Folotyn

(pralatrexate)

ApprovedSmall molecule

Folotyn is a small molecule that works as a Dihydrofolate Reductase Inhibitor.[2] It is being used across 10 indications, with its most advanced program in Approved.[1]

Folotyn is one of 217 small molecule programs targeting Lymphoid Malignancies. It is currently in Approved.

Indications

Total Trials

Active Trials

216

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

Lymphoid MalignanciesCompleted

Unspecified Peripheral T-Cell LymphomaActive, not recruiting

Mature T-Cell and NK-Cell Non-Hodgkin LymphomaActive, not recruiting

Lung CancerApproved

Multiple MyelomaApproved

Head and Neck Malignant NeoplasiaApproved

Recurrent Anaplastic Large Cell LymphomaNot yet recruiting

PembrolizumabActive, not recruiting

LymphomaUnknown status

T-Cell Non-Hodgkin LymphomaNot yet recruiting

Lymphoid MalignanciesPreclinical

Completed

Unspecified Peripheral T-Cell LymphomaApproved

Active, not recruiting

Mature T-Cell and NK-Cell Non-Hodgkin LymphomaApproved

Active, not recruiting

Lung CancerApproved

Approved

Multiple MyelomaApproved

Approved

Head and Neck Malignant NeoplasiaApproved

Approved

Recurrent Anaplastic Large Cell LymphomaPhase 1

Not yet recruiting

PembrolizumabPhase 1

Active, not recruiting

LymphomaApproved

Unknown status

T-Cell Non-Hodgkin LymphomaPhase 2

Not yet recruiting

Competition

Competitive Landscape

401 competitors in Lymphoma

#DrugCompanyPhaseTrials

Folotyn

AAcrotech Biopharma Inc.

Approved

13 2

Zofran

Novartis

Preclinical

2 3

Cabenuva

GSK

Preclinical

1 4

Norvir

AbbVie

Preclinical

1 5

Emend

CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Preclinical

1 6

Kenalog

BBausch Health Americas, Inc.

Preclinical

1 7

Nuvigil

NNuvo Research GmbH

Preclinical

1 8

Elitek

AAzienda U.S.L. 1 di Massa e Carrara

Preclinical

—9

Decadron

QQuince Therapeutics S.p.A.

Preclinical

—10

Solu-Medrol

MMassachusetts Eye and Ear Infirmary

Preclinical

—

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q3 2027

Phase 1Recruiting

Hematological Malignancy

NCT07036133

Q3 2028

Phase 3Recruiting

Lymphoma

NCT06561048

Q4 2028

Phase 3Recruiting

PTCL

NCT07234162

Q4 2029

Phase 1Not yet recruiting

Recurrent Anaplastic Large Cell Lymphoma

NCT07691450

Clinical

Trials by Indication[1]

Lymphoma13 trials

Alisertib (MLN8237) or Investigator's Choice in Patients With Relapsed/Refractory Peripheral T-Cell Lymphoma

Completed· Takeda logo

Takeda·Phase 3·NCT01482962·271 enrolled

10-Propargyl-10-Deazaaminopterin in Treating Patients With Recurrent or Refractory Non-Hodgkin's Lymphoma or Hodgkin's Lymphoma

Completed· Spectrum Pharmaceuticals, Inc logo

Spectrum Pharmaceuticals, Inc·Phase 1/2·NCT00052442·72 enrolled

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

Recruiting·CCorvus Pharmaceuticals, Inc.·Phase 3·NCT06561048·150 enrolled

Show 10 more trials

Pralatrexate vs Observation Following CHOP-based Chemotherapy in Undiagnosed Peripheral T-cell Lymphoma Patients

Terminated· Spectrum Pharmaceuticals, Inc logo

Spectrum Pharmaceuticals, Inc·Phase 3·NCT01420679·21 enrolled

Phase I/II Clinical Study of Pralatrexate in Japanese Patients With Relapsed or Refractory Peripheral T-cell Lymphoma

Completed·MMundipharma K.K.·Phase 1/2·NCT02013362·25 enrolled

Durvalumab in Different Combinations With Pralatrexate, Romidepsin and Oral 5-Azacitidine for Lymphoma

Recruiting·UUniversity of Virginia·Phase 1/2·NCT03161223·148 enrolled

A Dose-Finding Study of Folotyn® (Pralatrexate Injection) Plus CHOP With Peripheral T-Cell Lymphoma (PTCL)

