Drugs / Flucytosine
last change Aug 2026 re-read 9 days ago

Flucytosine

also known as 5-FC · 5-fluorocytosine · Alcobon · Ancoban · Ancobon · Ancotil · FLC · Flourocytosine · +6 more

Small molecule

Developed for
Cryptococcal meningitis · HIV infectious disease · anaplastic astrocytoma · anaplastic oligoastrocytoma · anaplastic oligodendroglioma · glioblastoma · adult glioblastoma · cancer
+9 more · giant cell glioblastoma · gliosarcoma · astrocytoma (excluding glioblastoma) · colorectal neoplasm · cryptococcosis · digestive system cancer · hepatocellular carcinoma · penicilliosis · prostate cancer
Investigated by
National Institute of Allergy and Infectious Diseases (NIAID) · Pfizer · City of Hope Medical Center · National Cancer Institute (NCI) · Tocagen Inc. · Transgene
+35 more · ANRS, Emerging Infectious Diseases · Anaeropharma Science, Inc. · Assign Data Management and Biostatistics GmbH · Bach Mai Hospital · Bausch Health Americas, Inc. · CHU Kamenge, BURUNDI · CSPC Ouyi Pharmaceutical Co., Ltd. · 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 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 22

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 16 trials
Phase 1 NCT04195373 Nov 2020 digestive system cancer Themis Bioscience GmbH Withdrawn No outcome recorded Stop: Enrollment
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 Stop: Business
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 NCT00978107 Sep 2009 → Sep 2011 hepatocellular carcinoma Transgene Completed No outcome recorded
Phase 1/23 trials
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 23 trials · 1 missed
Phase 2 NCT06414512 Apr → Oct 2024 Cryptococcal meningitis University of Minnesota Completed Missed primary
Phase 2 NCT01562132 Sep 2013 → Jul 2014 cryptococcosis Yale University Terminated No outcome recorded Stop: Enrollment
Phase 2 NCT00583492 Dec 2007 → Sep 2013 prostate cancer Henry Ford Health System Completed No outcome recorded
Phase 2/32 trials
Phase 2/3 NCT04105374 Jan 2020 → Nov 2025 anaplastic astrocytoma, glioblastoma, oligodendroglioma NRG Oncology Withdrawn 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 Nov 2026 → Sep 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
— NCT00002113 — Cryptococcal meningitis, HIV infectious disease Pfizer Completed No outcome recorded
— NCT00000639 ? → Sep 1997 Cryptococcal meningitis, HIV infectious disease National Institute of Allergy and Infectious Diseases (NIAID) Completed No outcome recorded
— NCT00000708 ? → Jul 1991 Cryptococcal meningitis, HIV infectious disease National Institute of Allergy and Infectious Diseases (NIAID) 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
Comparator or background therapy6 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 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 2/3 NCT06666322 Comparator May 2025 → Apr 2032 expected Cryptococcal meningitis, HIV infectious disease University of Minnesota Recruiting No outcome recorded

News releases announcing trial results or a regulatory action · 4

DateIssuerRelease
2021-12-14 Denovo Biopharma LLC Results Denovo Biopharma LLC Announces Breakthrough Discovery of a Novel Genetic Biomarker for DB107 for a Gene Therapy-Based Medicine denovobiopharma.com ↗
DGM7 has been shown to be associated with response to treatment of recurrent high grade glioma (HGG) with an investigational gene therapy combination treatment, DB107, via retrospective analysis.
2021-11-02 Denovo Biopharma LLC Results Denovo Biopharma LLC Announces Multiple Presentations at Major Conferences denovobiopharma.com ↗
Extended benefits in patients with recurrent high grade glioma that continuously receive Toca FC after Toca 511 Treatment
2021-09-16 Transgene Results Transgene presents data from Phase I clinical trial confirming the potential of the oncolytic virus TG6002 transgene.com ↗
Transgene presents data from Phase I clinical trial confirming the potential of the oncolytic virus TG6002
2021-04-09 Transgene Results Transgene presents initial Phase I data of TG6002, highlighting the potential of the intravenous administration of its oncolytic viruses transgene.com ↗

Evidence & citations 17 cited values

Every value below carries the sentence it was read from. 29 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 ↗

NCT06525389 ↗

NCT05471063 ↗

NCT00002305 ↗

NCT03724071 ↗

NCT04105374 ↗

NCT01562626 ↗

NCT01562132 ↗

Show 15 more sources

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)” NCT01562626 ↗

“Flucytosine (5-FC)” NCT04194034 ↗

“Flucytosine (5FC)” NCT06525389 ↗

“5-FC” NCT00978107 ↗

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 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 FC” NCT01470794 ↗
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 ↗
Modality Small molecule — CHEMBL1463 ↗
Route Oral “Non-AIDS patients assigned to AMB also take FLC by mouth daily.” NCT00000708 ↗