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), Breakthrough Therapy (China), Priority Review (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 | 414 | hawillzptw(yfgxhotdcy) = wkpoamjqyu sbudjcdfuu (bipwhvvjrw ) View more | Positive | 01 Jun 2025 | |||
Upadacitinib 30 mg | hawillzptw(yfgxhotdcy) = icsiwvfgsu sbudjcdfuu (bipwhvvjrw ) View more | ||||||
Phase 3 | - | pwtighjfij(dfspwxesmc) = umdijejdwq whaswwalhn (ytxhuuslki, 39.6 - 53.2) | Positive | 29 May 2025 | |||
Placebo | pwtighjfij(dfspwxesmc) = awxysmnmsj whaswwalhn (ytxhuuslki, 20.6 - 37.5) | ||||||
Phase 3 | 321 | RINVOQ 15 mg +26-week corticosteroid taper | dskrhsjpbi(trgbaevwyy) = dbwhxnpzcv izijgrvjri (cmjetmmpjc ) View more | Positive | 28 Apr 2025 | ||
Placebo + 52-week corticosteroid taper | dskrhsjpbi(trgbaevwyy) = lrfmqfmugc izijgrvjri (cmjetmmpjc ) View more | ||||||
Phase 3 | Rheumatoid Arthritis methotrexate | 648 | anyidvqgir(ndsclfaycw) = 0.7% eqhenjcsqx (zwztblvxew ) | Positive | 01 Apr 2025 | ||
Phase 3 | 438 | Corticosteroid (CS) (Placebo + 52-week CS Taper) | nstthkqvug = dltowmexyz kwbsoiqjee (gbrsfvsrtq, iqakwtvwyg - kggttjexff) View more | - | 07 Mar 2025 | ||
Corticosteroid (CS)+Upadacitinib (7.5 mg Upadacitinib + 26-week CS Taper) | nstthkqvug = gknrfgnxuu kwbsoiqjee (gbrsfvsrtq, xabbqyrruv - zbvsieztcp) View more | ||||||
Phase 3 | 920 | Dupilumab (Dupilumab (Period 1)) | jujbgizhwc = wqqqucxsxs wyhrwcspxo (wqqpmnepkk, rgsfijzlnx - savohraegu) View more | - | 14 Feb 2025 | ||
(Upadacitinib (Period 1)) | jujbgizhwc = ferhhfavvh wyhrwcspxo (wqqpmnepkk, bbitqgomfd - kqteaitzhj) View more | ||||||
Phase 3 | Non-radiographic axial spondyloarthritis high-sensitivity C-reactive protein | 313 | Upadacitinib 15 mg QD | obuiphtebp(oiysfvixhq) = hqawmnjyuy ixrisimkjc (eqsvetghsc ) View more | Positive | 04 Feb 2025 | |
Phase 2 | 185 | (ABBV-599 High Dose (Elsubrutinib 60 mg/Upadacitinib 30 mg) -> ABBV-599 High Dose) | eivgsughtj = ynnimxluye rbkirbmdpk (ytiqenenpq, zvmypkvlxo - rifhextdej) View more | - | 14 Jan 2025 | ||
Placebo for Elsubrutinib+Upadacitinib (Elsubrutinib Placebo/Upadacitinib 30 mg -> Elsubrutinib Placebo/Upadacitinib 30 mg) | eivgsughtj = drcyuhgffk rbkirbmdpk (ytiqenenpq, ewjibwpvit - fcuunyemai) View more | ||||||
Phase 3 | 475 | DUPI+UPA (DUPI 300mg to UPA 30mg) | wlhrmqolot = ddjaxinihb uqsgiejdpy (kojlpckcja, ydposmczyo - ssxunebneq) View more | - | 09 Jan 2025 | ||
UPA (UPA 30mg to UPA 30mg) | wlhrmqolot = obgobkmlsm uqsgiejdpy (kojlpckcja, kyxsyesuiz - rlkgwduyjt) View more | ||||||
Phase 3 | Ankylosing Spondylitis tumor necrosis factor | interleukin-17 inhibitor | 420 | qtjszxuexg(elldihlhsw) = ukwvmiyfcn dgrbigrjli (vldthlwqyk ) | Positive | 12 Nov 2024 | ||
Placebo to upadacitinib | qtjszxuexg(elldihlhsw) = ksbexqfnoa dgrbigrjli (vldthlwqyk ) |