Drugs / Itraconazole
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 392 · started per year
today
US approved 1992
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Also used as a comparator or background therapy in 74 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 03 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 136 trials | ||||||
| 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 | NCT05578950 Comparator | Mar → Aug 2022 | tinea unguium | Combined Military Hospital Abbottabad | Completed | No outcome recorded |
| Phase 1 | NCT05862714 Comparator | Mar → Sep 2022 | pityriasis versicolor | 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 |
| 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 1/21 trial | ||||||
| Phase 1/2 | NCT01974687 Background | Oct 2013 → Sep 2015 | chronic hepatitis C virus infection | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 213 trials | ||||||
| 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 |
| 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 | No outcome recorded |
| 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 |
| Phase 2 | NCT00012467 Background | Jan 2000 → Jul 2001 | Cryptococcal meningitis, HIV infectious disease | InterMune | Completed | No outcome recorded |
| Phase 2/32 trials | ||||||
| Phase 2/3 | NCT03572049 Comparator | Sep 2018 → May 2021 | fungal infectious disease | University of Alabama at Birmingham | 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 |
| Phase 36 trials | ||||||
| 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 | No outcome recorded |
| 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 | No outcome recorded |
| 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 44 trials | ||||||
| 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 |
| Phase not applicable9 trials | ||||||
| — | 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 |
Evidence & citations 36 cited values
Every value below carries the sentence it was read from. 471 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 ↗463“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 ↗ “multiple oral doses of a potent CYP3A4 inhibitor (itraconazole) and inducer (rifampicin)” PMID 36458825 ↗ Jan 2023 “Itraconazole capsule 200mg(2 capsules, 100mg/ capsule) ，oral in 30min after breakfast.” NCT05949385 ↗ “participants will receive a single oral dose of itraconazole on Day 4 through Day 8” NCT04743414 ↗ “Itraconazole, Amphotericin B liposomal, Fluconazole, Terbinafine, Voriconazole” NCT02366884 ↗ “thereafter, all the patients received maintenance therapy with itraconazole.” PMID 28614691 ↗ Jun 2017 “Daily ibrutinib (140mg QD) and itraconazole (100mg BID) for six months.” NCT05348096 ↗ “Drug-drug Interactions Between DZD9008 and Itraconazole/Carbamazepine” NCT05418582 ↗ “Oral dose of omeprazole, voriconazole, itraconazole, or rifampicin” NCT05822544 ↗ “intravenous itraconazole formulated with HPβCD in healthy adults” PMID 29197175 ↗ Dec 2017 “Drug: itraconazole” NCT04908800 ↗ |
| Known as | c-itra | “This open-label randomized trial evaluated the efficacy, safety, and pharmacokinetics SUBA-itra compared with conventional itraconazole (c-itra) treatment for endemic fungal infections.” PMID 38440302 ↗ Jan 2024 |
| Known as | C-ITZ | “Super bioavailability (SUBA) itraconazole (S-ITZ), which releases drug in the duodenum, and conventional itraconazole (C-ITZ), which releases drug in the stomach, were compared...” PMID 32457106 ↗ Jul 2020 |
| 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 | Conventional itraconazole | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03572049 ↗ |
| 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 ↗8“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 ↗ “Itraconazole (ITZ)” NCT07184203 ↗ “Itraconazole (ITZ)” NCT06084481 ↗ “Itraconazole (ITZ)” NCT06579300 ↗ “Itraconazole (ITZ)” NCT07420894 ↗ |
| 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 ↗ |