NDAINTRAVENOUSSOLUTIONPriority Review
Approved
Sep 2009
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
13
Data completeness
4/8 — Partial
Priority Review
FOLOTYN (pralatrexate) by Acrotech Biopharma. Approved for folate analog metabolic inhibitor [epc]. First approved in 2009.
Drug data last refreshed 19h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
FOLOTYN (pralatrexate) is a folate analog metabolic inhibitor administered intravenously for peripheral T-cell lymphoma (PTCL). It works by inhibiting dihydrofolate reductase and polyglutamylation, depleting thymidine and blocking DNA synthesis in cancer cells. This mechanism targets rapidly dividing malignant T cells in a rare hematologic malignancy.
LOE Approaching
Product is approaching loss of exclusivity with moderate competitive pressure (30/100), signaling potential team reductions or portfolio realignment within the sponsor organization.
Mechanism of Action
Pharmacologic Class:
Folate Analog Metabolic Inhibitor
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (13)
To Evaluate Efficacy of Belinostat or Pralatrexate in Combination Against CHOP Alone in PTCL
Started Oct 2023
504 enrolled
Peripheral T Cell Lymphoma
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
Study of Pembrolizumab Combined With Decitabine and Pralatrexate in PTCL and CTCL
Started Feb 2022
37 enrolled
PTCLCTCL
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)
Phase II Study of Folotyn With Leucovorin to Prevent/Reduce Mucositis in Patients With Hematological Malignancies
Started Jul 2014
36 enrolled
Relapsed Peripheral T-Cell LymphomaRefractory Peripheral T-Cell Lymphoma
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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.