Trexall

(Methotrexate)

ApprovedSmall molecule

Methotrexate is used to treat certain cancers, autoimmune diseases like rheumatoid arthritis and psoriasis, and to prevent rejection after organ transplants. It works by slowing down the growth of rapidly dividing cells in the body.[2] Trexall is currently approved and in use across 149 indications[4].[1]

Trexall is one of 1811 small molecule programs targeting Pompe Disease. It is currently in Approved.

149

Indications

1,190

Total Trials

Active Trials

1,810

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Pompe DiseaseCompleted

LeukemiaCompleted

Rheumatoid ArthritisTerminated

PsoriasisActive, not recruiting

Acute Lymphoblastic LeukemiaCompleted

T-Cell Acute Lymphoblastic LeukemiaActive, not recruiting

Myelodysplastic SyndromesActive, not recruiting

Central Nervous System LymphomaUnknown status

Metabolic SyndromeActive, not recruiting

TreatmentNot yet recruiting

Pompe DiseaseApproved

Completed

LeukemiaPhase 3

Completed

Rheumatoid ArthritisApproved

Terminated

PsoriasisApproved

Active, not recruiting

Acute Lymphoblastic LeukemiaApproved

Completed

T-Cell Acute Lymphoblastic LeukemiaPhase 3

Active, not recruiting

Myelodysplastic SyndromesPhase 2

Active, not recruiting

Central Nervous System LymphomaPhase 2

Unknown status

Metabolic SyndromeApproved

Active, not recruiting

TreatmentApproved

Not yet recruiting

Showing 10 of 149 indications

Competition

Competitive Landscape

449 competitors in Non-Small Cell Lung Cancer

#DrugCompanyPhaseTrials

Trexall

Jazz Pharmaceuticals

Approved

2 2

Tabrecta

Novartis

Phase 3

8 3

Rozlytrek

Roche

Phase 3

4 4

Zimberelimab

Arcus Biosciences

Phase 3

4 5

Remeron

OOrganon and Co

Preclinical

1 6

Valemetostat Tosylate

Daiichi Sankyo

Preclinical

1 7

Aqupla

Jiangsu Simcere Pharmaceutical Co., Ltd.

Preclinical

—8

Ftorafur

TThe First Affiliated Hospital with Nanjing Medical University

Preclinical

—9

Vibramycin

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Treatment

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

Timeline

Expected Milestones

Q4 2026

Phase 1/2Recruiting

Acute Lymphoblastic Leukemia

NCT06207123

Phase 1Recruiting

Acute Lymphoblastic Leukemia

NCT04872790

Post-ApprovalRecruiting

Efficacy

NCT05626348

Phase 1/2Active, not recruiting

T-Cell Acute Lymphoblastic Leukemia

NCT03808610

Post-ApprovalActive, not recruiting

Rheumatoid Arthritis

NCT05353829

Q1 2027

Phase 1/2Active, not recruiting

Acute Lymphoblastic Leukemia

NCT05192889

Clinical

Trials by Indication[1]

Rheumatoid Arthritis40 trials

Methotrexate Combined With Tofacitinib in Rheumatoid Arthritis

Recruiting·SSun Yat-Sen Memorial Hospital of Sun Yat-Sen University·N/A·NCT06301373·130 enrolled

A Study of MabThera (Rituximab) in Combination With Methotrexate in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to Anti-TNF Agents.

Completed· Roche logo

Roche·Phase 4·NCT00504777·36 enrolled

A Study to Compare the Response to Treatment With Abatacept vs Adalimumab, on Background Methotrexate, in Adults With Early, Seropositive, and Shared Epitope-positive Rheumatoid Arthritis and an Inadequate Response to Methotrexate

Active, not recruiting· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT04909801·338 enrolled

Show 37 more trials

Study of Etanercept Monotherapy vs Methotrexate Monotherapy for Maintenance of Rheumatoid Arthritis Remission

Completed· Amgen logo

Amgen·Phase 3·NCT02373813·371 enrolled

Clinical Trial to Evaluate Efficacy and Safety of Acellbia® (JSC "BIOCAD") With Methotrexate in First Line Biological Therapy of Patients With Active Rheumatoid Arthritis

Completed·BBiocad·Phase 3·NCT02744196·159 enrolled

Efficacy, Safety and Immunogenicity of Enerceptan Compared to Enbrel in Rheumatoid Arthritis

Completed·GGema Biotech S.A.·Phase 3·NCT03332719·168 enrolled

A Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to a TNF-Blocker.

Completed· Roche logo

Roche·Phase 4·NCT00424502·20 enrolled

A Study of CDP870 as Add-on Meditation to Methotrexate (MTX) in Patients With Rheumatoid Arthritis

Completed·KKorea Otsuka Pharmaceutical Co., Ltd.·Phase 3·NCT00993317·127 enrolled

A Study of Rituximab (MabThera®/Rituxan®) in Patients With Rheumatoid Arthritis and Inadequate Response to Methotrexate

Completed· Roche logo

Roche·Phase 3·NCT00578305·185 enrolled

Effect of Sarilumab on Patient-reported Outcomes in Patients With Active Rheumatoid Arthritis

Completed· Sanofi logo

Sanofi·Phase 4·NCT03449758·84 enrolled

A Study With Tocilizumab [RoActemra/Actemra] Monotherapy or in Combination With Methotrexate in Patients With Rheumatoid Arthritis (PICTURE)

Completed· Roche logo

Roche·Phase 3·NCT01063062·107 enrolled

A Pilot Study of the Feasibility of Discontinuation of Adalimumab in Stable Rheumatoid Arthritis Patients in Clinical Remission

Completed· AbbVie logo

AbbVie·Phase 4·NCT00808509·33 enrolled

Efficacy of Chinese Herbal Medicine Qing Re Huo Xue in Patients With Rheumatoid Arthritis

Completed·GGuang'anmen Hospital of China Academy of Chinese Medical Sciences·Phase 2/3·NCT04170504·204 enrolled

A Study to Assess the Effect of Tocilizumab + Methotrexate on Prevention of Structural Joint Damage in Patients With Moderate to Severe Active Rheumatoid Arthritis (RA)

Completed· Roche logo

Roche·Phase 3·NCT00106535·1,196 enrolled

Abatacept to Silence Anti-citrullinated Protein Antibody-expressing B Cells in Rheumatoid Arthritis (ASCARA)

Completed·LLeiden University Medical Center·Phase 4·NCT03492658·46 enrolled

A Study of Tocilizumab (RoActemra) in Tocilizumab-Naive Participants With Rheumatoid Arthritis and Inadequate Response to Non-Biologic Disease-Modifying Antirheumatic Drugs (DMARDs) and/or Biologic Therapy

Completed· Roche logo

Roche·Phase 3·NCT02001987·139 enrolled

A Study to Evaluate the Safety and Efficacy of SM03 in Patients With Rheumatoid Arthritis Receiving Methotrexate

Completed·SSinoMab BioScience Ltd·Phase 2·NCT04192617·156 enrolled

Methotrexate Withdrawal Study of Tofacitinib Modified Release Formulation in Subjects With Rheumatoid Arthritis

Completed· Pfizer logo

Pfizer·Phase 4·NCT02831855·694 enrolled

Dose Finding Study of Namilumab in Combination With Methotrexate in Participants With Moderate to Severe Rheumatoid Arthritis (RA)

Completed· Takeda logo

Takeda·Phase 2·NCT02379091·108 enrolled

A Drug Interaction Study Between Tocilizumab, Methotrexate and Simvastatin on Patients With Rheumatoid Arthritis.

Completed· Roche logo

Roche·Phase 1·NCT00365001·23 enrolled

A Phase 3 Study of Abatacept in Chinese Patients With Active Rheumatoid Arthritis and Inadequate Response to Methotrexate

Unknown status· Jiangsu Simcere Pharmaceutical Co., Ltd. logo

Jiangsu Simcere Pharmaceutical Co., Ltd.·Phase 3·NCT02722694·360 enrolled

Oral Baricitinib (LY3009104)Treatment in Japanese Participants With Active Rheumatoid Arthritis on Background Methotrexate Therapy

