Drugs / Ketoconazole
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Ketoconazole

Small molecule targets CYP3A4, CYP3A5 via inhibition

Developed for
prostate cancer · cancer · cancer of unknown primary site · pityriasis versicolor · chronic obstructive pulmonary disease · neuroblastoma · tinea pedis · bacterial vaginosis
+32 more · prostate adenocarcinoma · prostate neoplasm · vulvovaginal candidiasis · adrenal gland disorder · adult acne · adult acute respiratory distress syndrome · adult glioblastoma · astrocytoma (excluding glioblastoma) · brain glioblastoma · brain glioma · candidiasis · castration-resistant prostate carcinoma · central serous chorioretinopathy · esophageal candidiasis · female breast carcinoma · folliculitis · grade II glioma · grade III glioma · invasive breast carcinoma · metastatic malignant neoplasm in the brain · oligodendroglioma · ovarian cancer · ovarian granulosa cell tumor · primary peritoneal carcinoma · prostate disorder · psoriasis · seborrheic dermatitis · tinea infection · tinea unguium · acne · dermatophytosis of scalp or beard · scalp dermatosis
Investigated by
National Cancer Institute (NCI) · GlaxoSmithKline · Boehringer Ingelheim · Pfizer · Abbott · AstraZeneca
+104 more · Hoffmann-La Roche · Janssen Research & Development, LLC · Bayer · Eli Lilly and Company · Genentech, Inc. · M.D. Anderson Cancer Center · South Plains Oncology Consortium · ACM Global Laboratories · Cancer and Leukemia Group B · Celgene Corporation · Eastern Cooperative Oncology Group · Eisai Inc. · Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · Johnson & Johnson Pharmaceutical Research & Development, L.L.C. · Memorial Sloan Kettering Cancer Center · Millennium Pharmaceuticals, Inc. · Novum Pharmaceutical Research Services · Roswell Park Cancer Institute · SWOG Cancer Research Network · University of California, Davis · University of California, San Francisco · University of Washington · AbbVie · Ache Laboratorios Farmaceuticos S.A. · Affiliated Hospital of Nantong University · Akros Pharma Inc. · Allergan · American College of Clinical Pharmacy · Assiut University · Astellas Pharma Global Development, Inc. · Astellas Pharma Inc · Basilea Pharmaceutica International Ltd · Beth Israel Deaconess Medical Center · Boni Elewski, MD · Boryung Pharmaceutical Co., Ltd · Brigham and Women's Hospital · Case Comprehensive Cancer Center · Chong Kun Dang Pharmaceutical · Chulalongkorn University · CrystalGenomics, Inc. · Dana-Farber Cancer Institute · Dartmouth-Hitchcock Medical Center · Donald Trump, MD · Douglas Pharmaceuticals America Ltd · Encube Ethicals Pvt. Ltd. · Faculty of Medicine, University of Indonesia · Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal · Indonesia University · Jazz Pharmaceuticals · Kansas City Veteran Affairs Medical Center · LG Life Sciences · LuEsther T. Mertz Retinal Research Center · Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center · MAP Pharmaceuticals, Inc., a wholly owned subsidiary of Allergan · Manhattan Eye, Ear & Throat Hospital · Massachusetts General Hospital · Mayo Clinic · Medivation, Inc. · Merck Sharp & Dohme LLC · Milton S. Hershey Medical Center · Montefiore Medical Center · Mutual Pharmaceutical Company, Inc. · NRG Oncology · National Heart, Lung, and Blood Institute (NHLBI) · National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · National Institute of General Medical Sciences (NIGMS) · National Institutes of Health (NIH) · National University Hospital, Singapore · Neurocrine Biosciences · New Approaches to Neuroblastoma Therapy Consortium · PAEC General Hospital, Islamabad · PAEC general hospital · Padjadjaran University · all 110 on the full record

