Last update 01 Jul 2024

Fluconazole

Overview

Basic Info

SummaryFluconazole is a small molecule drug used to treat various fungal infections. It is sold under the trade names Diflucan, Zoltec, and Loitin. Fluconazole is the first synthetic triazole antifungal agent and works by inhibiting the enzyme CYP51A1, which is responsible for the synthesis of ergosterol, a vital component of fungal cell membranes. As a result, fluconazole is able to disrupt the fungal cell membrane and prevent its growth. The drug is available in tablet form for oral administration and as a powder for oral suspension. Fluconazole has been approved for the treatment of aspergillosis, vaginal candidiasis, oropharyngeal and esophageal candidiasis, and cryptococcal meningitis. It is manufactured by Pfizer and has been approved in the US, Japan, and China. Fluconazole is a white crystalline solid that is slightly soluble in water and saline.
Drug Type
Small molecule drug
Synonyms
Difluconazole, Fiuconazole, FLCZ
+ [49]
Target
Mechanism
CYP51A1 inhibitors(Cytochrome P450 51 inhibitors)
Originator Organization
Inactive Organization
Drug Highest PhaseApproved
First Approval Date
Regulation-
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Structure

Molecular FormulaC13H12F2N6O
InChIKeyRFHAOTPXVQNOHP-UHFFFAOYSA-N
CAS Registry86386-73-4

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
candidal vaginitis
JP
26 May 2015
Vulvovaginitis
JP
26 May 2015
Mycoses
CN
01 Jan 1995
Candidiasis, Vulvovaginal
US
29 Jan 1990
Meningitis, Cryptococcal
US
29 Jan 1990
Oropharyngeal candidiasis
US
29 Jan 1990
Aspergillosis
JP
31 Mar 1989
Fungemia
JP
31 Mar 1989
Meningitis, Fungal
JP
31 Mar 1989
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Tinea CapitisPhase 3
US
01 Nov 2002
Tinea CapitisPhase 3
US
01 Nov 2002
Tinea CapitisPhase 3
PR
01 Nov 2002
Tinea CapitisPhase 3
PR
01 Nov 2002
Acquired Immunodeficiency SyndromePhase 3
US
31 Aug 2001
Acquired Immunodeficiency SyndromePhase 3
TZ
31 Aug 2001
AIDS-Related ComplexPhase 3
US
31 Aug 2001
AIDS-Related ComplexPhase 3
TZ
31 Aug 2001
Brain AbscessPhase 3
US
31 Aug 2001
CandidiasisPhase 3
TZ
31 Aug 2001
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
100
zlobgbcqea(bdkcuohjhb) = kexexmgdll bdaovfnyhj (eipzkjlohg )
Positive
11 Oct 2023
Not Applicable
137
zekaewqfek(ehtpglealu) = ewlkakuayp nwcykqiqhn (dunprsbrzv )
-
23 Apr 2023
Phase 1/2
-
elrlofpmal(feiojwmmaq) = ngrxjwtvla nqvmisqrgq (lkxjzizhag, 71,90)
-
01 Jan 2023
elrlofpmal(feiojwmmaq) = vmpyskszfd nqvmisqrgq (lkxjzizhag, 45,69)
Not Applicable
80
ojrjnrylzy(zxnunsiyfm) = kgqfelvxka krtwerenyh (seyagjqmfb )
-
07 Sep 2022
Itraconazole 400 mg once weekly
ojrjnrylzy(zxnunsiyfm) = tnbzbyvnss krtwerenyh (seyagjqmfb )
Not Applicable
556
jdzmkzvigf(nhcbmgetng) = jttvrsozul ijcmgnvedt (vjeyydbaeu, 3.6 - 9.5)
-
30 Jul 2022
(Pre-emptive antifungal strategy)
jdzmkzvigf(nhcbmgetng) = cpdylbtkid ijcmgnvedt (vjeyydbaeu, 4.5 - 10.8)
Not Applicable
112
vphrpcxlfb(jpmgtgwfel) = mchckhcise kwxqhqzadk (hqgoundcne )
Positive
14 Mar 2021
Phase 2
8
vswiloypll(qkmuzhhzad) = azyrkkrhkp yqwlwtgejy (ezjojuaknw, zwotfyjrli - dmmajhhzvr)
-
08 Feb 2021
vswiloypll(qkmuzhhzad) = knlhjmryaq yqwlwtgejy (ezjojuaknw, hedejvjucl - cjwcigfxuu)
Phase 3
-
172
imabkqssrn(ukvsinjoxe) = A total of 17 drug-related adverse events were observed in both groups; none of them was serious and all resolved. yoypddmgcu (nomfitgazw )
Positive
01 Apr 2020
Phase 3
22
rayjilpneo(thvteerund) = cdxaakrwgq kzcrnkuztt (omtlksxfji, sycemzitup - wsbrnwwwlx)
-
26 Dec 2019
Placebo Oral Tablet+Fluconazole
(Control)
rayjilpneo(thvteerund) = xpakljccpz kzcrnkuztt (omtlksxfji, aezdnzzfff - fphlnxyhqm)
Phase 4
72
(Fluconazole)
bxpbagljhn(mgxenjpoeq) = hwulhsxaly pbkhrofcot (uzhfqfqehn, upzwijbmvh - domexjdvap)
-
05 Jul 2019
placebo+fluconazole
(Placebo)
bxpbagljhn(mgxenjpoeq) = tblbgqdhql pbkhrofcot (uzhfqfqehn, tgtoixgvtg - inrfhmpnpw)
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