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Ketoconazole tablet
Ketoconazole is a broad-spectrum antifungal agent that inhibits the synthesis of ergosterol, a vital component of fungal cell membranes, by blocking the cytochrome P450-dependent enzyme lanosterol 14α-demethylase.
Ketoconazole is a broad-spectrum antifungal agent that inhibits the synthesis of ergosterol, a vital component of fungal cell membranes, by blocking the cytochrome P450-dependent enzyme lanosterol 14α-demethylase. Used for Treatment of systemic fungal infections such as blastomycosis, coccidioidomycosis, histoplasmosis, and aspergillosis.
At a glance
| Generic name | Ketoconazole tablet |
|---|---|
| Also known as | Nizoral |
| Sponsor | Purdue Pharma LP |
| Drug class | Azole antifungal |
| Target | Lanosterol 14α-demethylase |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | Phase 2 |
Mechanism of action
By inhibiting lanosterol 14α-demethylase, ketoconazole disrupts the integrity of the fungal cell membrane, leading to cell death. It also has some anti-androgenic effects due to its inhibition of steroidogenesis.
Approved indications
- Treatment of systemic fungal infections such as blastomycosis, coccidioidomycosis, histoplasmosis, and aspergillosis
Common side effects
- Liver function abnormalities
- Nausea
- Headache
Key clinical trials
- Anticoagulation in ICH Survivors for Stroke Prevention and Recovery (PHASE3)
- Neuro-pharmacological Properties of Repurposed Ketoconazole in Glioblastomas (EARLY_PHASE1)
- Hormonal Mechanisms of Sleep Restriction - Axis Study in Older Men and Postmenopausal Women (EARLY_PHASE1)
- Non-vitamin K Antagonist Oral Anticoagulants in Patients With Atrial High Rate Episodes (PHASE3)
- Azoles Targeting Recurrent High Grade Gliomas (EARLY_PHASE1)
- Study to Evaluate the Effect of Rifampicin, Ketoconazole, and Omeprazole on the Pharmacokinetics of Sativex (PHASE1)
- A Study to Assess the Safety and Efficacy of Levoketoconazole in the Treatment of Endogenous Cushing's Syndrome. (PHASE3)
- RE-sensitizing With Supraphysiologic Testosterone to Overcome REsistance (The RESTORE Study) (PHASE2)
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 |
|---|---|
| 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:
- Ketoconazole tablet CI brief — competitive landscape report
- Ketoconazole tablet updates RSS · CI watch RSS
- Purdue Pharma LP portfolio CI