Drugs / Flucytosine
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Flucytosine

also known as 5-FC · Toca FC · DB107-FC · 5-fluorocytosine · Alcobon · Ancoban · Ancobon · Ancotil · +8 more

Small molecule

Developed for
Cryptococcal meningitis · anaplastic astrocytoma · HIV infectious disease · glioblastoma · anaplastic oligoastrocytoma · anaplastic oligodendroglioma · adult glioblastoma · cancer
+21 more · giant cell glioblastoma · gliosarcoma · urinary bladder cancer · astrocytoma (excluding glioblastoma) · colorectal cancer · colorectal neoplasm · cryptococcosis · digestive system cancer · head and neck cancer · hepatocellular carcinoma · high grade astrocytic tumor · lymphoma · malignant glioma · malignant pancreatic neoplasm · melanoma · non-small cell lung carcinoma · ovarian cancer · penicilliosis · prostate cancer · sarcoma · triple-negative breast carcinoma
Investigated by
Tocagen Inc. · National Cancer Institute (NCI) · National Institute of Allergy and Infectious Diseases (NIAID) · Pfizer · City of Hope Medical Center · Denovo Biopharma LLC
+40 more · Transgene · ANRS, Emerging Infectious Diseases · Anaeropharma Science, Inc. · Anova Enterprises, Inc · Ashish Shah · Assign Data Management and Biostatistics GmbH · Bach Mai Hospital · Bausch Health Americas, Inc. · CHU Kamenge, BURUNDI · CSPC Ouyi Pharmaceutical Co., Ltd. · California Institute for Regenerative Medicine (CIRM) · Duke University · Gilead Sciences · Henry Ford Health System · Hospital Avicenne · Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam · Hôpital Cocody · Hôpital de Treichville · Infectious Diseases Institute, Makerere University · Institut Pasteur · Institut de Médecine et Epidémiologie Appliquée (IMEA) · Kenya Medical Research Institute · Mbarara University of Science and Technology · Meningitis Foundation · NRG Oncology · National Hospital for Tropical Diseases, Hanoi, Vietnam · National Institute of Neurological Disorders and Stroke (NINDS) · Necker-Enfants Malades Hospital · Optimapharm · Peking Union Medical College Hospital · Pham Ngoc Thach University of Medicine · Shanghai Public Health Clinical Center · Tasly Tianjin Biopharmaceutical Co., Ltd. · Themis Bioscience GmbH · University of California, San Francisco · University of Minnesota · University of Nairobi · Viatris Inc. · Washington University School of Medicine · Yale University

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved US (FDA) ANCOBON 1971-11-26 fda.gov

