Drugs / Ketoconazole
Ketoconazole
also known as
Nizoral · KCZ · Daktarin gold · Daktarin intensiv · Dandrazol · Dandrid · Extina · Extina Foam · +15 more
Small molecule targets CYP3A4, CYP3A5 via inhibition
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence 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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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| 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 Stop: Enrollment |
| 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 Stop: Enrollment |
| Phase 0 | NCT03471364 | Sep 2018 → Sep 2024 | cancer | Mayo Clinic | Completed | No outcome recorded |
| Phase 184 trials · 1 met primary · 2 missed | ||||||
| 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 overdue | — | University of California, Davis | Recruiting | No outcome recorded |
| Phase 1 | NCT01787032 | Jan → Apr 2013 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT01760642 | Dec 2012 → Sep 2013 | — | Seoul National University Hospital | Completed | No outcome recorded |
| Phase 1 | NCT01735240 | Dec 2012 → Feb 2013 | asthma | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT01721070 | Nov → Dec 2012 | — | Talphera, Inc | Completed | No outcome recorded |
| Phase 1 | NCT01690286 | Oct → Dec 2012 | — | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT01707940 | Oct → Dec 2012 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT01340846 | Sep → Nov 2012 | cancer | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT01707407 | Sep → Nov 2012 | — | Celgene Corporation | Completed | No outcome recorded |
| Phase 1 | NCT01679613 | Sep → Nov 2012 | — | Boehringer Ingelheim | Completed | Missed primary |
| Phase 1 | NCT01625806 | Jul → Dec 2012 | — | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 1 | NCT01637636 | Jun → Aug 2012 | — | Vanda Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT01626651 | Jun → Aug 2012 | — | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT01657838 | May 2012 | — | Astellas Pharma Global Development, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01615913 | Apr 2012 → Jun 2013 | tinea unguium | Taiwan Biotech Co., Ltd. | Unknown | No outcome recorded |
| Phase 1 | NCT01588782 | Jan → Feb 2012 | — | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT01454076 | Nov 2011 → Apr 2015 | lymphoma | Millennium Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01473316 | Nov → Dec 2011 | — | Genentech, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01468714 | Oct 2011 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT01448824 | Oct 2011 → Feb 2012 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT01591850 | Sep → Nov 2011 | — | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 1 | NCT01324310 | Apr 2011 → Jan 2012 | lymphoma | Celgene Corporation | Completed | No outcome recorded |
| Phase 1 | NCT01548170 | Apr → Jul 2011 | cancer | Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal | Completed | No outcome recorded |
| Phase 1 | NCT01330563 | Mar → Jun 2011 | type 2 diabetes mellitus | Chong Kun Dang Pharmaceutical | Completed | No outcome recorded |
| Phase 1 | NCT01318265 | Mar → Jul 2011 | — | Bayer | Completed | No outcome recorded |
| Phase 1 | NCT02198170 | Feb → Jun 2011 | — | Eisai Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01426906 | Jan → Mar 2011 | — | LG Life Sciences | Completed | No outcome recorded |
| Phase 1 | NCT01240226 | Nov → Dec 2010 | — | Genentech, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01218620 | Sep 2010 → Jul 2012 | neoplasm | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 1 | NCT01202240 | Sep 2010 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT01189175 | Aug → Sep 2010 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT01165125 | Jul → Aug 2010 | asthma | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT01149785 | Jul → Sep 2010 | — | Pfizer | Completed | Met primary |
| Phase 1 | NCT01164488 | Jul → Aug 2010 | — | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 1 | NCT01468558 | Jul → Aug 2010 | — | Allergan | Completed | No outcome recorded |
| Phase 1 | NCT01153711 | May → Aug 2010 | chronic obstructive pulmonary disease | Boehringer Ingelheim | Completed | Missed primary |
