Ketoconazole Clinical Trials

Size	Price	Qty
100mg	USD 147
1g	USD 370

Clinical Trials

Numerous clinical trials spanning Early Phase 1 through Phase 4 have evaluated ketoconazole across diverse indications, including fungal infections like vaginal candidiasis, Cushing syndrome, glioblastoma, and metastatic breast cancer. Sponsored by academic institutions, government organizations, and pharmaceutical companies, these investigations encompass both completed and ongoing studies. Across this clinical body of work, recruitment statuses vary widely, ranging from actively recruiting to completed, terminated, or withdrawn.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT07649317	RECRUITING	Mild Autonomous Cortisol Secretion	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	2026-07-27	PHASE1
NCT03437005	RECRUITING	Healthy	University of California, Davis	2013-01-28	PHASE1
NCT07734441	RECRUITING	Seborrheic Dermatitis	Combined Military Hospital (CMH) institute of Medical Sciences Bahawalpur Pakistan	2026-01-07	EARLY_PHASE1
NCT07333170	NOT_YET_RECRUITING	Pityriasis Versicolor	PAEC General Hospital, Islamabad	2026-02	PHASE4
NCT07471178	NOT_YET_RECRUITING	Pityriasis Versicolor	Fakultas Kedokteran Universitas Indonesia	2026-02	PHASE4
NCT07802808	COMPLETED	Seborrheic Dermatitis	Indonesia University	2026-01-12	PHASE4
NCT07237763	ACTIVE_NOT_RECRUITING	Acne	Cairo University	2024-01-15
NCT03763396	NOT_YET_RECRUITING	Brain Tumor, Recurrent; Cancer, Advanced; Glioma of Brain	University Health Network, Toronto	2024-06-01	EARLY_PHASE1
NCT06560086	UNKNOWN	Cryptorchidism	Affiliated Hospital of Nantong University	2024-02-03
NCT05638763	UNKNOWN	Chronic Myeloid Leukemia, Chronic Phase	Hospital Universitario Dr. Jose E. Gonzalez	2024-11	PHASE2
NCT07585851	ACTIVE_NOT_RECRUITING	Diffuse Glioma; Diffuse Glioma, Grade I; Diffuse Glioma, Grade II; Diffuse Glioma, Grade III; Diffuse Glioma, Grade IV	Universitas Padjadjaran	2023-02-28	EARLY_PHASE1
NCT03471364	COMPLETED	Malignant Neoplasm	Mayo Clinic	2018-09-25	EARLY_PHASE1
NCT06305637	COMPLETED	Tinea Versicolor	Sun Pharmaceutical Industries, Inc.	2023-12-04	PHASE1
NCT06170333	COMPLETED	Pityriasis Versicolor	Universitas Padjadjaran	2023-08-25	PHASE4
NCT03621280	COMPLETED	Cushing Syndrome; Cushing Disease	Cortendo AB	2019-01-07	PHASE3
NCT03845348	UNKNOWN	Scalp Dermatitis	Sao Thai Duong Joint Stock Company	2019-05-22	PHASE3
NCT03796273	TERMINATED	Anatomic Stage IV Breast Cancer AJCC v8; Astrocytoma; Breast Carcinoma Metastatic in the Brain; Glioma; Invasive Breast Carcinoma; Oligodendroglioma; Prognostic Stage IV Breast Cancer AJCC v8; Recurrent Glioma	Wake Forest University Health Sciences	2019-03-13	EARLY_PHASE1
NCT04037605	ACTIVE_NOT_RECRUITING	Sleep Restriction	Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center	2020-02-09	EARLY_PHASE1
NCT04869449	TERMINATED	Glioblastoma; Glioblastoma Multiforme; Glioblastoma Multiforme of Brain; Glioblastoma Multiforme, Adult	Milton S. Hershey Medical Center	2022-05-11	EARLY_PHASE1
NCT04869449	Recruiting	Glioblastoma\|Glioblastoma Multiforme\|Glioblastoma Multiforme of Brain\|Glioblastoma Multiforme Adult	Milton S. Hershey Medical Center	2022-05-12	Early Phase 1
NCT00859781	ACTIVE_NOT_RECRUITING	Prostate Cancer	Weill Medical College of Cornell University	2009-06	PHASE2
NCT02147964	WITHDRAWN	Gonadotropin Deficiency	University of Washington	2019-06	PHASE2
NCT03142893	ACTIVE_NOT_RECRUITING	Sleep Restriction	Peter y. Liu	2017-05-08	PHASE1
NCT03277690	COMPLETED	Endogenous Cushing's Syndrome	Cortendo AB	2017-09-26	PHASE3
NCT04203342	COMPLETED	Tinea Pedis	Douglas Pharmaceuticals America Ltd	2019-12-11	PHASE3
NCT02582177	COMPLETED	Tinea	Ache Laboratorios Farmaceuticos S.A.	2019-06-11	PHASE3
NCT04212000	COMPLETED	Healthy	Cortendo AB	2019-12-16	PHASE1
NCT04212000	Completed	Healthy	Cortendo AB	2019-12-16	Phase 1
NCT03688971	UNKNOWN	Seborrheic Dermatitis	Maruho Co., Ltd.	2018-10-22	PHASE2
NCT04057950	COMPLETED	Scalp Dermatitis; Dermatitis	L'Oreal	2019-06-01
NCT03320486	COMPLETED	Tinea Pedis	Biolab Sanus Farmaceutica	2017-11-01	PHASE3
NCT03796273	Recruiting	Anatomic Stage IV Breast Cancer AJCC v8\|Astrocytoma\|Breast Carcinoma Metastatic in the Brain\|Glioma\|Invasive Breast Carcinoma\|Oligodendroglioma\|Prognostic Stage IV Breast Cancer AJCC v8\|Recurrent Glioma	Wake Forest University Health Sciences\|National Cancer Institute (NCI)	2019-03-13	Early Phase 1
NCT03824912	COMPLETED	Tinea Pedis	Encube Ethicals Pvt. Ltd.	2018-08-23	PHASE3
NCT04007237	COMPLETED	Pityriasis Versicolor	Indonesia University	2018-09-01	PHASE4
NCT04872920	Recruiting	Cushing Syndrome	HRA Pharma	2018-12-20	--
NCT03473418	UNKNOWN	Vaginal Candidiasis	Assiut University	2018-04-01	PHASE3
NCT03178994	COMPLETED	Post - Adolescence Acne	Chulalongkorn University	2017-08-01	PHASE3
NCT00675714	TERMINATED	Burns	The University of Texas Medical Branch, Galveston	2004-01	PHASE2; PHASE3
NCT02163356	TERMINATED	Recurrent Neuroblastoma; Neuroblastoma	South Plains Oncology Consortium	2014-05	PHASE1
NCT03473418	Unknown status	Vaginal Candidiasis	Assiut University	2018-04-01	Phase 3
NCT01838551	COMPLETED	Endogenous Cushing's Syndrome	Cortendo AB	2014-08	PHASE3
NCT03261336	TERMINATED	Castration-resistant Prostate Cancer	Donald Trump, MD	2017-01-06	PHASE2
NCT02256865	COMPLETED	Insulin Resistance	Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center	2014-10	EARLY_PHASE1
NCT02494713	TERMINATED	Prostate Cancer	The University of Texas Health Science Center, Houston	2015-10	PHASE2
NCT02560051	TERMINATED	Prostatic Neoplasms	The University of Texas Health Science Center, Houston	2015-11	PHASE2
NCT01535157	TERMINATED	Ovarian Cancer; Cancer of Ovary; Cancer of the Ovary; Ovary Neoplasms; Primary Peritoneal Carcinoma	South Plains Oncology Consortium	2012-02	PHASE1; PHASE2
NCT02606383	WITHDRAWN	Tinea Pedis	Biolab Sanus Farmaceutica	2016-06	PHASE3
NCT00536991	TERMINATED	Prostate Adenocarcinoma; Recurrent Prostate Carcinoma; Stage III Prostate Cancer; Stage IV Prostate Cancer	Roswell Park Cancer Institute	2006-10	PHASE1; PHASE2
