Drugs / Itraconazole
Itraconazole
also known as
ITZ · Sporanox · ICZ · ITCZ · Candistat · Canditral · Cladosal 100 · DFD-04 · +20 more
Small molecule targets CYP3A4 via inhibition
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (2) | US (FDA) | SPORANOX | — | 1994-03-29 – 2001-05-09 | fda.gov ↗ |
| Approved | US (FDA) | SPORANOX | — | 1992-09-11 | fda.gov ↗ |
Trials 403 · started per year
today
US approved 1992
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 06 trials | ||||||
| Phase 0 | NCT05076955 | Mar 2021 → Aug 2022 | ulcer of lower limbs | University of Mississippi Medical Center | Unknown | No outcome recorded |
| Phase 0 | NCT02699723 | Dec 2020 → Sep 2021 | skin basal cell carcinoma | Jean Yuh Tang | Withdrawn | No outcome recorded |
| Phase 0 | NCT02735356 | May 2016 → Sep 2017 | skin basal cell carcinoma | Jean Yuh Tang | Completed | No outcome recorded |
| Phase 0 | NCT02749513 | Jan 2016 → Sep 2019 | esophageal cancer | Dallas VA Medical Center | Unknown | No outcome recorded |
| Phase 0 | NCT02357836 | Jun 2015 → Jul 2018 | non-small cell lung carcinoma | University of Texas Southwestern Medical Center | Completed | No outcome recorded |
| Phase 0 | NCT02120677 | May 2014 → Jan 2019 | basal cell carcinoma | Johns Hopkins University | Completed | No outcome recorded |
| Phase 1322 trials · 2 met primary | ||||||
| Phase 1 | NCT07783503 | Sep → Nov 2026 expected | — | Novartis Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 1 | NCT07774325 | Sep → Oct 2026 expected | — | Boehringer Ingelheim | Recruiting | No outcome recorded |
| Phase 1 | NCT07800429 | Sep → Oct 2026 expected | — | Vaderis Therapeutics AG | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT07809815 | Sep 2026 → Apr 2027 expected | — | Betta Pharmaceuticals Co., Ltd. | Recruiting | No outcome recorded |
| Phase 1 | NCT07809789 | Sep 2026 → Jan 2027 expected | — | Betta Pharmaceuticals Co., Ltd. | Recruiting | No outcome recorded |
| Phase 1 | NCT07800897 | Aug 2026 → Mar 2027 expected | — | Bristol-Myers Squibb | Recruiting | No outcome recorded |
| Phase 1 | NCT07797478 | Aug 2026 → Jun 2027 expected | — | Genentech, Inc. | Recruiting | No outcome recorded |
| Phase 1 | NCT07071532 | Aug 2026 → Feb 2027 expected | bipolar disorder | AbbVie | Recruiting | No outcome recorded |
| Phase 1 | NCT07685600 | Jul → Oct 2026 expected | — | AstraZeneca | Recruiting | No outcome recorded |
| Phase 1 | NCT07661108 | Jun → Oct 2026 expected | — | Merck Sharp & Dohme LLC | Active not recruiting | No outcome recorded |
| Show all 322 trials opens the full record — a long page | ||||||
| Phase 1/214 trials · 1 met primary | ||||||
| Phase 1/2 | NCT07331792 | Feb → May 2026 overdue | pityriasis versicolor | Combined Military Hospital Abbottabad | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT07070232 | Aug 2025 → Mar 2028 expected | neoplasm | BioNTech SE | Recruiting | No outcome recorded |
| Phase 1/2 | NCT05914116 | Aug 2023 → Dec 2027 expected | cancer | DualityBio Inc. | Recruiting | No outcome recorded |
| Phase 1/2 | NCT05579366 | Dec 2022 → Jul 2027 expected | breast adenocarcinoma, cervical cancer, endometrial cancer, fallopian tube cancer +5 | Genmab | Recruiting | No outcome recorded |
| Phase 1/2 | NCT05384626 | Jun 2022 → Dec 2027 expected | metastatic neoplasm | Nuvalent Inc. | Recruiting | No outcome recorded |
| Phase 1/2 | NCT05150691 | Jan 2022 → Apr 2026 overdue | — | DualityBio Inc. | Recruiting | No outcome recorded |
| Phase 1/2 | NCT05359055 | Dec 2021 → Jan 2022 | — | Shanghai Pharmaceuticals Holding Co., Ltd | Completed | No outcome recorded |
| Phase 1/2 | NCT04067336 | Sep 2019 → Oct 2028 expected | mixed phenotype acute leukemia with MLL rearranged | Kura Oncology, Inc. | Active not recruiting | Met primary |
| Phase 1/2 | NCT03513211 | Aug 2018 → Aug 2023 | prostate cancer | St Vincent's Hospital, Sydney | Completed | No outcome recorded |
