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pralatrexate

Trade name: folotyn

Small moleculeapprovedOrphan Drug FDA

Approved

Sep 24, 2009

Pralatrexate (PDX or 10-propargyl-10-deazaaminopterin) is a folate analogue that is internalised by the reduced folate carrier 1 (RFC-1) protein, and polyglutamylated by the enzyme folylpolyglutamyl synthetase (FPGS), resulting in accumulation of the antifolate. Pralatrexate, a methotrexate analogue, is intended as an inhibitor of dihydrofolate reductase (DHFR), an enzyme which catalyses the reduction of dihydrofolic acid to tetrahydrofolic acid. Inhibition of DHFR leads to a depletion of intracellular reduced folate stores, thereby leading to a disruption of DNA synthesis. Preclinical studies in vitro and in models of B-cell lymphomas, T-cell lymphomas and NSCLC indicated that pralatrexate exhibited antitumor activity that was superior to the activity of other antifolates. FOLOTYN (pralatrexate injection) is indicated for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma. — NCATS

Clinical trial activity

42 trials · 32 clinical orgs · 5 marketing orgs

Phase 1
19
Phase 2
28
Phase 3
7
Phase 4
1

Earliest trial started Jul 1, 1999 (NCT00004238)

Timeline

1990s

  1. Jan 1, 1999

    Earliest Phase 2 Sponsor(trial)

2000s

  1. Jan 1, 2001

    Earliest Phase 1 Sponsor(trial)

  2. Jul 20, 2006

    Orphan Drug Designation

  3. Sep 24, 2009

    Allos Therapeutics — Earliest FDA Approval

  4. Sep 24, 2009

    Allos Therapeutics — NDA Organization

  5. Sep 24, 2009

    Aurobindo Pharma — Marketing Organization

  6. Sep 24, 2009

    Acrotech Biopharma LLC — Marketing Organization

  7. Sep 24, 2009

    Acrotech Biopharma LLC — NDA Secondary Org

2010s

  1. Jan 1, 2011

    Earliest Phase 3 Sponsor(trial)

  2. Jan 21, 2016

    Teva — Marketing Organization

2020s

  1. Mar 10, 2025

    Dr. Reddy's Laboratories — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedPriority reviewAcceleratedSep 24, 2009

Chemistry & pharmacology

Loading structure…

SMILES

NC1=NC(N)=C2N=C(CC(CC#C)C3=CC=C(C=C3)C(=O)N[C@@H](CCC(O)=O)C(O)=O)C=NC2=N1
Mol. weight
477.4726 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Racemic Mixture
Inorganic
No
Polymer
No
Delivery
Parenteral
Availability
Prescription Only

Oral

No

Parenteral

Yes

Topical

No

Sources

Also known as

  • 10-propargyl-10-deazaaminopterin
  • 10-propargyl-10-deazaaminopterin
  • 10-propargyl-10-deazaaminopterin
  • (2s)-2-({4-[1-(2,4-diaminopteridin-6-yl)pent-4-yn-2-yl]benzoyl}amino)pentanedioic acid
  • (2s)-2-({4-[1-(2,4-diaminopteridin-6-yl)pent-4-yn-2-yl]benzoyl}amino)pentanedioic acid
  • (2s)-2-((4-((1rs)-1-((2,4-diaminopteridin-6-yl)methyl)but-3-ynyl)benzoyl)amino)pentanedioic acid
  • (2s)-2-((4-((1rs)-1-((2,4-diaminopteridin-6-yl)methyl)but-3-ynyl)benzoyl)amino)pentanedioic acid
  • folotyn
  • folotyn
  • folotyn
  • folotyn
  • folotyn
  • n-(4-(1-((2,4-diamino-6-pteridinyl)methyl)-3-butynyl)benzoyl)-l-glutamic acid
  • n-(4-(1-((2,4-diamino-6-pteridinyl)methyl)-3-butynyl)benzoyl)-l-glutamic acid
  • pdx
  • pdx
  • pdx
  • pralatrexate
  • pralatrexate
  • pralatrexate
  • pralatrexate
  • pralatrexate
  • pralatrexate
  • pralatrexate
  • pralatrexate
  • pralatrexate
  • pralatrexate
  • pralatrexate
  • pralatrexate
  • pralatrexate
  • pralatrexato
  • pralatrexato
  • pralatrexatum
  • pralatrexatum