Completed· Eli Lilly logo

Eli Lilly·Phase 2·NCT01469013·145 enrolled

A Rheumatoid Arthritis Study in Participants on a Background Treatment of Methotrexate

Terminated· Eli Lilly logo

Eli Lilly·Phase 3·NCT01198002·1,041 enrolled

Tofacitinib Versus Methotrexate as the First Line DMARD in the Treatment of Rheumatoid Arthritis

Unknown status·—·Phase 4·NCT04464642·110 enrolled

Study of LX3305 and Methotrexate in Subjects With Stable Rheumatoid Arthritis

Completed·LLexicon Pharmaceuticals·Phase 1·NCT00847886·15 enrolled

A Pilot Study of MabThera (Rituximab) Evaluated by MRI in Patients With Rheumatoid Arthritis.

Completed· Roche logo

Roche·Phase 4·NCT00502853·10 enrolled

A Phase III Study of Abatacept in Patients With Rheumatoid Arthritis and an Inadequate Response to Methotrexate

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT00409838·113 enrolled

A Study to Evaluate the Safety and Efficacy of ASP015K in Moderate to Severe Rheumatoid Arthritis Subjects Who Have Had an Inadequate Response to Methotrexate

Completed· Astellas logo

Astellas·Phase 2·NCT01554696·379 enrolled

A Study to Evaluate Efficacy and Safety of ASP015K in Patients With Rheumatoid Arthritis (RA) Who Had an Inadequate Response to Methotrexate (MTX) Treatment

Completed· Astellas logo

Astellas·Phase 3·NCT02305849·519 enrolled

A Study of Ocrelizumab Compared to Placebo in Patients With Active Rheumatoid Arthritis Continuing Methotrexate Treatment (STAGE)

Terminated· Roche logo

Roche·Phase 3·NCT00406419·1,015 enrolled

Evaluation of Pharmacokinetics and Safety of GSK3196165 in Combination With Methotrexate in Japanese Subjects With Rheumatoid Arthritis

Completed· GSK logo

GSK·Phase 1/2·NCT03028467·15 enrolled

Comparison of Compliance and Evolution of Functional Capacity of Patients With Rheumatoid Arthritis Treated by Methotrexate Either by Auto-injector or by Conventional Sub-cutaneous Syringe

Completed·NNordic Pharma SAS·Phase 3·NCT02553018·278 enrolled

A Study of Subcutaneous (SC) Tocilizumab (RoActemra/Actemra) in Participants With Active Rheumatoid Arthritis (RA) and Inadequate Response to Disease-Modifying Anti-Rheumatic Drugs (DMARDs)

Completed· Roche logo

Roche·Phase 3·NCT02046616·133 enrolled

A Phase III Study of Abatacept (BMS-188667) in Patients With Active Rheumatoid Arthritis and Inadequate Response to Methotrexate

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT00048568·1,250 enrolled

A Study of The Effect of RoActemra/Actemra (Tocilizumab) in Combination With Methotrexate on Articular Damage in The Hand in Patients With Moderate to Severe Rheumatoid Arthritis Who Have an Inadequate Response to Non-Biological DMARDs

Withdrawn· Roche logo

Roche·Phase 4·NCT01878318

Paroxetine Safety and Efficacy in Rheumatoid Arthritis

Recruiting·MMostafa Bahaa·Phase 3·NCT06231745·100 enrolled

Study to Assess the Short- and Long-term Efficacy of Certolizumab Pegol Plus Methotrexate Compared to Adalimumab Plus Methotrexate in Subjects With Moderate to Severe Rheumatoid Arthritis (RA) Inadequately Responding to Methotrexate

Completed· UCB logo

UCB·Phase 4·NCT01500278·915 enrolled

Methotrexate Polyglutamate Levels as a Marker for the Clinical Outcome in the Treatment of Rheumatoid Arthritis

Completed·LLudwig-Boltzmann Institut fuer Rheumatologie, Balneologie und Rehabilitation·Phase 4·NCT00695188·19 enrolled

