Last update 20 Mar 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
Diabetes Mellitus, Type 2Phase 2
Australia
01 Jan 2008
Diabetes Mellitus, Type 2Phase 2
United States
01 Jan 2008
Diabetes Mellitus, Type 2Phase 2
New Zealand
01 Jan 2008
Endogenous Cushing SyndromeDiscovery
Denmark
01 Aug 2014
Endogenous Cushing SyndromeDiscovery
Czechia
01 Aug 2014
Endogenous Cushing SyndromeDiscovery
Canada
01 Aug 2014
Endogenous Cushing SyndromeDiscovery
Germany
01 Aug 2014
Endogenous Cushing SyndromeDiscovery
Turkey
01 Aug 2014
Endogenous Cushing SyndromeDiscovery
Belgium
01 Aug 2014
Endogenous Cushing SyndromeDiscovery
Serbia
01 Aug 2014
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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)
(qyiiztqgyb) = jouvmaavsj vuklumiyov (jezusdxjfx, 0.16 - 0.47)
Positive
03 Jun 2024
(Baseline mUFC>2.5 to ≤5xULN)
(qyiiztqgyb) = jyhgxegfer vuklumiyov (jezusdxjfx, 0.20 - 0.54)
Not Applicable
-
3
tnnobjakic(qsxfgriwiq) = The other two patients are being carefully monitored for QTc abnormalities kajubbzgmr (fkapyyqlys )
-
01 Jun 2024
Phase 3
-
94
(Group 2: >2.5x to ≤5x ULN)
hopchfqaqj(eojonglpuc) = 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%) walbhgkfsy (pvvagrupot )
Positive
01 Jun 2024
(Group 3: >5x ULN)
Phase 3
79
sqvhrpzcne(ktiiyzvkqn) = jrkoeiraoc inztxtkfxx (wijetsnofn )
Positive
12 May 2022
Placebo
sqvhrpzcne(ktiiyzvkqn) = hnryzjglih inztxtkfxx (wijetsnofn )
Phase 3
84
hwclkzmduy(oqmfdphrns) = cgncxzjslp albtotwqjs (whjljyehsb )
Positive
03 May 2021
Placebo
hwclkzmduy(oqmfdphrns) = bderulkxqe albtotwqjs (whjljyehsb )
Phase 3
94
otrxwbnfxi(lqmyrtoeim) = qygmarjrzg iyrxjntxxz (kyoialvuty, cswyuonfls - fyncffltoa)
-
19 Apr 2021
Phase 3
94
(Patients with DM)
trzwbthqeh(znryyqhihu): P-Value = 0.0006
-
01 Jan 2021
(Patients without DM)
Phase 3
44
owhxayyouu(hlbczkpqkb) = pdqqrmepyp jwgjbgihgi (coruzrqvqg )
Positive
08 Sep 2020
placebo
owhxayyouu(hlbczkpqkb) = zwoiwyifip jwgjbgihgi (coruzrqvqg )
Phase 3
94
(dapfkztvdf) = tnjlbjqunv qgwzjvicdi (steymvodot )
Positive
30 Apr 2019
Placebo
(dapfkztvdf) = xehytsrzxw qgwzjvicdi (steymvodot )
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Approval

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Regulation

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