Drugs / Voriconazole
last change Sep 2026 re-read 9 days ago

Voriconazole

Small molecule targets CYP2B6, CYP2C19, CYP3A4 via inhibition

Developed for
fungal infectious disease · aspergillosis · invasive aspergillosis · candidiasis · infectious disease · acute myeloid leukemia · allergic bronchopulmonary aspergillosis · candidemia
+23 more · myelodysplastic syndrome · corneal ulcer · fungal keratitis · fusariosis · blastomycosis · cancer · chronic obstructive pulmonary disease · Cryptococcal meningitis · cryptococcosis · cutaneous leishmaniasis · cystic fibrosis · dermatophytosis · immunodeficiency disease · neoplasm · opportunistic mycosis · penicilliosis · pityriasis versicolor · systemic mycosis · acute leukemia · fungal infection of eye · neuroaspergillosis · osteomyelitis · pulmonary aspergilloma
Investigated by
Pfizer · National Cancer Institute (NCI) · National Heart, Lung, and Blood Institute (NHLBI) · National Institute of Allergy and Infectious Diseases (NIAID) · Seoul National University Hospital · TFF Pharmaceuticals, Inc.
+106 more · Aravind Eye Hospitals, India · Blood and Marrow Transplant Clinical Trials Network · M.D. Anderson Cancer Center · Medical University of Vienna · Post Graduate Institute of Medical Education and Research, Chandigarh · University of California, San Francisco · Aarhus University Hospital · Abdul Wali Khan University Mardan · Academic Medical Center - University of Amsterdam · Amsterdam UMC, location VUmc · Astellas Pharma Global Development, Inc. · Astellas Pharma Inc · AstraZeneca · BeiGene · Beijing Union Pharmaceutical Factory Ltd · Boehringer Ingelheim · Bristol-Myers Squibb · Brynn Chappell · Chittagong Medical College · Chong Kun Dang Pharmaceutical · Cipla Ltd. · Dartmouth-Hitchcock Medical Center · Dr. Frank Arguello Cancer Clinic · Erasmus Medical Center · Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · European Organisation for Research and Treatment of Cancer - EORTC · European Society for Blood and Marrow Transplantation · Federal University of Rio de Janeiro · First Affiliated Hospital of Guangxi Medical University · First Affiliated Hospital of Zhejiang University · First People's Hospital of Hangzhou · Gilead Sciences · Guangxi Medical University · Guilin Medical College · Haga Hospital · Indiana University · Infectious Diseases Working Party (AGIHO) of the German Society of Hematology and Oncology (DGHO) · Instituto de Ciencia y Medicina Genomica, Torreon, Coah. Mexico www.institutodeciencia.com · Instituto de Investigación Hospital Universitario La Paz · Jan-Willem C Alffenaar · Janssen Research & Development, LLC · Johns Hopkins University · Jonsson Comprehensive Cancer Center · Kenneth Hargreaves · Klinikum Oldenburg gGmbH · L.V. Prasad Eye Institute · Lakefront Biotherapeutics NV · Leiden University Medical Center · Manjunath Prakash Pai · Martin-Luther-University Halle-Wittenberg · Masonic Cancer Center, University of Minnesota · McLean Hospital. Belmont, MA. · Mclean Hospital · Meander Medical Center · Medical College of Wisconsin · Min Kyu Park · Nanning Second People's Hospital · National Eye Institute (NEI) · National Institute of General Medical Sciences (NIGMS) · National Institutes of Health (NIH) · National Institutes of Health Clinical Center (CC) · National Marrow Donor Program · Ningbo People's Hospital · OHSU Knight Cancer Institute · OrsoBio, Inc · PETHEMA Foundation · Phillip Brian Smith · Red Cross Hospital, Hangzhou, China · Rennes University Hospital · Samyang Biopharmaceuticals Corporation · San Antonio Military Medical Center · Sara Botros · Scynexis, Inc. · Second Affiliated Hospital of Guangzhou Medical University · all 112 on the full record