Completed·AAcrotech Biopharma Inc.·Phase 1·NCT02594267·48 enrolled

Study of Pralatrexate With Vitamin B12 and Folic Acid in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma

Completed·AAcrotech Biopharma Inc.·Phase 2·NCT00364923·115 enrolled

Study of Pralatrexate to Treat Participants With Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma

Completed· Spectrum Pharmaceuticals, Inc logo

Spectrum Pharmaceuticals, Inc·Phase 2·NCT00998946·29 enrolled

Combination Chemotherapy and Pralatrexate as First-Line Therapy in Treating Patients With Non-Hodgkin Lymphoma

Completed·UUniversity of Nebraska·Phase 2·NCT01336933·34 enrolled

Pembrolizumab and Pralatrexate in Treating Patients With Relapsed or Refractory Peripheral T-Cell Lymphomas

Active, not recruiting·—·Phase 1/2·NCT03598998·13 enrolled

A Pralatrexate Study in Asian Patients With Peripheral T-cell Lymphoma After Prior Therapy

Unknown status·TTaiwan Mundipharma Pharmaceuticals Ltd.·Phase 4·NCT03150602·22 enrolled

Pralatrexate for Relapsed or Refractory Peripheral T-cell Lymphoma

Completed·SSamsung Medical Center··NCT03356678·33 enrolled

PTCL2 trials

A Phase 3 Multinational Study of Golidocitinib Versus Investigator's Choice in r/r PTCL (JACKPOT19)

Recruiting·DDizal Pharmaceuticals·Phase 3·NCT07234162·218 enrolled

Romidepsin Versus Combination of Romidepsin Plus Pralatrexate in PTCL

Withdrawn·JJennifer Amengual·Phase 3·NCT03355768

Non-Small Cell Lung Cancer2 trials

Study of Pralatrexate vs. Erlotinib for Non-Small Cell Lung Cancer After at Least 1 Prior Platinum-based Treatment

Completed· Spectrum Pharmaceuticals, Inc logo

Spectrum Pharmaceuticals, Inc·Phase 2·NCT00606502·201 enrolled

10-Propargyl-10-Deazaaminopterin in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer

Completed·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT00004238

Cutaneous T-cell lymphoma2 trials

Study of Pralatrexate in Patients With Relapsed or Refractory Cutaneous T-cell Lymphoma

Completed·AAcrotech Biopharma Inc.·Phase 1·NCT00554827·55 enrolled

Pralatrexate and Bexarotene in Patients With Relapsed or Refractory Cutaneous T-cell Lymphoma

Completed·AAcrotech Biopharma Inc.·Phase 1·NCT01134341·34 enrolled

Relapsed/Refractory2 trials

Study of Pralatrexate & Gemcitabine With B12 & Folic Acid to Treat Relapsed/Refractory Lymphoproliferative Malignancies

Completed·AAcrotech Biopharma Inc.·Phase 1/2·NCT00481871·119 enrolled

Phase I Bortezomib (VELCADE) in Combo With Pralatrexate in Relapsed/Refractory MM

Completed·SStanford University·Phase 1·NCT01114282·11 enrolled

17 more indications

Patients With Advanced Solid Tumors1 trial

10-Propargyl-10-Deazaaminopterin Plus Probenecid in Treating Patients With Advanced Solid Tumors

Completed·MMemorial Sloan Kettering Cancer Center·Phase 1·NCT00024245

Leukemia1 trial

KW-0761 or Investigator's Choice in Subjects With Previously Treated Adult T-cell Leukemia-Lymphoma (ATL)

Completed·KKyowa Kirin, Inc.·Phase 2·NCT01626664·71 enrolled

Advanced Malignancies1 trial

Erlotinib in Combination With Pralatrexate in Advanced Malignancies

Completed·MM.D. Anderson Cancer Center·Phase 1·NCT01532011·72 enrolled

Breast Cancer1 trial

Study of Pralatrexate in Female Patients With Previously-treated Breast Cancer

Completed·AAcrotech Biopharma Inc.·Phase 2·NCT01118624·22 enrolled

Transitional Cell Carcinoma1 trial

Study of Pralatrexate to Treat Advanced or Metastatic Relapsed Transitional Cell Carcinoma of the Urinary Bladder

Completed·AAcrotech Biopharma Inc.·Phase 2·NCT00722553·30 enrolled

Hematological Malignancy1 trial

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

Recruiting·AAcrotech Biopharma Inc.·Phase 1·NCT07036133·24 enrolled

Gastroesophageal Junction Cancer1 trial

Pralatrexate and Oxaliplatin in Treating Patients With Unresectable or Metastatic Esophageal, Stomach, or Gastroesophageal Junction Cancer