Regulatory milestones approvals, filings & regulatory actions · 4 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved EU (EMA) Ketoconazole Esteve (previously Ketoconazole HRA) 2014-11-18 europa.eu
Label expansions (2) US (FDA) NIZORAL 1993-01-27 – 1997-05-30 fda.gov
Approved US (FDA) NIZORAL 1981-06-12 fda.gov

Trials 140 · started per year

today
US approved 1981
EU approved 2014
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198119821983198419851986198719881989199019911992199319941995199619971998199920002001200220032004200520062007200820092010201120122013201420152016201720182019202020212022202320242025202620272028
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 06 trials
Phase 0 NCT03763396 Jun 2024 → Jun 2025 overdue brain glioma University Health Network, Toronto Not yet recruiting No outcome recorded
Phase 0 NCT07585851 Feb 2023 → Sep 2024 overdue grade II glioma, grade III glioma Padjadjaran University Active not recruiting No outcome recorded
Phase 0 NCT04869449 May 2022 adult glioblastoma, brain glioblastoma Milton S. Hershey Medical Center Terminated No outcome recorded
Phase 0 NCT04037605 Feb 2020 → Jul 2022 overdue Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center Active not recruiting No outcome recorded
Phase 0 NCT03796273 Mar 2019 → Oct 2022 astrocytoma (excluding glioblastoma), female breast carcinoma, invasive breast carcinoma, metastatic malignant neoplasm in the brain +1 Wake Forest University Health Sciences Terminated No outcome recorded
Phase 0 NCT03471364 Sep 2018 → Sep 2024 cancer Mayo Clinic Completed No outcome recorded
Phase 184 trials
Phase 1 NCT07649317 Jul 2026 → Dec 2027 expected adrenal gland disorder National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Recruiting No outcome recorded
Phase 1 NCT03142893 May 2017 → Oct 2020 overdue Peter y. Liu Active not recruiting No outcome recorded
Phase 1 NCT02163356 May 2014 → May 2018 neuroblastoma South Plains Oncology Consortium Terminated No outcome recorded
Phase 1 NCT01969669 Dec 2013 → Sep 2014 non-Hodgkin lymphoma AbbVie Completed No outcome recorded
Phase 1 NCT01765556 Oct 2013 melanoma Hoffmann-La Roche Withdrawn No outcome recorded
Phase 1 NCT01925638 Sep → Dec 2013 Bayer Completed No outcome recorded
Phase 1 NCT01924299 Aug → Nov 2013 Eli Lilly and Company Completed No outcome recorded
Phase 1 NCT01910480 Jul → Aug 2013 Neurocrine Biosciences Completed No outcome recorded
Phase 1 NCT01836198 May → Nov 2013 Eli Lilly and Company Completed No outcome recorded
Phase 1 NCT03437005 Jan 2013 → Sep 2026 expected University of California, Davis Recruiting No outcome recorded
Phase 1/25 trials
Phase 1/2 NCT01535157 Feb 2012 → Jun 2017 ovarian cancer, primary peritoneal carcinoma South Plains Oncology Consortium Terminated No outcome recorded
Phase 1/2 NCT01267084 Feb 2011 → Nov 2012 metastatic malignant neoplasm Janssen Research & Development, LLC Completed No outcome recorded
Phase 1/2 NCT01215292 Jan 2011 → Mar 2012 University of Washington Completed No outcome recorded
Phase 1/2 NCT00953576 Sep 2009 → Apr 2013 prostate cancer Dana-Farber Cancer Institute Terminated No outcome recorded
Phase 1/2 NCT00536991 Oct 2006 → Oct 2016 prostate adenocarcinoma Roswell Park Cancer Institute Terminated No outcome recorded
Phase 217 trials
Phase 2 NCT02147964 Jun 2019 → Dec 2021 hypogonadotropic hypogonadism University of Washington Withdrawn No outcome recorded
Phase 2 NCT03261336 Jan 2017 → Feb 2018 castration-resistant prostate carcinoma Donald Trump, MD Terminated No outcome recorded
