FLUCONAZOLE

Post-LOESM

fluconazole

Inpharmus

ANDAORALFOR SUSPENSION

Approved

Sep 2023

Lifecycle

Post-LOE

Competitive Pressure

30/100

Clinical Trials

Data completeness

5/8 — Partial

FLUCONAZOLE (fluconazole) by Inpharmus is cytochrome p450 2c19 inhibitors [moa]. Approved for azole antifungal [epc]. First approved in 2023.

Drug data last refreshed 19h ago

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Mechanism of Action

Cytochrome P450 2C19 Inhibitors

Pharmacologic Class:

Azole Antifungal

Indications

Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.

Clinical Trials (20)

NCT00000951Phase 4Completed

A Study to Compare the Use of Fluconazole as Continuous Therapy Versus Periodic Therapy in HIV-Positive Patients With Recurrent Thrush

948 enrolled

Candidiasis, OralHIV Infections

NCT00002112N/ACompleted

Comparative Randomized Study of the Efficacy, Safety, and Toleration of Fluconazole Oral Suspension or Nystatin Oral Suspension in the Treatment of Patients With Oropharyngeal Candidiasis in Association With the Acquired Immunodeficiency Syndrome

Candidiasis, OralHIV Infections

NCT00005920Phase 2Terminated

Safety and Effectiveness of Giving L-743,872 to Patients With Thrush That Has Not Been Cured With Fluconazole

70 enrolled

Candidiasis, OralHIV Infections

NCT00002304N/ACompleted

A Comparison of Fluconazole and Ketoconazole in the Treatment of Fungal Infections of the Throat in Patients With Weakened Immune Systems

Candidiasis, EsophagealHIV Infections

NCT00002133N/ACompleted

An Open Study of the Effect of Itraconazole Oral Solution for the Treatment of Fluconazole Refractory Oropharyngeal Candidiasis in HIV-Positive Subjects.

Candidiasis, OralHIV Infections

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Data Sources

Drug label: DailyMed / FDA
Clinical trials: ClinicalTrials.gov
Patent data: FDA Orange Book
Spending data: CMS Medicare

The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.