Methotrexate in Patients with Early Rheumatoid Arthritis

Active, not recruiting·RRegion Västerbotten·Phase 4·NCT05353829·212 enrolled

Quality of Life Study With Adalimumab in Rheumatoid Arthritis

Completed·AAbbott·Phase 3·NCT00234936·200 enrolled

Acute Lymphoblastic Leukemia29 trials

Ruxolitinib With Tacrolimus and Methotrexate for the Prevention of Graft Versus Host Disease in Pediatric and Young Adult Patients Undergoing Allogeneic Hematopoietic Cell Transplant for Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, or Myelodysplastic Syndrome

Recruiting·—·Phase 2·NCT06128070·40 enrolled

A Phase 2 Study of Ruxolitinib With Chemotherapy in Children With Acute Lymphoblastic Leukemia

Completed· Incyte logo

Incyte·Phase 2·NCT02723994·171 enrolled

Personalized Kinase Inhibitor Therapy Combined With Chemotherapy in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia and Acute Lymphoblastic Leukemia

Completed·OOHSU Knight Cancer Institute·Phase 1·NCT02779283·7 enrolled

Show 26 more trials

Intrathecal Chemoprophylaxis to Prevent Neurotoxicity Associated With Blinatumomab Therapy for Acute Lymphoblastic Leukemia

Recruiting·NNorthside Hospital, Inc.·Phase 2·NCT05519579·20 enrolled

Venetoclax, Dasatinib, Prednisone, Rituximab and Blinatumomab for the Treatment of Newly Diagnosed or Relapsed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia or Mixed Phenotype Acute Leukemia

Recruiting·OOHSU Knight Cancer Institute·Phase 1·NCT04872790·20 enrolled

Combination Chemotherapy and Alemtuzumab in Treating Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia

Terminated·NNational Cancer Institute (NCI)·Phase 2·NCT00262925·12 enrolled

Comparison of Different Combination Chemotherapy Regimens in Treating Infants With Acute Lymphoblastic Leukemia

Completed·DDutch Childhood Oncology Group·Phase 3·NCT00015873·350 enrolled

Combination Chemotherapy and Rituximab in Treating Young Patients With Recurrent or Refractory Non-Hodgkin's Lymphoma or Acute Lymphoblastic Leukemia

Terminated·NNational Cancer Institute (NCI)·Phase 2·NCT00058461·82 enrolled

Chemotherapy, Imatinib Mesylate, and Peripheral Stem Cell Transplantation in Treating Patients With Newly Diagnosed Acute Lymphoblastic Leukemia

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT00039377·58 enrolled

Azacitidine and Combination Chemotherapy in Treating Infants With Acute Lymphoblastic Leukemia and KMT2A Gene Rearrangement

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT02828358·78 enrolled

Erwinase for Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia (ALL) (IND 104224)

Terminated·TTherapeutic Advances in Childhood Leukemia Consortium·Phase 1·NCT00928200·1 enrolled

Combination Chemotherapy in Treating Children With Newly Diagnosed Acute Lymphoblastic Leukemia

Completed·CChildren's Oncology Group·Phase 3·NCT00005596·1,076 enrolled

Comparison of Different Combination Chemotherapy Regimens in Treating Children With Acute Lymphoblastic Leukemia

Completed·CChildren's Oncology Group·Phase 3·NCT00005945·3,054 enrolled

BEBT-908 Plus Chemotherapy Treatment for CR MRD-Positive MEF2D-Rearranged and Pre-B Acute Lymphoblastic Leukemia Patients

Not yet recruiting·RRuijin Hospital·Phase 2·NCT07301138·23 enrolled

Risk-Adjusted Combination Chemotherapy in Treating Young Patients With Acute Lymphoblastic Leukemia

Unknown status·—·Phase 3·NCT00764907·4,000 enrolled

Tagraxofusp and Low-Intensity Chemotherapy for the Treatment of CD123 Positive Relapsed or Refractory Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma

Terminated·MM.D. Anderson Cancer Center·Phase 1/2·NCT05032183·4 enrolled

Bortezomib With Chemotherapy for Relapsed Pediatric Acute Lymphoblastic Leukemia (ALL)

Completed·TTherapeutic Advances in Childhood Leukemia Consortium·Phase 1/2·NCT00440726·31 enrolled

Chemoimmunotherapy With Epratuzumab in Relapsed Acute Lymphoblastic Leukemia (ALL)