| Phase 1 | NCT01114191 | May 2010 → Feb 2011 | cancer | Abbott | Completed | No outcome recorded |
| Phase 1 | NCT01124760 | May → Jul 2010 | — | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT01473069 | Mar → Jul 2010 | — | Akros Pharma Inc. | Terminated | No outcome recorded |
| Phase 1 | NCT01021358 | Jan → Oct 2010 | B-cell chronic lymphocytic leukemia, cancer | Abbott | Completed | No outcome recorded |
| Phase 1 | NCT01405989 | Jan → Mar 2010 | — | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 1 | NCT01026415 | Dec 2009 → May 2012 | Hodgkins lymphoma, anaplastic large cell lymphoma, carcinoma | Seagen Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00915746 | Nov → Dec 2009 | — | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | Completed | No outcome recorded |
| Phase 1 | NCT01154764 | Oct 2009 → Mar 2010 | — | CrystalGenomics, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00975936 | Sep → Nov 2009 | autoimmune disease | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT00948662 | Sep 2009 → Dec 2010 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT00964106 | Aug 2009 → Aug 2011 | — | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT00931073 | Jul → Oct 2009 | Alzheimer disease, Huntington disease | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT02170675 | Jun → Jul 2009 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT00938262 | Apr → Jun 2009 | essential hypertension | Boryung Pharmaceutical Co., Ltd | Completed | No outcome recorded |
| Phase 1 | NCT00890318 | Apr → Jul 2009 | hepatitis C virus infection | Abbott | Completed | No outcome recorded |
| Phase 1 | NCT01000376 | Feb → Aug 2009 | cancer | Eisai Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00866515 | Dec 2008 → Mar 2009 | chronic obstructive pulmonary disease | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT00768690 | Oct 2008 → Feb 2009 | hepatitis C virus infection | Abbott | Completed | No outcome recorded |
| Phase 1 | NCT00770042 | Oct → Nov 2008 | erectile dysfunction | VIVUS LLC | Completed | No outcome recorded |
| Phase 1 | NCT00750425 | Aug 2008 → Apr 2009 | cancer | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT00983216 | Jul → Aug 2008 | — | Mutual Pharmaceutical Company, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00707551 | Jul → Nov 2008 | — | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT00659555 | Apr → May 2008 | macular degeneration | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT02264171 | Apr → Jun 2008 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT01323465 | Feb → Mar 2008 | — | Jazz Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT00680485 | Jun → Oct 2007 | bacterial infectious disease | GlaxoSmithKline | Terminated | No outcome recorded |
| Phase 1 | NCT00460707 | Apr → Aug 2007 | chemotherapy-induced toxicity | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT00468689 | Apr → Aug 2007 | osteoporosis | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT00501397 | Feb 2007 → ? | type 2 diabetes mellitus | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT00404378 | Oct 2006 → Jan 2007 | chemotherapy-induced toxicity | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT00411866 | Oct 2006 → Oct 2007 | schizophrenia | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT00384917 | Aug → Sep 2006 | — | Wyeth is now a wholly owned subsidiary of Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT00295919 | Dec 2005 → Mar 2014 | neuroblastoma | New Approaches to Neuroblastoma Therapy Consortium | Completed | No outcome recorded |
| Phase 1 | NCT00238225 | Nov 2004 → Jun 2006 | cancer of unknown primary site | Roswell Park Cancer Institute | Completed | No outcome recorded |
| Phase 1 | NCT00708591 | Oct 2004 → Dec 2008 | cancer of unknown primary site | University of Chicago | Completed | No outcome recorded |
| Phase 1 | NCT00096317 | Mar 2003 → Dec 2005 | cancer of unknown primary site | Montefiore Medical Center | Completed | No outcome recorded |
| Phase 1 | NCT01259115 | Oct 2002 → Jun 2003 | — | Purdue Pharma LP | Completed | No outcome recorded |
| Phase 1 | NCT00032825 | Mar 2002 → Jun 2011 | prostate neoplasm | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 1 | NCT00003249 | May 1998 → Dec 2001 | cancer of unknown primary site | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 1/25 trials · 1 met primary | ||||||
