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Pralatrexate injection
Pralatrexate is a folate analog that inhibits dihydrofolate reductase and other folate-dependent enzymes, disrupting DNA synthesis and cell division in rapidly dividing cells.
Pralatrexate is a folate analog that inhibits dihydrofolate reductase and other folate-dependent enzymes, disrupting DNA synthesis and cell division in rapidly dividing cells. Used for Peripheral T-cell lymphoma (PTCL), Relapsed or refractory T-cell lymphomas.
At a glance
| Generic name | Pralatrexate injection |
|---|---|
| Also known as | Folotyn®, FOLOTYN, PDX, Pralatrexate, (RS)-10-propargyl-10-deazaaminopterin |
| Sponsor | Mundipharma K.K. |
| Drug class | Antifolate antimetabolite |
| Target | Dihydrofolate reductase (DHFR), folate receptor, reduced folate carrier |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Pralatrexate is a 10-deazaaminopterin derivative that acts as an antifolate agent. It preferentially enters cells via the folate receptor and reduced folate carrier, then inhibits key enzymes in one-carbon metabolism including dihydrofolate reductase, leading to depletion of nucleotides and cell cycle arrest. This mechanism makes it particularly effective against rapidly dividing malignant cells.
Approved indications
- Peripheral T-cell lymphoma (PTCL)
- Relapsed or refractory T-cell lymphomas
Common side effects
- Mucositis
- Thrombocytopenia
- Anemia
- Neutropenia
- Nausea
- Fatigue
- Infection
Key clinical trials
- 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 (PHASE1)
- To Evaluate Efficacy of Belinostat or Pralatrexate in Combination Against CHOP Alone in PTCL (PHASE3)
- Pralatrexate vs Observation Following CHOP-based Chemotherapy in Undiagnosed Peripheral T-cell Lymphoma Patients (PHASE3)
- Study of Pralatrexate to Treat Participants With Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma (PHASE2)
- A Dose-Finding Study of Folotyn® (Pralatrexate Injection) Plus CHOP With Peripheral T-Cell Lymphoma (PTCL) (PHASE1)
- Study of Pralatrexate vs. Erlotinib for Non-Small Cell Lung Cancer After at Least 1 Prior Platinum-based Treatment (PHASE2)
- Study of Pralatrexate in Female Patients With Previously-treated Breast Cancer (PHASE2)
- Study of Pralatrexate & Gemcitabine With B12 & Folic Acid to Treat Relapsed/Refractory Lymphoproliferative Malignancies (PHASE1, PHASE2)
Primary sources
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| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |