Drug Type Small molecule drug |
Synonyms Upadacitinib Hydrate, Upadacitinib tartrate, 乌帕奴单抗 + [8] |
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), Orphan Drug (European Union), Priority Review (China), Breakthrough Therapy (China), Orphan Drug (Japan), 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 |
|---|---|---|---|---|
| Alopecia Areata | NDA/BLA | United States | 28 Apr 2026 | |
| Nonsegmental vitiligo | NDA/BLA | United States | 03 Feb 2026 | |
| Nonsegmental vitiligo | NDA/BLA | European Union | 03 Feb 2026 | |
| Pediatric Crohn's Disease | Phase 3 | United States | 08 Aug 2024 | |
| Pediatric Crohn's Disease | Phase 3 | China | 08 Aug 2024 | |
| Pediatric Crohn's Disease | Phase 3 | Japan | 08 Aug 2024 | |
| Pediatric Crohn's Disease | Phase 3 | Australia | 08 Aug 2024 | |
| Pediatric Crohn's Disease | Phase 3 | Belgium | 08 Aug 2024 | |
| Pediatric Crohn's Disease | Phase 3 | Brazil | 08 Aug 2024 | |
| Pediatric Crohn's Disease | Phase 3 | Bulgaria | 08 Aug 2024 |
Phase 3 | 492 | dikowbdlmj(luzeyrddck) = feuebkxbvx bikwrpnzzn (wzrkltaext ) View more | Positive | 01 Apr 2026 | |||
dikowbdlmj(luzeyrddck) = kltkbjaupc bikwrpnzzn (wzrkltaext ) View more | |||||||
Not Applicable | 103,275 | wipzdlxpfx(emdcuvlfmd) = median onset ranged from 103 to 358 days across drugs, with early-failure type pattern ( 31), indicating AE rates declined over time. Tofacitinib cumulative AE curve differed significantly from others (adj.p 3C2e-16). dkatjzwayv (daladkfwez ) View more | Positive | 27 Mar 2026 | |||
Not Applicable | 504 | (Atopic Dermatitis) | mldzamphcr(lpvfvstjwk) = doinmtydjd jphsdozpyd (bnxyobfppc ) View more | Positive | 27 Mar 2026 | ||
Not Applicable | 1,092 | syckxchrvh(wlpgbvofzo) = uoagkugdtf ygwrjdbdpz (ntjnsmixal ) View more | Positive | 27 Mar 2026 | |||
syckxchrvh(wlpgbvofzo) = dlczfsaatn ygwrjdbdpz (ntjnsmixal ) View more | |||||||
Not Applicable | 3,009 | dentpoayjd(owzfpmhjmb): RR = 1.64 (95.0% CI, 1.23 - 2.17), P-Value = 0.0007 View more | Positive | 27 Mar 2026 | |||
Not Applicable | 189 | (bio-naïve) | stgbduuino(gmplshcjrj) = atjggfqcrz xxwwyzwqys (ualfiagpns ) View more | Positive | 27 Mar 2026 | ||
(bio-experienced) | stgbduuino(gmplshcjrj) = sdzzvedvnb xxwwyzwqys (ualfiagpns ) View more | ||||||
Not Applicable | 24 | (Severe Atopic Dermatitis) | ywpemermyj(axljbiggzt) = dssbseyoaz mbdyuhozko (inuypihcnx ) View more | Positive | 27 Mar 2026 | ||
Phase 1 | 12 | rbnpmwnvyr(tflylviwbr) = dwotdqqpau tefcoyxfuf (caqnonjveu ) View more | Positive | 27 Mar 2026 | |||
Not Applicable | 1,159 | vgbbagbjnj(kzmbgixzlz) = tkccqdmtmf nnwvcxmbbj (yruktcskpd ) View more | Positive | 27 Mar 2026 | |||
Not Applicable | - | 4 | (Steroid-Refractory Immune-Related Cutaneous Adverse Events) | nvsyvjheuy(gasbaixpad) = No patients experienced progression of underlying malignancy, and in two cases serial PET/CT scans showed continued improvement (patients still on therapy >12 weeks). hhdmsrdkrp (wzesmyefea ) | Positive | 27 Mar 2026 |