| 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 | Met primary |
| 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 Stop: Enrollment |
| Phase 217 trials · 1 missed | ||||||
| Phase 2 | NCT02147964 | Jun 2019 → Dec 2021 | hypogonadotropic hypogonadism | University of Washington | Withdrawn | No outcome recorded Stop: Business |
| Phase 2 | NCT03261336 | Jan 2017 → Feb 2018 | castration-resistant prostate carcinoma | Donald Trump, MD | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT02494713 | Oct 2015 → Sep 2017 | prostate cancer | The University of Texas Health Science Center, Houston | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT01584297 | Oct 2012 → Nov 2014 | ovarian granulosa cell tumor | Spanish Group for Research in Orphan, Infrequent Tumors | Terminated | No outcome recorded Stop: Enrollment |
| 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 | NCT00697437 | Oct 2006 → Oct 2013 | cancer | National University Hospital, Singapore | Completed | No outcome recorded |
| Phase 2 | NCT00393848 | Oct 2006 → Oct 2012 | avascular necrosis, osteoarthritis | University of Arkansas | Completed | No outcome recorded |
| Phase 2 | NCT00460031 | Sep 2006 → Aug 2010 | prostate cancer | Case Comprehensive Cancer Center | Completed | Missed primary |
| Phase 2 | NCT00447473 | Jul 2006 → Aug 2008 | prostate neoplasm | The Methodist Hospital Research Institute | Terminated | No outcome recorded |
| Phase 2 | NCT00211393 | May 2005 → Mar 2008 | central serous chorioretinopathy | Manhattan Eye, Ear & Throat Hospital | Completed | No outcome recorded |
| Phase 2 | NCT00309894 | Apr 2004 → Nov 2007 | prostate cancer | University of California, San Francisco | Completed | No outcome recorded |
| Phase 2 | NCT00586898 | Jul 2001 → Mar 2009 | cancer, prostate disorder | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT00014352 | Sep 2000 → Mar 2003 | prostate cancer, thrombotic disease | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT00019695 | Mar 1999 → Mar 2005 | metastatic carcinoma in the bone, prostate adenocarcinoma | National Cancer Institute (NCI) | Terminated | No outcome recorded |
| Phase 2 | NCT00003084 | Dec 1997 → Nov 2002 | prostate cancer | M.D. Anderson 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 · 1 missed | ||||||
| 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 3 | NCT00024167 | Apr 2002 → Sep 2014 | prostate cancer | M.D. Anderson Cancer Center | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT00002855 | Aug 1996 → Jun 2005 | prostate cancer | M.D. Anderson Cancer Center | Completed | Missed primary |
| Phase 3 | NCT00000579 | Sep 1994 → Jul 2004 | adult acute respiratory distress syndrome | National Heart, Lung, and Blood Institute (NHLBI) | Completed | No outcome recorded |
| Phase 48 trials · 1 met primary | ||||||
| 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 | Met primary |
| 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 |
| Comparator or background therapy39 trials | ||||||
| Phase 0 | NCT02256865 Comparator | Oct 2014 → Nov 2017 | — | Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center | Completed | No outcome recorded |
| 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 1 | NCT01749085 Background | Dec 2012 → Feb 2013 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT01520896 Comparator | Feb → Apr 2012 | — | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT01627587 Background | Dec 2011 → Feb 2012 | obstetric disorder | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT01932320 Background | Feb → May 2010 | — | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | Completed | No outcome recorded |
| Phase 1 | NCT01039974 Background | Sep → Nov 2009 | gastroparesis | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT00860275 Comparator | Apr → Jun 2009 | Alzheimer disease | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1 | NCT00812344 Comparator | Dec 2008 → Mar 2009 | — | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT00419783 Comparator | Aug → Dec 2006 | — | Faes Farma, S.A. | Completed | No outcome recorded |
