FOLOTYN

LOE Approaching

pralatrexate

NDAINTRAVENOUSSOLUTIONPriority Review
Approved
Sep 2009
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
13

Mechanism of Action

reductase. It is also a competitive inhibitor for polyglutamylation by the enzyme folylpolyglutamyl synthetase. This inhibition results in the depletion of thymidine and other biological molecules the synthesis of which depends on single carbon transfer.

Pharmacologic Class:

Folate Analog Metabolic Inhibitor

Clinical Trials (5)

NCT06072131Phase 3Recruiting

To Evaluate Efficacy of Belinostat or Pralatrexate in Combination Against CHOP Alone in PTCL

Started Oct 2023
NCT07036133Phase 1Recruiting

Study to Evaluate the Pharmacokinetics and Safety of Pralatrexate in Patients With Advanced Solid Tumor or Hematological Malignancy and Either Normal Hepatic Function or Mild, Moderate, or Severe Hepatic Impairment

Started Dec 2022
NCT03240211Phase 1Active Not Recruiting

Study of Pembrolizumab Combined With Decitabine and Pralatrexate in PTCL and CTCL

Started Feb 2022
37 enrolled
PTCLCTCL
NCT02594267Phase 1Completed

A Dose-Finding Study of Folotyn® (Pralatrexate Injection) Plus CHOP With Peripheral T-Cell Lymphoma (PTCL)

Started Nov 2015
NCT02106650Phase 2Completed

Phase II Study of Folotyn With Leucovorin to Prevent/Reduce Mucositis in Patients With Hematological Malignancies

Started Jul 2014