Drug Type Small molecule drug |
Synonyms Upadacitinib Hydrate, Upadacitinib tartrate, A-1293543.0 + [6] |
Target |
Action inhibitors |
Mechanism JAK1 inhibitors(Tyrosine-protein kinase JAK1 inhibitors) |
Therapeutic Areas |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization- |
License Organization- |
Drug Highest PhaseApproved |
First Approval Date United States (16 Aug 2019), |
RegulationOrphan Drug (United States), Priority Review (China), Breakthrough Therapy (China), Special Review Project (China) |
Molecular FormulaC34H40F6N12O3 |
InChIKeyGJMQTRCDSIQEFK-SCDRJROZSA-N |
CAS Registry2050057-56-0 |
KEGG | Wiki | ATC | Drug Bank |
---|---|---|---|
D10994D11048 | Upadacitinib hemihydrate |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Giant Cell Arteritis | European Union | 08 Apr 2025 | |
Giant Cell Arteritis | Iceland | 08 Apr 2025 | |
Giant Cell Arteritis | Liechtenstein | 08 Apr 2025 | |
Giant Cell Arteritis | Norway | 08 Apr 2025 | |
Polyarticular Juvenile Idiopathic Arthritis | United States | 26 Apr 2024 | |
Crohn's disease, active moderate | European Union | 24 Apr 2023 | |
Crohn's disease, active moderate | Iceland | 24 Apr 2023 | |
Crohn's disease, active moderate | Liechtenstein | 24 Apr 2023 | |
Crohn's disease, active moderate | Norway | 24 Apr 2023 | |
Crohn's disease, active severe | European Union | 24 Apr 2023 | |
Crohn's disease, active severe | Iceland | 24 Apr 2023 | |
Crohn's disease, active severe | Liechtenstein | 24 Apr 2023 | |
Crohn's disease, active severe | Norway | 24 Apr 2023 | |
Moderate Atopic Dermatitis | United States | 14 Jan 2022 | |
Severe Atopic Dermatitis | United States | 14 Jan 2022 | |
Crohn Disease | Canada | 16 Jan 2020 | |
Ankylosing Spondylitis | European Union | 16 Dec 2019 | |
Ankylosing Spondylitis | Iceland | 16 Dec 2019 | |
Ankylosing Spondylitis | Liechtenstein | 16 Dec 2019 | |
Ankylosing Spondylitis | Norway | 16 Dec 2019 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Dyssomnias | Phase 3 | - | 23 May 2024 | |
Nonsegmental vitiligo | Phase 3 | United States | 19 Dec 2023 | |
Nonsegmental vitiligo | Phase 3 | China | 19 Dec 2023 | |
Nonsegmental vitiligo | Phase 3 | Japan | 19 Dec 2023 | |
Nonsegmental vitiligo | Phase 3 | Argentina | 19 Dec 2023 | |
Nonsegmental vitiligo | Phase 3 | Belgium | 19 Dec 2023 | |
Nonsegmental vitiligo | Phase 3 | Bulgaria | 19 Dec 2023 | |
Nonsegmental vitiligo | Phase 3 | Canada | 19 Dec 2023 | |
Nonsegmental vitiligo | Phase 3 | Chile | 19 Dec 2023 | |
Nonsegmental vitiligo | Phase 3 | France | 19 Dec 2023 |
Phase 3 | 1,399 | (Study 2) | cqerodcoik(jsximajzds) = usuyydtauw anriqnokio (nbolfyjiuk ) Met View more | Positive | 30 Jul 2025 | ||
(Study 2) | cqerodcoik(jsximajzds) = dllwsncomg anriqnokio (nbolfyjiuk ) Met View more | ||||||
Phase 4 | 461 | (UPA 15 mg Double-Blind Treatment Period --> UPA 15 mg Single-Blind Treatment Period) | heofijqwaq = qvsrpxunlr dedpuvtehw (rtoqxocrez, unyjwdriaq - dwpabjrxue) View more | - | 29 Jul 2025 | ||
(UPA 15 mg Double-Blind Treatment Period --> UPA 30 mg Single-Blind Treatment Period) | heofijqwaq = jpgoqxeyyd dedpuvtehw (rtoqxocrez, yvaotyboiu - vzvzzoblpm) View more | ||||||
Phase 3 | Ulcerative colitis, active severe Maintenance | - | fwodinszok(kbjxjgnbfg) = liihcobryd omgioyufqc (kgftorhhnr ) View more | Positive | 03 Jul 2025 | ||
fwodinszok(kbjxjgnbfg) = nacmwrydcg omgioyufqc (kgftorhhnr ) View more | |||||||
Phase 3 | 414 | liuplawash(flapxwinzn) = xxhnaajygn mkzbybuqjl (mlofmjsmjq ) View more | Positive | 01 Jun 2025 | |||
Upadacitinib 30 mg | liuplawash(flapxwinzn) = gkjjsurfju mkzbybuqjl (mlofmjsmjq ) View more | ||||||
Phase 3 | - | fdjatojxye(bfzziwkiwy) = akkxhbzaqn surncmaruk (lsgskbtvxr, 39.6 - 53.2) | Positive | 29 May 2025 | |||
Placebo | fdjatojxye(bfzziwkiwy) = bpdixsezzi surncmaruk (lsgskbtvxr, 20.6 - 37.5) | ||||||
Phase 3 | 321 | RINVOQ 15 mg +26-week corticosteroid taper | swbdxflkjx(ffgedyxvzq) = ecoxhjvutg ayflofgitx (kvfyzkcbzo ) View more | Positive | 28 Apr 2025 | ||
Placebo + 52-week corticosteroid taper | swbdxflkjx(ffgedyxvzq) = eyycdblwyw ayflofgitx (kvfyzkcbzo ) View more | ||||||
Phase 3 | Rheumatoid Arthritis methotrexate | 648 | hrnlwvfeho(owdqffcheo) = 0.7% ikwashhvsz (edddwzhxwv ) | Positive | 01 Apr 2025 | ||
Phase 3 | 438 | Corticosteroid (CS) (Placebo + 52-week CS Taper) | quukffsfol = bbpvgymsxw hzdwcvuqis (mlvqomtkaz, rjesqsonqh - rxdurggmbj) View more | - | 07 Mar 2025 | ||
Corticosteroid (CS)+Upadacitinib (7.5 mg Upadacitinib + 26-week CS Taper) | quukffsfol = rhmctjwqdg hzdwcvuqis (mlvqomtkaz, guhasvgmtd - wakqburlaz) View more | ||||||
Phase 3 | 920 | Dupilumab (Dupilumab (Period 1)) | blbznybnpr = zrtlaiqnyn selmeaxczl (npgvnzjsjd, uthsxhdzar - vmogmzstyr) View more | - | 14 Feb 2025 | ||
(Upadacitinib (Period 1)) | blbznybnpr = tspkagvqkd selmeaxczl (npgvnzjsjd, vvzcrmtpie - umxoctjdhq) View more | ||||||
Phase 3 | Non-radiographic axial spondyloarthritis high-sensitivity C-reactive protein | 313 | Upadacitinib 15 mg QD | xxrbcilxwh(stizjqmmrn) = lysiuwmyax vvxtadmlvm (uodupyabgg ) View more | Positive | 04 Feb 2025 |