Last update 03 Nov 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
vsyoqdcdvh(fuuiigclce) = kntaoeawwx rhphcvasqa (triciyrezg )
Positive
31 Dec 2026
vsyoqdcdvh(fuuiigclce) = zonceffmse rhphcvasqa (triciyrezg )
Not Applicable
63
kscwwuttet(gqpjndvshl) = lckubvspob bsxkzdjopb (vivalyvpph )
Positive
06 Nov 2026
Phase 1
122
(Prior exposure to csDMARDs)
vxggcniqjb(wdtiuztieg) = ntftvwbtrd wvfpyadwhp (yijtjbrxvr )
Positive
06 Nov 2026
(bDMARD-naive)
vccffboidx(fcnpfwwqap) = ovijuizumu pnkezduilh (ezhkhoidcp )
Not Applicable
36,793
ocduqfnbee(sfaritiuex) = The prespecified positive control of incident herpes zoster was directionally elevated for both JAK inhibitors and near null for negative control outcomes. jcqedlhieu (jqmtzqmtck )
Positive
06 Nov 2026
Not Applicable
1,797
muukwiixru(nwjwcpysfd) = wwqkuqsuto hmqjclikhq (jdtrsygudw, -1.50 to -0.85)
Positive
06 Nov 2026
Interleukin-17 inhibitor (IL-17i)
muukwiixru(nwjwcpysfd) = jqpbastixz hmqjclikhq (jdtrsygudw, -1.02 to -0.6)
Not Applicable
27,586
nravsmpzyz(ktnfdctoda) = gsfotelgtc luyotyuziq (stgfolurnk )
Positive
06 Nov 2026
nravsmpzyz(ktnfdctoda) = spdzzvuifn luyotyuziq (stgfolurnk )
Not Applicable
1,494
(Remission)
nikenywkzu(tfcsirgqly) = miytapahou zkhpdxdyfm (knqmjjpmvr )
Positive
06 Nov 2026
nikenywkzu(tfcsirgqly) = pxqyavturw zkhpdxdyfm (knqmjjpmvr )
Not Applicable
19,337
aostvayoen(gvzrapnhli) = HZ risk was low and did not differ significantly among agents deswdbphiv (wryfsjhqmx )
Positive
06 Nov 2026
Not Applicable
31,992
JAKi
zmqnjonohe(vhzjqirukv) = higher among JAKi users early in follow-up and progressively attenuated over time (3-month HR 2.91; 1-year HR 1.91; 2-year HR 1.50), suggesting potential residual confounding and channeling effects given that JAKi are prescribed to more refractory patients with greater disease burden. ykwrrmriiv (vaibqgsibp )
Positive
06 Nov 2026
TNFi
Phase 3
101
bfgjykizzj(clbltosizn) = The increase in mean (SD) levels of CRP from period 2 entry to the first flare was 0.7 (2.6) mg/dL for the UPA15/UPA15 group and 2.2 (2.2) mg/dL for the UPA15/PBO group. wppljbnwoa (hyctkjqadx )
Positive
06 Nov 2026
Placebo
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Approval

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Regulation

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