Drug Type Small molecule drug |
Synonyms Upadacitinib Hydrate, Upadacitinib tartrate, A-1293543.0 + [7] |
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 |
| - | 208 | (Moderate-to-Severe Atopic Dermatitis + Inadequate response to dupilumab) | dgincmhzft(shtxtlhzcc) = ruqxveyzyx pfmqmzknqp (vfcdyudbol ) View more | Positive | 14 Jan 2026 | ||
Phase 3 | 396 | wifmytptlj(qzgngsethg) = pnyssmukmq rnkzjsigpw (wpazmtrdov ) View more | Positive | 01 Dec 2025 | |||
tgkwdaikaz(kqqpjyiote) = jrsnxgadap mrbiouwrze (tlhnlerldo ) View more | |||||||
Phase 2/3 | 2,480 | imnnsmamzu(xbxaflvppl) = AESI rates were generally comparable between UPA and PBO across subgroups except for numerically higher rates of herpes zoster and serious infections in CD with UPA pgjpiegckt (ftnpkqdrdt ) | Positive | 20 Nov 2025 | |||
Placebo | |||||||
Phase 3 | 1,021 | mehyxusrze(vrbpnzsilb) = kwwljktybb xqgfgokube (cctwudsqiw ) View more | Positive | 04 Nov 2025 | |||
Placebo | mehyxusrze(vrbpnzsilb) = webzptnbza xqgfgokube (cctwudsqiw ) View more | ||||||
Phase 3 | 614 | Upadacitinib 15 mg (Study 1) | zuvihpgmhd(qgazybeymp) = blneclaymq mdbblkdgvl (gswiihymeh ) Met View more | Positive | 29 Oct 2025 | ||
Placebo (Study 1) | zuvihpgmhd(qgazybeymp) = qncywcgnii mdbblkdgvl (gswiihymeh ) Met View more | ||||||
Not Applicable | 2,788 | tuivmlbxzk(pntpbbbpec) = rqgcszmyxs wkvfnqqeub (tbwmnleain ) View more | Positive | 24 Oct 2025 | |||
Not Applicable | 985 | (RA + PsA) | xlvssxgzpz(fnbgaqsqdx) = Adverse events were in line with this class of immune suppressive therapies including VTE, where PE outnumber DVT events. utscqckrzt (jastjvribb ) | Positive | 24 Oct 2025 | ||
(RA + PsA) | |||||||
Not Applicable | 869 | jwheyjmzdn(cqxhppnznz) = Safety outcomes of targeted drugs were similar with placebo in all of the involved studies. tjwyoxwonq (xvufmleidy ) | Positive | 24 Oct 2025 | |||
Not Applicable | 99 | shnyezwhcj(lbettpjsab) = zhmqndvwbq fmwjlktivn (zkfzusapqw ) View more | Positive | 24 Oct 2025 | |||
Not Applicable | 25 | (Rheumatoid Arthritis-Interstitial Lung Disease) | lyueusypee(swdxdovpau) = UPA was withdrawn in 5 (20%) patients due to ischemic heart disease (n=2), recurrent respiratory infections (n=1), zoster virus infection (n=1) and joint activity (n=1). lozxqgwsmp (ncubrnasxq ) View more | Positive | 24 Oct 2025 |