| Phase 1/2 | NCT03081702 | Jul 2017 → Aug 2019 | — | University Health Network, Toronto | Completed | No outcome recorded |
| Phase 1/2 | NCT02770378 | Nov 2016 → Oct 2018 | glioblastoma | University of Ulm | Completed | No outcome recorded |
| Phase 1/2 | NCT02054793 | Jun 2014 → Jun 2015 | castration-resistant prostate carcinoma | Emmanuel Antonarakis, MD | Withdrawn | No outcome recorded Stop: Business |
| Phase 1/2 | NCT00045942 | Jan 2002 → Mar 2008 | acute myeloid leukemia, myelodysplastic syndrome | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 1/2 | NCT00004811 | Mar 1985 → ? | blastomycosis, histoplasmosis, sporotrichosis | National Center for Research Resources (NCRR) | Completed | No outcome recorded |
| Phase 221 trials · 2 met primary · 1 missed | ||||||
| Phase 2 | NCT06732388 | Jun 2026 → Aug 2030 expected | Barrett esophagus, esophageal adenocarcinoma | National Cancer Institute (NCI) | Recruiting | No outcome recorded |
| Phase 2 | NCT05563766 | Oct 2024 → Apr 2029 expected | esophageal adenocarcinoma, esophageal squamous cell carcinoma, gastroesophageal cancer | VA Office of Research and Development | Recruiting | No outcome recorded |
| Phase 2 | NCT05667662 | Feb 2023 → Feb 2024 | allergic bronchopulmonary aspergillosis | Pulmatrix Inc. | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT04809649 | May 2021 → Sep 2022 | coccidioidomycosis | George R Thompson | Withdrawn | No outcome recorded |
| Phase 2 | NCT04481100 | Oct 2020 → Jul 2021 | esophageal squamous cell carcinoma | Hangzhou Cancer Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT03960606 | Jul 2019 → Jul 2020 | allergic bronchopulmonary aspergillosis | Pulmatrix Inc. | Terminated | No outcome recorded |
| Phase 2 | NCT04018872 | Jun 2019 → Jun 2026 overdue | esophageal adenocarcinoma, esophageal squamous cell carcinoma, gastroesophageal junction adenocarcinoma | Dallas VA Medical Center | Recruiting | No outcome recorded |
| Phase 2 | NCT03664115 | Jul 2018 → Dec 2019 | lung cancer | Ain Shams University | Unknown | Met primary |
| Phase 2 | NCT04110834 | Feb → Jun 2018 | pityriasis versicolor | Sara Botros | Completed | No outcome recorded |
| Phase 2 | NCT02828241 | Jul 2016 → Jan 2017 | rosacea | Dr. Reddy's Laboratories Limited | Completed | No outcome recorded |
| Phase 2 | NCT02354261 | Aug 2015 → Mar 2019 | basal cell carcinoma | HedgePath Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT01576315 | Jun 2014 → Oct 2015 | aspergillosis, cystic fibrosis | Rennes University Hospital | Completed | No outcome recorded |
| Phase 2 | NCT01787331 | Oct 2013 → May 2017 | prostate adenocarcinoma | University of California, San Francisco | Completed | No outcome recorded |
| Phase 2 | NCT02366884 | Jul 2011 → Dec 2022 | neoplasm | Dr. Frank Arguello Cancer Clinic | Unknown | No outcome recorded |
| Phase 2 | NCT01450683 | Sep 2010 → Apr 2011 | castration-resistant prostate carcinoma, hormone-resistant prostate carcinoma, metastatic neoplasm | Stanford University | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT01108094 | Apr 2010 → Mar 2011 | skin basal cell carcinoma | Stanford University | Completed | Met primary |
| Phase 2 | NCT01160952 | May 2009 → Dec 2010 | disease related to hematopoietic stem cell transplant, hematologic disorder | Guangzhou General Hospital of Guangzhou Military Command | Unknown | Missed primary |
| Phase 2 | NCT00791219 | Nov 2008 → Jul 2010 | tinea unguium | Halcygen Pharmaceuticals Limited | Completed | No outcome recorded |
| Phase 2 | NCT00001280 | Jan 1991 → Mar 2001 | fungal infectious disease | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 2 | NCT00005668 | ? → Nov 2005 | pulmonary aspergilloma | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 2 | NCT00000975 | ? → Sep 1994 | HIV infectious disease, histoplasmosis | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 2/36 trials · 1 missed | ||||||
