Data updated: May 26, 2026
KETOZOLE (ketoconazole)
Cytochrome P450 3A4 Inhibitors
Dermatology
Approved 2002-12-18
KETOZOLE is indicated for the treatment of Tinea Versicolor.
Source: FDA Label • SUN PHARMA CANADA
1
Indication
--
Phase 3 Trials
23
Years on Market
Details
- Status
- Prescription
- First Approved
- 2002-12-18
- Routes
- TOPICAL
- Dosage Forms
- CREAM
KETOZOLE Approval History
2003
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2026
Original
New Indication
New Form
Label Update
1 FDA actions from 2002 to 2002
Dec 2002 ORIGINAL
Update
What KETOZOLE Treats
1 indicationsKETOZOLE is approved for 1 conditions since its original approval in 2002. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Tinea Versicolor
Source: FDA Label
KETOZOLE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
2
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to KETOZOLE
3 of 4FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
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Clinical Trial Registry
68 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT00859781 results posted | 0810010067 J591+Ketoconazole | Ph 2 | active not recruiting | 177Lu Radiolabeled Monoclonal Antibody HuJ591 (177Lu-J591) and Ketoconazole in Patients With Prostate Cancer |
| NCT01154764 results posted | CG100649-1-03 | Ph 1 | completed | Trial for Studying Pharmacokinetic Effects of Ketoconazole on CG100649 |
| NCT02163356 SPOC2013-001 | SPOC-2013-001 | Ph 1 | terminated | Fenretinide Lym-X-Sorb + Ketoconazole + Vincristine for Recurrent or Resistant Neuroblastoma |
| NCT03320486 | GDN 018/16 | Ph 3 | completed | Non-inferiority Trial of Dapaconazole Versus Ketoconazole |
| NCT01036594 Keto/Dex results posted | 09553 NCI-2011-01263 | Ph 2 | completed | Ketoconazole and Dexamethasone in Prostate Cancer |
| NCT04212000 | LKC101A | Ph 1 | completed | Bioavailability of Levoketoconazole and Ketoconazole Tablets |
| NCT02147964 ITT-5 | STUDY00001449 | Ph 2 | withdrawn | ITT-5 Mechanisms of Spermatogenesis in Man |
| NCT01324310 results posted | ROMI-ADVM-001 2010-022144-20 | Ph 1 | completed | Influence of Ketoconazole on the Pharmacokinetics of Romidepsin in Patients With Advanced Cancer |
| NCT01896323 | CC-223-CP-003 | Ph 1 | completed | CC-223 and Ketoconazole Drug-Drug Interaction Study |
| NCT01707407 DDI | CC-4047-CP-008 | Ph 1 | completed | A Phase 1 Open-Label Study to Evaluate the Effect of CYP450 and P-gp Inhibition and Induction on the Pharmacokinetics of Pomalidomide (CC-4047) in Healthy Male Subjects |
| NCT01448824 results posted | 14460 I1V-MC-EIAL | Ph 1 | completed | A Study of LY2484595 on Pharmacokinetics in Healthy Participants |
| NCT01836198 results posted | 14586 I1R-MC-GLBZ | Ph 1 | completed | The Effect of Gemfibrozil, Ketoconazole and Clarithromycin on the Amount of LY2409021 in the Bloodstream |
| NCT02560051 results posted | GU-13-101 HSC-MS-14-0949 | Ph 2 | terminated | Hormone Therapy Plus Chemotherapy as Initial Treatment for Local Failures or Advanced Prostate Cancer |
| NCT02494713 results posted | GU-14-101 HSC-MS-14-0424 | Ph 2 | terminated | Hormonal Therapy and Chemotherapy Followed by Prostatectomy in Patients With Prostate Cancer |
| NCT00953576 KHLAD results posted | 08-374 | Ph 1, Ph 2 | terminated | Ketoconazole, Hydrocortisone, Dutasteride and Lapatinib (KHAD-L) in Prostate Cancer |
| NCT01378520 KetoRLB results posted | CPHS22775 | Ph 4 | completed | Effect of Ketoconazole on Breathlessness |
| NCT00964106 | 112684 | Ph 1 | completed | Validation Study of Multiple Probe Compounds for Drug Interaction Evaluation |
| NCT01969669 | M13-364 | Ph 1 | completed | A Study to Assess the Effect of Ketoconazole on the Metabolism of ABT-199 |
| NCT01340846 | 113771 | Ph 1 | completed | A Pharmacokinetics Study of the Effects of GSK2118436 on Warfarin, the Effects of Ketoconazole and Gemfibrozil on GSK2118436, and the Effects of Repeat Doses of GSK2118436 in Subjects With BRAF Mutant Solid Tumors |
| NCT01454076 results posted | C16009 U1111-1183-0218 | Ph 1 | completed | Pharmacokinetics Study of Oral IXAZOMIB in Participants With Advanced Nonhematologic Malignancies or Lymphoma |
| NCT01802931 | 117016 | Ph 1 | completed | GSK239512 DDI Study |
| NCT00975936 | 113191 | Ph 1 | completed | Phase 0 Microdose Study |
| NCT01039974 | 112648 | Ph 1 | completed | GSK962040 Drug-drug Interaction Study With Ketoconazole |
| NCT01627587 | 115893 | Ph 1 | completed | A Two Cohort Study to Look at the Metabolites of GSK221149, the Metabolism of GSK221149 Administered With a High Fat Meal and With Ketoconazole |
| NCT01165125 | 105548 | Ph 1 | completed | A Drug Interaction Study With Fluticasone Furoate/GW642444 Inhalation Powder and Ketoconazole |
