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Drug

Ketoconazole

Approved · EMA
Emerging researchLate-stage development
Also known as Extina, Keto-C, Ketochlor, Ketoconazole Topical+12 more

Extina, Keto-C, Ketochlor, Ketoconazole Topical, Ketodan, Kuric, Mal-A-Ket, Mal-A-Ket Wipes, Malacetic, Nizoral, Recorlev, Suffusion, T8 Keto Flush, Xolegel, Ketoconazol, Ketoconazolum.

RxNorm6135ChEMBLCHEMBL295698UNIIR9400W927I
1
Research papers
4
Active clinical trials
1
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Ketoconazole Effects on Cortisol Circadian Rhythm in Mild Autonomous Cortisol Secretion: A Pilot Study

Clinical trial2026-07-10Results expected Q4 2027 · ClinicalTrials.gov

A Randomized Phase 2 Trial of 177Lu Radiolabeled Monoclonal Antibody HuJ591 (177Lu-J591) and Ketoconazole in Patients With High-Risk Castrate Biochemically Relapsed Prostate Cancer After Local Therapy

Clinical trial2026-04-08Results posted · ClinicalTrials.gov

A Phase 0 Clinical Trial of Two Candidate Azoles (Ketoconazole and Posaconazole) for Patients With Recurrent High Grade Glioma

Clinical trial2025-06-01Primary completion · ClinicalTrials.gov

Ketoconazole Contributes to Cryptorchidism Outcome Via Modulating Testicular Macrophage Trem2

Clinical trial2024-12-01Primary completion · ClinicalTrials.gov

Administration of Repurposed Ketoconazole in Glioma Patients: Early Phase 1 Clinical Trial

Clinical trial2024-09-25Primary completion · ClinicalTrials.gov

Double-Blinded, Placebo-Controlled Trial to Explore the Anti-Androgen, Ketoconazole, for Treating Patients With an Ongoing Epidermal Growth Factor Receptor (EGFR) Inhibitor-Induced Rash

Clinical trial2024-09-15Completed · ClinicalTrials.gov

A Randomized, Open, Crossover Clinical Study to Investigate the Effects of Ketoconazole on the Pharmacokinetics of CG100649 in Healthy Male Volunteers

Clinical trial2024-01-03Results posted · ClinicalTrials.gov

Hormonal Mechanisms of Sleep Restriction

Clinical trial2023-10-01Completed · ClinicalTrials.gov

A Phase III Randomized Trial for Evaluating Second Line Hormonal Therapy (Ketoconazole/Hydrocortisone) Versus Paclitaxel/Estramustine Combination Chemotherapy on Progression Free Survival in Asymptomatic Patients With a Rising PSA After Hormonal Therapy for Prostate Cancer

Clinical trial2023-06-15Completed · ClinicalTrials.gov

tGLI1 as a Therapeutic Target in Brain Metastases: A Window of Opportunity Study in Breast Cancer Brain Metastases and Primary Gliomas

Clinical trial2022-10-23Terminated · ClinicalTrials.gov

Accelerated approval: Ketoconazole Esteve (previously Ketoconazole HRA) (EMA)

Regulatory2014-11-18EMA

Effect of ketoconazole on the pharmacokinetic profile of buprenorphine following administration of a once-weekly buprenorphine transdermal system.

Research2012-09-01Clinical drug investigation

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Ketoconazole
Aliases & brands
ExtinaKeto-CKetochlorKetoconazole TopicalKetodanKuricMal-A-KetMal-A-Ket WipesMalaceticNizoralRecorlevSuffusionT8 Keto FlushXolegelKetoconazolKetoconazolum
RxNorm CUI
6135
ChEMBL ID
CHEMBL295698
UNII
R9400W927I
Regulatory jurisdictions
ema

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2014-11-18
Latest approval
2014-11-18
Authorities
EMA
Total events
1
emaEuropean Medicines Agency· 1 event
2014-11-18Accelerated approval
Accelerated approval: Ketoconazole Esteve (previously Ketoconazole HRA) (EMA)