| Phase 2/3 | NCT05881980 | May → Oct 2023 | dermatophytosis of groin and perianal area, tinea corporis | Dhaka Medical College | Unknown | No outcome recorded |
| Phase 2/3 | NCT03458221 | Jan 2023 → Oct 2026 expected | ovarian cancer | Gynaecologisch Oncologisch Centrum Zuid | Recruiting | No outcome recorded |
| Phase 2/3 | NCT03631602 | Oct 2017 → Oct 2019 | disease related to hematopoietic stem cell transplant | Fujian Medical University | Unknown | No outcome recorded |
| Phase 2/3 | NCT02440009 | May 2014 → Jul 2017 | allergic bronchopulmonary aspergillosis | Post Graduate Institute of Medical Education and Research, Chandigarh | Completed | No outcome recorded |
| Phase 2/3 | NCT01321827 | Apr 2011 → Mar 2013 | allergic bronchopulmonary aspergillosis | Post Graduate Institute of Medical Education and Research, Chandigarh | Completed | Missed primary |
| Phase 2/3 | NCT00673309 | Jul 2000 → Apr 2011 | — | The University of Texas Medical Branch, Galveston | Completed | No outcome recorded |
| Phase 38 trials · 1 met primary | ||||||
| Phase 3 | NCT07261150 | Nov 2026 → Dec 2030 expected | histoplasmosis | University of Minnesota | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT06160713 | Dec 2023 → Dec 2025 | bronchiectasis | Post Graduate Institute of Medical Education and Research, Chandigarh | Unknown | No outcome recorded |
| Phase 3 | NCT06174922 | Dec 2023 → Jun 2026 overdue | allergic bronchopulmonary aspergillosis | Post Graduate Institute of Medical Education and Research, Chandigarh | Recruiting | No outcome recorded |
| Phase 3 | NCT03920527 | Jul 2019 → Jul 2021 | aspergillosis | Post Graduate Institute of Medical Education and Research, Chandigarh | Completed | Met primary |
| Phase 3 | NCT03171584 | Jul 2017 → Jun 2019 | — | Assiut University | Unknown | No outcome recorded |
| Phase 3 | NCT00784368 | Jan 2008 → Apr 2009 | aspergillosis, blastomycosis, candidiasis, cryptococcosis +2 | Janssen Pharmaceutical K.K. | Completed | No outcome recorded |
| Phase 3 | NCT00003883 | Oct 1998 → Jul 2002 | cancer | Fred Hutchinson Cancer Center | Completed | No outcome recorded |
| Phase 3 | NCT00002159 | — | HIV infectious disease, blastomycosis, histoplasmosis | Janssen, LP | Completed | No outcome recorded |
| Phase 413 trials · 1 missed | ||||||
| Phase 4 | NCT07675239 | Oct 2026 → Mar 2027 expected | tinea corporis | Pak Emirates Military Hospital | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07283497 | Jun 2026 → Dec 2030 expected | bronchiectasis, fungal infectious disease | Mayo Clinic | Recruiting | No outcome recorded |
| Phase 4 | NCT07342153 | Nov 2025 → Feb 2026 overdue | tinea corporis | Urooj Fatima | Recruiting | No outcome recorded |
| Phase 4 | NCT06922344 | Mar → Dec 2025 overdue | pityriasis versicolor | Khyber Teaching Hospital | Recruiting | No outcome recorded |
| Phase 4 | NCT04035187 | Feb 2020 → May 2022 | fungal infectious disease | University of Maryland, Baltimore | Completed | No outcome recorded |
| Phase 4 | NCT03923010 | Aug 2019 → Mar 2020 | fungal infectious disease | Janssen Research & Development, LLC | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT02895529 | Nov 2016 → May 2018 | hematopoietic and lymphoid cell neoplasm | Xian-Janssen Pharmaceutical Ltd. | Terminated | No outcome recorded |
| Phase 4 | NCT01282879 | Dec 2009 → Dec 2010 | graft versus host disease | Samsung Medical Center | Terminated | No outcome recorded |
| Phase 4 | NCT01198236 | Jul 2008 → Sep 2010 | fungal infectious disease | Zhejiang University | Completed | No outcome recorded |
| Phase 4 | NCT00528190 | Oct 2007 → Aug 2010 | cystic fibrosis | Ottawa Hospital Research Institute | Completed | Missed primary |
| Phase 4 | NCT01823289 | Jun 2007 → Dec 2008 | fungal lung infectious disease | Xian-Janssen Pharmaceutical Ltd. | Completed | No outcome recorded |
| Phase 4 | NCT00871728 | Jan 2007 → May 2009 | fungal infection of the toenail | Janssen Korea, Ltd., Korea | Completed | No outcome recorded |
