pralatrexate (folotyn) Report issue

Small molecule Orphan Drug FDA Approved FDA Accelerated Approval FDA Priority Review FDA
AACT ChEMBL DrugBank Drug Central Drugs@FDA KEGG MeSH PubChem repoDB

Active Ingredient History

NOW
  • Now
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

Chemistry

  • 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
  • InChIKey: OGSBUKJUDHAQEA-WMCAAGNKSA-N
  • Mol. Mass: 477.4726
  • ALogP: 0.98
  • ChEMBL Molecule:
    pralatrexate  
More Chemistry

Pharmacology

  • Mechanism of Action:
  • Multi-specific: Missing data
  • Black Box: No
  • Availability: Prescription Only
  • Delivery Methods: Parenteral
  • Pro Drug: No

Drug Pricing (per unit)

Australia

$845.0770
More Pricing Detail

Note: This drug pricing data is preliminary, incomplete, and may contain errors.

Alternative names

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-((1rs)-1-((2,4-diaminopteridin-6-yl)methyl)but-3-ynyl)benzoyl)amino)pentanedioic acid | folotyn | n-(4-(1-((2,4-diamino-6-pteridinyl)methyl)-3-butynyl)benzoyl)-l-glutamic acid | pdx | pralatrexate | pralatrexato | pralatrexatum

Organizations (28)

Research & Development (25)

Organization Org Type FDA approvals Clinical Trials involvement Org ID Force Sort

Marketing (4)

Organization Org Type FDA approvals Clinical Trials involvement Org ID Force Sort

Indications (31)

Approved Indications (1)


 

Lymphoma, T-Cell, Peripheral

Experimental Indications - Clinical Trial Phases 1-4 (31)


 

Breast Neoplasms (Phase 2)

Carcinoma, Non-Small-Cell Lung (Phase 2)

Carcinoma, Transitional Cell (Phase 2)

Disease Progression (Phase 4)

Esophageal Neoplasms (Phase 2)

Esophageal Squamous Cell Carcinoma (Phase 2)

Fallopian Tube Neoplasms (Phase 1/Phase 2)

Hamartoma (Phase 1/Phase 2)

Head and Neck Neoplasms (Phase 2)

Hodgkin Disease (Phase 1/Phase 2)

Intestinal Neoplasms (Phase 1/Phase 2)

Leukemia (Early Phase 1)

Leukemia-Lymphoma, Adult T-Cell (Phase 2)

Lung Neoplasms (Phase 2)

Lymphoma (Phase 2)

Lymphoma, B-Cell (Phase 2)

Lymphoma, Follicular (Phase 1/Phase 2)

Lymphoma, Large-Cell, Anaplastic (Phase 2)

Lymphoma, Non-Hodgkin (Phase 1/Phase 2)

Lymphoma, Primary Cutaneous Anaplastic Large Cell (Phase 1)

Lymphoma, T-Cell (Phase 3)

Lymphoma, T-Cell, Cutaneous (Phase 1)

Lymphoma, T-Cell, Peripheral ()

Multiple Myeloma (Phase 1/Phase 2)

Mycosis Fungoides (Phase 1/Phase 2)

Neoplasms ()

Ovarian Neoplasms (Phase 1/Phase 2)

Sezary Syndrome (Phase 1)

Stomach Neoplasms (Phase 2)

Urinary Bladder Neoplasms (Phase 2)

Waldenstrom Macroglobulinemia (Phase 1/Phase 2)

Overview

  • Highest Phase: Phase 4
  • # of Trials: 37
  • # of Trial Organizations: 25

Trials by Phase

Trial Phase Start Date Organizations Indications

Feedback

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