Drugs / Pralatrexate
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Refused (EMA) | EU (EMA) | Folotyn | — | 2012-06-21 | europa.eu ↗ |
| Approved | US (FDA) | FOLOTYN | — | 2009-09-24 | fda.gov ↗ |
Trials 33 · a red edge is where a trial was stopped
Also used as a comparator or background therapy in 8 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT01820091 Background | Apr 2013 → Apr 2015 | non-small cell lung carcinoma | Acrotech Biopharma Inc. | Withdrawn | No outcome recorded |
| Phase 1 | NCT01789723 Background | Mar 2013 → Mar 2015 | non-Hodgkin lymphoma | Acrotech Biopharma Inc. | Withdrawn | No outcome recorded |
| Phase 23 trials | ||||||
| Phase 2 | NCT04747236 Comparator | Feb 2021 → Jun 2028 expected | — | University of Virginia | Recruiting | No outcome recorded |
| Phase 2 | NCT02106650 Background | Jul 2014 → Oct 2018 | peripheral T-cell lymphoma, not otherwise specified | Acrotech Biopharma Inc. | Completed | No outcome recorded |
| Phase 2 | NCT01626664 Comparator | Jun 2012 → Aug 2015 | adult T-cell leukemia/lymphoma | Kyowa Kirin, Inc. | Completed | No outcome recorded |
| Phase 33 trials | ||||||
| Phase 3 | NCT06561048 Comparator | Oct 2024 → Nov 2027 expected | Nodal T-follicular helper cell lymphoma, follicular type, anaplastic large cell lymphoma, angioimmunoblastic T-cell lymphoma, peripheral T-cell lymphoma, not otherwise specified | Corvus Pharmaceuticals, Inc. | Recruiting | No outcome recorded |
| Phase 3 | NCT06072131 Comparator | Oct 2023 → Jul 2030 expected | peripheral T-cell lymphoma, not otherwise specified | Acrotech Biopharma Inc. | Recruiting | No outcome recorded |
| Phase 3 | NCT01482962 Comparator | Jun 2012 → Jun 2015 | peripheral T-cell lymphoma, not otherwise specified | Millennium Pharmaceuticals, Inc. | Completed | No outcome recorded |
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 42 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | pralatrexate | “Ponatinib Pralatrexate Rapamycin” NCT02551718 ↗38“Pralatrexate (Folotyn)” NCT02106650 ↗ |
| Known as | Folotyn | “Pralatrexate (Folotyn)” NCT02106650 ↗ |
| Known as | Folotyn - (Pralatrexate) | “Folotyn - (Pralatrexate)” NCT01789723 ↗ |
| Known as | NSC-754230 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201746 ↗ |
| Known as | Pralatrexato | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201746 ↗ |
| Action | Inhibit | “Pralatrexate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.” NCT01129206 ↗ |
| Modality | Other / unclassified | “It is a type of dihydrofolate reductase (DHFR) inhibitor.” NCT07225985 ↗ |
| Route | Intravenous | “Pralatrexate (PDX) 135 mg/m\^2 administered as an intravenous (IV) infusion over one hour” NCT00052442 ↗ |
| Target | DHFR | “dihydrofolate reductase (DHFR) inhibitor” NCT07225985 ↗ |