| Phase 4 | NCT00336531 | Apr 2006 → Jun 2008 | Wilms tumor, brain neoplasm, fungal infectious disease, neuroblastoma +1 | Samsung Medical Center | Completed | No outcome recorded |
| Phase not applicable13 trials · 1 met primary | ||||||
| — | NCT07068256 | Apr → Sep 2025 | dermatophytosis of scalp or beard | Muhammad Aamir Latif | Completed | No outcome recorded |
| — | NCT06300138 | Mar 2024 → Dec 2026 expected | sporotrichosis | First Hospital of China Medical University | Recruiting | No outcome recorded |
| — | NCT07816510 | Mar → Aug 2021 | dermatophytosis | Chittagong Medical College | Completed | No outcome recorded |
| — | NCT03827278 | Dec 2018 → Dec 2021 | penicilliosis | Guangxi Medical University | Unknown | Met primary |
| — | NCT03972748 | Jan 2018 → Dec 2020 | basal cell carcinoma | Hospital de Clinicas de Porto Alegre | Unknown | No outcome recorded |
| — | NCT00798135 | Nov 2008 → Feb 2012 | breast cancer, metastatic malignant neoplasm | Indiana University | Completed | No outcome recorded |
| — | NCT00079222 | Nov 2003 → Apr 2005 | cancer | Jonsson Comprehensive Cancer Center | Completed | No outcome recorded |
| — | NCT00002370 | — | HIV infectious disease | Janssen, LP | Completed | No outcome recorded |
| — | NCT00002341 | — | HIV infectious disease, oral candidiasis | Janssen, LP | Completed | No outcome recorded |
| — | NCT00002438 | — | HIV infectious disease, histoplasmosis | Janssen, LP | Completed | No outcome recorded |
| — | NCT00000639 | ? → Sep 1997 | Cryptococcal meningitis, HIV infectious disease | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| — | NCT00002132 | — | HIV infectious disease, esophageal candidiasis | Janssen Pharmaceuticals | Completed | No outcome recorded |
| — | NCT00002133 | — | HIV infectious disease, oral candidiasis | Janssen, LP | Completed | No outcome recorded |
| Comparator or background therapy74 trials | ||||||
| Phase 0 | NCT05609253 Comparator | Sep 2022 → Feb 2024 overdue | Barrett esophagus | University of Kansas Medical Center | Active not recruiting | No outcome recorded |
| Phase 0 | NCT03614455 Background | Jul → Oct 2018 | — | Daiichi Sankyo | Completed | No outcome recorded |
| Phase 0 | NCT06967376 Comparator | May 2018 → Nov 2021 | keratitis | Research Institute of Ophthalmology, Egypt | Completed | No outcome recorded |
| Phase 1 | NCT07341672 Comparator | Dec 2026 → Apr 2027 expected | — | Sunshine Lake Pharma Co., Ltd. | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT06847464 Background | Jan → May 2025 | respiratory syncytial virus infectious disease | Enanta Pharmaceuticals, Inc | Completed | No outcome recorded |
| Phase 1 | NCT06722430 Background | Nov 2024 → Jan 2025 | — | AbbVie | Completed | No outcome recorded |
| Phase 1 | NCT06485505 Comparator | Jul 2024 → Jul 2026 overdue | tinea unguium | Zagazig University | Recruiting | No outcome recorded |
| Phase 1 | NCT06379958 Comparator | Apr → Sep 2024 overdue | — | Modern Biosciences Ltd | Recruiting | No outcome recorded |
| Phase 1 | NCT06194864 Background | Jan → May 2024 | — | Emalex Biosciences Inc. | Completed | No outcome recorded |
| Phase 1 | NCT06084481 Background | Nov 2023 → Jul 2026 overdue | biliary tract cancer, esophageal squamous cell carcinoma, head and neck squamous cell carcinoma, hepatocellular carcinoma +3 | AbbVie | Active not recruiting | 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 | NCT06644326 Comparator | Jun 2023 → Aug 2024 | — | ABLi Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT05518734 Background | Sep 2022 → Mar 2023 | — | Vertex Pharmaceuticals Incorporated | Completed | No outcome recorded |
| Phase 1 | NCT05862714 Comparator | Mar → Sep 2022 | pityriasis versicolor | Combined Military Hospital Abbottabad | Completed | No outcome recorded |
| Phase 1 | NCT05578950 Comparator | Mar → Aug 2022 | tinea unguium | Combined Military Hospital Abbottabad | Completed | No outcome recorded |
