Nizoral

(Ketoconazole)

ApprovedSmall molecule

Ketoconazole is used to treat fungal infections of the skin, hair, and nails, as well as serious internal fungal infections. It works by stopping the growth of fungus in the body.[2] Nizoral is currently approved and in use across 28 indications[4].[1]

Nizoral is one of 484 small molecule programs targeting Dermatophytosis of Scalp or Beard. It is currently in Approved.

Indications

117

Total Trials

Active Trials

483

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Dermatophytosis of Scalp or BeardActive, not recruiting

BlastomycosisActive, not recruiting

TineaActive, not recruiting

Fungal Infectious DiseaseActive, not recruiting

Pityriasis VersicolorApproved

Multiple SclerosisApproved

Erectile DysfunctionApproved

MelanomaApproved

Immune System DiseaseApproved

Chronic Myelogenous LeukemiaApproved

Dermatophytosis of Scalp or BeardPreclinical

Active, not recruiting

BlastomycosisApproved

Active, not recruiting

TineaApproved

Active, not recruiting

Fungal Infectious DiseaseApproved

Active, not recruiting

Pityriasis VersicolorApproved

Approved

Multiple SclerosisApproved

Approved

Erectile DysfunctionApproved

Approved

MelanomaApproved

Approved

Immune System DiseaseApproved

Approved

Chronic Myelogenous LeukemiaApproved

Approved

Showing 10 of 28 indications

Competition

Competitive Landscape

348 competitors in Prostate Cancer

#DrugCompanyPhaseTrials

Nizoral

WWim Janssens

Approved

21 2

Cabometyx

Bristol-Myers Squibb

Phase 3

12 3

Alinamin

Roche

Phase 3

6 4

Xaluritamig

Amgen

Phase 3

4 5

Radium-223

Bayer

Phase 3

6 6

Perflutren Lipid Microspheres

SSidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University

Phase 3

1 7

Androgen Deprivation Treatment

MMedical University of Vienna

Phase 3

1 8

Trexall

Jazz Pharmaceuticals

Preclinical

—9

Botox

VVitae Pharmaceuticals Inc., an Allergan affiliate

Preclinical

1 10

Duragesic

CCephalon

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q2 2027

Phase 1Not yet recruiting

Glioma

NCT03763396

Q4 2027

Phase 1Recruiting

Autonomous Cortisol Secretion

NCT07649317

Clinical

Trials by Indication[1]

Prostate Cancer21 trials

Hormone Therapy Compared With Combination Chemotherapy in Treating Patients With Prostate Cancer

Completed·EEastern Cooperative Oncology Group·Phase 3·NCT00027859

Ketoconazole, Hydrocortisone, Dutasteride and Lapatinib (KHAD-L) in Prostate Cancer

Terminated·—·Phase 1/2·NCT00953576·11 enrolled

Ketoconazole, Dexamethasone, and Hydrocortisone in Treating Patients With Prostate Cancer That Did Not Respond to Androgen-Deprivation Therapy

Withdrawn·RRoswell Park Cancer Institute·N/A·NCT00559481

Show 18 more trials

Chemotherapy With or Without Strontium-89 in Treating Patients With Prostate Cancer

Terminated·MM.D. Anderson Cancer Center·Phase 3·NCT00024167·265 enrolled

Use of Low Dose Ketoconazole in Prostate Cancer That Does Not Respond to Hormone Therapy and Prior Chemotherapy

Completed·UUniversity of California, Davis·Phase 2·NCT00895310·30 enrolled

Chemotherapy Plus Hormone Therapy Versus Androgen Suppression in Treating Patients With Metastatic or Unresectable Prostate Cancer

Completed·MM.D. Anderson Cancer Center·Phase 3·NCT00002855·306 enrolled

Neoadjuvant Therapy With Docetaxel and Ketoconazole in Patients With High-Risk Prostate Cancer: A Pilot Study

Unknown status·—·N/A·NCT00870714·20 enrolled

Combination Chemotherapy With Ketoconazole in Treating Patients With Prostate Cancer

Completed·MM.D. Anderson Cancer Center·Phase 2·NCT00003084·75 enrolled

Hormonal Therapy and Chemotherapy Followed by Prostatectomy in Patients With Prostate Cancer

Terminated·TThe University of Texas Health Science Center, Houston·Phase 2·NCT02494713·4 enrolled

Ketoconazole and Dexamethasone in Prostate Cancer

Completed·UUniversity of California, San Francisco·Phase 2·NCT01036594·32 enrolled

177Lu Radiolabeled Monoclonal Antibody HuJ591 (177Lu-J591) and Ketoconazole in Patients With Prostate Cancer

Active, not recruiting·WWeill Medical College of Cornell University·Phase 2·NCT00859781·55 enrolled

Rapid Hormonal Cycling as Treatment for Patients With Prostate Cancer: The Men's Cycle

Completed·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT00586898·36 enrolled

Trial of GM-CSF Given in Combination With Ketoconazole and Mitoxantrone in Patients With Progressive Prostate Cancer

Terminated·TThe Methodist Hospital Research Institute·Phase 2·NCT00447473·31 enrolled

Hormone Therapy Plus Chemotherapy as Initial Treatment for Local Failures or Advanced Prostate Cancer

Terminated·TThe University of Texas Health Science Center, Houston·Phase 2·NCT02560051·19 enrolled

Combination Chemotherapy Plus Warfarin in Treating Patients With Prostate Cancer

Completed·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT00014352

Ketoconazole, Hydrocortisone, and GM-CSF in Treating Patients With Progressive Prostate Cancer After Hormone Therapy

Completed·UUniversity of California, San Francisco·Phase 2·NCT00309894·49 enrolled

Calcitriol in Combination With Ketoconazole and Therapeutic Hydrocortisone in Treating Patients With Prostate Cancer

Terminated·RRoswell Park Cancer Institute·Phase 1/2·NCT00536991·51 enrolled

Treating Patients With Prostate Cancer That Did Not Respond to Hormone Therapy

Completed·—·Phase 2·NCT00460031·34 enrolled

Hormone Therapy Plus Chemotherapy in Treating Patients With Prostate Cancer

Completed· Radiation Therapy Oncology Group logo

Radiation Therapy Oncology Group·Phase 3·NCT00030654·21 enrolled

Antiandrogen Withdrawal in Treating Patients With Hormone-Refractory Prostate Cancer

Completed·AAlliance for Clinical Trials in Oncology·Phase 3·NCT00002760·260 enrolled

A Phase II Trial of Early Medical Adrenalectomy for "D0.5" Prostate Cancer

Terminated·HH. Lee Moffitt Cancer Center and Research Institute·Phase 2·NCT00006371·2 enrolled

Tics16 trials

Effect of Ketoconazole on the Pharmacokinetics of JNJ-38518168 in Healthy Volunteers

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT01690286·33 enrolled

Study to Assess the Effect of Ketoconazole on the Pharmacokinetics of NBI-98854 in Healthy Subjects

Completed· Neurocrine Biosciences logo

Neurocrine Biosciences·Phase 1·NCT01910480·24 enrolled

Pharmacokinetics of Tasimelteon Alone and in Combination With a CYP3A4 Inhibitor, Ketoconazole, or a CYP3A4 Inducer, Rifampin.

Completed·VVanda Pharmaceuticals·Phase 1·NCT01637636·48 enrolled

Show 13 more trials

Open Label Study, Assessing the Effect of Diltiazem or Ketoconazole on the Pharmacokinetics of AZD9742 in Healthy Volunteers

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT01124760·28 enrolled

A Study of LY2484595 on Pharmacokinetics in Healthy Participants

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT01448824·82 enrolled

Study to Determine the Impact of Multiple Doses of Ketoconazole on Single-Dose Pharmacokinetics of HCV-796

Completed· Pfizer logo

Pfizer·Phase 1·NCT00384917·24 enrolled

To Evaluate The Effect Of Ketoconazole, Ritonavir and Erythromycin on the Safety and Pharmacokinetics of Avanafil

Completed·VVIVUS LLC·Phase 1·NCT00770042·44 enrolled

Effect of Ketoconazole on the Pharmacokinetics of Refametinib

Completed· Bayer logo

Bayer·Phase 1·NCT01925638·18 enrolled

Study in Healthy Volunteers to Investigate the Effects of Ketoconazole on the Pharmacokinetics of NKTR-118

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT01520896·22 enrolled

Study to Determine the Effect of Ketoconazole on the Pharmacokinetics of GDC-0980

Completed· Roche logo

Roche·Phase 1·NCT01473316·22 enrolled

Study to Investigate the Effect of Ketoconazole Mediated CYP3A4 Inhibition on Pharmacokinetics of Tamsulosin in Healthy Male Volunteers

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT02264171·24 enrolled

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

Completed· Roche logo

Roche·Phase 1·NCT01240226·22 enrolled

Estimation Of Effect Of Ketoconazole On Pharmacokinetics Of Crizotinib In Healthy Volunteers

Completed· Pfizer logo

Pfizer·Phase 1·NCT01149785·15 enrolled

A Study to Assess the Effect of Ketoconazole on the Pharmacokinetics of Linifanib (ABT-869)

Completed·AAbbott·Phase 1·NCT01114191·12 enrolled

A Study to Assess the Effect of Ketoconazole on the Pharmacokinetics of Ibrutinib in Healthy Participants

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT01626651·21 enrolled

Pharmacokinetics & Tolerability Study of MAP0004 Co-administered With Ketoconazole

Completed· AbbVie logo

AbbVie·Phase 1·NCT01468558·24 enrolled

Interaction13 trials

A Study to Assess the Safety and Interaction Between Casopitant and Ketoconazole When Taken By Healthy Adults

Completed· GSK logo

GSK·Phase 1·NCT00460707·85 enrolled

Pharmacokinetic Drug Interaction Study in Healthy Male Subjects

Completed·LLG Life Sciences·Phase 1·NCT01426906·24 enrolled

A Drug-Drug Interaction Study of Ketoconazole, Rifampicin and Ritonavir-Boosted Atazanavir With Single-Dose RO5093151 in Healthy Volunteers

Completed· Roche logo

Roche·Phase 1·NCT01591850·51 enrolled

Show 10 more trials

CC-223 and Ketoconazole Drug-Drug Interaction Study

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT01896323·14 enrolled

Validation Study of Multiple Probe Compounds for Drug Interaction Evaluation

Completed· GSK logo

GSK·Phase 1·NCT00964106·87 enrolled

Drug-drug Interaction Trial of BI 113608 in Combination With Ketoconazole and Voriconazole in Healthy Male Subjects

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT01787032·20 enrolled

An Interaction Study of Ketoconazole/Verapamil Versus AZD1305

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT00707551·27 enrolled

A Study to Assess Pharmacokinetic Interaction of Multiple Dose Ketoconazole on Single Dose YM178 Oral Controlled Absorption System (OCAS) in Healthy Adult Volunteers

Completed· Astellas logo

Astellas·Phase 1·NCT01476800·24 enrolled

GSK962040 Drug-drug Interaction Study With Ketoconazole

Completed· GSK logo

GSK·Phase 1·NCT01039974·6 enrolled

Drug-Drug Interaction Study Between Colchicine and Ketoconazole

Completed·MMutual Pharmaceutical Company, Inc.·Phase 1·NCT00983216·24 enrolled

Investigation of Drug-drug Interaction of Nintedanib and Ketoconazole in Healthy Male Volunteers

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT01679613·34 enrolled

A Drug Interaction Study With Fluticasone Furoate/GW642444 Inhalation Powder and Ketoconazole

Completed· GSK logo

GSK·Phase 1·NCT01165125·18 enrolled

Drug-Drug Interaction (DDI) w/Ketoconazole or Fluconazole

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT00860275·30 enrolled

ESS4 trials

Effect of Ketoconazole on Breathlessness

Completed·—·Phase 4·NCT01378520·20 enrolled

Identification and Evaluation of Endogenous Markers for the Assessment of CYP3A Activity

Completed·SSeoul National University Hospital·Phase 1·NCT01760642·16 enrolled

STUDY TO ASSESS THE LONG-TERM SAFETY OF EXTINA (KETOCONAZOLE) FOAM, 2%

Completed· GSK logo

GSK·Phase 4·NCT00703846·498 enrolled

Show 1 more trial

Study Of Healthy Subjects To Assess The Effect Of Ketoconazole And The Way The Body Will React To Casopitant [GW679769]

Completed· GSK logo

GSK·Phase 1·NCT00404378·15 enrolled

Adult Subject3 trials

Evaluation Of SB-751689 Administered At Supratherapeutic Dose Levels In Healthy Adult Subjects.

Completed· GSK logo

GSK·Phase 1·NCT00468689·15 enrolled

Drug Interaction Study of the Effect of Ketoconazole at Steady State on the Pharmacokinetics of a Single Dose of Isavuconazole in Healthy Adult Subjects

Completed· Astellas logo

Astellas·Phase 1·NCT01657838·24 enrolled

A Study in Healthy Adult Subjects to Evaluate the Safety, Tolerability, and Pharmacokinetics of Multiple Doses of ABT-333

Completed·AAbbott·Phase 1·NCT00768690·45 enrolled

41 more indications

Single Dose3 trials

Phase I Study to Assess the Effect on Healthy Male Volunteers of Ketoconazole on the Pharmacokinetics of a Single Dose of AZD5069 Administered Orally.

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT01735240·15 enrolled

A Study of The Effects of Multiple Doses of Ketoconazole on Single Dose Pharmacokinetics of RO4602522 in Healthy Male Volunteers

Completed· Roche logo

Roche·Phase 1·NCT01625806·34 enrolled

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

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT02170675·24 enrolled

Neuroblastoma3 trials

N2004-04: Fenretinide LXS in Treating Patients With Recurrent, Refractory, or Persistent Neuroblastoma

Completed·—·Phase 1·NCT00295919·80 enrolled

Expanded Access Study of Fenretinide Lym-X-Sorb Plus Ketoconazole in Neuroblastoma

No longer available·SSouth Plains Oncology Consortium··NCT02075177

Fenretinide Lym-X-Sorb + Ketoconazole + Vincristine for Recurrent or Resistant Neuroblastoma

Terminated·SSouth Plains Oncology Consortium·Phase 1·NCT02163356·4 enrolled

Excretion2 trials

Effect of Ketoconazole on Biliary Excretion of AZD0837

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT00812344·20 enrolled

Effect of Ketoconazole Inhibition of CYP3A on Urinary Excretion of Docetaxel

Completed·NNational University Hospital, Singapore·Phase 2·NCT00697437·10 enrolled

Seborrheic Dermatitis2 trials

A 4 Week Study of Elidel (Pimecrolimus) for the Treatment of Seborrheic Dermatitis

Completed·DDermatology Specialists Research·Phase 2·NCT00403559·113 enrolled

Omiganan Twice a Day (BID) in Patients With Facial Seborrheic Dermatitis

Unknown status·MMaruho Co., Ltd.·Phase 2·NCT03688971·36 enrolled

Patients With Advanced Solid Tumors2 trials

Gamma-Secretase/Notch Signalling Pathway Inhibitor RO4929097 in Treating Patients With Advanced Solid Tumors

Completed·NNational Cancer Institute (NCI)·Phase 1·NCT01218620·17 enrolled

Ixabepilone and Ketoconazole in Treating Patients With Advanced Solid Tumors

Completed·MMontefiore Medical Center·Phase 1·NCT00096317·29 enrolled

Metabolism2 trials

A Study to Assess the Effect of Ketoconazole on the Metabolism of ABT-199

Completed· AbbVie logo

AbbVie·Phase 1·NCT01969669·12 enrolled

A Study to Assess the Effect of Ketoconazole on the Metabolism of ABT-263 (Navitoclax).

Completed·AAbbott·Phase 1·NCT01021358·12 enrolled

Trial2 trials

Trial for Studying Pharmacokinetic Effects of Ketoconazole on CG100649

Completed·CCrystalGenomics, Inc.·Phase 1·NCT01154764·28 enrolled

Non-inferiority Trial of Dapaconazole Versus Ketoconazole

Completed·BBiolab Sanus Farmaceutica·Phase 3·NCT03320486·360 enrolled

Advanced Cancers2 trials

Carboxyamidotriazole and Ketoconazole in Treating Patients With Advanced Cancers

Completed·NNational Cancer Institute (NCI)·Phase 1·NCT00003249·30 enrolled

Study of Rapamycin Plus Ketoconazole in Advanced Cancers

Completed·UUniversity of Chicago·Phase 1·NCT00708591·57 enrolled

Tinea Pedis2 trials

Non-inferiority Phase III Trial Comparing Dapaconazole Cream 2% With Ketoconazole Cream 2% in Patients With Tinea Pedis

Withdrawn·BBiolab Sanus Farmaceutica·Phase 3·NCT02606383

Clinical Trial Comparing BL123 Versus Ketoconazole in Patients With Tinea Pedis

Completed·GGilberto De Nucci·Phase 2·NCT02824926·60 enrolled

Oral2 trials

Study Evaluating The Safety And Tolerability Of Administration Of Single Oral Doses Of SAM-760 To Healthy Subjects

Completed· Pfizer logo

Pfizer·Phase 1·NCT00948662·124 enrolled

A Study of the Effects of Ketoconazole Taken Orally Has on the PK Profiles of a Dose of GSK189075 in Healthy Volunteers

Completed· GSK logo

GSK·Phase 1·NCT00501397·22 enrolled

EGFR1 trial

Ketoconazole in Treating Participants With Ongoing EGFR Inhibitor-Induced Rash

Completed·MMayo Clinic·Phase 1·NCT03471364·58 enrolled

Glioma1 trial

Azoles Targeting Recurrent High Grade Gliomas

Not yet recruiting·UUniversity Health Network, Toronto·Phase 1·NCT03763396·30 enrolled

Buprenorphine1 trial

Buprenorphine Accumulation and Description of Its Metabolites During Co-Medication of Buprenorphine Transdermal System (BTDS) and Ketoconazole

Completed·PPurdue Pharma LP·Phase 1·NCT01259115·20 enrolled

Concentration1 trial

To Evaluate if Multiple Doses of Ketoconazole Change the Blood Concentration of YM150 (Darexaban)

Completed· Astellas logo

Astellas·Phase 1·NCT01405989·26 enrolled

Retinopathy1 trial

A Pilot Study of the Treatment of Central Serous Chorioretinopathy With Ketoconazole

Completed·MManhattan Eye, Ear & Throat Hospital·Phase 2·NCT00211393·5 enrolled

Effectiveness1 trial

Effectiveness of Two Types of Treatment in Restoring Muscle After Hip or Knee Surgery

Completed·UUniversity of Arkansas·Phase 2·NCT00393848·40 enrolled

Glioblastoma1 trial

Neuro-pharmacological Properties of Repurposed Ketoconazole in Glioblastomas

Terminated·MMilton S. Hershey Medical Center·Phase 1·NCT04869449·1 enrolled

Candidiasis1 trial

Ketoconazole Gel Versus Terconazole Cream for Vaginal Candidiasis

Unknown status·—·Phase 3·NCT03473418·69 enrolled

Metastatic Melanoma1 trial

A Pharmacokinetics Study to Investigate the Effect of Ketoconazole on Vemurafenib in Patients With BRAFV600 Mutation-Positive Metastatic Melanoma

Withdrawn· Roche logo

Roche·Phase 1·NCT01765556

Locally Advanced1 trial

Ketoconazole as Inhibitor of the Enzyme CYP17 in Locally Advanced or Disseminated Granulosa Cell Tumour of Ovary

Terminated·GGrupo Español de Tumores Huérfanos e Infrecuentes·Phase 2·NCT01584297·6 enrolled

Advanced Cancer1 trial

Influence of Ketoconazole on the Pharmacokinetics of Romidepsin in Patients With Advanced Cancer

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT01324310·15 enrolled

Drug1 trial

Effects Of The Drug Ketoconazole On How The Body Handles The Drug SB773812

Completed· GSK logo

GSK·Phase 1·NCT00411866·36 enrolled

Outcome1 trial

Ketoconazole Contributes to Cryptorchidism Outcome Via Modulating Macrophage Trem2

Unknown status·—·N/A·NCT06560086·10 enrolled

Clinical Pharmacology1 trial

Clinical Pharmacology Study of Brentuximab Vedotin (SGN-35)

Completed· Pfizer logo

Pfizer·Phase 1·NCT01026415·73 enrolled

Rehabilitation1 trial

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

Terminated·TThe University of Texas Medical Branch, Galveston·Phase 2/3·NCT00675714·1,126 enrolled

Cohort Study1 trial

A Two Cohort Study to Look at the Metabolites of GSK221149, the Metabolism of GSK221149 Administered With a High Fat Meal and With Ketoconazole

Completed· GSK logo

GSK·Phase 1·NCT01627587·46 enrolled

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1/2·NCT01267084·12 enrolled

Fungal Infection1 trial

A Comparison of Fluconazole and Ketoconazole in the Treatment of Fungal Infections of the Throat in Patients With Weakened Immune Systems

Completed· Pfizer logo

Pfizer·N/A·NCT00002304

Solid Tumors1 trial

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

Completed· GSK logo

GSK·Phase 1·NCT01340846·48 enrolled

Absorption1 trial

A Study to Evaluate the Relative Bioavailability, Food Effect and Effect of Ketoconazole on the Rate and Extent of Absorption of Solid Dosage Formulation(s) of JNJ-40411813

Completed· Johnson & Johnson Pharmaceutical Research & Development, L.L.C. logo

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·Phase 1·NCT01932320·36 enrolled

Sleep Restriction1 trial

Hormonal Mechanisms of Sleep Restriction

Completed·LLundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center·Phase 1·NCT02256865·40 enrolled

Metastatic Prostate Cancer1 trial

Ketoconazole With or Without Alendronate Sodium in Treating Patients With Metastatic Prostate Cancer