Completed·CChildren's Oncology Group·Phase 1/2·NCT00098839·134 enrolled

Combination Chemotherapy in Treating Children With Newly Diagnosed Acute Lymphoblastic Leukemia

Completed·CChildren's Oncology Group·Phase 3·NCT00002744·1,970 enrolled

Trial Treating Relapsed Acute Lymphoblastic Leukemia With Venetoclax and Navitoclax

Active, not recruiting·SSt. Jude Children's Research Hospital·Phase 1/2·NCT05192889·35 enrolled

Pegaspargase and Combination Chemotherapy in Treating Younger Patients With Newly Diagnosed High-Risk Acute Lymphoblastic Leukemia (Closed to Accrual 4-22-2011)

Completed·CChildren's Oncology Group·Phase 1·NCT00866307·104 enrolled

Combination Chemotherapy Based on Risk of Relapse in Treating Young Patients With Acute Lymphoblastic Leukemia

Completed·AAssociazione Italiana Ematologia Oncologia Pediatrica·Phase 3·NCT00613457·2,039 enrolled

Dasatinib Combined With Chemotherapy in Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia

Completed·IInstitute of Hematology & Blood Diseases Hospital, China·Phase 2·NCT02523976·30 enrolled

Treosulfan, Fludarabine Phosphate, and Total-Body Irradiation Before Donor Stem Cell Transplant in Treating Patients With High-Risk Acute Myeloid Leukemia, Myelodysplastic Syndrome, Acute Lymphoblastic Leukemia

Completed·FFred Hutchinson Cancer Center·Phase 2·NCT00860574·96 enrolled

Nilotinib and Combination Chemotherapy in Treating Patients With Newly Diagnosed Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia or Blastic Phase Chronic Myelogenous Leukemia

Withdrawn·MMayo Clinic·Phase 2·NCT01670084

German Multicenter Trial for Treatment of Elderly Patients With Newly Diagnosed Acute Lymphoblastic Leukemia

Completed·GGoethe University·Phase 4·NCT00198978·377 enrolled

A Study to Investigate LP-118, Ponatinib, Vincristine and Dexamethasone in Relapsed/Refractory Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Lymphoma (LBL)

Recruiting·UUniversity of Chicago·Phase 1/2·NCT06207123·15 enrolled

Malaysia-Singapore Acute Lymphoblastic Leukemia 2010 Study

Unknown status·NNational University Hospital, Singapore·Phase 4·NCT02894645·500 enrolled

Combination Chemotherapy in Treating Young Adult Patients With Acute Lymphoblastic Leukemia

Completed·GGruppo Italiano Malattie EMatologiche dell'Adulto·N/A·NCT01156883·76 enrolled

Lymphoma11 trials

Treatment of Mature B-ALL and Burkitt Lymphoma (BL) in Adult Patients. BURKIMAB-14.

Unknown status·PPETHEMA Foundation·Phase 2·NCT05049473·100 enrolled

Chemotherapy for Relapsed Epstein Barr Virus Associated Lymphoma

Terminated·UUniversity of Miami·Phase 2·NCT01964755·6 enrolled

Whole Brain Irradiation in Primary Central Nervous System (CNS) Lymphoma (PCNSL)

Completed·—·Phase 4·NCT00153530·604 enrolled

Show 8 more trials

Chemotherapy and HAART to Treat AIDS-related Primary Brain Lymphoma

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT00267865·12 enrolled

Combination Chemotherapy in Treating Children With Lymphoma

Completed·CChildren's Oncology Group·Phase 2·NCT00002590·221 enrolled

Study of AMG 531 to Evaluate the Safety & Efficacy in Patients With Non-Hodgkin's Lymphoma

Completed·MM.D. Anderson Cancer Center·Phase 1/2·NCT00299182·50 enrolled

Thiotepa, Busulfan and Fludarabin for pt With Refractory/Early Relapsed Aggressive B-cell Non Hodgkin Lymphomas

Unknown status·AAzienda Ospedaliera San Giovanni Battista·Phase 2·NCT01786018·42 enrolled

Combination Chemotherapy, Rituximab, and Ixazomib Citrate in Treating Patients With Non-Hodgkin Lymphoma

