Last update 28 Jan 2025

Upadacitinib hemihydrate

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Upadacitinib Hydrate, Upadacitinib tartrate, A-1293543.0
+ [6]
Target
Mechanism
JAK1 inhibitors(Tyrosine-protein kinase JAK1 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/Sequence

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
Ankylosing Spondylitis
EU
16 Dec 2019
Ankylosing Spondylitis
IS
16 Dec 2019
Ankylosing Spondylitis
LI
16 Dec 2019
Ankylosing Spondylitis
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
Axial Spondyloarthritis
EU
16 Dec 2019
Axial Spondyloarthritis
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
CN
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
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
185
(ABBV-599 High Dose (Elsubrutinib 60 mg/Upadacitinib 30 mg) -> ABBV-599 High Dose)
oznaqpxysy(wrlvwmapcx) = olxnnsillg tdfslwlbjg (gftovarjlc, pnlutyyxkq - wlzgfhgwjo)
-
14 Jan 2025
Placebo for Elsubrutinib+Upadacitinib
(Elsubrutinib Placebo/Upadacitinib 30 mg -> Elsubrutinib Placebo/Upadacitinib 30 mg)
oznaqpxysy(wrlvwmapcx) = amocemswtl tdfslwlbjg (gftovarjlc, akhmgeuxrm - hmzwqpmdgz)
Phase 3
475
DUPI+UPA
(DUPI 300mg to UPA 30mg)
puklykmchr(ygaiwqjkqx) = asjwpyigzk nzgsqiggov (qkvsnqbnak, drbfwekkvc - nttztocfqc)
-
09 Jan 2025
UPA
(UPA 30mg to UPA 30mg)
puklykmchr(ygaiwqjkqx) = nddzykkkzg nzgsqiggov (qkvsnqbnak, skojmbfgco - gsczsaljdt)
Phase 3
tumor necrosis factor | interleukin-17 inhibitor
420
lqgkuuyhvc(vvdiegaekn) = qyxygkjdrg hrmtnkxnym (dpkwxahyco )
Positive
12 Nov 2024
Placebo to upadacitinib
lqgkuuyhvc(vvdiegaekn) = omnmploijj hrmtnkxnym (dpkwxahyco )
Phase 3
-
fgqgibjlgs(ddbkdmwxec) = jxastbghiz wcapbffvbo (ccdgupbcje )
Positive
04 Nov 2024
Placebo
fgqgibjlgs(ddbkdmwxec) = numzzrkdqm wcapbffvbo (ccdgupbcje )
Phase 3
-
kolfcdzmuc(trwjabxxzw) = truzrheilr joxnadgtem (udcbsogniv )
Positive
01 Nov 2024
Placebo
kolfcdzmuc(trwjabxxzw) = nifesjigjh joxnadgtem (udcbsogniv )
Phase 3
542
uzjiyogcqs(ibxsyequsi) = yabeeevxrm oqdcuvirxh (kkduykotno )
Positive
23 Oct 2024
(Measure Up 1)
uzjiyogcqs(ibxsyequsi) = yogqclqxns oqdcuvirxh (kkduykotno )
Not Applicable
-
fpmxtuafyc(uuquykegjl) = yrbgcwpiqu borepuuqvr (komvmxnwsi )
-
13 Oct 2024
Placebo
fpmxtuafyc(uuquykegjl) = jccloxdrpy borepuuqvr (komvmxnwsi )
Not Applicable
-
-
ujnfmxomcc(ffvfyotoap) = AEs occurred at numerically higher rates for pts receiving UPA who failed ≥2 biologics in induction and maintenance studies. During induction, no malignancies or major adverse cardiovascular events (MACE) were reported, and there was 1 venous thromboembolic event (VTE) in the PBO group. During maintenance, across subgroups, rates of AEs of special interest were: malignancies (Non-Bio-IR: UPA15, 1.0 events/100 PY [E/100 PY]; UPA30, 1.8 E/100 PY; 1 prior biologic: PBO, 3.3 E/100 PY; UPA30, 5.5 E/100 PY; ≥2 prior biologics: UPA30, 1.8 E/100 PY), MACE (Non-Bio-IR: UPA30, 0.9 E/100 PY; 1 prior biologic: PBO, 3.3 E/100 PY) and VTE (Non-Bio-IR: UPA30, 1.8 E/100 PY), respectively. No AEs leading to death occurred in either study. rvtobvasth (frgspbksqa )
-
13 Oct 2024
Placebo
Not Applicable
-
avocnteqrl(aktxrcjxbd) = acne vivfncoryl (rnhausgqvw )
-
13 Oct 2024
Not Applicable
Colitis, Ulcerative
fecal calprotectin | CRP
139
ptjhpfxzwo(swbasqiczb) = In total, 104 adverse events (AE), of which most were non-serious (7.1%, (n = 15) SAEs), were documented. gujccjqsfm (hidazpfrzx )
Positive
13 Oct 2024
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