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Diflucan (fluconazole)
Fluconazole (Diflucan), marketed by Pfizer Inc., is a triazole antifungal primarily indicated for vaginal candidiasis with a strong market presence. Its key strength lies in its excellent oral bioavailability and CNS penetration, effectively disrupting ergosterol synthesis by inhibiting fungal CYP51. The primary risk is the key composition patent expiry in 2028, which could lead to increased competition from generics.
At a glance
| Generic name | fluconazole |
|---|---|
| Also known as | Diflucan |
| Sponsor | Pfizer Inc. |
| Drug class | Azole Antifungal [EPC] |
| Target | Cytochrome P450 2C19, Cytochrome P450 2C9, Lanosterol 14-alpha demethylase |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | FDA-approved |
| First approval | 1990-01-29 (United States) |
Approved indications
- Vaginal candidiasis
- Oropharyngeal candidiasis
- Esophageal candidiasis
- Candida urinary tract infections
- Candida peritonitis
- Systemic Candida infections
- Cryptococcal meningitis
- Prophylaxis of candidiasis
Common side effects
- headache
- nausea
- abdominal pain
- diarrhea
- dyspepsia
- dizziness
- taste perversion
- nausea
- headache
- skin rash
- vomiting
- abdominal pain
Drug interactions
- Oral Contraceptives (ethinyl estradiol and levonorgestrel)
- Cimetidine
- Antacid (Maalox ®)
Key clinical trials
- A Randomized Comparative Study of Fluconazole Versus Micafungin for the Treatment of Candida Bloodstream Infection in Non-Neutropenic Patients (Phase 4)
- An Open Multicenter Trial of Fluconazole Oral Suspension in the Treatment of Esophageal Candidiasis in Immunocompromised Patients (Phase 3)
- An Open-Label Extension Study of Maintenance Therapy in HIV-Positive Subjects With Fluconazole-Refractory Oropharyngeal Candidiasis Who Have Responded to Itraconazole Oral Solution (NA)
- Combination Therapy: Hyperbaric Oxygen and PENTOCLO for Treatment of Osteoradionecrosis of the Mandible, a Pilot Randomized Control Trial (Phase 3)
- Association of Candida and Antifungal Therapy With Pro-inflammatory Cytokines in Oral Leukoplakia- A Pilot Study (N/A)
- AN OPEN-LABEL, RANDOMIZED, SINGLE DOSE, CROSSOVER PIVOTAL BIOEQUIVALENCE STUDY OF FLUCONAZOLE CAPSULE 50 MG IN HEALTHY ADULT SUBJECTS (Phase 1)
- Implementation and Evaluation of a Screening Strategy to Reduce Morbidity and Mortality Due to Cryptoccocal Meningo-encephalitis in ART Naive AIDS Patients With <100 CD4 Count at the Day Hospital of t (NA)
- A Phase 2, Multicenter, Randomized, Double-Blind, Double-Dummy, Active-Controlled, Dose-Finding Study to Compare the Safety and Efficacy of Oral Ibrexafungerp (SCY-078) vs. Oral Fluconazole in Subject (Phase 2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Diflucan CI brief — competitive landscape report
- Diflucan updates RSS · CI watch RSS
- Pfizer Inc. portfolio CI