Last update 17 Apr 2025

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
+ [52]
Target
Action
inhibitors
Mechanism
CYP51A1 inhibitors(Cytochrome P450 51 inhibitors)
Originator Organization
Inactive Organization
Drug Highest PhaseApproved
First Approval Date
Japan (31 Mar 1989),
Regulation-
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Structure/Sequence

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
Japan
26 May 2015
Vulvovaginitis
Japan
26 May 2015
Candidiasis, Vulvovaginal
United States
29 Jan 1990
Meningitis, Cryptococcal
United States
29 Jan 1990
Oropharyngeal candidiasis
United States
29 Jan 1990
Aspergillosis
Japan
31 Mar 1989
Fungemia
Japan
31 Mar 1989
Meningitis, Fungal
Japan
31 Mar 1989
Mycoses
Japan
31 Mar 1989
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Tinea CapitisPhase 3
United States
01 Nov 2002
Tinea CapitisPhase 3
United States
01 Nov 2002
Tinea CapitisPhase 3
Puerto Rico
01 Nov 2002
Tinea CapitisPhase 3
Puerto Rico
01 Nov 2002
Acquired Immunodeficiency SyndromePhase 3
United States
31 Aug 2001
Acquired Immunodeficiency SyndromePhase 3
Tanzania
31 Aug 2001
AIDS-Related ComplexPhase 3
United States
31 Aug 2001
AIDS-Related ComplexPhase 3
Tanzania
31 Aug 2001
Brain AbscessPhase 3
United States
31 Aug 2001
CandidiasisPhase 3
Tanzania
31 Aug 2001
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
100
xqdsuwgqmw(ghvdeesghx) = sgcoicxkjk emacftnxji (mogjmasxov )
Positive
11 Oct 2023
Not Applicable
-
aqnlyuvdje(uvhttmhrpl) = gpdjdbqwmo mcbubjzkec (qgsbbstgug )
Positive
05 Oct 2023
aqnlyuvdje(uvhttmhrpl) = sanpagjhzw mcbubjzkec (qgsbbstgug )
Not Applicable
137
hmemnebtjk(yqnqiztbzj) = qqzzdetijs zlwggvidhp (dyjrajrctr )
-
23 Apr 2023
Not Applicable
-
ktrzpktpfm(ocqsomjdsp) = Fixed Drug Eruption (FDE) secondary to fluconazole ghemcadkap (zldzevbufv )
-
10 Nov 2022
Not Applicable
80
iokbvbkbka(jgxjqpxjgr) = qacntptjuz lokdxvgars (fckabtmhtt )
-
07 Sep 2022
Itraconazole 400 mg once weekly
iokbvbkbka(jgxjqpxjgr) = osbqolhhsj lokdxvgars (fckabtmhtt )
Not Applicable
-
-
arfsdgnpac(axscfqddse) = lvbeuhxrts jmgifnyvao (jsjoukfyni )
Positive
03 May 2021
Not Applicable
112
yejklljhpo(ftgiwxeuuz) = awnvcdhsnw ofveczghdx (xfksrjrrkq )
Positive
14 Mar 2021
Phase 2
8
qsjktopwfs(hfdhflbikv) = acugfnmfag adbclioazm (wxtchemyku, kpiqufsfdk - yuhvqwdupq)
-
08 Feb 2021
qsjktopwfs(hfdhflbikv) = mrjclrbwvb adbclioazm (wxtchemyku, qawoisilav - gyidrxsctr)
Phase 3
-
172
wmcdegpsln(mkltwezjlf) = A total of 17 drug-related adverse events were observed in both groups; none of them was serious and all resolved. beobrwxiro (kwqbbzlnvs )
Positive
01 Apr 2020
Phase 3
22
nphoiglwdt = wnvajxbhvr vukreehyaz (wpfcchdtow, vqojgtbxzj - ipmczxkykp)
-
26 Dec 2019
Placebo Oral Tablet+Fluconazole
(Control)
nphoiglwdt = yefypywpmd vukreehyaz (wpfcchdtow, ccjmtnthii - nopiojiyly)
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Regulation

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