Regulatory milestones approvals, filings & regulatory actions · 4 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Label expansions (2) US (FDA) VFEND — 2004-12-21 – 2019-01-29 fda.gov ↗
Approved US (FDA) VFEND — 2002-05-24 fda.gov ↗
Approved EU (EMA) Vfend — 2002-03-19 europa.eu ↗

Trials 99 · started per year

today
EU approved 2002
US approved 2002
3
1
2
1
2
7
1
5
4
3
8
6
3
4
2
3
4
5
4
1
8
3
5
4
4
1
2
2
19971998199920002001200220032004200520062007200820092010201120122013201420152016201720182019202020212022202320242025202620272028
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 01 trial
Phase 0 NCT04072640 Jan 2021 → Jul 2022 Cryptococcal meningitis, HIV infectious disease First Affiliated Hospital of Zhejiang University Unknown No outcome recorded
Phase 126 trials · 1 met primary
Phase 1 NCT07426042 Apr → May 2026 overdue — Min Kyu Park Not yet recruiting No outcome recorded
Phase 1 NCT07457203 Apr → May 2026 overdue — Beijing Union Pharmaceutical Factory Ltd Not yet recruiting No outcome recorded
Phase 1 NCT06493409 Aug → Dec 2024 — Bristol-Myers Squibb Completed No outcome recorded
Phase 1 NCT05822544 Apr 2023 → Feb 2026 overdue obesity disorder, type 2 diabetes mellitus OrsoBio, Inc Recruiting No outcome recorded
Phase 1 NCT05458102 Aug 2022 → May 2023 HIV infectious disease Gilead Sciences Terminated No outcome recorded
Phase 1 NCT05264142 Apr 2022 → Mar 2023 — University Hospital, Geneva Unknown No outcome recorded
Phase 1 NCT04865419 Jun 2021 → Aug 2023 hematopoietic and lymphoid cell neoplasm AstraZeneca Terminated No outcome recorded
Phase 1 NCT04576325 Nov 2020 → Nov 2021 asthma TFF Pharmaceuticals, Inc. Completed No outcome recorded
Phase 1 NCT04551963 Nov 2020 → Feb 2022 B-cell neoplasm BeiGene Completed Mixed
Phase 1 NCT05330000 May → Jul 2020 — The Affiliated Hospital of Qingdao University Completed No outcome recorded
Phase 1/23 trials
Phase 1/2 NCT02014558 Oct 2013 → Aug 2017 acute myeloid leukemia Astellas Pharma Global Development, Inc. Completed No outcome recorded
Phase 1/2 NCT00150319 Jun → Oct 2005 kidney failure Pfizer Terminated No outcome recorded
Phase 1/2 NCT00174473 Jun 2003 → Aug 2005 neutropenia Pfizer Completed No outcome recorded
Phase 215 trials
Phase 2 NCT03672292 Jan 2019 → Mar 2023 invasive aspergillosis Scynexis, Inc. Terminated No outcome recorded Stop: Enrollment
Phase 2 NCT02689713 Jun → Nov 2018 — Kenneth Hargreaves Withdrawn No outcome recorded Stop: Enrollment
Phase 2 NCT03327727 Feb 2018 → Jan 2019 invasive aspergillosis Vical Terminated No outcome recorded Stop: Business
Phase 2 NCT04110860 Feb → Jun 2018 pityriasis versicolor Sara Botros Completed No outcome recorded
Phase 2 NCT01887457 Sep 2014 → Nov 2016 aspergillosis, fusariosis, immunodeficiency disease Brynn Chappell Suspended No outcome recorded
Phase 2 NCT01576315 Jun 2014 → Oct 2015 aspergillosis, cystic fibrosis Rennes University Hospital Completed No outcome recorded
Phase 2 NCT01501708 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 NCT01383993 Sep 2011 → May 2013 aspergillosis Pfizer Completed No outcome recorded
Phase 2 NCT02366884 Jul 2011 → Dec 2022 neoplasm Dr. Frank Arguello Cancer Clinic Unknown No outcome recorded
Phase 2 NCT00739934 Dec 2008 → Oct 2009 candidemia Pfizer Completed No outcome recorded
Phase 2/33 trials · 1 missed
Phase 2/3 NCT03230058 Jan 2017 → Mar 2018 fungal infectious disease L.V. Prasad Eye Institute Unknown Missed primary
Phase 2/3 NCT01621321 Jun 2013 → Apr 2016 allergic bronchopulmonary aspergillosis Post Graduate Institute of Medical Education and Research, Chandigarh Completed No outcome recorded
Phase 2/3 NCT00159822 Jul 2005 → Dec 2008 aspergillosis Pfizer Completed No outcome recorded
Phase 320 trials · 1 met primary · 6 missed
Phase 3 NCT05708625 Jan 2022 → Dec 2023 cutaneous leishmaniasis Zagazig University Unknown No outcome recorded
Phase 3 NCT04824417 Mar 2021 → May 2024 aspergillosis Post Graduate Institute of Medical Education and Research, Chandigarh Completed Missed primary
Phase 3 NCT02731638 Sep 2016 → Jul 2018 corneal ulcer, fungal keratitis University of California, San Francisco Completed Missed primary