| Phase 1 | NCT05255276 Comparator | Feb → May 2022 | — | Mirati Therapeutics Inc. | Completed | No outcome recorded |
| Phase 1 | NCT05567484 Comparator | May → Dec 2021 | nail infection | Combined Military Hospital Abbottabad | Completed | No outcome recorded |
| Phase 1 | NCT04619251 Background | Nov 2020 → Jul 2021 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT05063318 Comparator | Oct 2020 → Apr 2022 | cancer | PharmaMar | Completed | No outcome recorded |
| Phase 1 | NCT04411030 Background | May → Aug 2020 | — | Astex Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT04290390 Comparator | Feb 2020 → Jan 2021 | — | TherapeuticsMD | Completed | No outcome recorded |
| Phase 1 | NCT04154800 Background | Dec 2019 → Aug 2021 | — | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1 | NCT04011241 Background | Jul → Sep 2019 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02989389 Background | Dec 2016 → Jul 2017 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT02675452 Background | Jun 2016 → May 2024 | acute myeloid leukemia, refractory plasma cell neoplasm | Amgen | Terminated | No outcome recorded Stop: Business |
| Phase 1 | NCT02706535 Background | May 2016 → Jan 2017 | neoplasm | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT02809768 Background | Apr → Aug 2016 | — | Eisai Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02729467 Background | Mar → Jun 2016 | — | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT02698267 Background | Feb → Apr 2016 | neuropathy, painful | Biogen | Completed | No outcome recorded |
| Phase 1 | NCT02653872 Comparator | Jan → Apr 2016 | — | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT02567773 Background | Sep 2015 → Dec 2016 | hypoproteinemia, hypercatabolic | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT02493738 Comparator | Jul → Oct 2015 | candidiasis, dermatomycosis, histoplasmosis, superficial mycosis | Boryung Pharmaceutical Co., Ltd | Completed | No outcome recorded |
| Phase 1 | NCT02341482 Background | Feb → Mar 2015 | — | Biogen | Completed | No outcome recorded |
| Phase 1 | NCT02365571 Background | Feb → May 2015 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT02341638 Background | Sep 2014 → Sep 2015 | thrombotic disease | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1 | NCT02155504 Comparator | May → Oct 2014 | — | Astellas Pharma Europe B.V. | Completed | No outcome recorded |
| Phase 1 | NCT01568411 Comparator | Apr → Jun 2012 | — | Glycyx Therapeutics | Completed | No outcome recorded |
| Phase 1 | NCT00805090 Comparator | Dec 2008 → Mar 2009 | chronic kidney disease, liver disorder | Javelin Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT00695071 Comparator | Jun → Jul 2008 | — | Stiefel, a GSK Company | Completed | No outcome recorded |
| Phase 1/2 | NCT01974687 Background | Oct 2013 → Sep 2015 | chronic hepatitis C virus infection | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 2 | NCT07069933 Comparator | Jul 2025 overdue | acute myeloid leukemia | Mansoura University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07039877 Background | Jan 2025 → Feb 2026 overdue | acute lymphoblastic leukemia | Hospital Universitario Dr. Jose E. Gonzalez | Recruiting | No outcome recorded |
| Phase 2 | NCT05348096 Background | Apr 2022 → Apr 2023 | chronic graft versus host disease | Hospital Universitario Dr. Jose E. Gonzalez | Unknown | No outcome recorded |
| Phase 2 | NCT05049525 Comparator | Feb 2022 → Feb 2024 | Crohn disease | Montreal Heart Institute | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT05048615 Background | Jul 2021 → Jan 2023 | acute myeloid leukemia | Hospital Universitario Dr. Jose E. Gonzalez | Completed | No outcome recorded |
| Phase 2 | NCT04577378 Comparator | Oct → Nov 2020 | COVID-19 | Kafrelsheikh University | Unknown | No outcome recorded |
| Phase 2 | NCT03471455 Comparator | Apr 2018 → Jan 2019 | tinea infection | Post Graduate Institute of Medical Education and Research, Chandigarh | Unknown | No outcome recorded |