Phase 2 NCT02494713 Oct 2015 → Sep 2017 prostate cancer The University of Texas Health Science Center, Houston Terminated No outcome recorded
Phase 2 NCT01584297 Oct 2012 → Nov 2014 ovarian granulosa cell tumor Spanish Group for Research in Orphan, Infrequent Tumors Terminated No outcome recorded
Phase 2 NCT01036594 Dec 2009 → Dec 2012 prostate cancer University of California, San Francisco Completed No outcome recorded
Phase 2 NCT00895310 May 2009 → Dec 2014 prostate cancer University of California, Davis Completed No outcome recorded
Phase 2 NCT00678756 Mar 2008 → Oct 2009 psoriasis Technical University Dresden Unknown No outcome recorded
Phase 2 NCT00393848 Oct 2006 → Oct 2012 avascular necrosis, osteoarthritis University of Arkansas Completed No outcome recorded
Phase 2 NCT00697437 Oct 2006 → Oct 2013 cancer National University Hospital, Singapore Completed No outcome recorded
Phase 2 NCT00460031 Sep 2006 → Aug 2010 prostate cancer Case Comprehensive Cancer Center Completed No outcome recorded
Phase 2/31 trial
Phase 2/3 NCT00675714 Jan 2004 → Sep 2018 The University of Texas Medical Branch, Galveston Terminated No outcome recorded
Phase 313 trials
Phase 3 NCT04203342 Dec 2019 → May 2020 tinea pedis Douglas Pharmaceuticals America Ltd Completed No outcome recorded
Phase 3 NCT02582177 Jun 2019 → Jan 2020 tinea infection Ache Laboratorios Farmaceuticos S.A. Completed No outcome recorded
Phase 3 NCT03824912 Aug 2018 → Jan 2019 tinea pedis Encube Ethicals Pvt. Ltd. Completed No outcome recorded
Phase 3 NCT03473418 Apr → Oct 2018 vulvovaginal candidiasis Assiut University Unknown No outcome recorded
Phase 3 NCT03178994 Aug 2017 → Sep 2018 adult acne Chulalongkorn University Completed No outcome recorded
Phase 3 NCT01293643 May 2010 → Jan 2011 bacterial vaginosis, vulvovaginal candidiasis Merck Sharp & Dohme LLC Completed No outcome recorded
Phase 3 NCT00889356 Sep 2009 → Mar 2010 bacterial vaginosis, candidiasis Zodiac Produtos Farmaceuticos S.A. Unknown No outcome recorded
Phase 3 NCT01110330 Jul 2007 → Oct 2008 tinea pedis Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Terminated No outcome recorded
Phase 3 NCT00027859 Oct 2003 → Dec 2004 prostate cancer Eastern Cooperative Oncology Group Completed No outcome recorded
Phase 3 NCT00030654 Oct 2002 → Feb 2005 prostate cancer Radiation Therapy Oncology Group Completed No outcome recorded
Phase 48 trials
Phase 4 NCT07471178 Feb → May 2026 overdue pityriasis versicolor Faculty of Medicine, University of Indonesia Not yet recruiting No outcome recorded
Phase 4 NCT07333170 Feb → Jul 2026 overdue pityriasis versicolor PAEC General Hospital, Islamabad Not yet recruiting No outcome recorded
Phase 4 NCT04007237 Sep → Dec 2018 pityriasis versicolor Indonesia University Completed No outcome recorded
Phase 4 NCT01378520 Jun 2011 → Feb 2012 chronic obstructive pulmonary disease Dartmouth-Hitchcock Medical Center Completed No outcome recorded
Phase 4 NCT00824863 Dec 2008 → May 2010 folliculitis Wayne Fujita, M.D. Completed No outcome recorded
Phase 4 NCT00830388 Nov 2008 → Aug 2010 pityriasis versicolor Boni Elewski, MD Completed No outcome recorded
Phase 4 NCT01288521 Oct 2008 → Jun 2011 Sony Tuteja Completed No outcome recorded
Phase 4 NCT00703846 Jun 2008 → Apr 2010 seborrheic dermatitis Stiefel, a GSK Company Completed No outcome recorded
Phase not applicable5 trials
