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fluconazole

Generic: FLUCONAZOLE·Brand: DIFLUCAN, DIFLUCAN IN DEXTROSE 5% IN PLASTIC CONTAINER, DIFLUCAN IN SODIUM CHLORIDE 0.9%, DIFLUCAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, Diflucan, FLUCONAZOLE, FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER, FLUCONAZOLE IN SODIUM CHLORIDE 0.9%, FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

fluconazole: sourced relationships with 1 company · 7 clinical trials tracked · 1 FDA decision.

fluconazole evidence translation

What we can confirm

1 FDA record · 7 tracked trials

What it means

Source-backed records connect fluconazole to ANIP; that link alone does not prove the drug works.

What to watch

Watch active trials and any change in FDA or trial status.
BioSniper AIPage evidence connected

Prepared research question

How could fluconazole → ANIP affect its developer, and what evidence supports the link?

Run cited research

Traceable citations · Unknowns marked

See linked entities and source evidence3 indications · 3 study sponsors
Dated Pipeline Records (1)
CompanyDated record stage
ANI PHARMACEUTICALS INC (ANIP)
Reported 2011-03-07 · Current development: unknownSource
Approved
Clinical Trial Registry Records (7)

The Drug-Drug Interaction Study of Clifutinib

NCT07341672Registry updated 2026-04-27·Phase 1
Not yet recruiting

Primary endpoint: Cmax

InterventionalRandomizedopen80 targetStarted 2026-12Completion 2027-051 site · ChinaSunshine Lake Pharma Co., Ltd.

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

NCT07439250Registry updated 2026-05-19·Phase 1
Completed

Primary endpoint: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Olomorasib

Interventionalopen15 enrolledStarted 2026-03Completion 2026-041 site · United StatesEli Lilly and Company

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

NCT07395024Registry updated 2026-02-09·Phase 1
Not yet recruiting

Primary endpoint: Pharmacokinetics (PK) of ASP3082 in plasma: Maximum Concentration (Cmax) in ASP3082

Interventionalopen54 targetStarted 2026-02Completion 2026-07Astellas Pharma Global Development, Inc.

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

NCT07636018Registry updated 2026-06-09·Phase 1·PFE
Completed

Primary endpoint: Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of PF-07248144 - Period 1

Interventionalopen12 enrolledStarted 2025-08Completion 2025-111 site · BelgiumPfizer

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

NCT06847464Registry updated 2025-07-01·Phase 1·ENTA
Completed

Primary endpoint: Cmax of EDP-323 with and without coadministration with Itraconazole

Interventionalopen48 enrolledStarted 2025-01Completion 2025-061 site · United StatesEnanta Pharmaceuticals, Inc

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

NCT06345794Registry updated 2025-04-27·Phase 1
Completed

Primary endpoint: Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY4100511 (DC-853)

Interventionalopen50 enrolledStarted 2024-04Completion 2024-061 site · United StatesDICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company

A Phase 3, Multicenter, Prospective, Randomized, Double-blind Study of Two Treatment Regimens for Candidemia and/or Invasive Candidiasis: Intravenous Echinocandin Followed by Oral Ibrexafungerp Versus Intravenous Echinocandin Followed by Oral Fluconazole (MARIO)

NCT05178862Registry updated 2026-08-10·Phase 3·SCYX
Terminated

Primary endpoint: All-cause Mortality

InterventionalRandomizedquadruple68 enrolledStarted 2022-08Completion 2025-1250 sites · Belgium, Bulgaria, Canada, China…Scynexis, Inc.
FDA Decisions1 records
ANDA078423OralTablet

Frequently asked questions

Which companies have sourced relationships with fluconazole?

fluconazole has dated SEC/FDA relationship records for ANI PHARMACEUTICALS INC.

How many clinical trials involve fluconazole?

BioSniper tracks 7 clinical trials involving fluconazole.

What is fluconazole's latest FDA decision?

The most recent tracked FDA decision for fluconazole is Approval, dated March 7, 2011.