Phase 3 NCT01092832 Oct 2010 → May 2013 candidiasis Pfizer Terminated No outcome recorded Stop: Enrollment
Phase 3 NCT00996736 Apr 2010 → Jul 2012 corneal ulcer, fungal keratitis University of California, San Francisco Completed Met primary
Phase 3 NCT00836875 May 2009 → May 2013 invasive aspergillosis Pfizer Terminated No outcome recorded Stop: Enrollment
Phase 3 NCT00904995 May 2009 → Jul 2010 fungal infectious disease, leukemia M.D. Anderson Cancer Center Completed No outcome recorded
Phase 3 NCT00893555 Apr 2009 → Nov 2016 fungal infectious disease, hematopoietic and lymphoid cell neoplasm Jan-Willem C Alffenaar Completed Missed primary
Phase 3 NCT00531479 Jul 2008 → Apr 2011 aspergillosis Pfizer Completed Missed primary
Phase 3 NCT00289991 Mar 2006 → Feb 2009 opportunistic mycosis Pfizer Completed No outcome recorded
Phase 420 trials
Phase 4 NCT06582186 Oct 2024 → Oct 2027 expected hematopoietic and lymphoid cell neoplasm, invasive aspergillosis University Hospital, Grenoble Not yet recruiting No outcome recorded
Phase 4 NCT04238884 Jan 2020 fungal infectious disease Instituto de Investigación Hospital Universitario La Paz Unknown No outcome recorded
Phase 4 NCT05380245 Nov 2018 — Abdul Wali Khan University Mardan Completed No outcome recorded
Phase 4 NCT03731169 Jan 2018 → Aug 2019 invasive aspergillosis University Health Network, Toronto Completed No outcome recorded
Phase 4 NCT02912156 Jun → Jul 2016 fungal infectious disease Yung Shin Pharm. Ind. Co., Ltd. Completed No outcome recorded
Phase 4 NCT02576366 Jun 2016 → May 2017 — Universitaire Ziekenhuizen KU Leuven Completed No outcome recorded
Phase 4 NCT02283905 Jun 2015 → Sep 2020 blastomycosis University of Manitoba Terminated No outcome recorded Stop: Enrollment
Phase 4 NCT02234739 Oct 2014 → Oct 2016 chronic obstructive pulmonary disease, invasive aspergillosis Red Cross Hospital, Hangzhou, China Unknown No outcome recorded
Phase 4 NCT01416025 Jan 2012 → Dec 2014 fungal infectious disease Johns Hopkins University Completed No outcome recorded
Phase 4 NCT01030653 Nov 2009 → Apr 2010 — Manjunath Prakash Pai Completed No outcome recorded
Phase not applicable10 trials · 1 met primary
— NCT06710600 Sep 2022 → Apr 2024 photosensitivity disease Medical University of Vienna Completed 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
— NCT02396225 Mar 2015 → Dec 2016 invasive aspergillosis University of Aarhus Terminated No outcome recorded Stop: Enrollment
— NCT01344512 Jun 2011 → Sep 2014 — University Hospital, Bordeaux Completed No outcome recorded
— NCT01104376 Mar 2010 → Apr 2011 efavirenz toxicity Indiana University Completed No outcome recorded
— NCT00890708 Nov 2008 → Dec 2011 fungal infectious disease Seoul National University Hospital Completed No outcome recorded
— NCT02714504 Aug 2008 → Dec 2014 fusariosis, tinea unguium Federal University of Rio de Janeiro Completed No outcome recorded
— NCT00079222 Nov 2003 → Apr 2005 cancer Jonsson Comprehensive Cancer Center Completed No outcome recorded
— NCT00023530 Sep 2001 → Aug 2006 graft versus host disease, leukemia, myelodysplastic syndrome, plasma cell myeloma National Heart, Lung, and Blood Institute (NHLBI) Completed No outcome recorded
Phase not stated1 trial
— NCT05897294 — allergic bronchopulmonary aspergillosis, invasive aspergillosis TFF Pharmaceuticals, Inc. No longer available No outcome recorded
Comparator or background therapy31 trials
Phase 0 NCT05528354 Background Jun 2022 → Dec 2025 disease related to hematopoietic stem cell transplant Zhejiang University Unknown No outcome recorded
Phase 0 NCT05268718 Comparator Aug 2021 → Dec 2023 corneal ulcer Second Affiliated Hospital, School of Medicine, Zhejiang University Unknown 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 NCT00833482 Comparator Sep 2009 → Jul 2010 HIV infectious disease Bristol-Myers Squibb Completed No outcome recorded
Phase 1 NCT01080651 Comparator Dec 2008 → Mar 2009 invasive aspergillosis Seoul National University Hospital Completed No outcome recorded

News releases announcing trial results or a regulatory action · 3

DateIssuerRelease
2020-07-20 Yung Shin Pharm. Ind. Co., Ltd. Regulatory 感染疾病日益複雜 永信聚焦發展重症感染藥物 com.tw ↗
以原料藥垂直整合藥品策略,成功開發triazole 類第二代廣效性抗黴菌藥物-Voriconazole,具有錠劑及注射劑兩種規格可提供轉換治療,目前已取得台灣與日本上市許可,未來將持續佈局歐、美等高法規市場。
2018-07-18 Zydus Lifesciences Limited Regulatory Zydus receives four consecutive ANDA approvals from the USFDA zyduslife.com ↗
Zydus Cadila announced that it has received four consecutive final approvals from the USFDA to market Olanzapine Tablets USP, Glipizide Extended -Release Tablets, Voriconazole for Injection and Fluocinonide Topical Solution USP.
2016-06-06 Lupin Limited Regulatory Lupin Receives FDA Approvals for Generic Vfend® Tablets 50mg, 200mg & Vfend® Oral Suspension, 40 mg/mL lupin.com ↗
has received final approvals for its Voriconazole® Tablets, 50 mg & 200 mg and Voriconazole® Oral Suspension, 40 mg/mL from the United States Food and Drug Administration (FDA)

Evidence & citations 18 cited values

Every value below carries the sentence it was read from. 133 sources stand behind the page.

FieldValueCited text
Known as Voriconazole “Calcium sulfate beads will be loaded with best available antibiotics based on surgeon/infectious disease specialist determination from the following options (vancomycin,...” NCT07072923 ↗
127

“Group C (TV group) receiving Oral Terbinafine (250 mg once daily) combined with Voriconazole, dosed according to body weight at or over 40 kg body weight: 200 mg twice daily...” NCT07816510 ↗

“Voriconazole or isavuconazole or posaconazole will be dosed according to the SPC and according to the route of administration (IV or orally) that is preferred by the treating physician.” NCT04876716 ↗

