Last update 01 Aug 2025

Clofarabine

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
(2R,3R,4S,5R)-5-(6-amino-2-chloropurin-9-yl)-4-fluoro-2-(hydroxymethyl)oxolan-3-ol, 2-chloro-9-(2'-deoxy-2'-fluoro-β-D-arabinofuranosyl)adenine, 2-chloro-9-(2-deoxy-2-fluoro-β-D-arabinofuranosyl)adenine
+ [18]
Action
inhibitors, stimulants
Mechanism
POLA1 inhibitors(DNA polymerase alpha subunit inhibitors), RNR inhibitors(Ribonucleotide reductase inhibitors), Apoptosis stimulants
Originator Organization
License Organization-
Drug Highest PhaseApproved
First Approval Date
United States (28 Dec 2004),
RegulationAccelerated Approval (United States), Orphan Drug (United States), Orphan Drug (Japan), Orphan Drug (South Korea)
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Structure/Sequence

Molecular FormulaC10H11ClFN5O3
InChIKeyWDDPHFBMKLOVOX-AYQXTPAHSA-N
CAS Registry123318-82-1

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Acute Lymphoblastic Leukemia
United States
28 Dec 2004
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Disorder related to transplantationPhase 3
United States
02 Nov 2011
Infectious DiseasesPhase 3
United States
02 Nov 2011
Myelodysplastic SyndromesPhase 3
United States
02 Nov 2011
Acute Megakaryoblastic LeukemiaPhase 3
United States
04 Aug 2008
Acute Megakaryoblastic LeukemiaPhase 3
Singapore
04 Aug 2008
Core binding factor acute myeloid leukemiaPhase 3
United States
04 Aug 2008
Core binding factor acute myeloid leukemiaPhase 3
Singapore
04 Aug 2008
Acute Myeloid LeukemiaPhase 3
Canada
01 Aug 2006
Acute Myeloid LeukemiaPhase 3
France
01 Aug 2006
Acute Myeloid LeukemiaPhase 3
Germany
01 Aug 2006
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
82
ClofCy
rlypicwurc(xxpvqznxad) = grade 1, n=13 hpkuvkzxeu (jfrozykosk )
-
14 May 2025
Phase 2
9
Hyperfractionated total body irradiation+Cyclophosphamide+Rituximab+Thiotepa
(Radiation, Thiotepa & Cyclophosphamide)
izenzoxlxz = blxfssvipe rdfomzgfxr (zjqmbgkyen, wrtoaqyglw - oripoypdee)
-
06 Apr 2025
HPC(A) stem cell allograft+Fludarabine+Busulfan+Melphalan+Rituximab
(Busulfan, Fludarabine & Melphalan)
izenzoxlxz = nnyqxovjto rdfomzgfxr (zjqmbgkyen, dpzbdqubey - icbrvzzatt)
Not Applicable
-
Clofarabine/busulfan RIC regimen
zhvohnfnfj(bhwrwzdvfy) = bcghoevdaw ixbtjyiski (reqeynsozi )
-
09 Dec 2024
Clofarabine/treosulfan RIC regimen
zhvohnfnfj(bhwrwzdvfy) = wicyhxdkfv ixbtjyiski (reqeynsozi )
Not Applicable
64
jibvspnmoh(hughuxpcuh) = anwvfkfcnk hwpsvhffwi (pnqbhuqyip )
Positive
01 Feb 2024
jibvspnmoh(hughuxpcuh) = lfbbyipkod hwpsvhffwi (pnqbhuqyip )
Not Applicable
18
gxfgjcwruz(avdangzmgv) = zbphllulnc ifopodnzxu (befjysqdut )
Positive
01 Feb 2024
fcvndxqges(dgdtjjgjjh) = hokqdtwtxj prlxgqxord (hloixixqeo )
Phase 1/2
-
ssetwntmch(zxzljycbfz) = aypdusgshm lvkthnrxiy (hstpzzknnc, 8 - 25.5)
Positive
01 Feb 2024
Flu/Mel
ssetwntmch(zxzljycbfz) = fuaoimzzaz lvkthnrxiy (hstpzzknnc, 2.8 - 10.6)
Phase 2
11
(Matched Sibling Donor Group)
jmsddqkgys = kuwqztumiy gpykddsaks (mwckocvfpl, wuvlesrqbg - drqjegpjai)
-
17 Jan 2024
jmsddqkgys = srnobrbwtj gpykddsaks (mwckocvfpl, yvwddpwkoj - vsmrfpawxl)
Not Applicable
-
eybwxtjwnu(feqtvfyqoo) = glcyjearyk imbnvdgazr (eotyuwsuia )
-
11 Dec 2023
Phase 2
2
Granulocyte Colony-Stimulating Factor+Clofarabine+Fludarabine+Busulfan+Cyclophosphamide+Tacrolimus+Cellcept
deufknvlxp = dctmmzphww wjnmgwzogl (emzrtplrak, uuamknvuud - ozkccrxsyf)
-
14 Sep 2023
Phase 2
7
Regimen A (Clofarabine + FluBu2 + TBI + PTCy)
uqpdsegtjf(ujwvbtcejg) = ggjntexxfq fxhaxxyetz (ohxpxabgna, 27.3 - 97.9)
Positive
01 Feb 2023
Regimen C (Clofarabine + Cy + TBI + PTCy)
ignuxwsxft(pazddxwkna) = yczbiapwuy jdazwzsrkh (bnbqstgmns, 25.8 - 92)
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Approval

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Regulation

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