NCT01454076	COMPLETED	Nonhematologic Malignancies; Lymphoma	Millennium Pharmaceuticals, Inc.	2011-11-10	PHASE1
NCT02824926	COMPLETED	Tinea Pedis	Gilberto De Nucci	2014-07	PHASE2
NCT00895310	COMPLETED	Prostate Cancer	University of California, Davis	2009-05	PHASE2
NCT01584297	TERMINATED	Granulosa Cell Tumour of the Ovary	Grupo Español de Tumores Huérfanos e Infrecuentes	2012-10	PHASE2
NCT01969669	COMPLETED	Non-Hodgkin's Lymphoma	AbbVie	2013-12	PHASE1
NCT00024167	TERMINATED	Prostate Cancer	M.D. Anderson Cancer Center	2002-04	PHASE3
NCT01576575	COMPLETED	Healthy	Washington University School of Medicine	2010-06
NCT00295919	COMPLETED	Neuroblastoma	New Approaches to Neuroblastoma Therapy Consortium	2005-12	PHASE1
NCT01925638	COMPLETED	Drug Interactions	Bayer	2013-09	PHASE1
NCT01836198	COMPLETED	Healthy Volunteers	Eli Lilly and Company	2013-05	PHASE1
NCT01924299	COMPLETED	Healthy Volunteers	Eli Lilly and Company	2013-08	PHASE1
NCT00697437	COMPLETED	Solid Tumors	National University Hospital, Singapore	2006-10	PHASE2
NCT01765556	WITHDRAWN	Malignant Melanoma, Neoplasms	Hoffmann-La Roche	2013-10	PHASE1
NCT01760642	COMPLETED	Healthy	Seoul National University Hospital	2012-12	PHASE1
NCT01896323	COMPLETED	Healthy Volunteers	Celgene	2013-07-01	PHASE1
NCT01910480	COMPLETED	Effect of Ketoconazole on the PK of NBI-98854 in Healthy Subjects	Neurocrine Biosciences	2013-07	PHASE1
NCT01203189	COMPLETED	Seborrheic Dermatitis	St. Louis University	2010-09
NCT01615913	UNKNOWN	Onychomycosis	Taiwan Biotech Co., Ltd.	2012-04	PHASE1
NCT01802931	COMPLETED	Multiple Sclerosis	GlaxoSmithKline	2013-01-07	PHASE1
NCT00953576	TERMINATED	Prostate Cancer	Dana-Farber Cancer Institute	2009-09-29	PHASE1; PHASE2
NCT01787032	COMPLETED	Healthy	Boehringer Ingelheim	2013-01	PHASE1
NCT01735240	COMPLETED	Asthma,; Pharmacokinetics,; Cmax,; Tmax,; λz,; AUC,; Ketoconazole,; Metabolite	AstraZeneca	2012-12	PHASE1
NCT01749085	COMPLETED	Healthy Volunteers	Pfizer	2012-12	PHASE1
NCT01199146	COMPLETED	Prostate Cancer	University of California, San Francisco	2010-09-10	PHASE2
NCT01036594	COMPLETED	Prostate Cancer	University of California, San Francisco	2009-12-11	PHASE2
NCT01690286	COMPLETED	Healthy	Janssen Research & Development, LLC	2012-10	PHASE1
NCT01721070	COMPLETED	Pharmacokinetics	Talphera, Inc	2012-11	PHASE1
NCT01707940	COMPLETED	Healthy	Boehringer Ingelheim	2012-10	PHASE1
NCT01625806	COMPLETED	Healthy Volunteer	Hoffmann-La Roche	2012-07	PHASE1
NCT01340846	COMPLETED	Cancer	GlaxoSmithKline	2012-09-03	PHASE1
NCT01707407	COMPLETED	Pharmacology, Clinical; Healthy	Celgene	2012-09-01	PHASE1
NCT01267084	COMPLETED	Neoplasm Metastases	Janssen Research & Development, LLC	2011-02	PHASE1; PHASE2
NCT01679613	COMPLETED	Healthy	Boehringer Ingelheim	2012-09	PHASE1
NCT00393848	COMPLETED	Hip Fracture; Osteoarthritis; Femur Head Necrosis	University of Arkansas	2006-10	PHASE2
NCT01637636	COMPLETED	Healthy	Vanda Pharmaceuticals	2012-06	PHASE1
NCT01626651	COMPLETED	Healthy	Janssen Research & Development, LLC	2012-06	PHASE1
NCT01218620	COMPLETED	Adult Solid Neoplasm	National Cancer Institute (NCI)	2010-09	PHASE1
NCT01657838	COMPLETED	Pharmacokinetics of Isavuconazole; Pharmacokinetics of Ketoconazole; Healthy Adult Volunteers	Astellas Pharma Global Development, Inc.	2012-05	PHASE1
NCT01026415	COMPLETED	Carcinomas; Disease, Hodgkin; Lymphoma, Large-Cell, Anaplastic; Lymphoma, Non-Hodgkin; Neoplasms	Seagen Inc.	2009-12	PHASE1
NCT01520896	COMPLETED	Bioavailability; Healthy Volunteers; Drug- Drug Interactions	AstraZeneca	2012-02	PHASE1
NCT01215292	COMPLETED	Healthy Males	University of Washington	2011-01	PHASE1; PHASE2
NCT01627587	COMPLETED	Obstetric Labour, Premature	GlaxoSmithKline	2011-12-12	PHASE1
NCT01448824	COMPLETED	Healthy Participants	Eli Lilly and Company	2011-10	PHASE1
NCT00673127	COMPLETED	Prostate Cancer	Beth Israel Deaconess Medical Center	2005-02	PHASE2
NCT01378520	COMPLETED	Chronic Obstructive Pulmonary Disease	Dartmouth-Hitchcock Medical Center	2011-06	PHASE4
NCT01588782	COMPLETED	Healthy Volunteers	Janssen Research & Development, LLC	2012-01	PHASE1
NCT01549106	COMPLETED	Healthy Volunteers	SecuraBio	2011-08	PHASE1
NCT01324310	COMPLETED	Hematologic Malignancy; Malignant Lymphoma	Celgene	2011-04-01	PHASE1
NCT01473316	COMPLETED	Healthy Volunteer	Genentech, Inc.	2011-11	PHASE1
NCT01591850	COMPLETED	Healthy Volunteer	Hoffmann-La Roche	2011-09	PHASE1
NCT01468714	COMPLETED	Human Volunteers	Pfizer	2011-10	PHASE1
NCT00964106	COMPLETED	Drug Interactions	GlaxoSmithKline	2009-08-26	PHASE1
NCT01205230	COMPLETED	Cancer	GlaxoSmithKline	2010-09	PHASE4
NCT01548170	COMPLETED	Cancer	Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal	2011-04	PHASE1
NCT01363778	COMPLETED	Healthy	AVEO Pharmaceuticals, Inc.	2011-05	PHASE1
NCT01318265	COMPLETED	Pharmacokinetics	Bayer	2011-03	PHASE1
NCT01288521	COMPLETED	Kidney Transplantation	Sony Tuteja	2008-10	PHASE4
NCT02198170	COMPLETED	Healthy Volunteers	Eisai Inc.	2011-02	PHASE1
NCT01330563	COMPLETED	Type 2 Diabetes Mellitus	Chong Kun Dang Pharmaceutical	2011-03	PHASE1
NCT01426906	COMPLETED	Healthy Male Volunteers	LG Life Sciences	2011-01	PHASE1
NCT01114191	COMPLETED	Solid Tumors	Abbott	2010-05	PHASE1
NCT01293643	COMPLETED	Vaginosis, Bacterial; Candidiasis, Vulvovaginal	Merck Sharp & Dohme LLC	2010-05	PHASE3
NCT01240226	COMPLETED	Healthy Volunteer	Genentech, Inc.	2010-11	PHASE1
NCT00948662	COMPLETED	Healthy	Pfizer	2009-09	PHASE1
NCT01021358	COMPLETED	Lymphoma; Chronic Lymphocytic Leukemia; Solid Tumors	Abbott	2010-01	PHASE1
NCT01189175	COMPLETED	Healthy	Boehringer Ingelheim	2010-08	PHASE1
NCT01202240	COMPLETED	Healthy	Pfizer	2010-09	PHASE1
NCT01149785	COMPLETED	Healthy	Pfizer	2010-07	PHASE1
NCT00870714	UNKNOWN	Prostate Cancer	Kansas City Veteran Affairs Medical Center	2004-09
NCT00460031	COMPLETED	Prostate Cancer	Case Comprehensive Cancer Center	2006-09-01	PHASE2
NCT01165125	COMPLETED	Asthma	GlaxoSmithKline	2010-07-01	PHASE1
NCT01153711	COMPLETED	Healthy; Pulmonary Disease, Chronic Obstructive	Boehringer Ingelheim	2010-05	PHASE1
NCT01164488	COMPLETED	Healthy Volunteer	Hoffmann-La Roche	2010-07	PHASE1
NCT00830388	COMPLETED	Tinea Versicolor	Boni Elewski, MD	2008-11	PHASE4
NCT01468558	COMPLETED	Healthy	Allergan	2010-07	PHASE1
NCT01473069	TERMINATED	Healthy	Akros Pharma Inc.	2010-03	PHASE1
NCT01124760	COMPLETED	Pharmacokinetics	AstraZeneca	2010-05	PHASE1
NCT00298155	COMPLETED	Cancer; Prostate Neoplasms	University of Washington	2006-07	PHASE2
NCT01932320	COMPLETED	Healthy	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.	2010-02	PHASE1
NCT00824863	COMPLETED	Pityrosporum Folliculitis	Wayne Fujita, M.D.	2008-12	PHASE4
NCT00703846	COMPLETED	Dermatitis, Seborrheic	Stiefel, a GSK Company	2008-06	PHASE4
NCT00503451	COMPLETED	Non-Hodgkin Lymphoma; Neoplasms	Novartis Pharmaceuticals	2007-09	PHASE1
NCT01405989	COMPLETED	Pharmacokinetics of Darexaban and Metabolites; Healthy Subjects	Astellas Pharma Inc	2010-01	PHASE1
NCT01154764	COMPLETED	Healthy	CrystalGenomics, Inc.	2009-10	PHASE1
NCT00889356	UNKNOWN	Candidiasis; Bacterial Vaginosis	Zodiac Produtos Farmaceuticos S.A.	2009-09	PHASE3
NCT00862654	COMPLETED	Scalp Seborrheic Dermatitis	Galderma R&D	2009-03	PHASE3
NCT01039974	COMPLETED	Gastroparesis	GlaxoSmithKline	2009-09-18	PHASE1
NCT00975936	COMPLETED	Autoimmune Diseases	GlaxoSmithKline	2009-09-21	PHASE1
NCT00931073	COMPLETED	Alzheimer's Disease; Huntington's Disease	Pfizer	2009-07	PHASE1
NCT01000376	COMPLETED	Cancer	Eisai Limited	2009-02	PHASE1
NCT00890318	COMPLETED	HCV Infection	Abbott	2009-04	PHASE1
NCT02170675	COMPLETED	Healthy	Boehringer Ingelheim	2009-06	PHASE1
NCT00860275	COMPLETED	Alzheimer Disease	Bristol-Myers Squibb	2009-04	PHASE1
NCT00938262	COMPLETED	Essential Hypertension	Boryung Pharmaceutical Co., Ltd	2009-04	PHASE1
NCT00750425	COMPLETED	Advanced Solid Tumors	AstraZeneca	2008-08	PHASE1
NCT00866515	COMPLETED	Pulmonary Disease, Chronic Obstructive	GlaxoSmithKline	2008-12-22	PHASE1
NCT00586898	COMPLETED	Prostate; Cancer; Hormonal Cycling	Memorial Sloan Kettering Cancer Center	2001-07	PHASE2
NCT00812344	COMPLETED	Healthy	AstraZeneca	2008-12	PHASE1
NCT00403559	COMPLETED	Seborrheic Dermatitis	Dermatology Specialists Research	2007-05-07	PHASE2
NCT00768690	COMPLETED	HCV Infection	Abbott	2008-10	PHASE1
NCT00708591	COMPLETED	Advanced Cancer	University of Chicago	2004-10	PHASE1
NCT00707551	COMPLETED	Healthy	AstraZeneca	2008-07	PHASE1
NCT00770042	COMPLETED	Erectile Dysfunction	VIVUS LLC	2008-10	PHASE1
NCT01110330	TERMINATED	Tinea Pedis	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.	2007-07	PHASE3
NCT00559481	WITHDRAWN	Prostate Cancer	Roswell Park Cancer Institute	2007-10
NCT00983216	COMPLETED	Pharmacokinetics	Mutual Pharmaceutical Company, Inc.	2008-07	PHASE1
NCT00447473	TERMINATED	Prostatic Neoplasms	The Methodist Hospital Research Institute	2006-07	PHASE2
