Drugs / Pralatrexate
last change May 2026 re-read 9 days ago

Pralatrexate

Other / unclassified targets DHFR via inhibition

Developed for
peripheral T-cell lymphoma, not otherwise specified · T-cell non-Hodgkin lymphoma · anaplastic large cell lymphoma · angioimmunoblastic T-cell lymphoma · cancer of unknown primary site · hepatosplenic T-cell lymphoma · enteropathy-associated T-cell lymphoma · esophageal adenocarcinoma
+36 more · gastroesophageal junction adenocarcinoma · Hodgkins lymphoma · monomorphic epitheliotropic intestinal T-cell lymphoma · mycosis fungoides · Nodal T-follicular helper cell lymphoma, follicular type · plasma cell myeloma · primary cutaneous T-cell lymphoma · subcutaneous panniculitis-like T-cell lymphoma · acute leukemia of ambiguous lineage · acute lymphoblastic leukemia · B-cell non-Hodgkin lymphoma · breast carcinoma · cancer · esophageal squamous cell carcinoma · fallopian tube cancer · follicular lymphoma · gastric adenocarcinoma · gastric squamous cell carcinoma · head and neck cancer · hematopoietic and lymphoid cell neoplasm · lung cancer · lymphoma · non-Hodgkin lymphoma · non-small cell lung carcinoma · ovarian cancer · peritoneum cancer · primary cutaneous aggressive epidermotropic CD8+ T-cell lymphoma · primary cutaneous anaplastic large cell lymphoma · primary cutaneous gamma-delta t-cell lymphoma · Sezary syndrome · transitional cell carcinoma · undifferentiated carcinoma of esophagus · undifferentiated carcinoma of stomach · urinary bladder cancer · Waldenstrom macroglobulinemia · adult T-cell leukemia/lymphoma
Investigated by
National Cancer Institute (NCI) · Acrotech Biopharma Inc. · Spectrum Pharmaceuticals, Inc · National Comprehensive Cancer Network · Memorial Sloan Kettering Cancer Center · City of Hope Medical Center
+21 more · Jennifer Amengual · University of Nebraska · University of Virginia · Axis Clinicals Limited · Brigham and Women's Hospital · Columbia University · Dana-Farber Cancer Institute · Fred Hutchinson Cancer Center · M.D. Anderson Cancer Center · Massachusetts General Hospital · Merck Sharp & Dohme LLC · Mundipharma (China) Pharmaceutical Co. Ltd · Mundipharma K.K. · NYU Langone Health · New York University Cancer Institute · Ohio State University Comprehensive Cancer Center · Otsuka Pharmaceutical Development & Commercialization, Inc. · Roswell Park Cancer Institute · Stanford University · Taiwan Mundipharma Pharmaceuticals Ltd. · University of Washington

Regulatory milestones approvals, filings & regulatory actions · 2 recorded

MilestoneJurisdictionBrandIndicationDateSentence 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