Completed·RRoswell Park Cancer Institute·Phase 2·NCT01178944·35 enrolled

T-cell non-Hodgkin lymphoma1 trial

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

Not yet recruiting·FFred Hutchinson Cancer Center·Phase 1/2·NCT07225985·50 enrolled

Azacytidine1 trial

Randomized Phase IIB Trial of Oral Azacytidine Plus Romidepsin Versus Investigator's Choice in PTCL

Recruiting·UUniversity of Virginia·Phase 2·NCT04747236·50 enrolled

Primary Peritoneal Cancer1 trial

Carboplatin/Pralatrexate in Recurrent Platinum-Sensitive Ovarian, Fallopian or Primary Peritoneal Cancer

Completed·MMassachusetts General Hospital·Phase 1/2·NCT01188876·50 enrolled

Pembrolizumab1 trial

Study of Pembrolizumab Combined With Decitabine and Pralatrexate in PTCL and CTCL

Active, not recruiting·UUniversity of Virginia·Phase 1·NCT03240211·37 enrolled

Relapsed or Refractory1 trial

A Single Arm Study Evaluating the Efficacy and Safety of Pralatrexate in Subjects With Relapsed or Refractory PTCL

Completed·MMundipharma (China) Pharmaceutical Co. Ltd·Phase 3·NCT03349333·85 enrolled

Solid Tumors1 trial

Pralatrexate and Fluorouracil in Treating Patients With Recurrent Solid Tumors

Completed·UUniversity of Nebraska·Phase 1·NCT01206465·29 enrolled

Esophageal Cancer1 trial

Pralatrexate and Docetaxel in Treating Patients With Stage IV Esophageal or Gastroesophageal Cancer Who Have Failed Platinum-Based Therapy

Completed·OOhio State University Comprehensive Cancer Center·Phase 2·NCT01129206·6 enrolled

Lymphoid Malignancies1 trial

Phase I/IIA Study of the Novel Antifolate Agent Pralatrexate in Combination With the Histone Deacetylase Inhibitor Romidepsin for the Treatment of Patients With Peripheral T-cell Lymphoma

Terminated·JJennifer Amengual·Preclinical·NCT01947140·57 enrolled

Peripheral T-Cell Lymphoma1 trial

A Phase 3, Randomized, Open-Label Study Comparing the Efficacy and Safety of the Combination of Beleodaq-CHOP or Folotyn-COP to the CHOP Regimen Alone in Newly Diagnosed Patients With Peripheral T-Cell Lymphoma

Recruiting·AAcrotech Biopharma Inc.·Phase 3·NCT06072131·504 enrolled

Recurrent Anaplastic Large Cell Lymphoma1 trial

Phase 1 Investigation of Belinostat-Based Combinations in Relapsed/Refractory T-Cell Lymphoma

Not yet recruiting·CCity of Hope Medical Center·Phase 1·NCT07691450·40 enrolled

Regulatory

FDA Approval Timeline[4]

Sep 24, 2009

FOLOTYN

NDA NDA022468

Sources

References

[1]
ClinicalTrials.gov — 38 trial records for pralatrexate. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — pralatrexate compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for pralatrexate. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA022468). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Acrotech Biopharma Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Dihydrofolate Reductase Inhibitor[2]
Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: AAcrotech Biopharma Inc.

Folotyn

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q3 2027

Q3 2028

Q4 2028

Q4 2029

Trials by Indication[1]

Lymphoma13 trials

PTCL2 trials

Non-Small Cell Lung Cancer2 trials

Cutaneous T-cell lymphoma2 trials

Relapsed/Refractory2 trials

Patients With Advanced Solid Tumors1 trial

Leukemia1 trial

Advanced Malignancies1 trial

Breast Cancer1 trial

Transitional Cell Carcinoma1 trial

Hematological Malignancy1 trial

Gastroesophageal Junction Cancer1 trial

T-cell non-Hodgkin lymphoma1 trial

Azacytidine1 trial

Primary Peritoneal Cancer1 trial

Pembrolizumab1 trial

Relapsed or Refractory1 trial

Solid Tumors1 trial

Esophageal Cancer1 trial

Lymphoid Malignancies1 trial

Peripheral T-Cell Lymphoma1 trial

Recurrent Anaplastic Large Cell Lymphoma1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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