| Phase 2 | NCT03086226 Comparator | May 2017 → Jun 2021 | mycetoma | Drugs for Neglected Diseases | Completed | Missed primary |
| Phase 2 | NCT01501708 Background | Dec 2011 → Jun 2017 | disease related to hematopoietic stem cell transplant, leukemia | Shanghai Jiao Tong University School of Medicine | Unknown | No outcome recorded |
| Phase 2 | NCT01344681 Comparator | Jun 2011 → Mar 2014 | neutropenia | Yonsei University | Completed | No outcome recorded |
| Phase 2 | NCT00887458 Comparator | Jul 2009 → May 2011 | prostate cancer | Johns Hopkins University | Completed | No outcome recorded |
| Phase 2 | NCT00769600 Comparator | Nov 2008 → Jan 2013 | non-small cell lung carcinoma | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT00012467 Background | Jan 2000 → Jul 2001 | Cryptococcal meningitis, HIV infectious disease | InterMune | Completed | No outcome recorded |
| Phase 2/3 | NCT02285283 Comparator | Nov 2014 → May 2019 | chronic rhinosinusitis | The University of Texas Health Science Center, Houston | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT07825259 Comparator | Nov 2026 → Dec 2029 expected | aspergillosis | Post Graduate Institute of Medical Education and Research, Chandigarh | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT04880980 Comparator | Mar 2021 → Mar 2022 | dermatophytosis, poisoning | Pak Emirates Military Hospital | Completed | No outcome recorded |
| Phase 3 | NCT04824417 Comparator | Mar 2021 → May 2024 | aspergillosis | Post Graduate Institute of Medical Education and Research, Chandigarh | Completed | Missed primary |
| Phase 3 | NCT03656081 Background | Dec 2018 → Jun 2027 expected | aspergillosis | Poitiers University Hospital | Recruiting | No outcome recorded |
| Phase 3 | NCT00794703 Comparator | Nov 2008 → Nov 2009 | fungal infectious disease | Astellas Pharma Inc | Completed | Met primary |
| Phase 3 | NCT00356915 Comparator | Jul 2006 → Oct 2008 | fungal infection of the toenail | Stiefel, a GSK Company | Completed | No outcome recorded |
| Phase 3 | NCT00289991 Comparator | Mar 2006 → Feb 2009 | opportunistic mycosis | Pfizer | Completed | No outcome recorded |
| Phase 4 | NCT02621905 Comparator | Nov 2015 → Nov 2016 | neutropenia | Mayne Pharma International Pty Ltd | Completed | No outcome recorded |
| Phase 4 | NCT01214941 Comparator | Sep → Dec 2010 | — | Turku University Hospital | Completed | No outcome recorded |
| Phase 4 | NCT01259336 Comparator | Jul 2010 → Jun 2011 | aspergillosis | Post Graduate Institute of Medical Education and Research, Chandigarh | Completed | No outcome recorded |
| Phase 4 | NCT00787917 Background | Nov 2008 → Jul 2010 | allergic bronchopulmonary aspergillosis, cystic fibrosis | Novartis Pharmaceuticals | Terminated | No outcome recorded |
| — | NCT07242703 Comparator | Dec 2025 → Apr 2026 overdue | fungal infectious disease | Cairo University | Not yet recruiting | No outcome recorded |
| — | NCT07184203 Comparator | Mar → Dec 2025 overdue | dermatophytosis of scalp or beard | Alexandria University | Recruiting | No outcome recorded |
| — | NCT07420894 Background | Jan → Jul 2025 | dermatophytosis | Multan Medical And Dental College | Completed | No outcome recorded |
| — | NCT05591560 Comparator | Oct 2022 → Oct 2024 | ovarian carcinoma | Tanta University | Unknown | No outcome recorded |
| — | NCT04886323 Comparator | Aug 2022 → Dec 2023 | folliculitis | The Second Hospital of Anhui Medical University | Completed | No outcome recorded |
| — | NCT05444946 Comparator | Jun 2022 → Jan 2027 expected | allergic bronchopulmonary aspergillosis | Post Graduate Institute of Medical Education and Research, Chandigarh | Recruiting | No outcome recorded |
| — | NCT05129033 Comparator | Nov 2021 → Jun 2023 | allergic bronchopulmonary aspergillosis | Shanghai Zhongshan Hospital | Unknown | No outcome recorded |