Indication: Ketoconazole Esteve is indicated for the treatment of endogenous Cushing’s syndrome in adults and adolescents above the age of 12 years.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

117 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
117
registered trials across all phases
LATEST COMPLETION 2024
4
Active studies
2
Recruiting
17
Late-stage (III+)
92
Completed
21
Discontinued
PHASE DISTRIBUTIONn = 117
Early Phase 16Phase 171Phase 1 / 23Phase 220Phase 2 / 31Phase 39Phase 42Phase N / A5

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

The Effect of Ketoconazole on Breathlessness During Resistive Load Breathing in Patients With Chronic Obstructive Pulmonary Disease

CompletedPH IVDartmouth-Hitchcock Medical Centern=202012

A PHASE 4, OPEN-LABEL STUDY TO ASSESS THE LONG-TERM SAFETY OF EXTINA (KETOCONAZOLE) FOAM, 2% IN THE TREATMENT OF SEBORRHEIC DERMATITIS

CompletedPH IVStiefel, a GSK Companyn=4982010

Phase 3, Multicenter, Double-blind, Randomized, Non-inferiority Clinical Trial of Dapaconazole Cream 2% (Biolab Sanus Farmacêutica Ltda.) Versus Ketoconazole Cream 2% (Nizoral®, Janssen-Cilag Farmacêutica Ltda.) in Patients With Tinea Pedis

CompletedPH IIIBiolab Sanus Farmaceutican=3602019

Assessment of the Treatment of the Severely Burned With Anabolic Agents on Clinical Outcomes, Recovery and Rehabilitation

TerminatedPH II/IIIKey trialThe University of Texas Medical Branch, Galvestonn=1,1262019

Ketoconazole In Situ Gel Versus Terconazole Cream for Treatment of Vaginal Candidiasis

Unknown statusPH IIIAssiut Universityn=692019

Recent completions

Trials that read out recently, adding to the completed evidence base.

Double-Blinded, Placebo-Controlled Trial to Explore the Anti-Androgen, Ketoconazole, for Treating Patients With an Ongoing Epidermal Growth Factor Receptor (EGFR) Inhibitor-Induced Rash

CompletedPH IMayo Clinicn=582024

Hormonal Mechanisms of Sleep Restriction

CompletedPH ILundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Centern=402023

A Phase 1 Randomized, Open-Label, Two-Period,Two-Sequence Crossover Study to Evaluate the Relative Oral Bioavailability of Levoketoconazole and Ketoconazole Tablets in Healthy Subjects

CompletedPH ICortendo ABn=342020

Phase 3, Multicenter, Double-blind, Randomized, Non-inferiority Clinical Trial of Dapaconazole Cream 2% (Biolab Sanus Farmacêutica Ltda.) Versus Ketoconazole Cream 2% (Nizoral®, Janssen-Cilag Farmacêutica Ltda.) in Patients With Tinea Pedis

CompletedPH IIIBiolab Sanus Farmaceutican=3602019

A Phase 1 Study of Oral IXAZOMIB (MLN9708) to Assess Relative Bioavailability, Food Effect, Drug-Drug Interaction With Ketoconazole, Clarithromycin or Rifampin; and Safety and Tolerability in Patients With Advanced Nonhematologic Malignancies or Lymphoma

CompletedPH IMillennium Pharmaceuticals, Inc.n=1122016

Phase I Study of Fenretinide (4-HPR, NSC 374551) Lym-X-Sorb™ (LXS) Oral Powder in Patients With Recurrent or Resistant Neuroblastoma

CompletedPH INew Approaches to Neuroblastoma Therapy Consortiumn=802015

Research activity

1 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Journals, researchers & institutions
Top journals
  • Clinical drug investigation1
Leading researchers
  • Cipriano A1
  • Colucci SV1
  • Harris SC1
  • Kapil RP1
  • Michels GH1
  • Noveck RJ1
  • O'Keefe SA1
  • Perrino P1
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.