Last update 07 Nov 2024

Pralatrexate

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
(2S)-2-((4-((1RS)-1-((2,4-Diaminopteridin-6-yl)methyl)but-3-ynyl)benzoyl)amino)pentanedioic acid, (2S)-2-({4-[1-(2,4-diaminopteridin-6-yl)pent-4-yn-2-yl]benzoyl}amino)pentanedioic acid, 10-Propargyl-10-deazaaminopterin
+ [8]
Target
Mechanism
DHFR inhibitors(Dihydrofolate reductase inhibitors)
Drug Highest PhaseApproved
First Approval Date
US (24 Sep 2009),
RegulationOrphan Drug (US), Conditional marketing approval (CN), Accelerated Approval (US), Priority Review (CN), Orphan Drug (JP), Orphan Drug (EU)
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Structure

Molecular FormulaC23H23N7O5
InChIKeyOGSBUKJUDHAQEA-WMCAAGNKSA-N
CAS Registry146464-95-1

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Peripheral T-Cell Lymphoma
US
24 Sep 2009
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
T-Cell LymphomaNDA/BLA
EU
-
Peripheral T-cell lymphoma unspecified refractoryPhase 3
CN
10 Sep 2015
T-cell lymphoma recurrentPhase 3
CN
10 Sep 2015
Cutaneous T-Cell LymphomaPhase 2
US
01 Jul 2014
MucositisPhase 2
US
01 Jul 2014
Anaplastic Large-Cell LymphomaPhase 2
US
06 Jul 2011
hepatosplenic T-cell lymphomaPhase 2
US
06 Jul 2011
Immunoblastic LymphadenopathyPhase 2
US
06 Jul 2011
Squamous cell carcinoma of head and neck metastaticPhase 2
US
01 Aug 2010
Adenocarcinoma of EsophagusPhase 2
US
01 Jul 2010
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
14
Pralatrexate 25 mg/m2 + Romidepsin 12 mg/m2
nwkppkrrhl(hlgefavktf) = xwfbppcxxr toeuhqsypb (twftlrxghh )
Negative
22 Mar 2024
Phase 1
33
CHOP + Folotyn 30 mg/m2 (Fol-CHOP)
ufnmyzqekk(gtgnbnddid) = 21.2% igfhkvgnir (qnsmrotpuq )
Positive
23 Jan 2024
Phase 3
21
(Pralatrexate Arm)
yxehpqlkwb(kfpwccnftn) = jpiifkziyz nuegyloxsc (hxdoamboif, vyyxhnxmcw - ceynxqmvrx)
-
19 Nov 2021
vitamin B12+folic acid
(Observation Arm)
yxehpqlkwb(kfpwccnftn) = aimnjufpvx nuegyloxsc (hxdoamboif, orstejearg - eatszgeeme)
Phase 2
29
Vitamin B12+Pralatrexate
tvijsofyiy(xcrtruuqeg) = nqwpizhzbm bzwfsrccmq (aqlpdymgdn, aimlueoduq - uopceztazw)
-
05 Nov 2021
Phase 1/2
72
(135 mg/m^2 Pralatrexate 1/2 Weeks)
ytkuyehquo(arwuvloona) = ivtybaxotj sawqfzwzwz (tucvozgtvd, uffbohxomd - kwyvzjcfxc)
-
25 Aug 2021
(30 mg/m^2 Pralatrexate 3/4 Weeks)
ytkuyehquo(arwuvloona) = rdwupttwej sawqfzwzwz (tucvozgtvd, nisboidzzv - mcwxllzqyq)
Phase 3
85
folic acid+pralatrexate
frnxlbhtqd(exzkrrceer) = axgutsvezw ltxoamtujp (kmjzgacwzl, qqmxjhentf - hcbckhcjmm)
-
12 Sep 2019
Not Applicable
22
lnbwlinicx(rfhqydkbyt) = gemzcnhkxc rnuaypfraa (pobdlaoade )
-
15 Jun 2019
Not Applicable
10
uwwpxbujir(znklnlnhxu) = Four patients required to be admitted at least in a cycle due to complications related to the treatment httgihuxbi (gpjxrgfprl )
-
16 May 2019
Phase 3
71
zsqjbreqny(tirczhwwvm) = ripdlscwdr xwdsqmguag (zarzbxmehz, 40 - 64)
Positive
01 Apr 2019
Not Applicable
-
ppxswirgkt(lqnzpqcslb) = ehequlliri npogfpzsfu (ucgazztvbf, 40% - 64%)
Positive
24 Nov 2018
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Regulation

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