NCT00777530	COMPLETED	Breast Cancer; Tumors; Leukemia	Wyeth is now a wholly owned subsidiary of Pfizer	2008-04	PHASE1
NCT02264171	COMPLETED	Healthy	Boehringer Ingelheim	2008-04	PHASE1
NCT00659555	COMPLETED	Macular Degeneration	GlaxoSmithKline	2008-04-04	PHASE1
NCT00127868	COMPLETED	Tinea Capitis	Chen, Catherine, M.D.	2005-03
NCT01323465	COMPLETED	Evaluation of Pharmacokinetics of Sativex in the Absence and Presence of a Known Inducer of CYP3A4; Evaluation of Pharmacokinetics of Sativex in the Absence and Presence of a Potent Inhibitor of CYP3A4; Evaluation of Pharmacokinetics of Sativex in the Absence and Presence of a CYP2C19 Inhibitor	Jazz Pharmaceuticals	2008-02	PHASE1
NCT00211393	COMPLETED	Chronic Central Serous Chorioretinopathy	Manhattan Eye, Ear & Throat Hospital	2005-05	PHASE2
NCT00431197	COMPLETED	Hypogonadism	Mayo Clinic	2004-02	PHASE1
NCT00309894	COMPLETED	Prostate Cancer	University of California, San Francisco	2004-04	PHASE2
NCT00411866	COMPLETED	Schizophrenia	GlaxoSmithKline	2006-10-13	PHASE1
NCT00680485	TERMINATED	Bacterial Infection; Infections, Bacterial	GlaxoSmithKline	2007-06	PHASE1
NCT00460707	COMPLETED	Nausea and Vomiting, Chemotherapy-Induced	GlaxoSmithKline	2007-04-16	PHASE1
NCT00468689	COMPLETED	Osteoporosis	GlaxoSmithKline	2007-04	PHASE1
NCT00212095	COMPLETED	Metastatic Breast Cancer	National University Hospital, Singapore	2005-06	PHASE2
NCT00162214	TERMINATED	Tumors	Bristol-Myers Squibb	2005-08	PHASE1
NCT00392457	COMPLETED	Kallmann Syndrome; Hypogonadism; Gonadal Disorder	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	1995-07
NCT00404378	COMPLETED	Nausea and Vomiting, Chemotherapy-Induced	GlaxoSmithKline	2006-10-20	PHASE1
NCT00419783	COMPLETED	Healthy	Faes Farma, S.A.	2006-08	PHASE1
NCT01476800	COMPLETED	Healthy Subjects; Pharmacokinetics of YM178	Astellas Pharma Inc	2006-07	PHASE1
NCT00129207	COMPLETED	Tumors	Millennium Pharmaceuticals, Inc.		PHASE1
NCT00238225	COMPLETED	Unspecified Adult Solid Tumor, Protocol Specific	Roswell Park Cancer Institute	2004-11	PHASE1
NCT00096317	COMPLETED	Unspecified Adult Solid Tumor, Protocol Specific	Montefiore Medical Center	2003-03	PHASE1
NCT00002855	COMPLETED	Prostate Cancer	M.D. Anderson Cancer Center	1996-08	PHASE3
NCT00030654	COMPLETED	Prostate Cancer	Radiation Therapy Oncology Group	2002-10	PHASE3
NCT00027859	COMPLETED	Prostate Cancer	Eastern Cooperative Oncology Group	2003-10-08	PHASE3
NCT00002760	COMPLETED	Prostate Cancer	Alliance for Clinical Trials in Oncology	1996-08	PHASE3
NCT01259115	COMPLETED	Healthy	Purdue Pharma LP	2002-10	PHASE1
NCT00014352	COMPLETED	Prostate Cancer; Thromboembolism	Memorial Sloan Kettering Cancer Center	2000-09	PHASE2
NCT00003084	COMPLETED	Prostate Cancer	M.D. Anderson Cancer Center	1997-12	PHASE2
NCT00006371	TERMINATED	Prostate Cancer	H. Lee Moffitt Cancer Center and Research Institute	2000-05	PHASE2
NCT00003249	COMPLETED	Unspecified Adult Solid Tumor, Protocol Specific	National Cancer Institute (NCI)	1998-05	PHASE1
NCT00410501	COMPLETED	Healthy	Novartis	2006-12	PHASE1
