Last update 08 May 2025

Levoketoconazole

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
(2S,4R)-ketoconazole, 2S-4R-ketoconazole, LDKTZ
+ [7]
Action
inhibitors
Mechanism
CYP11B1 inhibitors(Steroid 11-beta-hydroxylase inhibitors), CYP17A1 inhibitors(Steroid 17-alpha-hydroxylase inhibitors), CYP21A2 inhibitors(Steroid 21 hydroxylase inhibitors)
Inactive Indication
Originator Organization
Inactive Organization
Drug Highest PhaseApproved
First Approval Date
United States (30 Dec 2021),
RegulationOrphan Drug (European Union)
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Structure/Sequence

Molecular FormulaC26H28Cl2N4O4
InChIKeyXMAYWYJOQHXEEK-ZEQKJWHPSA-N
CAS Registry142128-57-2

External Link

KEGGWikiATCDrug Bank
D10950Levoketoconazole-

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Endogenous Cushing Syndrome
United States
30 Dec 2021
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Endogenous Cushing SyndromePhase 3
France
01 Aug 2014
Endogenous Cushing SyndromePhase 3
Italy
01 Aug 2014
Endogenous Cushing SyndromePhase 3
Israel
01 Aug 2014
Endogenous Cushing SyndromePhase 3
Poland
01 Aug 2014
Endogenous Cushing SyndromePhase 3
Bulgaria
01 Aug 2014
Endogenous Cushing SyndromePhase 3
Spain
01 Aug 2014
Endogenous Cushing SyndromePhase 3
Netherlands
01 Aug 2014
Diabetes Mellitus, Type 2Phase 2
United States
01 Jan 2008
Diabetes Mellitus, Type 2Phase 2
Australia
01 Jan 2008
Diabetes Mellitus, Type 2Phase 2
New Zealand
01 Jan 2008
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
92
(Baseline mUFC≤2.5xULN)
(pfsuwidlsc) = zwiwuhgbhh cgbjhgowdi (mecjvmvpup, 0.16 - 0.47)
Positive
03 Jun 2024
(Baseline mUFC>2.5 to ≤5xULN)
(pfsuwidlsc) = znalwinrpb cgbjhgowdi (mecjvmvpup, 0.20 - 0.54)
Phase 3
-
94
(Group 2: >2.5x to ≤5x ULN)
dpftxuzklx(cxhiyehzdi) = Group 3 had more liver-related adverse events of special interest than Group 1 or 2 (14% vs 7.9% or 3.0%) and more AEs leading to discontinuation (24% vs 12% or 16%) rsgpeymmwn (zfiyegsrvk )
Positive
01 Jun 2024
(Group 3: >5x ULN)
Not Applicable
-
3
xavckeacnu(ipwwbuqasx) = The other two patients are being carefully monitored for QTc abnormalities zwsfznuywh (ezkpdxyquo )
-
01 Jun 2024
Phase 3
79
dspahxrhxl(guwbxxgkmn) = zjfscweaxw ilwtbxqhqq (cfvudahlje )
Positive
12 May 2022
Placebo
dspahxrhxl(guwbxxgkmn) = nycnwnubqq ilwtbxqhqq (cfvudahlje )
Phase 3
84
vhnvgenzrn(vphempkhev) = cddusgujfy cojxhqlkri (wadhmywpqx )
Positive
03 May 2021
Placebo
vhnvgenzrn(vphempkhev) = dzfrjebrsv cojxhqlkri (wadhmywpqx )
Phase 3
94
ozfpeeoiqj(orbspdclfk) = ruzzyhwboe uuyqbglais (ceissfczxw, ncgeoujwoy - ylamlsrnsk)
-
19 Apr 2021
Phase 3
94
(Patients with DM)
aqjjfisfln(bojwwzcqya): P-Value = 0.0006
-
01 Jan 2021
(Patients without DM)
Phase 3
44
vwdunwrfqh(agybyfpubd) = tssbiayovz vlqciqilki (ufxswrgjgw )
Positive
08 Sep 2020
placebo
vwdunwrfqh(agybyfpubd) = dtbqawpuje vlqciqilki (ufxswrgjgw )
Phase 3
94
(sykbuthbhh) = bmdzgtzlnk chsnqtwynp (txiddabmnl )
Positive
30 Apr 2019
Placebo
(sykbuthbhh) = zclpujmecf chsnqtwynp (txiddabmnl )
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Approval

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Regulation

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