FOLOTYN (pralatrexate)
FOLOTYN is indicated for the treatment of Peripheral T-Cell Lymphoma.
How FOLOTYN Works
Pralatrexate is a folate analog metabolic inhibitor that competitively inhibits dihydrofolate reductase (DHFR) and is also a competitive inhibitor of polyglutamylation by the enzyme folylpolyglutamyl synthetase (FPGS). This dual inhibition depletes the intracellular supply of thymidine and other biological molecules dependent on single-carbon transfer reactions, thereby disrupting DNA synthesis and inducing cell death in malignant cells.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2009-09-24
- Routes
- INTRAVENOUS
- Dosage Forms
- SOLUTION
FOLOTYN Approval History
What FOLOTYN Treats
1 indicationsFOLOTYN is approved for 1 conditions since its original approval in 2009. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Peripheral T-Cell Lymphoma
FOLOTYN Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in FOLOTYN's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications FOLOTYN treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to FOLOTYN
FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
23 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07225985 | RG1125830 NCI-2025-07661, FHIRB0021079 | Ph 1, Ph 2 | recruiting | Pralatrexate With Bendamustine and Total-Body Irradiation Followed by Donor Stem Cell Transplant for the Treatment of Relapsed or Refractory T-Cell Non-Hodgkin Lymphoma |
| NCT06561048 | CPI-818-004 | Ph 3 | recruiting | Soquelitinib vs Standard of Care in Participants With Relapsed/Refractory Peripheral T-cell Lymphoma Not Otherwise Specified, Follicular Helper T-cell Lymphomas, or Systemic Anaplastic Large-cell Lymphoma |
| NCT03240211 | PTCL-002 | Ph 1 | active not recruiting | Study of Pembrolizumab Combined With Decitabine and Pralatrexate in PTCL and CTCL |
| NCT04747236 PTCL | PTCL-001 FD-R-006814-01 | Ph 2 | recruiting | Randomized Phase IIB Trial of Oral Azacytidine Plus Romidepsin Versus Investigator's Choice in PTCL |
| NCT07234162 | DZ2022J0004 | Ph 3 | recruiting | A Phase 3 Multinational Study of Golidocitinib Versus Investigator's Choice in r/r PTCL (JACKPOT19) |
| NCT03598998 results posted | 17501 NCI-2018-01420, 17501 | Ph 1, Ph 2 | active not recruiting | Pembrolizumab and Pralatrexate in Treating Patients With Relapsed or Refractory Peripheral T-Cell Lymphomas |
| NCT01626664 results posted | PROTOCOL 0761-009 | Ph 2 | completed | KW-0761 or Investigator's Choice in Subjects With Previously Treated Adult T-cell Leukemia-Lymphoma (ATL) |
| NCT01206465 results posted | 0238-10-FB NCI-14191 | Ph 1 | completed | Pralatrexate and Fluorouracil in Treating Patients With Recurrent Solid Tumors |
| NCT01336933 results posted | 0569-10-FB NCI-2011-00254, P30CA036727 | Ph 2 | completed | Combination Chemotherapy and Pralatrexate as First-Line Therapy in Treating Patients With Non-Hodgkin Lymphoma |
| NCT01947140 PDX+Romi | AAAJ5656 | Ph 1, Ph 2 | completed | Pralatrexate + Romidepsin in Relapsed/Refractory Lymphoid Malignancies |
| NCT03161223 | AAAR0365 | Ph 1, Ph 2 | recruiting | Durvalumab in Different Combinations With Pralatrexate, Romidepsin and Oral 5-Azacitidine for Lymphoma |
| NCT00998946 results posted | PDX-015 | Ph 2 | completed | Study of Pralatrexate to Treat Participants With Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma |
| NCT00606502 results posted | PDX-012 2007-004673-26 | Ph 2 | completed | Study of Pralatrexate vs. Erlotinib for Non-Small Cell Lung Cancer After at Least 1 Prior Platinum-based Treatment |
| NCT01820091 | SPI-FUS-12-103 | Ph 1 | withdrawn | Phase 1 Study of Fusilev® to Prevent or Reduce Mucositis in Patients With Non-Small Cell Lung Cancer Receiving Folotyn® |
| NCT01789723 | SPI-FUS-12-102 | Ph 1 | withdrawn | Phase 1 Study of Fusilev to Prevent or Reduce Mucositis in Patients With Non-Hodgkin's Lymphoma Receiving Folotyn |
| NCT03349333 results posted | FOT12-CN-301 | Ph 3 | completed | A Single Arm Study Evaluating the Efficacy and Safety of Pralatrexate in Subjects With Relapsed or Refractory PTCL |
| NCT03355768 | AAAR5550 | Ph 3 | withdrawn | Romidepsin Versus Combination of Romidepsin Plus Pralatrexate in PTCL |
| NCT01482962 results posted | C14012 2011-003545-18, DRKS00004503 | Ph 3 | completed | Alisertib (MLN8237) or Investigator's Choice in Patients With Relapsed/Refractory Peripheral T-Cell Lymphoma |
| NCT01188876 results posted | 10-113 | Ph 1, Ph 2 | completed | Carboplatin/Pralatrexate in Recurrent Platinum-Sensitive Ovarian, Fallopian or Primary Peritoneal Cancer |
| NCT01178944 results posted | I 169210 NCI-2010-01583, I 169210 | Ph 2 | completed | Pralatrexate and Oxaliplatin in Treating Patients With Unresectable or Metastatic Esophageal, Stomach, or Gastroesophageal Junction Cancer |
| NCT01114282 | HEMMYL0014 SU-04282010-5783 | Ph 1 | completed | Phase I Bortezomib (VELCADE) in Combo With Pralatrexate in Relapsed/Refractory MM |
| NCT01532011 | 2011-0916 NCI-2012-00219 | Ph 1 | completed | Erlotinib in Combination With Pralatrexate in Advanced Malignancies |
| NCT01129206 results posted | OSU-10018 NCI-2010-01225 | Ph 2 | completed | Pralatrexate and Docetaxel in Treating Patients With Stage IV Esophageal or Gastroesophageal Cancer Who Have Failed Platinum-Based Therapy |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
FOLOTYN FDA Label Details
Indications & Usage
FDA Label (PDF)FOLOTYN is indicated for the treatment of Peripheral T-Cell Lymphoma.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment