TheraRadar
Data updated: May 26, 2026

KETOCONAZOLE

Cytochrome P450 3A4 Inhibitors
Dermatology Approved 1999-06-15

KETOCONAZOLE is indicated for the treatment of Tinea Versicolor.

Source: FDA Label • ZYDUS LIFESCIENCES
Jump to: Indications Approvals Trials Competitors Similar Safety Patents
16
Indications
--
Phase 3 Trials
26
Years on Market

Details

Status
Prescription
First Approved
1999-06-15
Routes
TOPICAL, ORAL
Dosage Forms
SHAMPOO, TABLET, CREAM, AEROSOL, FOAM

Companies

ZYDUS LIFESCIENCES AAIPHARMA LLC STRIDES PHARMA ENCUBE CHARTWELL RX NOVITIUM PHARMA HERITAGE PHARMA Teva Sun Pharma TARO Aurobindo Pharma PADAGIS ISRAEL XIROMED FOUGERA PHARMS COSETTE SENORES PHARMS PADAGIS US
Active Ingredient: KETOCONAZOLE

KETOCONAZOLE Approval History

2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
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2025
2026
Original
New Indication
New Form
Label Update
70 FDA actions from 1999 to 2025
Jul 2025 ORIGINAL
Update
Mar 2025 ORIGINAL
Update
Sep 2024 ORIGINAL
Update

What KETOCONAZOLE Treats

1 indications

KETOCONAZOLE is approved for 1 conditions since its original approval in 1999. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Tinea Versicolor
Source: FDA Label

KETOCONAZOLE Competitive Set

Pro

Three rings of competition based on shared molecular targets and treated indications.

Indication competitors

1

Same indication, different mechanism — what else might this patient receive?

CLOTRIMAZOLE
Hikma
1993 5 indic.

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 KETOCONAZOLE

3 of 4

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

CLOTRIMAZOLE
CLOTRIMAZOLE
1 shared
Hikma
Shared indications:
Tinea Versicolor
EXELDERM
SULCONAZOLE NITRATE
1 shared
JOURNEY
Shared indications:
Tinea Versicolor
KETOZOLE
KETOCONAZOLE
1 shared
SUN PHARMA CANADA
Shared indications:
Tinea Versicolor
View all 4 similar drugs Pro
📋

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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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

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.

KETOCONAZOLE FDA Label Details

Indications & Usage

FDA Label (PDF)

KETOCONAZOLE is indicated for the treatment of Tinea Versicolor.

Looking for the branded version?

KETOZOLE

Full clinical data, patents, trials, and competitive landscape for ketoconazole.

See KETOZOLE

Data Sources

FDA Approval: ANDA218559 → Label: DailyMed → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.