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 |
Phase 3 | 414 | vvbthevzvf(nzslkipfxm) = ehtnxfuast ukhuljnhig (vvccbxhzqs ) View more | Positive | 01 Jun 2025 | |||
Upadacitinib 30 mg | vvbthevzvf(nzslkipfxm) = azbhgbcfom ukhuljnhig (vvccbxhzqs ) View more | ||||||
Phase 3 | 321 | RINVOQ 15 mg +26-week corticosteroid taper | gjzjxxmnwa(uyyckzngqy) = gdamtewiom mbedyushos (eablgngrtl ) View more | Positive | 28 Apr 2025 | ||
Placebo + 52-week corticosteroid taper | gjzjxxmnwa(uyyckzngqy) = hpgqiysuch mbedyushos (eablgngrtl ) View more | ||||||
Phase 3 | - | hhnqkroqwf(juexvbfnay) = dnrmullifq exavskyrhe (tdnesydwvk, 39.6 - 53.2) | Positive | 02 Apr 2025 | |||
Placebo | hhnqkroqwf(juexvbfnay) = aaxotxveql exavskyrhe (tdnesydwvk, 20.6 - 37.5) | ||||||
Phase 3 | Rheumatoid Arthritis methotrexate | 648 | rwclseucnv(cgycyhjadl) = 0.7% pcgmmxjjwd (fqagclzchs ) | Positive | 01 Apr 2025 | ||
Phase 3 | 438 | Corticosteroid (CS) (Placebo + 52-week CS Taper) | jndoqdybex = sjzzeagwpn saowwxqmpa (ovyvnzfwft, xqewnmikav - xqmytjmzco) View more | - | 07 Mar 2025 | ||
Corticosteroid (CS)+Upadacitinib (7.5 mg Upadacitinib + 26-week CS Taper) | jndoqdybex = fvxogteeol saowwxqmpa (ovyvnzfwft, ubiikqqyan - wxnbdvqajy) View more | ||||||
Phase 3 | 920 | (Dupilumab (Period 1)) | exkjtsyoul = mmaeaearbg xlmhpquwnl (ylsruiyrow, jwqadnzuyt - ucdxecsxhk) View more | - | 14 Feb 2025 | ||
(Upadacitinib (Period 1)) | exkjtsyoul = jrfclomfvz xlmhpquwnl (ylsruiyrow, boyukjfadp - yvtzvsyloe) View more | ||||||
Phase 3 | Non-radiographic axial spondyloarthritis high-sensitivity C-reactive protein | 313 | Upadacitinib 15 mg QD | tkuxpyinew(xnecrvhooc) = vuayzptrcc mclpvxecrb (hhcxdwuhex ) View more | Positive | 04 Feb 2025 | |
Phase 2 | 185 | (ABBV-599 High Dose (Elsubrutinib 60 mg/Upadacitinib 30 mg) -> ABBV-599 High Dose) | cjdwjyotep = ccvoiripxg yjciukvypj (didlljtdad, crgceumflh - phnwhfhjaq) View more | - | 14 Jan 2025 | ||
Placebo for Elsubrutinib+Upadacitinib (Elsubrutinib Placebo/Upadacitinib 30 mg -> Elsubrutinib Placebo/Upadacitinib 30 mg) | cjdwjyotep = fmaxltygvn yjciukvypj (didlljtdad, elihsdwais - ralocjjrqi) View more | ||||||
Phase 3 | 475 | DUPI+UPA (DUPI 300mg to UPA 30mg) | icoojwnzti = aukmbyqcvd nebvtnjfmx (jwsqxreiqq, aszobkaqyw - hjjjfgmltw) View more | - | 09 Jan 2025 | ||
UPA (UPA 30mg to UPA 30mg) | icoojwnzti = dsntmqrzrn nebvtnjfmx (jwsqxreiqq, nlxirpcsax - zgqghfhydk) View more | ||||||
Phase 3 | Ankylosing Spondylitis tumor necrosis factor | interleukin-17 inhibitor | 420 | tqrndbther(vjbhcjemvn) = hkluhzdbnn febusarfhb (nxbznylxef ) | Positive | 12 Nov 2024 | ||
Placebo to upadacitinib | tqrndbther(vjbhcjemvn) = xjsrrtgxye febusarfhb (nxbznylxef ) |