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 110 trials
Phase 1 NCT07691450 Jan 2027 → Nov 2029 expected Nodal T-follicular helper cell lymphoma, follicular type, anaplastic large cell lymphoma, angioimmunoblastic T-cell lymphoma, enteropathy-associated T-cell lymphoma +6 City of Hope Medical Center Not yet recruiting No outcome recorded
Phase 1 NCT07036133 Dec 2022 → Feb 2027 expected cancer, hematopoietic and lymphoid cell neoplasm Acrotech Biopharma Inc. Recruiting No outcome recorded
Phase 1 NCT03240211 Feb 2022 → Jul 2025 overdue primary cutaneous T-cell lymphoma University of Virginia Active not recruiting No outcome recorded
Phase 1 NCT02594267 Nov 2015 → Apr 2017 peripheral T-cell lymphoma, not otherwise specified Acrotech Biopharma Inc. Completed No outcome recorded
Phase 1 NCT01532011 Mar 2012 → Jun 2016 cancer of unknown primary site M.D. Anderson Cancer Center Completed No outcome recorded
Phase 1 NCT01206465 Sep 2010 → Feb 2015 cancer of unknown primary site University of Nebraska Completed No outcome recorded
Phase 1 NCT01114282 Aug 2010 → Feb 2014 plasma cell myeloma Stanford University Completed No outcome recorded
Phase 1 NCT01134341 Mar 2010 → Aug 2015 Sezary syndrome, mycosis fungoides, primary cutaneous anaplastic large cell lymphoma Acrotech Biopharma Inc. Completed No outcome recorded
Phase 1 NCT00554827 Aug 2007 → Jan 2012 primary cutaneous T-cell lymphoma Acrotech Biopharma Inc. Completed No outcome recorded
Phase 1 NCT00024245 May 2001 → Apr 2003 cancer of unknown primary site Memorial Sloan Kettering Cancer Center Completed No outcome recorded
Phase 1/28 trials
Phase 1/2 NCT07225985 Apr 2026 → Sep 2030 expected T-cell non-Hodgkin lymphoma Fred Hutchinson Cancer Center Recruiting No outcome recorded
Phase 1/2 NCT03598998 Feb 2019 → May 2023 overdue Nodal T-follicular helper cell lymphoma, follicular type, anaplastic large cell lymphoma, angioimmunoblastic T-cell lymphoma, enteropathy-associated T-cell lymphoma +6 City of Hope Medical Center Active not recruiting No outcome recorded
Phase 1/2 NCT03161223 May 2018 → Feb 2023 overdue T-cell non-Hodgkin lymphoma University of Virginia Recruiting No outcome recorded
Phase 1/2 NCT02013362 Mar 2014 → Dec 2015 peripheral T-cell lymphoma, not otherwise specified Mundipharma K.K. Completed No outcome recorded
Phase 1/2 NCT01947140 Sep 2013 → Sep 2022 Hodgkins lymphoma, non-Hodgkin lymphoma, plasma cell myeloma Jennifer Amengual Terminated No outcome recorded Stop: Enrollment
Phase 1/2 NCT01188876 Aug 2010 → Jul 2016 fallopian tube cancer, ovarian cancer, peritoneum cancer Massachusetts General Hospital Completed No outcome recorded
Phase 1/2 NCT00481871 May 2007 → May 2011 Hodgkins lymphoma, T-cell non-Hodgkin lymphoma, Waldenstrom macroglobulinemia Acrotech Biopharma Inc. Completed No outcome recorded
Phase 1/2 NCT00052442 Aug 2002 → Mar 2009 lymphoma Spectrum Pharmaceuticals, Inc Completed No outcome recorded
Phase 210 trials · 1 missed
Phase 2 NCT01336933 Jul 2011 → Dec 2016 anaplastic large cell lymphoma, angioimmunoblastic T-cell lymphoma, hepatosplenic T-cell lymphoma, peripheral T-cell lymphoma, not otherwise specified University of Nebraska Completed No outcome recorded
Phase 2 NCT01178944 Sep 2010 → Jan 2015 esophageal adenocarcinoma, gastric adenocarcinoma, gastric squamous cell carcinoma, gastroesophageal junction adenocarcinoma +2 Roswell Park Cancer Institute Completed No outcome recorded
Phase 2 NCT01183065 Aug 2010 → Apr 2014 head and neck cancer Memorial Sloan Kettering Cancer Center Completed No outcome recorded
Phase 2 NCT01129206 Jul 2010 → Sep 2012 esophageal adenocarcinoma, esophageal squamous cell carcinoma, gastroesophageal junction adenocarcinoma Ohio State University Comprehensive Cancer Center Completed No outcome recorded
Phase 2 NCT01118624 Mar 2010 → Apr 2012 breast carcinoma Acrotech Biopharma Inc. Completed No outcome recorded
Phase 2 NCT00998946 Sep 2009 → Aug 2012 B-cell non-Hodgkin lymphoma Spectrum Pharmaceuticals, Inc Completed No outcome recorded
Phase 2 NCT00722553 Jul 2008 → Apr 2011 transitional cell carcinoma, urinary bladder cancer Acrotech Biopharma Inc. Completed No outcome recorded
Phase 2 NCT00606502 Jan 2008 → Jun 2010 non-small cell lung carcinoma Spectrum Pharmaceuticals, Inc Completed Missed primary
Phase 2 NCT00364923 Aug 2006 → Jan 2009 peripheral T-cell lymphoma, not otherwise specified Acrotech Biopharma Inc. Completed No outcome recorded
Phase 2 NCT00004238 Jul 1999 → Jun 2002 lung cancer Memorial Sloan Kettering Cancer Center Completed No outcome recorded
Phase 33 trials · 1 met primary
Phase 3 NCT03355768 Sep → Nov 2018 peripheral T-cell lymphoma, not otherwise specified Jennifer Amengual Withdrawn No outcome recorded Stop: Business
Phase 3 NCT03349333 Sep 2015 → Jul 2017 T-cell non-Hodgkin lymphoma, peripheral T-cell lymphoma, not otherwise specified Mundipharma (China) Pharmaceutical Co. Ltd Completed Met primary
Phase 3 NCT01420679 Aug 2011 → Dec 2017 peripheral T-cell lymphoma, not otherwise specified Spectrum Pharmaceuticals, Inc Terminated No outcome recorded
Phase 41 trial
Phase 4 NCT03150602 Aug 2016 → Dec 2020 lymphoid system deterioration, progressive, peripheral T-cell lymphoma, not otherwise specified Taiwan Mundipharma Pharmaceuticals Ltd. Unknown No outcome recorded
Phase not applicable1 trial
— NCT02551718 Sep 2015 → Jun 2020 acute leukemia of ambiguous lineage, acute lymphoblastic leukemia University of Washington Completed No outcome recorded
Comparator or background therapy8 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 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

Evidence & citations 9 cited values

Every value below carries the sentence it was read from. 42 sources stand behind the page.

FieldValueCited text
Known as Pralatrexate “Ponatinib Pralatrexate Rapamycin” NCT02551718 ↗
38

“Pralatrexate (Folotyn)” NCT02106650 ↗

NCT07225985 ↗

NCT00004238 ↗

NCT00554827 ↗

NCT00722553 ↗

NCT01532011 ↗

NCT00024245 ↗

NCT00481871 ↗

NCT03349333 ↗

NCT01626664 ↗

Show 28 more sources

Known as Folotyn “Pralatrexate (Folotyn)” NCT02106650 ↗
2

NCT01789723 ↗

NCT01820091 ↗

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 ↗