Trials 29 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 110 trials
Phase 1 NCT04195373 Nov 2020 digestive system cancer Themis Bioscience GmbH Withdrawn No outcome recorded
Phase 1 NCT04089163 Dec 2019 → Jan 2022 urinary bladder cancer Tocagen Inc. Withdrawn No outcome recorded
Phase 1 NCT02598011 Jan 2017 → Nov 2022 malignant glioma Tocagen Inc. Withdrawn No outcome recorded
Phase 1 NCT02576665 Jul 2016 → May 2019 colorectal cancer, head and neck cancer, high grade astrocytic tumor, lymphoma +7 Tocagen Inc. Terminated No outcome recorded
Phase 1 NCT02015819 Oct 2014 → Oct 2017 adult glioblastoma, anaplastic astrocytoma, anaplastic oligoastrocytoma, anaplastic oligodendroglioma +2 City of Hope Medical Center Completed No outcome recorded
Phase 1 NCT01470794 Feb 2012 → Apr 2016 anaplastic astrocytoma, anaplastic oligoastrocytoma, anaplastic oligodendroglioma, glioblastoma Tocagen Inc. Completed No outcome recorded
Phase 1 NCT04327011 Feb 2011 → Dec 2019 astrocytoma (excluding glioblastoma), glioblastoma Tocagen Inc. Terminated No outcome recorded
Phase 1 NCT01172964 Aug 2010 → Feb 2015 adult glioblastoma, anaplastic astrocytoma, anaplastic oligoastrocytoma, anaplastic oligodendroglioma +2 City of Hope Medical Center Completed No outcome recorded
Phase 1 NCT01156584 Jul 2010 → Aug 2016 anaplastic astrocytoma, anaplastic oligoastrocytoma, anaplastic oligodendroglioma, glioblastoma Tocagen Inc. Completed No outcome recorded
Phase 1 NCT00978107 Sep 2009 → Sep 2011 hepatocellular carcinoma Transgene Completed No outcome recorded
Phase 1/24 trials
Phase 1/2 NCT06504381 Jan 2025 → Jan 2028 expected glioblastoma University of California, San Francisco Recruiting No outcome recorded
Phase 1/2 NCT04226066 Nov 2019 → May 2021 cancer Tasly Tianjin Biopharmaceutical Co., Ltd. Unknown No outcome recorded
Phase 1/2 NCT03724071 Oct 2018 → Feb 2023 colorectal neoplasm Transgene Terminated No outcome recorded
Phase 1/2 NCT01562626 Sep 2012 → May 2021 cancer Anaeropharma Science, Inc. Suspended No outcome recorded
Phase 24 trials
Phase 2 NCT06264388 May 2024 → May 2034 expected anaplastic astrocytoma Ashish Shah Recruiting No outcome recorded
Phase 2 NCT06414512 Apr → Oct 2024 Cryptococcal meningitis University of Minnesota Completed No outcome recorded
Phase 2 NCT01562132 Sep 2013 → Jul 2014 cryptococcosis Yale University Terminated No outcome recorded
Phase 2 NCT00583492 Dec 2007 → Sep 2013 prostate cancer Henry Ford Health System Completed No outcome recorded
Phase 2/33 trials
Phase 2/3 NCT04105374 Jan 2020 → Nov 2025 anaplastic astrocytoma, glioblastoma, oligodendroglioma NRG Oncology Withdrawn No outcome recorded
Phase 2/3 NCT02414165 Nov 2015 → May 2019 anaplastic astrocytoma, glioblastoma Tocagen Inc. Terminated No outcome recorded
Phase 2/3 NCT01715922 May 2012 → Sep 2015 Cryptococcal meningitis, HIV infectious disease ANRS, Emerging Infectious Diseases Unknown No outcome recorded
Phase 32 trials
Phase 3 NCT06525389 Jul 2026 → Jul 2030 expected penicilliosis Duke University Not yet recruiting No outcome recorded
Phase 3 NCT04140461 Jan 2020 → Mar 2022 Cryptococcal meningitis, HIV infectious disease Shanghai Public Health Clinical Center Unknown No outcome recorded
Phase not applicable6 trials
NCT05471063 Aug 2022 → Feb 2023 Cryptococcal meningitis Peking Union Medical College Hospital Unknown No outcome recorded
NCT00000639 ? → Sep 1997 Cryptococcal meningitis, HIV infectious disease National Institute of Allergy and Infectious Diseases (NIAID) Completed No outcome recorded
NCT00002113 Cryptococcal meningitis, HIV infectious disease Pfizer Completed No outcome recorded
NCT00002075 Cryptococcal meningitis, HIV infectious disease Pfizer Completed No outcome recorded
NCT00002305 Cryptococcal meningitis, HIV infectious disease Pfizer Completed No outcome recorded
NCT00000708 ? → Jul 1991 Cryptococcal meningitis, HIV infectious disease National Institute of Allergy and Infectious Diseases (NIAID) Completed No outcome recorded
Also used as a comparator or background therapy in 7 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 11 trial
Phase 1 NCT01985256 Background Feb 2014 → Mar 2016 anaplastic astrocytoma, anaplastic oligoastrocytoma, anaplastic oligodendroglioma, glioblastoma Tocagen Inc. Completed No outcome recorded
Phase 1/22 trials
Phase 1/2 NCT04194034 Background Jan 2020 → Feb 2023 colorectal neoplasm Transgene Terminated No outcome recorded
Phase 1/2 NCT06562621 Background Aug 2018 → Aug 2022 glioblastoma Beijing Neurosurgical Institute Completed No outcome recorded
Phase 22 trials
Phase 2 NCT00012467 Background Jan 2000 → Jul 2001 Cryptococcal meningitis, HIV infectious disease InterMune Completed No outcome recorded
Phase 2 NCT00000776 Background ? → Sep 1996 Cryptococcal meningitis, HIV infectious disease National Institute of Allergy and Infectious Diseases (NIAID) Completed No outcome recorded
Phase 2/31 trial
Phase 2/3 NCT06666322 Comparator May 2025 → Apr 2032 expected Cryptococcal meningitis, HIV infectious disease University of Minnesota Recruiting No outcome recorded
Phase 41 trial
Phase 4 NCT06178627 Comparator Aug 2023 → Aug 2025 overdue Cryptococcal meningitis Huashan Hospital Enrolling by invitation No outcome recorded

