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Pralatrexate injection
Pralatrexate injection is a Antifolate antimetabolite Small molecule drug developed by Mundipharma K.K.. It is currently in Phase 3 development for Peripheral T-cell lymphoma (PTCL), Relapsed or refractory T-cell lymphomas. Also known as: Folotyn®, FOLOTYN, PDX, Pralatrexate.
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.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Oncology Phase 3 boost
+3.0pp
Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
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
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Pralatrexate injection CI brief — competitive landscape report
- Pralatrexate injection updates RSS · CI watch RSS
- Mundipharma K.K. portfolio CI
Frequently asked questions about Pralatrexate injection
What is Pralatrexate injection?
How does Pralatrexate injection work?
What is Pralatrexate injection used for?
Who makes Pralatrexate injection?
Is Pralatrexate injection also known as anything else?
What drug class is Pralatrexate injection in?
What development phase is Pralatrexate injection in?
What are the side effects of Pralatrexate injection?
What does Pralatrexate injection target?
Related
- Drug class: All Antifolate antimetabolite drugs
- Target: All drugs targeting Dihydrofolate reductase (DHFR), folate receptor, reduced folate carrier
- Manufacturer: Mundipharma K.K. — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Peripheral T-cell lymphoma (PTCL)
- Indication: Drugs for Relapsed or refractory T-cell lymphomas
- Also known as: Folotyn®, FOLOTYN, PDX, Pralatrexate, (RS)-10-propargyl-10-deazaaminopterin
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing