbbVie Advances Upadacitinib (RINVOQ®) to Phase 3 Clinical Trials in Systemic Lupus Erythematosus abbvie.com ↗ |
| 2023-02-27 | AbbVie | AbbVie Receives Positive CHMP Opinion for Upadacitinib (RINVOQ®) for the Treatment of Adults with Moderate to Severe Crohn's Disease abbvie.com ↗ |
| 2022-10-21 | AbbVie | RINVOQ® (Upadacitinib) Receives Its Sixth U.S. FDA Approval abbvie.com ↗ |
| 2022-07-29 | AbbVie | RINVOQ® (upadacitinib) Approved by European Commission as an Oral Treatment for Adults with Active Non-Radiographic Axial Spondyloarthritis abbvie.com ↗ |
| 2022-07-27 | AbbVie | AbbVie Submits Regulatory Applications to FDA and EMA for Upadacitinib (RINVOQ®) in Crohn's Disease abbvie.com ↗ |
| 2022-07-26 | AbbVie | European Commission Approves RINVOQ® (upadacitinib) for the Treatment of Adults With Moderate to Severe Ulcerative Colitis abbvie.com ↗ |
| 2022-06-27 | AbbVie | CHMP Recommends Approval of Upadacitinib (RINVOQ®) for the Treatment of Adults with Active Non-Radiographic Axial Spondyloarthritis abbvie.com ↗ |
| 2022-06-01 | AbbVie | AbbVie Presents Positive Results from Phase 3 SELECT-AXIS 2 Trials of Upadacitinib (RINVOQ®) in Patients with Axial Spondyloarthritis at EULAR 2022 abbvie.com ↗ |
| 2022-05-27 | AbbVie | The Lancet Publishes Results from Phase 3 Induction and Maintenance Programs Evaluating Upadacitinib (RINVOQ®) in Ulcerative Colitis abbvie.com ↗ |
| 2022-05-23 | AbbVie | 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 | Upadacitinib (RINVOQ®) Achieved Clinical Remission and Endoscopic Response at One Year in Phase 3 Maintenance Study in Patients with Crohn's Disease abbvie.com ↗ |
| 2022-04-29 | AbbVie | RINVOQ® (upadacitinib) Approved by U.S. FDA as an Oral Treatment for Adults with Active Ankylosing Spondylitis abbvie.com ↗ |
| 2022-03-16 | AbbVie | RINVOQ® (upadacitinib) Receives FDA Approval for the Treatment of Adults with Moderately to Severely Active Ulcerative Colitis abbvie.com ↗ |
| 2022-02-24 | AbbVie | Second Phase 3 Induction Study Confirms Upadacitinib (RINVOQ®) Improved Clinical and Endoscopic Outcomes in Patients with Crohn's Disease abbvie.com ↗ |
| 2022-01-14 | AbbVie | U.S. FDA Approves RINVOQ® (upadacitinib) to Treat Adults and Children 12 Years and Older with Refractory, Moderate to Severe Atopic Dermatitis abbvie.com ↗ |
| 2022-01-11 | AbbVie | AbbVie Confirms Guidance of Greater Than $15 Billion in Combined Risk-Adjusted Sales for Rinvoq and Skyrizi in 2025 abbvie.com ↗ |
| 2022-01-07 | AbbVie | 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 | RINVOQ® (upadacitinib) Receives U.S. FDA Approval for Active Psoriatic Arthritis abbvie.com ↗ |
| 2021-12-06 | AbbVie | Upadacitinib (RINVOQ®) Achieved Primary and Key Secondary Endpoints in First Phase 3 Induction Study in Patients with Crohn's Disease abbvie.com ↗ |
| 2021-12-03 | AbbVie | AbbVie Provides Update on RINVOQ® (upadacitinib) for the Treatment of Rheumatoid Arthritis in the U.S. abbvie.com ↗ |
| 2021-11-09 | AbbVie | AbbVie to Present New Long-term Analysis Evaluating the Sustainability of Response to RINVOQ® (Upadacitinib) Among Patients with Rheumatoid Arthritis abbvie.com ↗ |
| 2021-11-09 | AbbVie | AbbVie Presents New Efficacy Data on Upadacitinib (RINVOQ®) in People with Active Psoriatic Arthritis and Axial Involvement at ACR Convergence 2021 abbvie.com ↗ |
| 2021-10-07 | AbbVie | AbbVie's Upadacitinib (RINVOQ®) Met Primary and Most Ranked Secondary Endpoints in Phase 3 Study for Non-Radiographic Axial Spondyloarthritis abbvie.com ↗ |
| 2021-10-07 | AbbVie | AbbVie's RINVOQ® (upadacitinib) Met Primary and All Ranked Secondary Endpoints in Phase 3 Study in Ankylosing Spondylitis abbvie.com ↗ |
| 2021-09-30 | AbbVie | AbbVie Presents New Analyses Evaluating RINVOQ® (upadacitinib) in Atopic Dermatitis Across Patient Characteristics and Body Regions at EADV Virtual Congress abbvie.com ↗ |
| 2021-09-16 | AbbVie | 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 ↗ |
| 2021-08-24 | AbbVie | 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 ↗ |
| 2021-08-04 | AbbVie | 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 ↗ |
| 2021-07-16 | AbbVie | AbbVie Provides Update Regarding RINVOQ® (upadacitinib) for the Treatment of Moderate to Severe Atopic Dermatitis in the U.S. abbvie.com ↗ |
| 2021-06-29 | AbbVie | Upadacitinib (RINVOQ®) Met the Primary and All Secondary Endpoints in the 52-Week Phase 3 Maintenance Study in Ulcerative Colitis Patients abbvie.com ↗ |
| 2021-06-25 | AbbVie | CHMP Recommends Approval of RINVOQ® (upadacitinib) for the Treatment of Atopic Dermatitis abbvie.com ↗ |
| 2021-06-25 | AbbVie | AbbVie Provides Update Regarding RINVOQ® (upadacitinib) in Psoriatic Arthritis and Ankylosing Spondylitis in the U.S. abbvie.com ↗ |
| 2021-06-02 | AbbVie | 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 ↗ |
| 2021-06-02 | AbbVie | AbbVie to Present Analysis Evaluating Continuous RINVOQ® (upadacitinib) Treatment in Psoriatic Arthritis for More Than One Year at EULAR 2021 Virtual Congress abbvie.com ↗ |
| 2021-05-24 | AbbVie | The Lancet Publishes Results from Pivotal Global Phase 3 Program Evaluating RINVOQ® (upadacitinib) in Atopic Dermatitis abbvie.com ↗ |
| 2021-04-02 | AbbVie | AbbVie Announces Extension of Review for Supplemental New Drug Application of Upadacitinib for the Treatment of Moderate to Severe Atopic Dermatitis abbvie.com ↗ |
| 2021-04-01 | AbbVie | 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 | AbbVie Announces Extension of Review for Supplemental New Drug Application of Upadacitinib for the Treatment of Adults with Active Psoriatic Arthritis abbvie.com ↗ |
| 2021-02-22 | AbbVie | Second Phase 3 Induction Study Confirms Upadacitinib (RINVOQ™) Improved Clinical, Endoscopic and Histologic Outcomes in Ulcerative Colitis Patients abbvie.com ↗ |
| 2021-01-25 | AbbVie | European Commission Approves AbbVie's RINVOQ™ (Upadacitinib) for the Treatment of Psoriatic Arthritis and Ankylosing Spondylitis abbvie.com ↗ |
| 2020-12-11 | AbbVie | CHMP Recommends the Approvals of RINVOQ™ (Upadacitinib) for the Treatment of Adults with Active Psoriatic Arthritis and Ankylosing Spondylitis abbvie.com ↗ |
| 2020-12-10 | AbbVie | 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 ↗ |
| 2020-12-09 | AbbVie | Upadacitinib (RINVOQ™) Meets Primary and All Ranked Secondary Endpoints in First Phase 3 Induction Study in Ulcerative Colitis abbvie.com ↗ |
| 2020-10-29 | AbbVie | AbbVie to Present New Analyses from Pivotal Phase 3 Studies for RINVOQ™ (upadacitinib) in Atopic Dermatitis abbvie.com ↗ |
| 2020-10-19 | AbbVie | AbbVie Submits Regulatory Applications to FDA and EMA for RINVOQ™ (upadacitinib) in Atopic Dermatitis abbvie.com ↗ |
| 2020-08-25 | AbbVie | AbbVie Submits Regulatory Application to FDA for RINVOQ™ (upadacitinib) for the Treatment of Adults with Active Ankylosing Spondylitis abbvie.com ↗ |
| 2020-07-28 | AbbVie | Third Pivotal Phase 3 Study Shows RINVOQ™ (upadacitinib) Plus Topical Corticosteroids Improves Skin and Itch Symptoms in Atopic Dermatitis Patients abbvie.com ↗ |
| 2020-07-21 | AbbVie | RINVOQ™ (upadacitinib) Monotherapy Meets All Primary and Secondary Endpoints in Second Phase 3 Study for Atopic Dermatitis abbvie.com ↗ |
| 2020-06-18 | AbbVie | RINVOQ™ (upadacitinib) Monotherapy Shows Improvement in Skin Clearance and Itch in First Phase 3 Study for Atopic Dermatitis abbvie.com ↗ |
| 2020-06-06 | AbbVie | 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 ↗ |
| 2020-06-04 | AbbVie | 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 ↗ |
| 2020-06-01 | AbbVie | AbbVie Submits Regulatory Applications to FDA and EMA for RINVOQ™ (upadacitinib) for the Treatment of Adults with Active Psoriatic Arthritis abbvie.com ↗ |
| 2020-02-05 | AbbVie | RINVOQ™ (upadacitinib) Meets Primary and Key Secondary Endpoints in Phase 3 Study in Psoriatic Arthritis abbvie.com ↗ |