Evidence & citations 19 cited values

Every value below carries the sentence it was read from. 37 sources stand behind the page.

FieldValueCited text
Known as Flucytosine “2. Flucytosine 100mg/kg/day for 14 days in divided doses” NCT06666322
25

“ONF is an extended-release formulation of flucytosine.” NCT06562621

flucytosine, 5-FC, 5-FC XR, Toca FC” NCT01470794

“Oral Flucytosine (5-FC)” NCT04226066

NCT04140461

NCT04105374

NCT01562132

NCT00978107

NCT06414512

NCT01172964

NCT06178627

NCT00000639

NCT03724071

NCT01715922

NCT00000776

NCT01562626

NCT00002075

NCT02015819

NCT00012467

NCT00000708

NCT05471063

NCT04194034

NCT00002305

NCT04327011

NCT00002113

NCT06525389

Known as 5-FC “The combination of amphotericin and flucytosine (5-FC) has been the mainstay of therapy for the initial management of cryptococcal meningitis for 4 decades.” NCT06666322
9

“Combination of amphotericin and flucytosine (5-FC) is the mainstay of therapy for the initial management of CM.” NCT06414512

“Plus 2 week course (weekdays only) of 5-FC and vGCV prodrug therapy” NCT00583492

“Flucytosine (5-FC, Ancotil)” NCT03724071

“Flucytosine (5-FC)” NCT04194034

“Flucytosine (5-FC)” NCT01562626

“Flucytosine (5FC)” NCT06525389

5-FCNCT00978107

NCT04226066

NCT04195373

Known as 5-fluorocytosine “To evaluate the effectiveness and safety of amphotericin B plus flucytosine (5-fluorocytosine) compared to amphotericin B alone for a first episode of acute cryptococcal...” NCT00000639
Known as Alcobon ChEMBL registry synonym — accepted as the source's own label CHEMBL1463
Known as Ancoban ChEMBL registry synonym — accepted as the source's own label CHEMBL1463
Known as Ancobon ChEMBL registry synonym — accepted as the source's own label CHEMBL1463
Known as Ancotil “Flucytosine (5-FC, Ancotil)” NCT03724071
Known as DB107-FC ClinicalTrials.gov intervention name — accepted as the source's own label NCT06264388
1

NCT06504381

Known as FLC “fluconazole (FCZ) and amphotericin B (AMB), alone or in combination with flucytosine (FLC), as treatment for acute cryptococcal meningitis” NCT00000708
Known as Flourocytosine ChEMBL registry synonym — accepted as the source's own label CHEMBL1463
Known as Flucitosina ChEMBL registry synonym — accepted as the source's own label CHEMBL1463
Known as flucytosine, 5-FC, 5-FC XR, Toca FC flucytosine, 5-FC, 5-FC XR, Toca FCNCT01470794
Known as Flucytosinum ChEMBL registry synonym — accepted as the source's own label CHEMBL1463
Known as Fluorocytosine ChEMBL registry synonym — accepted as the source's own label CHEMBL1463
Known as NSC-103805 ChEMBL registry synonym — accepted as the source's own label CHEMBL1463
Known as RO 2-9915 ChEMBL registry synonym — accepted as the source's own label CHEMBL1463
Known as Toca FC ClinicalTrials.gov intervention name — accepted as the source's own label NCT02576665
5

NCT01985256

NCT02414165

NCT01156584

NCT02598011

NCT04089163

Modality Small molecule CHEMBL1463
Route Oral “Non-AIDS patients assigned to AMB also take FLC by mouth daily.” NCT00000708