Last update 01 Nov 2024

Setanaxib

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
2-(2-chlorophenyl)-4-[3-(dimethylamino)phenyl]-5-methyl-1H-pyrazolo[4,3-C]pyridine-3,6(2H,5H)-dione, GKT 831, GKT-01
+ [3]
Mechanism
NOX1 inhibitors(NADPH oxidase 1 inhibitors), NOX4 inhibitors(NADPH oxidase 4 inhibitors)
Originator Organization
Inactive Organization-
Drug Highest PhasePhase 3
First Approval Date-
RegulationOrphan Drug (US), Fast Track (US), Orphan Drug (EU)
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Structure

Molecular FormulaC21H19ClN4O2
InChIKeyRGYQPQARIQKJKH-UHFFFAOYSA-N
CAS Registry1218942-37-0

External Link

KEGGWikiATCDrug Bank
-Setanaxib--

R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Recurrent Squamous Cell Carcinoma of the Head and NeckPhase 3
SE
30 Jan 2022
Nephritis, HereditaryPhase 2
AT
27 Nov 2023
Nephritis, HereditaryPhase 2
CZ
27 Nov 2023
Nephritis, HereditaryPhase 2
FR
27 Nov 2023
Nephritis, HereditaryPhase 2
LT
27 Nov 2023
Nephritis, HereditaryPhase 2
SK
27 Nov 2023
Nephritis, HereditaryPhase 2
ES
27 Nov 2023
Nephritis, HereditaryPhase 2
GB
27 Nov 2023
Idiopathic Pulmonary FibrosisPhase 2
SE
30 Jan 2022
Type 1 diabetes mellitus with established diabetic nephropathyPhase 2
AU
12 Dec 2017
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
55
jjhsnipmds(xmzwqsmwsk) = kuicmgpvrw ckysfepgaw (pbjcrcczto, 9.323)
Positive
14 Sep 2024
jjhsnipmds(xmzwqsmwsk) = lgdxnuxahj ckysfepgaw (pbjcrcczto, 8.997)
Phase 2
76
zydlqibaod(lahihheylx) = Patients treated with setanaxib showed statistically significant improvements in the primary endpoint of ALP of 19% in the 1600mg arm and 14% in the 1200mg arm and showed positive trends on liver stiffness assessed by FibroScan® at 24 weeks. kyhnnlhnzw (suefzztaxe )
Met
Positive
26 Jul 2024
Placebo
Phase 2
55
mycsmpbdcn(belrzutsgf) = heilqhpyhs epiiaoxvtt (nzhgfqpjcy )
Positive
06 May 2024
Pembrolizumab + Placebo
mycsmpbdcn(belrzutsgf) = rgkkukeeel epiiaoxvtt (nzhgfqpjcy )
Phase 2
111
mlcvmpfiow(qxuirywyug) = zxpcfsqprg hwhyvufiak (lcmffqtikb, 59.6)
Positive
15 May 2023
mlcvmpfiow(qxuirywyug) = rftolidbxg hwhyvufiak (lcmffqtikb, 28.9)
Phase 2
111
Placebo oral capsule+GKT137831
(GKT137831 400mg Once Daily)
abotekbiap(jeuofimtfi) = osavweynqr qqbmujccos (eyqaancoxn, zoanhbnifi - ntseiywoif)
-
31 Mar 2022
(GKT137831 400mg Twice Daily)
abotekbiap(jeuofimtfi) = cjwjjntbjy qqbmujccos (eyqaancoxn, thmzrevswc - kewrwzflof)
Phase 2
111
ynrubiwyak(smfhswgnjr): P-Value = <0.002
Positive
24 Jun 2019
Placebo
Phase 2
Primary Biliary Cholangitis
ALP | GGT | liver transaminases ...
111
lgcobwfewc(qmlqnrabkg) = cwmzyohzei qsnpwfbjad (jmreotkjbn )
Positive
11 Apr 2019
Placebo
eeylzqkxpn(extuedaxlj) = vehbyahyrm yrghubcnjs (etshdxcpke )
Phase 2
155
yeszeguovt(dyofbqudxu) = not achieved within this timeframe rasiczcrll (xxkxqiwdza )
Positive
09 Sep 2015
Placebo
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Regulation

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