NCT00032825	COMPLETED	Prostatic Neoplasms	National Cancer Institute (NCI)	2002-03-19	PHASE1
NCT00019695	TERMINATED	Stage IV Prostate Cancer; Bone Metastases; Adenocarcinoma of the Prostate; Recurrent Prostate Cancer	National Cancer Institute (NCI)	1999-03	PHASE2
NCT00384917	COMPLETED	Healthy	Wyeth is now a wholly owned subsidiary of Pfizer	2006-08	PHASE1
NCT00128323	COMPLETED	Candidiasis, Oral	Kamuzu University of Health Sciences	2002-11	PHASE3
NCT00388596	COMPLETED	Osteoporosis	GlaxoSmithKline	2006-10	PHASE1
NCT00302224	COMPLETED	Type 2 Diabetes	DiObex	2005-02	PHASE1; PHASE2
NCT00915746	COMPLETED	Healthy; Pharmacokinetics; Drug Interactions	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.	2009-11	PHASE1
NCT00388557	COMPLETED	Cancer	Bristol-Myers Squibb	2005-10	PHASE1
NCT00002304	COMPLETED	Candidiasis, Esophageal; HIV Infections	Pfizer
NCT00380328	COMPLETED	Healthy	Puma Biotechnology, Inc.	2006-10	PHASE1
NCT00501397	COMPLETED	Type 2 Diabetes Mellitus; Diabetes Mellitus, Type 2	GlaxoSmithKline	2007-02	PHASE1
NCT00000579	COMPLETED	Respiratory Distress Syndrome, Adult; Lung Diseases	National Heart, Lung, and Blood Institute (NHLBI)	1994-09	PHASE3
NCT00434486	COMPLETED	Healthy	Wyeth is now a wholly owned subsidiary of Pfizer	2007-03	PHASE1

(data from https://clinicaltrials.gov, updated on 2026-08-31)

Check the Ketoconazole product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Ketoconazole directly targets and inhibits cytochrome P450 enzymes, including fungal 14 alpha-demethylase as well as steroidogenic enzymes such as cyclosporine oxidase and testosterone 6 beta-hydroxylase, thereby blocking downstream ergosterol synthesis and steroid hormone biosynthesis pathways. This dual pathway disruption compromises fungal cell membrane integrity while suppressing androgen and cortisol production, providing the mechanistic basis for its clinical utility in treating fungal infections and its investigation in endocrine disorders like Cushing syndrome and malignancies such as glioblastoma and breast cancer.

Appendix RUO and cGMP Quality Standards

Quality Dimension	RUO (Research Use Only)	cGMP (Current Good Manufacturing Practice)
Clinical Applicability	Prohibited in human clinical trials or medical diagnostics.	Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status	Non-regulated grade; exempt from drug manufacturing laws.	Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment	Unclassified analytical or research laboratories.	Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control	Basic purity and activity testing.	Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation	Basic equipment calibration; no process validation required.	Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance	Vendor self-declared without required formal QMS.	Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact	High risk of IND rejection if used as a critical raw material.	Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).