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07225985Phase 1/Phase 2 (Phase 2)May 1, 2026University of Washington
NCT06671717N/ADec 31, 2024Huazhong University of Science and Technology, Jiao Tong University, Peking University, Sichuan University
NCT06561048Phase 3Oct 2, 2024Corvus Pharmaceuticals, Inc.
NCT07234162Phase 3May 13, 2024Dizal (Jiangsu) Pharmaceutical Co., Ltd., Jiao Tong University
NCT06072131Phase 3Oct 4, 2023Acrotech Biopharma LLC
NCT07036133Phase 1Dec 28, 2022Acrotech Biopharma LLC
NCT04747236Phase 2Feb 19, 2021Celgene, University of Virginia
NCT03719105Early Phase 1 (Phase 1)Mar 1, 2019New York Medical College, University of Alabama, Birmingham
NCT03598998Phase 1/Phase 2 (Phase 2)Oct 27, 2018City of Hope National Medical Center, National Cancer Institute (NCI)
NCT03355768Phase 3Sep 30, 2018Columbia University
NCT03240211Phase 1Jun 1, 2018Columbia University, Merck, Sungkyunkwan University, University of Bologna
NCT03161223Phase 1/Phase 2 (Phase 2)Jun 15, 2017Columbia University
NCT03150602Phase 4Aug 30, 2016Mundipharma, National Taiwan University
NCT02594267Phase 1Oct 1, 2015Spectrum Pharmaceuticals
NCT03349333Phase 3Sep 10, 2015Mundipharma
NCT02106650Phase 2Jul 1, 2014Spectrum Pharmaceuticals
NCT02013362Phase 1/Phase 2 (Phase 2)Dec 1, 2013Mundipharma
NCT01947140Phase 1/Phase 2 (Phase 2)Sep 9, 2013Columbia University
NCT01820091Phase 1Apr 1, 2013Spectrum Pharmaceuticals
NCT01789723Phase 1Mar 1, 2013Columbia University, Spectrum Pharmaceuticals
Showing 20 of 42 trials
Page 1 / 3

Organizations

Research & Development (32)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Spectrum PharmaceuticalsFor profit151332006
National Cancer Institute (NCI)Government7021999
Columbia UniversityAcademic/Hospital6432006
National Comprehensive Cancer NetworkAcademic/Hospital5022010
Cornell UniversityAcademic/Hospital4421999
MundipharmaFor profit3332013
Acrotech Biopharma LLCFor profit2222022
Jiao Tong UniversityAcademic/Hospital2022024
University of NebraskaAcademic/Hospital2222010
CelgeneFor profit1012021
City of Hope National Medical CenterAcademic/Hospital1112018
Corvus Pharmaceuticals, Inc.For profit1112024
Dizal (Jiangsu) Pharmaceutical Co., Ltd.For profit1112024
Harvard UniversityAcademic/Hospital1112010
Huazhong University of Science and TechnologyAcademic/Hospital1012024
Kyowa Hakko KirinFor profit1112012
MerckFor profit1012018
Millennium PharmaceuticalsFor profit1112012
National Taiwan UniversityAcademic/Hospital1012016
New York Medical CollegeAcademic/Hospital1112019
32 organizations
Page 1 / 2

Marketing (6)

OrganizationOrg typeRelationshipDate
Acrotech Biopharma LLCFor profitMKTGSep 24, 2009
Acrotech Biopharma LLCFor profitNDA2Sep 24, 2009
Allos TherapeuticsFor profitNDASep 24, 2009
Aurobindo PharmaFor profitMKTGSep 24, 2009
Dr. Reddy's LaboratoriesFor profitMKTGMar 10, 2025
TevaFor profitMKTGJan 21, 2016