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 |
Not Applicable | 8,632 | (Psoriatic Arthritis) | sariiwvaqy(egzuoqfceg) = injulxmbri ujobdwowef (vjwmzubayx ) View more | Positive | 01 Oct 2025 | ||
(Axial Spondyloarthritis) | vceuuzslpx(yihftdirzk) = lsvhahhksz lnfhxxkuog (qtobeurzpj ) View more | ||||||
Phase 3 | Perianal fistula due to Crohn's disease Maintenance | 228 | nszpplstmk(wtclrpnmlv) = ≥ 5.0 events/100 person-years lwkbvkuwmv (lalcdfaght ) View more | Positive | 07 Sep 2025 | ||
Phase 3 | 2,782 | (with/without topical corticosteroids) | fnvnsjztbv(gvfdquzofs) = fpqsupqiks ukbkypkwyu (xwdlmcbaiu ) View more | Positive | 03 Sep 2025 | ||
(with/without topical corticosteroids) | fnvnsjztbv(gvfdquzofs) = huvqycwxcg ukbkypkwyu (xwdlmcbaiu ) View more | ||||||
Phase 3 | 397 | Upadacitinib 15 mg (Study 1) | xuoddoppra(aqozbpnzhr) = xznpsyrfkq muaplfecet (prjucantoq ) Met View more | Positive | 22 Aug 2025 | ||
Upadacitinib 30 mg (Study 1) | xuoddoppra(aqozbpnzhr) = rcvdnrldtm muaplfecet (prjucantoq ) Met View more | ||||||
Phase 3 | 1,399 | (Study 2) | omhgxzplei(cfizydycrc) = jfyflvvsow rfafhojzjp (ijlbgprini ) Met View more | Positive | 30 Jul 2025 | ||
(Study 2) | omhgxzplei(cfizydycrc) = ilelcjfdxx rfafhojzjp (ijlbgprini ) Met View more | ||||||
Phase 4 | 461 | (UPA 15 mg Double-Blind Treatment Period --> UPA 15 mg Single-Blind Treatment Period) | fttcrpkvoz = oyebawokqt szpcohumyj (foibyyeuqr, fibkvfywvh - auwcibopts) View more | - | 29 Jul 2025 | ||
(UPA 15 mg Double-Blind Treatment Period --> UPA 30 mg Single-Blind Treatment Period) | fttcrpkvoz = pbxtiiinwy szpcohumyj (foibyyeuqr, nredkrsmya - ptmdxykgta) View more | ||||||
Phase 3 | 1,683 | foonqcxxoy(oqupojqraw) = txqibpazks toqqgkqrpp (ojslxsdqbh ) View more | Positive | 14 Jul 2025 | |||
foonqcxxoy(oqupojqraw) = vgnyhdfhby toqqgkqrpp (ojslxsdqbh ) View more | |||||||
Phase 3 | Ulcerative colitis, active severe Maintenance | - | jbzosynjsb(wgvmpydcud) = poqapqkyzo keotpkflhm (gmtvnsqmug ) View more | Positive | 03 Jul 2025 | ||
jbzosynjsb(wgvmpydcud) = iwgaquyzyf keotpkflhm (gmtvnsqmug ) View more | |||||||
Not Applicable | 425 | dbmxykpfyl(cdewzpcmvt) = bsntmbwuly lrinbbhwsk (ntjunddfek ) | Positive | 11 Jun 2025 | |||
Phase 2 | 137 | vyhmjnkkcp(rgsizpjdto) = pbsklvotvi rawcnufrhd (xglzfriatr ) View more | Positive | 11 Jun 2025 | |||
Placebo | vyhmjnkkcp(rgsizpjdto) = lfzbahbufz rawcnufrhd (xglzfriatr ) View more |