| 2019-12-18 | AbbVie | AbbVie Receives European Commission Approval of RINVOQ™ (upadacitinib) for the Treatment of Adults with Moderate to Severe Active Rheumatoid Arthritis abbvie.com ↗ |
| 2019-11-12 | AbbVie | 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 | RINVOQ™ (upadacitinib) Meets Primary and All Ranked Secondary Endpoints in Phase 3 Study in Psoriatic Arthritis abbvie.com ↗ |
| 2019-10-18 | AbbVie | AbbVie Receives CHMP Positive Opinion for Upadacitinib (RINVOQ™) for the Treatment of Adults with Moderate to Severe Active Rheumatoid Arthritis abbvie.com ↗ |
| 2019-08-16 | AbbVie | AbbVie Receives FDA Approval of RINVOQ™ (upadacitinib), an Oral JAK Inhibitor For The Treatment of Moderate to Severe Rheumatoid Arthritis abbvie.com ↗ |
| 2019-06-12 | AbbVie | 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 ↗ |
| 2019-02-19 | AbbVie | 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 ↗ |
| 2018-12-20 | AbbVie | 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 | 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 ↗ |
| 2018-10-22 | AbbVie | Positive Phase 2b Data for AbbVie's Upadacitinib Show Significant Induction of Clinical Remission and Response in Patients with Ulcerative Colitis abbvie.com ↗ |
| 2018-10-08 | AbbVie | AbbVie to Present New Data for Upadacitinib and HUMIRA® (adalimumab) at the 2018 ACR/ARHP Annual Meeting abbvie.com ↗ |
| 2018-09-13 | AbbVie | 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 ↗ |
| 2018-06-12 | AbbVie | 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 ↗ |
| 2018-06-05 | AbbVie | Upadacitinib Monotherapy Meets All Primary and Ranked Secondary Endpoints Versus Methotrexate in a Phase 3 Study in Rheumatoid Arthritis abbvie.com ↗ |
| 2018-04-25 | AbbVie | AbbVie's Upadacitinib Meets Primary and Key Efficacy Endpoints in Phase 2b/3 Rheumatoid Arthritis Study in Japanese Patients abbvie.com ↗ |
| 2018-04-09 | AbbVie | Upadacitinib Meets All Primary and Ranked Secondary Endpoints Including Superiority Versus Adalimumab in Phase 3 Study in Rheumatoid Arthritis abbvie.com ↗ |
| 2018-02-17 | AbbVie | AbbVie Presents New Late-Breaking Phase 2b Data on Upadacitinib in Atopic Dermatitis at the 2018 American Academy of Dermatology Annual Meeting abbvie.com ↗ |
| 2018-02-16 | AbbVie | 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 | AbbVie's Upadacitinib Granted Breakthrough Therapy Designation from the U.S. Food and Drug Administration for Atopic Dermatitis abbvie.com ↗ |
| 2017-12-20 | AbbVie | AbbVie's Upadacitinib Shows Positive Results as Monotherapy in Phase 3 Rheumatoid Arthritis Study, Meeting All Primary and Key Secondary Endpoints abbvie.com ↗ |
| 2017-09-11 | AbbVie | AbbVie's Upadacitinib (ABT-494) Meets All Primary and Ranked Secondary Endpoints in Second Phase 3 Study in Rheumatoid Arthritis abbvie.com ↗ |
| 2017-09-07 | AbbVie | AbbVie's Upadacitinib (ABT-494) Meets Primary Endpoint in Phase 2b Study in Atopic Dermatitis abbvie.com ↗ |
| 2017-06-07 | AbbVie | AbbVie's Upadacitinib (ABT-494) Meets All Primary and Ranked Secondary Endpoints in Phase 3 Study in Rheumatoid Arthritis abbvie.com ↗ |
| 2017-05-09 | AbbVie | AbbVie Announces Positive Phase 2 Study Results for Upadacitinib (ABT-494), an Investigational JAK1-Selective Inhibitor, in Crohn's Disease abbvie.com ↗ |
| 2016-01-08 | AbbVie | AbbVie Announces the Launch of Robust Phase 3 Clinical Trial Program Evaluating ABT-494, an Investigational Selective JAK1 Inhibitor, for the Treatment of Rheumatoid Arthritis abbvie.com ↗ |
| 2015-09-25 | AbbVie | AbbVie's ABT-494 Meets Primary Endpoint in Two Phase 2 Studies in Rheumatoid Arthritis abbvie.com ↗ |
| 2015-09-25 | AbbVie | AbbVie to Advance Once-Daily ABT-494 to Phase 3 in Rheumatoid Arthritis by Year-End abbvie.com ↗ |
Evidence & citations 17 cited values
Every value below carries the sentence it was read from. 113 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 ↗101“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 ↗ |