NCT06560086 Feb → Dec 2024 cryptorchidism Affiliated Hospital of Nantong University Unknown No outcome recorded
NCT01576575 Jun 2010 → Mar 2014 Washington University School of Medicine Completed No outcome recorded
NCT00870714 Sep 2004 → Sep 2010 prostate cancer Kansas City Veteran Affairs Medical Center Unknown No outcome recorded
NCT00392457 Jul 1995 → Feb 2007 Kallmann syndrome Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Completed No outcome recorded
NCT00002304 HIV infectious disease, esophageal candidiasis Pfizer Completed No outcome recorded
Phase not stated1 trial
NCT02075177 neuroblastoma South Plains Oncology Consortium No longer available No outcome recorded
Also used as a comparator or background therapy in 38 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 01 trial
Phase 0 NCT02256865 Comparator Oct 2014 → Nov 2017 Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center Completed No outcome recorded
Phase 117 trials
Phase 1 NCT06305637 Comparator Dec 2023 → Feb 2024 pityriasis versicolor Sun Pharmaceutical Industries, Inc. Completed No outcome recorded
Phase 1 NCT06616168 Background Sep 2023 → Aug 2026 overdue bacterial vaginosis Danylo Halytsky Lviv National Medical University Active not recruiting No outcome recorded
Phase 1 NCT04212000 Comparator Dec 2019 → Jan 2020 Cortendo AB Completed No outcome recorded
Phase 1 NCT01896323 Comparator Jul → Aug 2013 Celgene Corporation Completed No outcome recorded
Phase 1 NCT01802931 Comparator Jan → Apr 2013 multiple sclerosis GlaxoSmithKline Completed No outcome recorded
Phase 210 trials
Phase 2 NCT05638763 Background Nov 2024 chronic myeloid leukemia Hospital Universitario Dr. Jose E. Gonzalez Unknown No outcome recorded
Phase 2 NCT03688971 Comparator Oct 2018 → Dec 2019 seborrheic dermatitis Maruho Co., Ltd. Unknown No outcome recorded
Phase 2 NCT02560051 Comparator Nov 2015 → Sep 2017 prostate neoplasm The University of Texas Health Science Center, Houston Terminated No outcome recorded
Phase 2 NCT02824926 Comparator Jul → Dec 2014 tinea pedis Gilberto De Nucci Completed No outcome recorded
Phase 2 NCT00859781 Background Jun 2009 → Feb 2022 overdue prostate cancer Weill Medical College of Cornell University Active not recruiting No outcome recorded
Phase 35 trials
Phase 3 NCT03845348 Comparator May 2019 → Dec 2022 scalp dermatosis Sao Thai Duong Joint Stock Company Unknown No outcome recorded
Phase 3 NCT03320486 Comparator Nov 2017 → Aug 2019 tinea pedis Biolab Sanus Farmaceutica Completed No outcome recorded
Phase 3 NCT02606383 Comparator Jun → Dec 2016 tinea pedis Biolab Sanus Farmaceutica Withdrawn No outcome recorded
Phase 3 NCT00862654 Comparator Mar 2009 → Feb 2010 seborrheic dermatitis Galderma R&D Completed No outcome recorded
Phase 3 NCT00002760 Comparator Aug 1996 → Mar 2004 prostate cancer Alliance for Clinical Trials in Oncology Completed No outcome recorded
Phase 41 trial
Phase 4 NCT06170333 Background Aug → Dec 2023 pityriasis versicolor Padjadjaran University Completed No outcome recorded
Phase not applicable4 trials
NCT07237763 Comparator Jan 2024 → Dec 2025 overdue acne Cairo University Active not recruiting No outcome recorded
NCT01203189 Comparator Sep 2010 → Jun 2013 seborrheic dermatitis St. Louis University Completed No outcome recorded
NCT00559481 Background Oct 2007 → Sep 2008 prostate cancer Roswell Park Cancer Institute Withdrawn No outcome recorded
NCT00127868 Comparator Mar 2005 → Apr 2008 dermatophytosis of scalp or beard Chen, Catherine, M.D. Completed No outcome recorded

