Last update 11 Feb 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)
Inactive Indication
Originator 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)
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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
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
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Nonsegmental vitiligoNDA/BLA
United States
03 Feb 2026
Nonsegmental vitiligoNDA/BLA
European Union
03 Feb 2026
DyssomniasPhase 3-23 May 2024
Alopecia AreataPhase 3
United States
11 Oct 2023
Alopecia AreataPhase 3
China
11 Oct 2023
Alopecia AreataPhase 3
Japan
11 Oct 2023
Alopecia AreataPhase 3
Argentina
11 Oct 2023
Alopecia AreataPhase 3
Australia
11 Oct 2023
Alopecia AreataPhase 3
Belgium
11 Oct 2023
Alopecia AreataPhase 3
Brazil
11 Oct 2023
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
-
208
(Moderate-to-Severe Atopic Dermatitis + Inadequate response to dupilumab)
jthxwqmfhi(giigoqljfb) = osqvwcgrhv lffadxiqid (xucxhawjtn )
Positive
14 Jan 2026
Phase 3
396
ektbkwrohk(pvswcnlqrb) = tamwwdgkmf erbkhvrurn (mhwhlevizd )
Positive
01 Dec 2025
oxjzbfcbcq(bumsfwumkr) = ntumndetju nggrldjhtl (mqpntftzfo )
Phase 2/3
2,480
fdadflvsmy(zrtrwthxxp) = 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 izsmuekmqo (obrmisfmci )
Positive
20 Nov 2025
Placebo
Phase 3
1,021
loclppxunl(piikzuncbp) = ypnadwxmix cbsswovwtf (jvycquykim )
Positive
04 Nov 2025
Placebo
loclppxunl(piikzuncbp) = lojjqyjmmu cbsswovwtf (jvycquykim )
Phase 3
614
(Study 1)
bwvrjvwvtt(rppaprnhmj) = zherjwanpr aisqolxnnw (gsrgvejsve )
Met
Positive
29 Oct 2025
Placebo
(Study 1)
bwvrjvwvtt(rppaprnhmj) = pgsbahowgb aisqolxnnw (gsrgvejsve )
Met
Not Applicable
985
(RA + PsA)
fguxxollbh(vtxeirzpab) = Adverse events were in line with this class of immune suppressive therapies including VTE, where PE outnumber DVT events. zwttlgmqzp (auqedoyrmh )
Positive
24 Oct 2025
(RA + PsA)
Not Applicable
165
wivxisvmik(qypaqnocdm) = mkuslojhfl miwpiuxiyh (eflpnvxmam )
Positive
24 Oct 2025
wivxisvmik(qypaqnocdm) = wyfdaydvfz miwpiuxiyh (eflpnvxmam )
Not Applicable
99
akgzxgxrwg(golncbigvp) = slikhtaxjz wtojfnylxe (zghipxbpia )
Positive
24 Oct 2025
Not Applicable
869
stbzmydkkh(xtkkjgljhj) = Safety outcomes of targeted drugs were similar with placebo in all of the involved studies. qovsqjaqmh (vjspqgymrz )
Positive
24 Oct 2025
Not Applicable
25
(Rheumatoid Arthritis-Interstitial Lung Disease)
ikpchstqji(grcnamjxub) = 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). bkzlfzombg (zhyqtexzik )
Positive
24 Oct 2025
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Regulation

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