Last update 16 May 2025

Flucytosine

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
5-FC, 5-Fluorocystosine, 5-Fluorocytosine
+ [9]
Target-
Action-
Mechanism-
Active Indication
Originator Organization
License Organization-
Drug Highest PhaseApproved
First Approval Date
United States (26 Nov 1971),
RegulationOrphan Drug (United States), Orphan Drug (European Union)
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Structure/Sequence

Molecular FormulaC4H4FN3O
InChIKeyXRECTZIEBJDKEO-UHFFFAOYSA-N
CAS Registry2022-85-7

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Fungemia
Japan
31 May 1988
Mycoses
China
01 Jan 1982
Meningitis, Fungal
Japan
13 Mar 1979
Respiratory Tract Infections
Japan
13 Mar 1979
Candidiasis
United States
26 Nov 1971
Cryptococcosis
United States
26 Nov 1971
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Colorectal Liver MetastasesPhase 2
France
17 Jan 2020
Colorectal Liver MetastasesPhase 2
United Kingdom
17 Jan 2020
Metastatic Colorectal CarcinomaPhase 2
France
17 Jan 2020
Metastatic Colorectal CarcinomaPhase 2
United Kingdom
17 Jan 2020
Colorectal CancerPhase 2
Belgium
16 Oct 2018
Colorectal CancerPhase 2
Spain
16 Oct 2018
Recurrent GlioblastomaPhase 2
France
12 Oct 2017
Meningitis, CryptococcalPhase 2
Kenya
01 Sep 2013
Hepatocellular CarcinomaPhase 1
France
01 Sep 2009
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
-
DB107-RRV + DB107-FC
ldqkrvdrcd(rltdxvjjru) = axrtbvbokz igotxgxaik (qrrpirsfun )
Positive
11 Nov 2024
DB107-RRV
(Standard of Care (SOC))
ldqkrvdrcd(rltdxvjjru) = ijrjjnwwtw igotxgxaik (qrrpirsfun )
AACR2023
ManualManual
Phase 1
15
jlevxyndeo(pabvzisulh) = lrhkknsbgy ekwejecybd (wpdjmelcve )
Positive
14 Apr 2023
Phase 1
16
NSC+5-FC
(Dose Level 1: (NSC 5x10^7 and 5-FC 37.5 mg/kg))
wqavtrgydm = mjmjyfwewa vhtxhphvhs (slesivpcaf, wyavbzrkus - flohcmryoj)
-
29 Sep 2021
NSC+5-FC
(Dose Level 2: (NSC 1x10^8 and 5-FC 37.5 mg/kg))
wqavtrgydm = hcexznjfhn vhtxhphvhs (slesivpcaf, aewemjebgy - okfdfzhdiu)
Phase 1
21
zswwejdzdx(oegfevwiti) = no related Grade 4 adverse events qhpnnbuulo (ejxodhbcoc )
Positive
01 Nov 2019
Not Applicable
-
arwlipokit(vasbkzhuzm) = tumor growth in Toca 511/5-FC treated group was significantly inhibited compared to control group wvvlaudmua (mazgmdvawz )
-
22 Apr 2019
Phase 1
15
5-Fluorocytosine (5-FC)
(CD-NSCs 150 x 10^6)
fefsxczqkh(jtljdkyzvd) = One dose-limiting toxicity occurred: grade 3 wound infection zsasadpwvn (hpatahatzu )
Positive
05 Nov 2018
Phase 1
24
Toca 511
nhqgtjpcpk(bshvloiezm) = byqudtvane ollinzrzkh (shjrltbepd )
Positive
06 Nov 2017
Phase 1
16
ykcjmfkqrv(aepiscfgca) = 4 × 108 p.f.u. fxwneglzjt (ijatooljqp )
Positive
01 Jan 2017
Phase 1
45
lnnbijagkg(xqpcgypbde) = ruvqrcwmtq lntpojsumf (yytpmjrnbm, 10.8 - 20.0)
Positive
01 Jun 2016
5-fluorocytosine+subgroup from an external control
-
Not Applicable
-
Toca 511+5-FC
jtfxrckqlz(ozwhtvpgbs) = zppvmmchwk egcpvdtbau (nyvmjmyoow )
-
01 May 2016
PBS
jtfxrckqlz(ozwhtvpgbs) = nqxociuayn egcpvdtbau (nyvmjmyoow )
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Core Patent

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Approval

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Regulation

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