Press releases naming this drug 1 release

DateIssuerRelease
2000-04-26 Teva Branded Pharmaceutical Products R&D, Inc. Teva Pharmaceutical Receives First FDA Approval of Ketoconazole 2% Cream tevapharm.com

Evidence & citations 28 cited values

Every value below carries the sentence it was read from. 181 sources stand behind the page.

FieldValueCited text
Known as Ketoconazole “The purpose of this study is to determine multiple dose safety, tolerability and pharmacokinetics of ABT-072 under nonfasting conditions in healthy adult subjects, and to...” NCT00890318
175

“The study aimed to reveal the mycological efficacy, safety, recurrence and cost-effectiveness of selenium sulfide 1.8% shampoo (SeS2) and ketoconazole 2% shampoo in the...” NCT04007237

“Candicort® is a cream composed by ketoconazole 20mg/g and betamethasone dipropionate 0,64 mg/g that will be dispensed to 80 participants of this group in the first stage.” NCT02582177

“Triazoles (Fluconazole, Itraconazole, Voriconazole), Imidazoles (Ketoconazole), Nystatin and Amphotericin B are used the most” NCT06616168

“Along with the soap or placebo, patients will receive 2% ketoconazole shampoo, left on for five minutes and then washed off.” NCT06170333

“Effect of Ketoconazole on the Pharmacokinetics of Intravenous (IV) Vinflunine in Patients With Advanced Cancer” NCT00388557

“repeat oral dosing of ketoconazole on the pharmacokinetics of a single dose of pazopanib (GW786034)” NCT00659555

Ketoconazole dose will be 600mg per day (given 200 mg, three times a day)” NCT00032825