Unknown status·NNorthwestern University·Phase 1/2·NCT02481310·38 enrolled

Zanubrutinib in Combination With Pola-R-CHP and High-dose Methotrexate in Patients With Secondary CNS Lymphoma

Recruiting·—·Phase 1·NCT06730542·20 enrolled

New Combination of Chemoimmunotherapy for Systemic B-cell Lymphoma With Central Nervous System Involvement

Completed·IInternational Extranodal Lymphoma Study Group (IELSG)·Phase 2·NCT02329080·79 enrolled

MESA Versus ESA in the Treatment of Early Stage NK/T-cell Lymphoma

Unknown status·RRuijin Hospital·Phase 3·NCT02631239·256 enrolled

Central Nervous System Lymphoma7 trials

A Study of MabThera (Rituximab) in Primary Central Nervous System Lymphoma.

Terminated· Roche logo

Roche·Phase 2·NCT00517699·5 enrolled

A Trial to Compare Ibrutinib Versus Lenalidomide in Combination With MRE-chemotherapy for Adult Patients With Recurrent/Refractory Primary Central Nervous System Lymphoma (PCNSL)

Unknown status·SSecond Affiliated Hospital, School of Medicine, Zhejiang University·Phase 2·NCT04129710·120 enrolled

Rituximab, Lenalidomide Combined With Methotrexate and Temozolomide For Primary Central Nervous System Lymphoma

Recruiting·HHenan Cancer Hospital·Phase 2·NCT04737889·30 enrolled

Show 4 more trials

A Study of Pomadomide in Combination With Rituximab and Methotrexate for Newly-diagnosed Primary Central Nervous System Lymphoma

Recruiting·SSecond Affiliated Hospital, School of Medicine, Zhejiang University·Phase 1/2·NCT06554561·43 enrolled

Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Newly Diagnosed Central Nervous System Lymphoma

Completed·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT00003632·30 enrolled

Methotrexate, Glucarpidase, and Leucovorin in Treating Patients With Newly Diagnosed Primary Central Nervous System Lymphoma

Completed·UUniversity College, London·Phase 1/2·NCT00727831·4 enrolled

Methotrexate, Mannitol, Rituximab, and Carboplatin in Treating Patients With Newly Diagnosed Primary Central Nervous System Lymphoma

Unknown status·OOHSU Knight Cancer Institute·Phase 1/2·NCT00293475·81 enrolled

Leukemia6 trials

Comparison of Two Combination Chemotherapy Regimens in Treating Adults With Previously Untreated Leukemia or Lymphoma

Completed·MMemorial Sloan Kettering Cancer Center·Phase 3·NCT00002766·170 enrolled

Inotuzumab Ozogamicin for Children With MRD Positive CD22+ Lymphoblastic Leukemia

Terminated·SSt. Jude Children's Research Hospital·Phase 2·NCT03913559·5 enrolled

Methotrexate With or Without Cyclophosphamide in Treating Patients With Lymphocytic Leukemia

Terminated·EEastern Cooperative Oncology Group·Phase 2·NCT00003910·59 enrolled

Show 3 more trials

Combination Chemotherapy and Rituximab in Treating Patients With Newly Diagnosed Burkitt's Lymphoma or Leukemia

Completed·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins·Phase 2·NCT00133991·23 enrolled

Monoclonal Antibody Therapy, Cyclophosphamide, and Total-Body Irradiation Followed by Peripheral Stem Cell Transplantation in Treating Patients With Advanced Recurrent Acute Lymphocytic Leukemia

Completed·FFred Hutchinson Cancer Center·Phase 2·NCT00003870·40 enrolled

Combination Chemotherapy in Treating Children With Relapsed Acute Lymphocytic Leukemia

Unknown status·GGrupo Argentino de Tratamiento de la Leucemia Aguda·Phase 2/3·NCT00002499

77 more indications

Breast Cancer6 trials

Sunitinib, Cyclophosphamide, and Methotrexate in Treating Patients With Metastatic Breast Cancer

Terminated·UUniversity of California, San Francisco·Phase 1/2·NCT00616122·32 enrolled