Terminated·NNational Cancer Institute (NCI)·Phase 2·NCT00019695

Baricitinib1 trial

A Study of Baricitinib When Administered With Ketoconazole or Fluconazole in Healthy Participants

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT01924299·36 enrolled

Pomalidomide1 trial

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

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT01707407·32 enrolled

Unresectable Solid Tumor1 trial

Calcitriol, Ketoconazole, and Dexamethasone in Treating Patients With Metastatic or Unresectable Solid Tumors

Completed·RRoswell Park Cancer Institute·Phase 1·NCT00238225·15 enrolled

Lymphoma1 trial

Pharmacokinetics Study of Oral IXAZOMIB in Participants With Advanced Nonhematologic Malignancies or Lymphoma

Completed· Takeda logo

Takeda·Phase 1·NCT01454076·112 enrolled

Autonomous Cortisol Secretion1 trial

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

Recruiting·NNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)·Phase 1·NCT07649317·36 enrolled

Anatomic Stage IV Breast Cancer AJCC v81 trial

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

Terminated·WWake Forest University Health Sciences·Phase 1·NCT03796273·15 enrolled

Unspecified8 trials

Relative Bioavailability of of Olodaterol and Ketoconazole

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT01153711·32 enrolled

Bioavailability of Levoketoconazole and Ketoconazole Tablets

Completed·CCortendo AB·Phase 1·NCT04212000·34 enrolled

The Effect of Gemfibrozil, Ketoconazole and Clarithromycin on the Amount of LY2409021 in the Bloodstream

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT01836198·30 enrolled

Show 5 more trials

Phase 0 Microdose Study

Completed· GSK logo

GSK·Phase 1·NCT00975936·12 enrolled

A Study of RO5190591 (Danoprevir) in Healthy Volunteers

Completed· Roche logo

Roche·Phase 1·NCT01164488·18 enrolled

Bioavailability of BI 144807 Given Alone and in Combination With Ketoconazole in Healthy Male Volunteers

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT01707940·24 enrolled

ITT-5 Mechanisms of Spermatogenesis in Man

Withdrawn·UUniversity of Washington·Phase 2·NCT02147964

GSK239512 DDI Study

Completed· GSK logo

GSK·Phase 1·NCT01802931·22 enrolled

Regulatory

FDA Approval Timeline[5]

Jan 1, 1982

NIZORAL

NDA NDA018533

Dec 31, 1985

NIZORAL

NDA NDA019084

Aug 31, 1990

NIZORAL

NDA NDA019927

Oct 10, 1997

NIZORAL ANTI-DANDRUFF

NDA NDA020310

Jul 28, 2006

XOLEGEL

NDA NDA021946

Jun 12, 2007

EXTINA

NDA NDA021738

Sources

References

[1]
ClinicalTrials.gov — 117 trial records for Ketoconazole. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Nizoral drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Ketoconazole compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Ketoconazole. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA021738). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Wim Janssens company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Cytochrome P450 51 Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: WWim Janssens

Nizoral

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q2 2027

Q4 2027

Trials by Indication[1]

Prostate Cancer21 trials

Tics16 trials

Interaction13 trials

ESS4 trials

Adult Subject3 trials

Single Dose3 trials

Neuroblastoma3 trials

Excretion2 trials

Seborrheic Dermatitis2 trials

Patients With Advanced Solid Tumors2 trials

Metabolism2 trials

Trial2 trials

Advanced Cancers2 trials

Tinea Pedis2 trials

Oral2 trials

EGFR1 trial

Glioma1 trial

Buprenorphine1 trial

Concentration1 trial

Retinopathy1 trial

Effectiveness1 trial

Glioblastoma1 trial

Candidiasis1 trial

Metastatic Melanoma1 trial

Locally Advanced1 trial

Advanced Cancer1 trial

Drug1 trial

Outcome1 trial

Clinical Pharmacology1 trial

Rehabilitation1 trial

Cohort Study1 trial

Acute Respiratory Distress Syndrome1 trial

Adult1 trial

Advanced Malignancies1 trial

Fungal Infection1 trial

Solid Tumors1 trial

Absorption1 trial

Sleep Restriction1 trial

Metastatic Prostate Cancer1 trial

Baricitinib1 trial

Pomalidomide1 trial

Unresectable Solid Tumor1 trial

Lymphoma1 trial

Autonomous Cortisol Secretion1 trial

Anatomic Stage IV Breast Cancer AJCC v81 trial

Unspecified8 trials

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

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