“20 mg cediranib plus 400 mg ketoconazole from Days 8-10” NCT00750425

“Drug: ketoconazoleNCT01124760

KetoconazoleNCT01288521

NCT00915746

NCT03178994

NCT00862654

NCT02606383

NCT01787032

NCT01218620

NCT02170675

NCT01036594

NCT01576575

NCT01520896

NCT01476800

NCT00953576

NCT03437005

NCT00403559

NCT01707407

NCT01707940

NCT02494713

NCT00824863

NCT06560086

NCT00298155

NCT01637636

NCT00938262

NCT01405989

NCT00586898

NCT00006371

NCT03796273

NCT00703846

NCT01021358

NCT02264171

NCT00675714

NCT00673127

NCT01426906

NCT00419783

NCT00975936

NCT02163356

NCT00889356

NCT05638763

NCT01591850

NCT03320486

NCT03688971

NCT00404378

NCT00003249

NCT00768690

NCT01615913

NCT01760642

NCT01448824

NCT01802931

NCT00964106

NCT00162214

NCT01836198

NCT00024167

NCT01259115

NCT00212095

NCT00501397

NCT03142893

NCT01924299

NCT00127868

NCT01318265

NCT01330563

NCT00830388

NCT00003084

NCT03261336

NCT01925638

NCT07471178

NCT00393848

NCT00309894

NCT01749085

NCT00000579

NCT02198170

NCT01110330

NCT01026415

NCT00002855

NCT00447473

NCT00460031

NCT02147964

NCT01588782

NCT00211393

NCT00948662

NCT00460707

NCT00895310

NCT01627587

NCT00096317

NCT00392457

NCT01153711

NCT01535157

NCT00238225

NCT07649317

NCT00027859

NCT01473316

NCT01679613

NCT00812344

NCT00014352

NCT01473069

NCT00866515

NCT00931073

NCT01293643

NCT03824912

NCT01323465

NCT01626651

NCT00859781

NCT07237763

NCT00002760

NCT03763396

NCT01765556

NCT00019695

NCT01288521

NCT04203342

NCT01721070

NCT00770042

NCT01000376

NCT00295919

NCT01215292

NCT01340846

NCT00697437

NCT01114191

NCT00431197

NCT02560051

NCT00707551

NCT01625806

NCT01149785

NCT01165125

NCT01454076

NCT00860275

NCT03471364

NCT03845348

NCT07585851

NCT04037605

NCT00870714

NCT01690286

NCT01468558

NCT02075177

NCT03473418

NCT00384917

NCT01240226

NCT01969669

NCT04212000

NCT00983216

NCT01039974

NCT01468714

NCT01267084

NCT01324310

NCT06305637

NCT00680485

NCT00559481

NCT00536991

NCT01896323

NCT01910480

NCT01203189

NCT01378520

NCT01584297

NCT00002304

NCT01202240

NCT01657838

NCT01735240

NCT00468689

NCT00411866

NCT01164488

NCT02824926

NCT02256865

NCT04869449

NCT00708591

NCT01932320

NCT00030654

NCT07333170

NCT01154764

Known as Daktarin gold ChEMBL registry synonym — accepted as the source's own label CHEMBL157101
Known as Daktarin intensiv ChEMBL registry synonym — accepted as the source's own label CHEMBL157101
Known as Dandrazol ChEMBL registry synonym — accepted as the source's own label CHEMBL157101
Known as Dandrid ChEMBL registry synonym — accepted as the source's own label CHEMBL157101
Known as Extina Extina (ketoconazole) Foam, 2% was approved for marketing in the United States (US) in June 2007.” NCT00703846
Known as Extina Foam “ketaconozole 2% foam brand name is Extina Foam.” NCT00824863
Known as J02AB02 ChEMBL registry synonym — accepted as the source's own label CHEMBL157101
Known as KCZ “We would like to translate these preclinical findings into the clinical setting by implementing a proof-of biological concept study with two azole drugs: ketoconazole (KCZ) and...” NCT03763396
1

“Antiandrogen stopped; plus Ketoconazole, KCZ; Hydrocortisone, HC, NSC-10483.” NCT00002760

Known as ketaconozole 2% foam ketaconozole 2% foam brand name is Extina Foam.” NCT00824863
Known as Ketoconazol ClinicalTrials.gov intervention name — accepted as the source's own label NCT01548170
Known as Ketoconazole hra ChEMBL registry synonym — accepted as the source's own label CHEMBL157101
Known as Ketoconazolum ChEMBL registry synonym — accepted as the source's own label CHEMBL157101
Known as Ketokonazol ClinicalTrials.gov intervention name — accepted as the source's own label NCT00678756
Known as Ketokonazole ClinicalTrials.gov intervention name — accepted as the source's own label NCT01189175
Known as Ketopine ChEMBL registry synonym — accepted as the source's own label CHEMBL157101
Known as Ketozole ChEMBL registry synonym — accepted as the source's own label CHEMBL157101
Known as nizoral “In the second stage Nizoral ® will be dispensed to the same participants. It´s a cream composed by ketoconazole 20mg/g that will be applied in the affected area once a day for 14 days.” NCT02582177
3

“Ketoconazole 2% cream (formulation F012) (Nizoral)” NCT01110330

“Ketoconazole (NIZORAL) oral tablets (200 mg)” NCT00468689

“Ketoconazole Pill (also known as nizoral)” NCT04037605

Known as Nizoral a-d ChEMBL registry synonym — accepted as the source's own label CHEMBL157101
Known as Nizoral anti-dandruff ChEMBL registry synonym — accepted as the source's own label CHEMBL157101
Known as Nizorelle ChEMBL registry synonym — accepted as the source's own label CHEMBL157101
Known as NSC-317629 ChEMBL registry synonym — accepted as the source's own label CHEMBL157101
Known as R 41,400 ChEMBL registry synonym — accepted as the source's own label CHEMBL157101
Known as Xolegel ChEMBL registry synonym — accepted as the source's own label CHEMBL157101
Action Inhibit “It also assessed the efficacy of ketoconazole, a thromboxane synthetase inhibitor, in reducing mortality and morbidity in patients with acute lung injury and ARDS.” NCT00000579