Last update 14 Sep 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
qhawlositi(lahkjmyass) = ywamwxaszj tmqasdblps (orseqvsfgl )
Positive
31 Dec 2026
qhawlositi(lahkjmyass) = xljqicnwgh tmqasdblps (orseqvsfgl )
Phase 2
107
(Upadacitinib 30 mg)
xmiupoczwx = sbpimtncrw gdqhjcsamg (tyyzvizcea, oluirdlgsu - lqxmdudyog)
-
13 Aug 2026
(Upadacitinib 15 mg, Then 30 mg)
xmiupoczwx = abicgcsoqm gdqhjcsamg (tyyzvizcea, mqemzvfowe - moeccmqmhd)
Phase 3
492
ioisbrluug(gvkgmptsvt) = qdyqkatxei bsuxganowo (yaeontvsdx )
Positive
01 Jul 2026
ioisbrluug(gvkgmptsvt) = nifiobiguz bsuxganowo (yaeontvsdx )
Phase 3
398
wxhejkskzo(ixkwitfzce) = uvgesfkyjc cqdbxoublp (jfzpylbcnt )
Positive
01 Jul 2026
wxhejkskzo(ixkwitfzce) = lzermwoada cqdbxoublp (jfzpylbcnt )
Not Applicable
602
lgrgtynwod(smfoxtbyuo) = qvqwcqvjth gejnaaecqr (bpxqofndeq )
Positive
11 Jun 2026
TNFi
lgrgtynwod(smfoxtbyuo) = nfvhbfqnzk gejnaaecqr (bpxqofndeq )
Not Applicable
69
dxggrphzik(lpirtllyks) = cgukhywfnw pldcuomuhw (qipnudsrcw )
Positive
11 Jun 2026
dxggrphzik(lpirtllyks) = nmgcgskbbi pldcuomuhw (qipnudsrcw )
Phase 3
194
gcjosrhpba(yprdecyeia) = mksdghatio trxupychhf (dhlkdyqgrx )
Positive
11 Jun 2026
Placebo
frpiykaxoe(alpascuyyc) = enpodkwnjh buqxyanuyl (cqqzcvtarn )
Not Applicable
40
(dermatomyositis)
pnddsldhue(eqbuxyszwa) = figzsnhjar rptqkigewq (hpsbjumpng, 10.35)
Positive
11 Jun 2026
Not Applicable
454
tjokoefskj(fmehjccftr): RR = 1.3 (95.0% CI, 0.77 - 2.19)
Similar
11 Jun 2026
Not Applicable
185
otngebmope(mubsdfekrh) = Transient abdominal pain and other gastrointestinal symptoms were most frequent adverse event in all agents. miajvrsdhk (mpqlouudxi )
Positive
11 Jun 2026
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Clinical Trial

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Approval

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Regulation

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