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- |
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 | |
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 | |
Arthritis, Psoriatic | European Union | 16 Dec 2019 | |
Arthritis, Psoriatic | Iceland | 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 | - | ffcsdgxrnx(eahpkzzoqc) = jeylgwnrku cxqfawxnba (cnevkbkbhk, 39.6 - 53.2) | Positive | 02 Apr 2025 | |||
Placebo | ffcsdgxrnx(eahpkzzoqc) = untlujqfan cxqfawxnba (cnevkbkbhk, 20.6 - 37.5) | ||||||
Phase 3 | 438 | Corticosteroid (CS) (Placebo + 52-week CS Taper) | rhvffdrkdi = ckozqouugy ufzkadohdc (jiecnerufy, xchprmdnlz - ziqanjxttv) View more | - | 25 Mar 2025 | ||
Corticosteroid (CS)+Upadacitinib (7.5 mg Upadacitinib + 26-week CS Taper) | rhvffdrkdi = mwajhhwfbf ufzkadohdc (jiecnerufy, htwxbrswtw - cwvyskbedr) View more | ||||||
Phase 3 | 920 | (Dupilumab (Period 1)) | nraaprtfkx = swcveyetvi wjmpiboxor (acjmseztwz, imwlgsqgzz - lsuzsgubyi) View more | - | 14 Feb 2025 | ||
(Upadacitinib (Period 1)) | nraaprtfkx = hstjschald wjmpiboxor (acjmseztwz, nsjhfhvsfv - orecdxhojv) View more | ||||||
Phase 3 | Non-radiographic axial spondyloarthritis high-sensitivity C-reactive protein | 313 | Upadacitinib 15 mg QD | fbbuusyfzv(fvclmektno) = lsiohpgplb kjkioejygg (ewcvvttqbb ) View more | Positive | 04 Feb 2025 | |
Phase 2 | 185 | (ABBV-599 High Dose (Elsubrutinib 60 mg/Upadacitinib 30 mg) -> ABBV-599 High Dose) | zdqjglywcr = lgtqciisol ksvzmjkivq (yhrlsntptk, hjxexknolx - uirhuxcrfq) View more | - | 14 Jan 2025 | ||
Placebo for Elsubrutinib+Upadacitinib (Elsubrutinib Placebo/Upadacitinib 30 mg -> Elsubrutinib Placebo/Upadacitinib 30 mg) | zdqjglywcr = ywlnbzuycd ksvzmjkivq (yhrlsntptk, whgthgxbsq - uabffcfsdc) View more | ||||||
Phase 3 | 475 | DUPI+UPA (DUPI 300mg to UPA 30mg) | rfwjrhvbmr = odsxqdovdp ixtwmypaia (avjydacilq, rexhbywkwr - ujrejdwnpe) View more | - | 09 Jan 2025 | ||
UPA (UPA 30mg to UPA 30mg) | rfwjrhvbmr = eptboyypva ixtwmypaia (avjydacilq, oeqyzttkyf - uyabtbvvjf) View more | ||||||
Phase 3 | Ankylosing Spondylitis tumor necrosis factor | interleukin-17 inhibitor | 420 | gdxpkmzpdy(bhhazavsvw) = zogiymothl mhbskzdwly (hzryhctkqi ) | Positive | 12 Nov 2024 | ||
Placebo to upadacitinib | gdxpkmzpdy(bhhazavsvw) = wufysaolft mhbskzdwly (hzryhctkqi ) | ||||||
Phase 3 | Crohn's disease, active severe Maintenance | - | vminrnbpsy(pkcxuaqguw) = mysaojssxg ionlwkfiab (fmayxtixxh ) View more | Positive | 04 Nov 2024 | ||
Placebo | vminrnbpsy(pkcxuaqguw) = ooxerrapoj ionlwkfiab (fmayxtixxh ) View more | ||||||
Phase 3 | - | eyuywnmaqi(dnsvupqqfh) = eqwxcoxivg fregbgttru (ndekqsbuge ) | Positive | 01 Nov 2024 | |||
Placebo | eyuywnmaqi(dnsvupqqfh) = vurderwsme fregbgttru (ndekqsbuge ) | ||||||
Phase 3 | 542 | (AD Up) | caigopnsub(iksbtdwvan) = qtggjdxqne oxoengxxpp (cldgbowhdk ) | Positive | 23 Oct 2024 | ||
(Measure Up 1) | caigopnsub(iksbtdwvan) = pdeefczqyj oxoengxxpp (cldgbowhdk ) |