Combination Chemotherapy With Trastuzumab in Treating Women With Metastatic Breast Cancer

Completed·EEuropean Organisation for Research and Treatment of Cancer - EORTC·Phase 2·NCT00036868·90 enrolled

ZD6474 (Zactima) and Metronomic Chemotherapy in Advanced Breast Cancer

Completed·—·Phase 1·NCT00496665·25 enrolled

Show 3 more trials

Hormone Therapy and Combination Chemotherapy Before and After Surgery in Treating Patients With Stage I-IIIA Breast Cancer

Terminated·UUniversity of Washington·Phase 2·NCT00194792·28 enrolled

A Study of Cyclophosphamide/Methotrexate/5-Fluorouracil (CMF) With Pegfilgrastim in Subjects With Breast Cancer

Completed· Amgen logo

Amgen·Phase 2·NCT00124111

Tamoxifen With or Without Combination Chemotherapy in Treating Postmenopausal Women With Operable Invasive Breast Cancer

Completed·SScottish Cancer Therapy Network·Phase 3·NCT00002581·1,000 enrolled

Myelodysplastic Syndrome5 trials

Low-Dose or High-Dose Conditioning Followed by Peripheral Blood Stem Cell Transplant in Treating Patients With Myelodysplastic Syndrome or Acute Myelogenous Leukemia

Completed·FFred Hutchinson Cancer Center·Phase 3·NCT00322101·25 enrolled

Combination Chemotherapy in Treating Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome

Completed·CChildren's Oncology Group·Phase 2·NCT00002805·115 enrolled

Pevonedistat, Azacitidine, Fludarabine Phosphate, and Cytarabine in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome

Completed·NNational Cancer Institute (NCI)·Phase 1·NCT03813147·12 enrolled

Show 2 more trials

S9920 Busulfan Compared With Cyclophosphamide in Patients Undergoing Total-Body Irradiation Plus Peripheral Stem Cell Transplantation for Advanced Myelodysplastic Syndrome or Related Acute Myeloid Leukemia

Completed·SSWOG Cancer Research Network·Phase 3·NCT00005866·240 enrolled

Busulfan, Fludarabine Phosphate, and Anti-Thymocyte Globulin Followed By Donor Stem Cell Transplant and Azacitidine in Treating Patients With High-Risk Myelodysplastic Syndrome and Older Patients With Acute Myeloid Leukemia

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT01168219·68 enrolled

Stem Cell Transplant5 trials

Treosulfan and Fludarabine Phosphate Before Donor Stem Cell Transplant in Treating Patients With Nonmalignant Inherited Disorders

Completed·FFred Hutchinson Cancer Center·Phase 2·NCT00919503·98 enrolled

Allogeneic Stem Cell Transplant for CLL

Terminated·MM.D. Anderson Cancer Center·Phase 1/2·NCT01629511·15 enrolled

Alemtuzumab, Busulfan, and Cyclophosphamide Followed By a Donor Stem Cell Transplant in Treating Patients With Hematologic Cancer

Terminated·FFred Hutchinson Cancer Center·Phase 1/2·NCT00555048·1 enrolled

Show 2 more trials

Donor Stem Cell Transplant or Donor White Blood Cell Infusions in Treating Patients With Hematologic Cancer

Terminated·OOHSU Knight Cancer Institute·Phase 2·NCT00281879·200 enrolled

Donor Peripheral Stem Cell Transplant in Treating Patients With Advanced Hematologic Cancer or Other Disorders

Active, not recruiting·—·Phase 2·NCT00544115·260 enrolled

Treatment4 trials

Clinical Guidelines for APL Treatment

Unknown status·PPETHEMA Foundation·Phase 4·NCT02020161·200 enrolled

BHCG Level in Day 4,7, in Comparison to Day 10 as an Indicator for Treatment Success

Unknown status·MMeir Medical Center·Phase 4·NCT01860690·100 enrolled

Intercontinental Multidisciplinary Registry and Treatment Optimization Study for Choroid Plexus Tumors