| — | NCT03138785 Background | Jan 2015 → Jun 2017 | — | Farabi Eye Hospital | Unknown | No outcome recorded |
| — | NCT00895453 Comparator | May 2000 → Feb 2006 | vulvovaginal candidiasis | Medical University of Vienna | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2020-09-01 | Vertex Pharmaceuticals Incorporated | Regulatory FDA Accepts Vertex’s Supplemental New Drug Applications for TRIKAFTA® (elexacaftor/tezacaftor/ivacaftor and ivacaftor), SYMDEKO® (tezacaftor/ivacaftor and ivacaftor) and KALYDECO® (ivacaftor) for Additional CFTR Mutations vrtx.com ↗
Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced the U.S. Food and Drug Administration (FDA) accepted three supplemental New Drug Applications (sNDAs) for TRIKAFTA® (elexacaftor/tezacaftor/ivacaftor and ivacaftor), SYMDEKO® (tezacaftor/ivacaftor and ivacaftor) and KALYDECO® (ivacaftor). |
| 2017-09-15 | Zydus Lifesciences Limited | Regulatory Zydus receives final approval from the USFDA for Itraconazol Capsule 100 mg zyduslife.com ↗
Zydus Cadila has received the final approval from the USFDA to market Itraconazole Capsules 100 mg . |
All press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2020-09-01 | Vertex Pharmaceuticals Incorporated | FDA Accepts Vertex’s Supplemental New Drug Applications for TRIKAFTA® (elexacaftor/tezacaftor/ivacaftor and ivacaftor), SYMDEKO® (tezacaftor/ivacaftor and ivacaftor) and KALYDECO® (ivacaftor) for Additional CFTR Mutations vrtx.com ↗ |
| 2017-09-15 | Zydus Lifesciences Limited | Zydus receives final approval from the USFDA for Itraconazol Capsule 100 mg zyduslife.com ↗ |
Evidence & citations 33 cited values
Every value below carries the sentence it was read from. 480 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Itraconazole | “The purpose of this study is to assess the pharmacokinetics (how the drug is absorbed in the body, distributed within the body, and how it is removed from the body over time)...” NCT00784368 ↗475“A Multi-center, Randomized, Double-Blind, Parallel-group, Placebo-Controlled Study to Assess the Efficacy, Safety and Tolerability of DFD-04 (Itraconazole) Ointment, 5% in...” NCT02828241 ↗ “Initial antimicrobial therapy for both groups consisted of fortified vancomycin eye drops 50 mg/ml, fortified ceftazidime eye drops 50 mg/ml hourly, and the antifungal agent...” NCT06967376 ↗ “All patients received azoles as prophylaxis (fluconazole as prophylaxis and itraconazole or voriconazole as secondary prophylaxis), combination with liposomal amphotericin B at...” NCT01501708 ↗ “If a subject enters the study already receiving itraconazole prophylaxis at a dose of itraconazole higher than 100 mg twice a day” NCT02621905 ↗ “Triazoles (Fluconazole, Itraconazole, Voriconazole), Imidazoles (Ketoconazole), Nystatin and Amphotericin B are used the most” NCT06616168 ↗ “compare the efficacy and safety of posaconazole oral suspension vs itraconazole oral solution in preventing IFD post-HSCT.” NCT03631602 ↗ “Arm (3) will receive Itraconazole (400mg/day for one week per month followed by 3 free weeks ,, 2 pulses for finger nail)” NCT03171584 ↗ “PUR1900 contains itraconazole as the active ingredient, and it is formulated as a dry powder for oral inhalation.” NCT03960606 ↗ “Group B (TI group) receiving Oral Terbinafine (250 mg once daily) and Itraconazole (100 mg twice daily);” NCT07816510 ↗ “multiple oral doses of a potent CYP3A4 inhibitor (itraconazole) and inducer (rifampicin)” PMID 36458825 ↗ Jan 2023 |
| Known as | Candistat | ChEMBL registry synonym — accepted as the source's own label CHEMBL64391 ↗ |
| Known as | Canditral | ChEMBL registry synonym — accepted as the source's own label CHEMBL64391 ↗ |
| Known as | Cladosal 100 | ChEMBL registry synonym — accepted as the source's own label CHEMBL64391 ↗ |
| Known as | DFD-04 | “A Multi-center, Randomized, Double-Blind, Parallel-group, Placebo-Controlled Study to Assess the Efficacy, Safety and Tolerability of DFD-04 (Itraconazole) Ointment, 5% in...” NCT02828241 ↗ |
| Known as | Fungitraxx | ChEMBL registry synonym — accepted as the source's own label CHEMBL64391 ↗ |
| Known as | ICZ | “Itraconazole (ICZ) capsule will be administered in 3 cycles (Week 1, Week 5 and Week 9) and each cycle will consist of taking 2 capsules of 100 milligram (mg) each, orally...” NCT00871728 ↗1“A Clinical Study of the Interactions Between Azvudine Tablets (FNC) and Itraconazole Capsules (ICZ)” NCT07001501 ↗ |
| Known as | ITCZ | “The purpose of this study is to assess the pharmacokinetics (how the drug is absorbed in the body, distributed within the body, and how it is removed from the body over time)...” NCT00784368 ↗1“itraconazole (ITCZ) for primary antifungal prophylaxis in allo-HSCT recipients” PMID 24593273 ↗ Mar 2014 |
| Known as | Itrac | ChEMBL registry synonym — accepted as the source's own label CHEMBL64391 ↗ |
| Known as | Itraconazol | ChEMBL registry synonym — accepted as the source's own label CHEMBL64391 ↗ |
| Known as | Itraconazole component of suba- | ChEMBL registry synonym — accepted as the source's own label CHEMBL64391 ↗ |
| Known as | Itraconazole(spranox) | “Itraconazole(spranox)” NCT01409018 ↗ |
| Known as | Itralek | ChEMBL registry synonym — accepted as the source's own label CHEMBL64391 ↗ |
| Known as | Itrizole | ChEMBL registry synonym — accepted as the source's own label CHEMBL64391 ↗ |
| Known as | ITZ | “A Trial to Evaluate the Effect of Itraconazole (ITZ), a CYP3A4 Inhibitor, on the Pharmacokinetics of Praliciguat (IW-1973) in Healthy Volunteers” NCT03499106 ↗9“Itraconazole (ITZ) is an approved drug often used for the treatment of fungal infections and possibly inhibits the breakdown of BAY1902607.” NCT03789890 ↗ “Participants will be administered with GSK3915393 along with ITZ orally” NCT04604795 ↗ “Itraconazole (ITZ), a CYP3A4 Inhibitor” NCT03892499 ↗ “Drug: Itraconazole (ITZ)” NCT06722430 ↗ “Drug: Itraconazole (ITZ)” NCT07825259 ↗ “Itraconazole (ITZ)” NCT07184203 ↗ “Itraconazole (ITZ)” NCT07420894 ↗ “Itraconazole (ITZ)” NCT06579300 ↗ “Itraconazole (ITZ)” NCT06084481 ↗ |
| Known as | NSC-759239 | ChEMBL registry synonym — accepted as the source's own label CHEMBL64391 ↗ |
| Known as | Orungal | ChEMBL registry synonym — accepted as the source's own label CHEMBL64391 ↗ |
| Known as | R51,211 | “different doses of itraconazole (R51,211)” NCT00004811 ↗ |
| Known as | Sempera | ChEMBL registry synonym — accepted as the source's own label CHEMBL64391 ↗ |
| Known as | Spherazole cr | ChEMBL registry synonym — accepted as the source's own label CHEMBL64391 ↗ |
| Known as | Spherazole ir | ChEMBL registry synonym — accepted as the source's own label CHEMBL64391 ↗ |
| Known as | Sporamelt | ChEMBL registry synonym — accepted as the source's own label CHEMBL64391 ↗ |
| Known as | Sporanox | “Drug: Itraconazole (Sporanox)” NCT06672900 ↗ |
| Known as | Sporanox i.v. | ChEMBL registry synonym — accepted as the source's own label CHEMBL64391 ↗ |
| Known as | Sporanox-pulse | ChEMBL registry synonym — accepted as the source's own label CHEMBL64391 ↗ |
| Known as | Sporonox | ChEMBL registry synonym — accepted as the source's own label CHEMBL64391 ↗ |
| Known as | SUBA-itraconazole | “Oral SUBA-itraconazole 65 mg 2 capsules BD for 4 months” NCT06174922 ↗ |
| Known as | Traconal | ChEMBL registry synonym — accepted as the source's own label CHEMBL64391 ↗ |
| Known as | Triasporin | ChEMBL registry synonym — accepted as the source's own label CHEMBL64391 ↗ |
| Action | Inhibit | “itraconazole specifically inhibits proliferation, migration, and tube formation of endothelial cells” PMID 23546045 ↗ May 2013 |
| Modality | Small molecule | “Itraconazole is a triazole compound” NCT00000975 ↗ |
| Route | Oral | “Patients receive itraconazole for 3 days followed by daily oral doses for a total of 12 weeks.” NCT00000975 ↗ |
| Target | CYP3A4 | “inhibitor of cytochrome P450 isoenzyme 3A4 (CYP3A4)” NCT01568411 ↗ |