“This is a study to investigate the pharmacokinetics, safety and tolerability of intravenous voriconazole and SBECD in patients with moderate renal insufficiency” NCT00150319 ↗

“To assess the pharmacokinetics (PK) of voriconazole and anidulafungin in patients with invasive aspergillosis (IA) in comparison with other populations” PMID 24913161 ↗ Jun 2014

“This is a study to investigate the safety and efficacy of voriconazole for the treatment of candidemia in critically ill non-neutropenic patients” NCT00163111 ↗

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

“topical antifungal medications like natamycin eye drops and voriconazole eye drops” NCT02328053 ↗

“Itraconazole, Amphotericin B liposomal, Fluconazole, Terbinafine, Voriconazole” NCT02366884 ↗

“if Voriconazole or Posaconazole is used to prevent or treat fungal infections” NCT05528354 ↗

“Voriconazole dose will be adjusted based on per protocol obtained TDM levels” NCT01416025 ↗

Show 117 more sources

Known as NSC-759888 ChEMBL registry synonym — accepted as the source's own label CHEMBL638 ↗
Known as UK-109,496 ChEMBL registry synonym — accepted as the source's own label CHEMBL638 ↗
Known as Vaway FC Tablets “Vaway FC Tablets 200mg (Voriconazole)” NCT02912156 ↗
Known as vfend “The purpose of this study was to evaluate the pharmacokinetic equivalency of a test formulation and reference formulation (Vfend®) of Voriconazole.” PMID 36869387 ↗ Mar 2023
7

“Study to Evaluate the Pharmacokinetic Properties of SYP-1018 (Voriconazole-loaded PNP) and Voriconazole (Vfend)” NCT01657201 ↗

“To be determined mg of Voriconazole (Vfend®, anti-fungal agent)” NCT03760276 ↗

“Vfend (voriconazole) intravenous infusion” NCT02906176 ↗

“Antifungal drug. VORICONAZOL. (VFEND®)” NCT00386802 ↗

“Drug: Vfend (voriconazole)” NCT00496197 ↗

“Drug: voriconazole (Vfend)” NCT00150345 ↗

NCT01887457 ↗

Known as VFEND FC Tablets “VFEND FC Tablets 200mg (Voriconazole)” NCT02912156 ↗
Known as VFEND I.V. “Voriconazole (VFEND® I.V., Pfizer, New York, NY) will be prepared as a 1% solution.” NCT00557362 ↗
Known as VFend(R) “To evaluate the efficacy of voriconazole (VFend(R)) as first line treatment for proven chronic bronchopulmonary aspergillosis, in minimally immunocompromised or...” NCT00159822 ↗
Known as Vori “Voriconazole (Vori) 6mg/kg BID IV loading dose on Day 1 followed by 4mg/kg IV BID thereafter.” NCT07215273 ↗
Known as VORICONAZOL ClinicalTrials.gov intervention name — accepted as the source's own label NCT00386802 ↗
Known as Voriconazol Aristo “voriconazole (Voriconazol Aristo®) 200mg” NCT06710600 ↗
Known as Voriconazole accord ChEMBL registry synonym — accepted as the source's own label CHEMBL638 ↗
Known as Voriconazole hikma (previously voriconazole hospira) ChEMBL registry synonym — accepted as the source's own label CHEMBL638 ↗
Action Inhibit “Voriconazole inhibits an essential step of the biosynthesis of an important component of the fungal cell wall (ergosterol).” NCT00418951 ↗
Modality Small molecule “Voriconazole is a new triazole that has shown in phase II studies to be very active against Aspergillus sp.” NCT00015665 ↗
Route Intravenous “available in an intravenous and oral formulation” NCT00001646 ↗
Route Oral “available in an intravenous and oral formulation” NCT00001646 ↗
Target CYP2B6 “Efavirenz, a nonnucleoside HIV-1 reverse transcriptase inhibitor, is mainly cleared by CYP2B6, an enzyme strongly inhibited in vitro by voriconazole.” PMID 27600044 ↗ Oct 2016