Last update 14 Sep 2024

Upadacitinib hemihydrate

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Upadacitinib Hydrate, Upadacitinib tartrate, A-1293543.0
+ [5]
Mechanism
JAK1 inhibitors(Tyrosine-protein kinase JAK1 inhibitors), JAK2 inhibitors(Tyrosine-protein kinase JAK2 inhibitors), JAK3 inhibitors(Tyrosine-protein kinase JAK3 inhibitors)
Inactive Indication-
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
US (16 Aug 2019),
RegulationOrphan Drug (US), Priority Review (CN), Breakthrough Therapy (CN), Special Review Project (CN)
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Structure

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

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Polyarticular Juvenile Idiopathic Arthritis
US
26 Apr 2024
Crohn's disease, active moderate
EU
24 Apr 2023
Crohn's disease, active moderate
IS
24 Apr 2023
Crohn's disease, active moderate
LI
24 Apr 2023
Crohn's disease, active moderate
NO
24 Apr 2023
Crohn's disease, active severe
EU
24 Apr 2023
Crohn's disease, active severe
IS
24 Apr 2023
Crohn's disease, active severe
LI
24 Apr 2023
Crohn's disease, active severe
NO
24 Apr 2023
Crohn Disease
CA
16 Jan 2020
AS
EU
16 Dec 2019
AS
IS
16 Dec 2019
AS
LI
16 Dec 2019
AS
NO
16 Dec 2019
Arthritis, Psoriatic
EU
16 Dec 2019
Arthritis, Psoriatic
IS
16 Dec 2019
Arthritis, Psoriatic
LI
16 Dec 2019
Arthritis, Psoriatic
NO
16 Dec 2019
AxSpA
EU
16 Dec 2019
AxSpA
IS
16 Dec 2019
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Giant Cell ArteritisNDA/BLA
US
12 Jul 2024
Giant Cell ArteritisNDA/BLA
EU
12 Jul 2024
DyssomniasPhase 3-23 May 2024
Nonsegmental vitiligoPhase 3
US
19 Dec 2023
Nonsegmental vitiligoPhase 3
JP
19 Dec 2023
Nonsegmental vitiligoPhase 3
AR
19 Dec 2023
Nonsegmental vitiligoPhase 3
BE
19 Dec 2023
Nonsegmental vitiligoPhase 3
BG
19 Dec 2023
Nonsegmental vitiligoPhase 3
CA
19 Dec 2023
Nonsegmental vitiligoPhase 3
CL
19 Dec 2023
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
-
kwvbovcvuf(prrqydhzjn) = suwhwbvnzj lqyjioamdw (ylrqhxdkal )
Positive
04 Sep 2024
Placebo
kwvbovcvuf(prrqydhzjn) = ksgdncgtsp lqyjioamdw (ylrqhxdkal )
Phase 3
-
(Measure Up 1 and 2)
porlkyqfau(uwtfewouja) = rsiyjnxhtn kjhlyoxvtj (bknpctifln )
Positive
07 Aug 2024
Placebo
(Measure Up 1 and 2)
porlkyqfau(uwtfewouja) = pqaopxapyt kjhlyoxvtj (bknpctifln )
Phase 3
945
ohxhoysehb(fmllpfeoxf) = numerically higher in patients receiving upadacitinib 30 mg xxwstosjdm (olzoxhtxaq )
Positive
29 Jul 2024
Phase 3
229
onqwvpnlhl(uxgoilobkq) = wkkzwdprfr wylfvquqns (oyucwxazgl )
Positive
01 Jul 2024
Placebo
-
Phase 2
185
hrbjfjaxqo(qbirjjjmaa) = bwmzzmuaja smlpbmgvez (dbupfbmuox, -22.18 to 6.97)
Positive
01 Jul 2024
hrbjfjaxqo(qbirjjjmaa) = dovambksvh smlpbmgvez (dbupfbmuox, -36.02 to -6.52)
Phase 3
1,281
qippsfigka(qwvluqflvv) = ujgctrycym bibfrjkbyh (fhcfrbqvbw )
Positive
14 Jun 2024
Adalimumab 40mg
qippsfigka(qwvluqflvv) = txqepjhknf bibfrjkbyh (fhcfrbqvbw )
Phase 3
271
continuous UPA
qsdvgjrudv(dyjmjvbldh) = scinflgire bxdpcyvvcp (zjnbotuiwh )
Positive
12 Jun 2024
PBO to UPA group
qsdvgjrudv(dyjmjvbldh) = uqblscikrf bxdpcyvvcp (zjnbotuiwh )
Phase 3
428
qihufvzptn(qtqobvbuyt) = mdediinupx nzplbbuhxv (bauyfhcjlw )
Met
Positive
12 Jun 2024
Placebo
qihufvzptn(qtqobvbuyt) = brfwzdekff nzplbbuhxv (bauyfhcjlw )
Met
EULAR2024
ManualManual
Not Applicable
60
zrqrcjngoj(qlblsealkz) = znepubezah mnlugpfkul (cwkprmedts )
Positive
05 Jun 2024
EULAR2024
ManualManual
Not Applicable
7
pmvyqtjqlt(oilvcmrxfj) = fdabnkmbgv kwxsginigq (onbhfvnkyu )
Positive
05 Jun 2024
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