PRALATREXATE

Post-LOE

pralatrexate

Dr. Reddy's Laboratories

ANDAINTRAVENOUSSOLUTION

Approved

Mar 2025

Lifecycle

Post-LOE

Competitive Pressure

30/100

Clinical Trials

Data completeness

4/8 — Partial

PRALATREXATE (pralatrexate) by Dr. Reddy's Laboratories is reductase. Approved for refractory peripheral t-cell lymphoma (ptcl). First approved in 2025.

Drug data last refreshed 19h ago

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

Indications (1)

refractory peripheral T-cell lymphoma (PTCL)

Clinical Trials (10)

NCT06072131Phase 3Recruiting

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

Started Oct 2023

504 enrolled

Peripheral T Cell Lymphoma

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

24 enrolled

Advanced Solid TumorsHematologic Malignancies

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

48 enrolled

Peripheral T-Cell Lymphoma (PTCL)

NCT01134341Phase 1Completed

Pralatrexate and Bexarotene in Patients With Relapsed or Refractory Cutaneous T-cell Lymphoma

Started Mar 2010

34 enrolled

Cutaneous T-cell LymphomaMycosis FungoidesSezary Syndrome+1 more

Worked on PRALATREXATE at Dr. Reddy's Laboratories? Share your interview experience or compensation data (+7 days Pro)

Data Sources

Drug label: DailyMed / FDA
Clinical trials: ClinicalTrials.gov
Patent data: FDA Orange Book
Spending data: CMS Medicare

The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.