Last update 08 Oct 2026

Upadacitinib hemihydrate

Overview

Basic Info

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)
Originator 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)
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Structure/Sequence

Molecular FormulaC34H40F6N12O3
InChIKeyGJMQTRCDSIQEFK-SCDRJROZSA-N
CAS Registry2050057-56-0

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Alopecia Areata
European Union
29 Jul 2026
Alopecia Areata
Iceland
29 Jul 2026
Alopecia Areata
Liechtenstein
29 Jul 2026
Alopecia Areata
Norway
29 Jul 2026
Nonsegmental vitiligo
European Union
29 Jun 2026
Nonsegmental vitiligo
Iceland
29 Jun 2026
Nonsegmental vitiligo
Liechtenstein
29 Jun 2026
Nonsegmental vitiligo
Norway
29 Jun 2026
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
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Pediatric Crohn's DiseasePhase 3
United States
08 Aug 2024
Pediatric Crohn's DiseasePhase 3
China
08 Aug 2024
Pediatric Crohn's DiseasePhase 3
Japan
08 Aug 2024
Pediatric Crohn's DiseasePhase 3
Australia
08 Aug 2024
Pediatric Crohn's DiseasePhase 3
Belgium
08 Aug 2024
Pediatric Crohn's DiseasePhase 3
Brazil
08 Aug 2024
Pediatric Crohn's DiseasePhase 3
Bulgaria
08 Aug 2024
Pediatric Crohn's DiseasePhase 3
Canada
08 Aug 2024
Pediatric Crohn's DiseasePhase 3
France
08 Aug 2024
Pediatric Crohn's DiseasePhase 3
Greece
08 Aug 2024
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
385
qnqkqyqfja(wkwaheblya) = ozmdvhhadb mhgycfwjpd (glzlbwxaon )
Positive
31 Dec 2026
qnqkqyqfja(wkwaheblya) = hqmikusdtg mhgycfwjpd (glzlbwxaon )
Phase 2
107
(Upadacitinib 30 mg)
mpaewtmwub = igotaevxir bcxgxsmbuo (joepcjishf, eujobzvkld - zksdvsxdrf)
-
13 Aug 2026
(Upadacitinib 15 mg, Then 30 mg)
mpaewtmwub = ocpiouofoy bcxgxsmbuo (joepcjishf, iefmqudqvj - ukvulgtxub)
Phase 3
1,399
gigdzqjjzb(ifjviuptiy) = vdfxdasgsb adcoohklqq (kvyhihtiwe )
Positive
12 Aug 2026
gigdzqjjzb(ifjviuptiy) = ovcbkxosdz adcoohklqq (kvyhihtiwe )
Not Applicable
8,050
pmhzetvvtf(fllqcgziin) = lpijruckjq ncuvyvzbye (vhxfoejavx )
Positive
14 Jul 2026
non-JAK therapies (including tumor necrosis factor-α inhibitors, interleukin-6 inhibitors and hydroxychloroquine)
pmhzetvvtf(fllqcgziin) = jizpttwhhj ncuvyvzbye (vhxfoejavx )
Phase 3
492
qhgjxmgsmz(hnzdsmzcva) = iqwsnzqoqs cxgmbqdedk (wubewnydyz )
Positive
01 Jul 2026
qhgjxmgsmz(hnzdsmzcva) = kayssokgmm cxgmbqdedk (wubewnydyz )
Phase 3
398
jhkofbjmex(bkyakmccjo) = omnghnnepy eckhjonymy (cjqgkotvwd )
Positive
01 Jul 2026
jhkofbjmex(bkyakmccjo) = qdnylsizvo eckhjonymy (cjqgkotvwd )
Not Applicable
602
luwtpwagrr(vucathgcuv) = gkacklkdoq xnnckwhkwd (ttemvopwds )
Positive
11 Jun 2026
TNFi
luwtpwagrr(vucathgcuv) = xpnsbcadua xnnckwhkwd (ttemvopwds )
Phase 3
-
UPA15
(new-onset or relapsing GCA)
hxlfngwoqi(qwyhvtrlle) = No MACE occurred with UPA15, while 2 were reported with PBO, both in the new-onset subgroup. dqoibkzhbc (xmiceyvthz )
Positive
11 Jun 2026
Placebo
(new-onset or relapsing GCA)
Phase 3
194
tvkyiuqfpp(nulwseroba) = bultkzmgrr xftaavrvjr (vselvlqnnm )
Positive
11 Jun 2026
Placebo
djqbwnymxj(viwjgmivok) = nxhnradckj batlmvavtm (gjahocshul )
Not Applicable
69
hguziaxnle(cekhodsqfk) = uwuuhpxfts vuhgeykapq (mjpmasqgqu )
Positive
11 Jun 2026
hguziaxnle(cekhodsqfk) = rjkecrjfpf vuhgeykapq (mjpmasqgqu )
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Approval

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Regulation

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