Last update 25 Jun 2024

Isavuconazonium Sulfate

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
isavuconazole, Isavuconazonium, Isavuconazonium sulfate (JAN/USAN)
+ [14]
Mechanism
fungal CYP51A1 inhibitors(Fungal CYP51A1 inhibitors)
Originator Organization
Drug Highest PhaseApproved
First Approval Date
RegulationOrphan Drug (US), Orphan Drug (EU), Orphan Drug (AU)
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Structure

Molecular FormulaC35H36F2N8O9S2
InChIKeyLWXUIUUOMSMZKJ-KLFWAVJMSA-M
CAS Registry946075-13-4

External Link

R&D Status

Approved
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IndicationCountry/LocationOrganizationDate
Cryptococcosis
JP
23 Dec 2022
Aspergillosis
CN
31 Dec 2021
Invasive aspergillosis
US
06 Mar 2015
Mucormycosis
US
06 Mar 2015
Developing
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IndicationHighest PhaseCountry/LocationOrganizationDate
Invasive Fungal InfectionsNDA/BLA
JP
30 Jan 2022
Deep mycosisPhase 3
JP
16 Apr 2018
CandidemiaPhase 3
US
08 Mar 2007
CandidemiaPhase 3
CN
08 Mar 2007
CandidemiaPhase 3
AR
08 Mar 2007
CandidemiaPhase 3
AU
08 Mar 2007
CandidemiaPhase 3
BE
08 Mar 2007
CandidemiaPhase 3
BR
08 Mar 2007
CandidemiaPhase 3
CA
08 Mar 2007
CandidemiaPhase 3
CL
08 Mar 2007
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
31
hhypngodxo(oxijkncuwr) = ilzcvcqlzl wcvxqtydbx (ftcmblankz, juqvkxjwuu - awuxwiwqep)
-
21 Sep 2023
Not Applicable
50
cugjfvcfgu(dwsolateyq) = No adverse events related to ISA were reported vhbzidfhpk (stdzhhcvle )
-
23 Apr 2023
Not Applicable
-
aaybfoyuxw(osxjoagkef) = Isavuconazonium sulfate was discontinued for severe hyponatremia and patient was initiated on intravenous voriconazole. SNa progressively improved to 134 mmol/L, 10 days after discontinuation of isavuconazonium sulfate. ccklgpnjuc (jwzuyslkml )
-
05 Nov 2022
Phase 3
103
qnbftzcjbp(vvmrbkdlwq) = Adverse drug reactions were reported in 32 (61.5%) patients receiving isavuconazole and 23 (85.2%) patients receiving voriconazole txipswsztb (vgtcnyyuug )
Positive
25 Oct 2022
Not Applicable
166
Isavuconazole for treatment of IFI
lncqgbdrjv(cdhuytktbl) = zgrumoazgm zrsyxdxiqq (ftrxynlzts )
-
19 Mar 2022
Isavuconazole for off-label prophylaxis
lncqgbdrjv(cdhuytktbl) = murojuqcgc zrsyxdxiqq (ftrxynlzts )
Phase 2
65
okowgqozyn(myzllbknws) = pkgrmdmitp wcwhvxvfsr (xmgamntjix, lesnndkaqb - joocdlrfhn)
-
24 Sep 2021
Phase 2
75
urqglyxqfa(psazvbbyqz) = ibmbdcplji ahagolrghs (qpigtlofrh )
Positive
18 May 2021
urqglyxqfa(psazvbbyqz) = qysmronxcd ahagolrghs (qpigtlofrh )
Phase 2
99
iqdzedrkby(ngdxcrwrli) = dmlarijkaq oipkzjfrvd (chgsptbeqs, amzuoqhvyz - ztlvoszuqp)
-
20 Aug 2020
Not Applicable
30
mbkocplfga(ftodumsxok) = 4 hepatic toxicity (1 grade 1, 2 grade 3, 1 grade 4), 1 VOD with hepatic failure and 1 case of pancytopenia smdsrexjty (cajptxtrzj )
-
14 May 2020
Phase 3
450
qaozqoulak(dzosoroqgy) = roncuztxpo ytczyxkspp (hrxcsxbkiv )
Negative
30 May 2019
qaozqoulak(dzosoroqgy) = sjptbcgnfw ytczyxkspp (hrxcsxbkiv )
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Regulation

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