| Phase 1 | NCT01476800 Comparator | Jul → Nov 2006 | — | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 1 | NCT00388557 Background | Oct 2005 → Sep 2007 | cancer | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1 | NCT00162214 Comparator | Aug 2005 → Mar 2007 | neoplasm | Bristol-Myers Squibb | Terminated | No outcome recorded |
| Phase 1 | NCT00431197 Background | Feb 2004 → Dec 2007 | hypogonadism | Mayo Clinic | Completed | No outcome recorded |
| 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 Stop: Enrollment |
| 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 | Missed primary |
| Phase 2 | NCT00403559 Comparator | May 2007 → Feb 2009 | seborrheic dermatitis | Dermatology Specialists Research | Completed | No outcome recorded |
| Phase 2 | NCT00298155 Comparator | Jul 2006 → Jun 2010 | cancer, prostate neoplasm | University of Washington | Completed | No outcome recorded |
| Phase 2 | NCT00212095 Background | Jun 2005 → Apr 2007 | breast cancer | National University Hospital, Singapore | Completed | No outcome recorded |
| Phase 2 | NCT00673127 Background | Feb 2005 → Feb 2012 | prostate cancer | Beth Israel Deaconess Medical Center | Completed | No outcome recorded |
| Phase 2 | NCT00006371 Comparator | May 2000 → Dec 2001 | prostate cancer | H. Lee Moffitt Cancer Center and Research Institute | Terminated | No outcome recorded Stop: Enrollment |
| 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 | Met primary |
| Phase 3 | NCT00002760 Comparator | Aug 1996 → Mar 2004 | prostate cancer | Alliance for Clinical Trials in Oncology | Completed | No outcome recorded |
| Phase 4 | NCT07802808 Comparator | Jan → Feb 2026 | seborrheic dermatitis | Indonesia University | Completed | No outcome recorded |
| Phase 4 | NCT06170333 Background | Aug → Dec 2023 | pityriasis versicolor | Padjadjaran University | Completed | No outcome recorded |
| — | 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 Stop: Enrollment |
| — | NCT00127868 Comparator | Mar 2005 → Apr 2008 | dermatophytosis of scalp or beard | Chen, Catherine, M.D. | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2025-03-10 | Zydus Lifesciences Limited | Regulatory zZydus receives final approval from USFDA for Ketoconazole Shampoo, 2% zyduslife.com ↗
Zydus Lifesciences Limited (including its subsidiaries/ affiliates, hereafter referred to as “Zydus”) has received final approval from the United States Food and Drug Administration (USFDA) to manufacture Ketoconazole Shampoo, 2% (USRLD: Nizoral® Shampoo, 2%). |
| 2011-08-30 | Perrigo Company | Regulatory Perrigo Announces FDA Final Approval for Ketoconazole Foam, 2% perrigo.com ↗
Perrigo Company (Nasdaq: PRGO; TASE) today announced that it has received final approval from the U.S. Food and Drug Administration for its abbreviated new drug application for Ketoconazole Foam, 2%, the generic version of Extina® Ketoconazole Foam, 2%. |
| 2000-04-26 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Pharmaceutical Receives First FDA Approval of Ketoconazole 2% Cream tevapharm.com ↗
Teva Pharmaceutical Industries Ltd. (NASDAQ:TEVA) today announced that it had received from the US Food and Drug Administration an approval to manufacture and market Ketoconazole 2% Cream. |
All press releases naming this drug 4 releases
| Date | Issuer | Release |
|---|---|---|
| 2025-03-10 | Zydus Lifesciences Limited | zZydus receives final approval from USFDA for Ketoconazole Shampoo, 2% zyduslife.com ↗ |
| 2021-08-02 | Xiromed LLC | Xiromed LLC Launches Ketoconazole Foam, 2% xiromed.com ↗ |
| 2011-08-30 | Perrigo Company | Perrigo Announces FDA Final Approval for Ketoconazole Foam, 2% perrigo.com ↗ |
| 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. 182 sources stand behind the page.
| Field | Value | Cited 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 ↗176“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: ketoconazole” NCT01124760 ↗ “Ketoconazole” NCT01288521 ↗ |
| 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 ↗ |
| Modality | Small molecule | “Ketoconazole is a broad spectrum anti-fungal drug from imidazole group that has been reported to be effective in PV.” NCT04007237 ↗ |
| Route | Oral | “400 mg orally [p.o.] tid” PMID 15020604 ↗ Mar 2004 |
| Target | CYP3A4 | “ketoconazole as an inhibitor of CYP3A4” PMID 18451235 ↗ May 2008 |