Drug

Fluconazole

In clinical development

Emerging researchLate-stage development

Also known as Diflucan, Difluconazole, Fluconazol, Fluconazolum.

RxNorm4450 ChEMBLCHEMBL106UNII8VZV102JFY

Research papers

Active clinical trials

Latest activity

beta

Recent clinical, regulatory, research and industry developments relating to this drug.

A Phase 1 Crossover Design Study to Assess the Effect of CYP3A Moderate and Strong Inhibitors (Fluconazole and Itraconazole) and Strong Inducer (Carbamazepine) on the Single-dose Pharmacokinetics of ASP3082 in Healthy Adults

Clinical trial2026-07-31Primary completion · ClinicalTrials.gov

An Interventional Efficacy and Safety Phase 3 Double-blind 2-arm Study to Investigate IV Followed by Oral Fosmanogepix Compared With IV Caspofungin Followed by Oral Fluconazole in Adult Participants With Candidemia and/or Invasive Candidiasis

Clinical trial2026-06-15Results expected Q1 2028 · ClinicalTrials.gov

Prospective Studies of Vaginal Yeast and Microbiome Related to Vulvovaginal Candidiasis in Canadian Females

Clinical trial2026-05-06Results expected Q2 2029 · ClinicalTrials.gov

A Single-center, Non-randomized, Open-label, Self-controlled, Phase I Clinical Study to Evaluate Drug-Drug Interactions (DDI) of JMKX003142 Tablets in Chinese Healthy Participants.

Clinical trial2026-05-04Results expected Q4 2026 · ClinicalTrials.gov

Effect of Fluconazole on the Pharmacokinetics of a Single Oral Dose of BI 425809 in Healthy Male Subjects (an Open-label, Two-period Fixed-sequence Design Study)

Clinical trial2026-05-04Results posted · ClinicalTrials.gov

Evaluation of CrAg Screening With Enhanced Antifungal Therapy for Asymptomatic CrAg+ Persons

Clinical trial2026-04-28Results expected Q2 2027 · ClinicalTrials.gov

The Drug-Drug Interaction Study of Clifutinib

Clinical trial2026-04-27Results expected Q2 2027 · ClinicalTrials.gov

A Randomized Controlled Trial: the Effect of a Medical Grade Honey Formulation (L-Mesitran) on Clinical Symptoms of Recurrent Vulvovaginal Candidiasis

Clinical trial2026-04-22Primary completion · ClinicalTrials.gov

A Phase 1, Open-Label, Fixed-Sequence Study to Investigate the Effect of Fluconazole on the Pharmacokinetics of Olomorasib (LY3537982) in Healthy Participants

Clinical trial2026-04-17Completed · ClinicalTrials.gov

The Role of Endothelial-Derived Hyperpolarization Factors on 24-hr Blood Pressure Regulation Following a Bout of Prolonged Sitting

Clinical trial2026-04-13Results expected Q4 2026 · ClinicalTrials.gov

The efficacy and safety of clotrimazole vaginal tablet vs. oral fluconazole in treating severe vulvovaginal candidiasis.

Research2016-04-13Mycoses

A randomized clinical trial of the efficacy and safety of terconazole vaginal suppository versus oral fluconazole for treating severe vulvovaginal candidiasis.

Research2015-04-15Medical mycology

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name

Fluconazole

Aliases & brands

DiflucanDifluconazoleFluconazolFluconazolum

RxNorm CUI

4450

ChEMBL ID

CHEMBL106

UNII

8VZV102JFY

Clinical trials

172 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme

CLINICALTRIALS.GOV · LIVE REGISTRY

172

registered trials across all phases

LATEST COMPLETION 2026

Active studies

Recruiting

Late-stage (III+)

134

Completed

Discontinued

PHASE DISTRIBUTIONn = 172

Early Phase 12Phase 149Phase 1 / 22Phase 223Phase 2 / 35Phase 340Phase 420Phase N / A31

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

IMPACT - the Introduction of Mycotic Prophylaxis At Cystectomy Trial. Perioperative Mycotic Prophylaxis to Reduce Postoperative Complications Following Cystectomy - a Double-blinded, Placebo-controlled, Randomized Trial

RecruitingPH IVRigshospitalet, Denmarkn=4842027

REINFORCE - Reducing Infection-related Readmissions Following Cystectomy. a Multicentre Randomised Clinical Trial Testing Superiority of Individualised Targeted Antibiotic Prophylaxis Over Empiric Prophylaxis At Ureteral Stent Removal to Reduce Infection-related Readmissions Following Cystectomy.

RecruitingPH IVRigshospitalet, Denmarkn=2482027

Comparing the Efficacy of Oral Fluconazole Versus Oral Itraconazole in Treating Resistant Tinea Corporis

RecruitingPH IVUrooj Fatiman=1262026

Comparison of Efficacy of Oral Fluconazole Versus Oral Itraconazole in the Treatment of Pityriasis Versicolor

RecruitingPH IVKhyber Teaching Hospitaln=1062025

Endothelial Derived Hyperpolarization Factor and Regulation of Cerebral and Muscle Blood Flow

RecruitingPH IVUniversity of Oklahoman=302025

Recent completions

Trials that read out recently, adding to the completed evidence base.

A Phase 1, Open-Label, Fixed-Sequence Study to Investigate the Effect of Fluconazole on the Pharmacokinetics of Olomorasib (LY3537982) in Healthy Participants

CompletedPH IEli Lilly and Companyn=152026

A Phase 3, Multicenter, Randomized, Double-Blind Study of the Efficacy and Safety of Rezafungin for Injection Versus the Standard Antimicrobial Regimen to Prevent Invasive Fungal Diseases in Adults Undergoing Allogeneic Blood and Marrow Transplantation (The ReSPECT Study)

CompletedPH IIIMundipharma Research Limitedn=6022026

A PHASE 1, OPEN-LABEL, FIXED SEQUENCE, 2-PERIOD, CROSSOVER STUDY IN HEALTHY PARTICIPANTS TO INVESTIGATE THE EFFECT OF FLUCONAZOLE ON PF-07248144 PHARMACOKINETICS

CompletedPH IPfizern=122025

A Non-Randomized, Open-Label, Drug-Drug Interaction Study to Evaluate the Effects of Itraconazole, Carbamazepine, Quinidine, and Fluconazole on the Pharmacokinetics and Safety of EDP-323 in Healthy Participants

CompletedPH IEnanta Pharmaceuticals, Incn=482025

Multicenter, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Fluconazole in Hypercalcicuric Patients With Increased 1.25(OH) 2D Levels

CompletedPH IIHospices Civils de Lyonn=562024

A Phase 1, Single-Center, Open-Label, 3-Cohort, Fixed-Sequence, Drug-Drug Interaction Study To Assess The Pharmacokinetics Of LY4100511 (DC-853) When Orally Administered Alone, When Coadministered With Itraconazole, Fluconazole, Or Carbamazepine In Healthy Adult Participants

CompletedPH IDICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Companyn=502024

Research activity

2 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time

20152016

Most influential

The efficacy and safety of clotrimazole vaginal tablet vs. oral fluconazole in treating severe vulvovaginal candidiasis.

Mycoses · 2016 · 21 cites

A randomized clinical trial of the efficacy and safety of terconazole vaginal suppository versus oral fluconazole for treating severe vulvovaginal candidiasis.

Medical mycology · 2015 · 18 cites