| NCT01924299 results posted | 14607 I4V-MC-JAGJ | Ph 1 | completed | A Study of Baricitinib When Administered With Ketoconazole or Fluconazole in Healthy Participants |
| NCT00895310 results posted | 200916901 UCDCC#218 | Ph 2 | completed | Use of Low Dose Ketoconazole in Prostate Cancer That Does Not Respond to Hormone Therapy and Prior Chemotherapy |
| NCT01787032 results posted | 1314.7 2012-002538-36 | Ph 1 | completed | Drug-drug Interaction Trial of BI 113608 in Combination With Ketoconazole and Voriconazole in Healthy Male Subjects |
| NCT01240226 | GDC4931g | Ph 1 | completed | A Study to Determine the Relative Bioavailability of a Tablet Formulation of GDC-0941 and the Effect of Ketoconazole on the Pharmacokinetics of the GDC-0941 Tablet |
| NCT02606383 | GDN 007/15 | Ph 3 | withdrawn | Non-inferiority Phase III Trial Comparing Dapaconazole Cream 2% With Ketoconazole Cream 2% in Patients With Tinea Pedis |
| NCT00703846 results posted | 114568 | Ph 4 | completed | STUDY TO ASSESS THE LONG-TERM SAFETY OF EXTINA (KETOCONAZOLE) FOAM, 2% |
| NCT01765556 | GO28054 2012-003143-29 | Ph 1 | withdrawn | A Pharmacokinetics Study to Investigate the Effect of Ketoconazole on Vemurafenib in Patients With BRAFV600 Mutation-Positive Metastatic Melanoma |
| NCT01625806 | BP28236 2012-001195-11 | Ph 1 | completed | A Study of The Effects of Multiple Doses of Ketoconazole on Single Dose Pharmacokinetics of RO4602522 in Healthy Male Volunteers |
| NCT01591850 | BP27852 | Ph 1 | completed | A Drug-Drug Interaction Study of Ketoconazole, Rifampicin and Ritonavir-Boosted Atazanavir With Single-Dose RO5093151 in Healthy Volunteers |
| NCT01473316 | GP27913 | Ph 1 | completed | Study to Determine the Effect of Ketoconazole on the Pharmacokinetics of GDC-0980 |
| NCT01164488 | NP25293 | Ph 1 | completed | A Study of RO5190591 (Danoprevir) in Healthy Volunteers |
| NCT02824926 | GDN 083/13 | Ph 2 | completed | Clinical Trial Comparing BL123 Versus Ketoconazole in Patients With Tinea Pedis |
| NCT01267084 | CR017539 ET743OVC1003 | Ph 1, Ph 2 | completed | A Study to Assess the Potential Effects of Ketoconazole on the Pharmacokinetics of Trabectedin in Patients With Advanced Malignancies |
| NCT01657838 | 9766-CL-0040 | Ph 1 | completed | Drug Interaction Study of the Effect of Ketoconazole at Steady State on the Pharmacokinetics of a Single Dose of Isavuconazole in Healthy Adult Subjects |
| NCT01735240 | D3550C00011 | Ph 1 | completed | Phase I Study to Assess the Effect on Healthy Male Volunteers of Ketoconazole on the Pharmacokinetics of a Single Dose of AZD5069 Administered Orally. |
| NCT01584297 GreKo | GETHI 2011-03 2012-001948-21 | Ph 2 | terminated | Ketoconazole as Inhibitor of the Enzyme CYP17 in Locally Advanced or Disseminated Granulosa Cell Tumour of Ovary |
| NCT01218620 | NCI-2012-02916 NCI-2012-02916, CDR0000685426 | Ph 1 | completed | Gamma-Secretase/Notch Signalling Pathway Inhibitor RO4929097 in Treating Patients With Advanced Solid Tumors |
| NCT01026415 | SGN35-008 | Ph 1 | completed | Clinical Pharmacology Study of Brentuximab Vedotin (SGN-35) |
| NCT01679613 results posted | 1199.161 2012-001009-26 | Ph 1 | completed | Investigation of Drug-drug Interaction of Nintedanib and Ketoconazole in Healthy Male Volunteers |
| NCT01520896 | D3820C00012 | Ph 1 | completed | Study in Healthy Volunteers to Investigate the Effects of Ketoconazole on the Pharmacokinetics of NKTR-118 |
| NCT02264171 | 527.78 | Ph 1 | completed | Study to Investigate the Effect of Ketoconazole Mediated CYP3A4 Inhibition on Pharmacokinetics of Tamsulosin in Healthy Male Volunteers |
| NCT02170675 | 1160.101 | Ph 1 | completed | Relative Bioavailability of Single Doses of Dabigatran Etexilate When Administered Alone or in Combination With a Single Dose of Ketoconazole or in Combination With q.d. Ketoconazole at Steady State in Healthy Male and Female Volunteers |
| NCT01760642 | CYP_metabolomics | Ph 1 | completed | Identification and Evaluation of Endogenous Markers for the Assessment of CYP3A Activity |
| NCT01153711 results posted | 1222.47 2010-018527-25 | Ph 1 | completed | Relative Bioavailability of of Olodaterol and Ketoconazole |
| NCT01405989 | 150-CL-037 2009-015761-32 | Ph 1 | completed | To Evaluate if Multiple Doses of Ketoconazole Change the Blood Concentration of YM150 (Darexaban) |
Showing 50 of 68 trials
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Trial Timeline
Full development history with FDA approval milestones
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
KETOZOLE FDA Label Details
Indications & Usage
KETOZOLE is indicated for the treatment of Tinea Versicolor.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.