Terminated·TTufts Medical Center·Phase 3·NCT01014767·27 enrolled

Show 1 more trial

a Retrospective Study on the Systemic Treatment of LPP and FFA

Completed·EErasmus Medical Center··NCT06512766·315 enrolled

Psoriasis4 trials

Trial in Patients With Psoriasis Treated With Methotrexate Using an Optimized Treatment Schedule (METOP)

Completed·—·Phase 3·NCT02902861·120 enrolled

Dose Response and Safety Study of Topical Methotrexate for the Treatment of Fingernail Psoriasis

Unknown status·MMediQuest Therapeutics·Phase 2·NCT00666354·83 enrolled

Safety and Efficacy of UC-MSCs in Patients With Plaque Psoriasis

Unknown status·TTianjin Ever Union Biotechnology Co., Ltd.·Phase 1·NCT03424629·57 enrolled

Show 1 more trial

Methotrexate in the Treatment of Distal Interphalangeal Joint Extensor Tendon Enthesopathy in Nail Psoriasis

Completed·RRyszard Górecki··NCT03757364·32 enrolled

Methotrexate3 trials

CAMEO: Canadian Methotrexate and Etanercept Outcome Study

Completed· Amgen logo

Amgen·Phase 4·NCT00654368·258 enrolled

GOLimumab and Methotrexate Versus Methotrexate in Very Early PsA

Completed·TThe Leeds Teaching Hospitals NHS Trust·Phase 3·NCT04108468·84 enrolled

Phase I/II Study of Pentostatin Combined With Tacrolimus and Mini-Methotrexate for GVHD Prevention After MUD BMT

Completed·MM.D. Anderson Cancer Center·Phase 1/2·NCT00506922·150 enrolled

Uveitis2 trials

Efficacy Study of Methotrexate to Treat Sarcoid-associated Uveitis

Terminated·AAssistance Publique - Hôpitaux de Paris·Phase 4·NCT00918554·7 enrolled

Phase II Study to Analyze Sarilumab in Non-Infectious Uveitis

Completed· Sanofi logo

Sanofi·Phase 2·NCT01900431·58 enrolled

Psoriatic Arthritis2 trials

Efficacy of Golimumab in Combination With Methotrexate (MTX) Versus MTX Monotherapy, in Improving Dactylitis, in MTX naïve Psoriatic Arthritis Patients

Completed·IInstituto de Medicina Molecular João Lobo Antunes·Phase 3·NCT02065713·44 enrolled

Preventing Structural Damage in Early Psoriatic Arthritis

Recruiting·—·Phase 4·NCT07486843·108 enrolled

Stem Cell Transplantation2 trials

Allogeneic Blood Stem Cell Transplantation and Adoptive Immunotherapy for Hodgkin's Disease

Completed·MM.D. Anderson Cancer Center·Phase 2·NCT00385788·52 enrolled

Stem Cell Transplantation for Metastatic Solid Tumors

Terminated·NNational Heart, Lung, and Blood Institute (NHLBI)·Phase 2·NCT00001880·42 enrolled

Bladder Cancer2 trials

Risk Enabled Therapy After Initiating Neoadjuvant Chemotherapy for Bladder Cancer (RETAIN)

Active, not recruiting·FFox Chase Cancer Center·Phase 2·NCT02710734·78 enrolled

4B951, Combination Chemotherapy in Treating Patients With Bladder Cancer

Terminated·SSWOG Cancer Research Network·Phase 3·NCT00005047·521 enrolled

Mantle Cell Lymphoma2 trials

Ibrutinib, Rituximab, and Consolidation Chemotherapy in Treating Young Patients With Newly Diagnosed Mantle Cell Lymphoma

Active, not recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT02427620·131 enrolled

Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Mantle Cell Lymphoma

Completed·AAlliance for Clinical Trials in Oncology·Phase 2·NCT00006747·4 enrolled

Osteosarcoma2 trials

Combination Chemotherapy, PEG-Interferon Alfa-2b, and Surgery in Treating Patients With Osteosarcoma

Completed·CChildren's Oncology Group·Phase 3·NCT00134030·1,334 enrolled

Combination Chemotherapy Plus Dexrazoxane in Treating Patients With Newly Diagnosed Nonmetastatic Osteosarcoma

Completed·CChildren's Oncology Group·Phase 3·NCT00003937·253 enrolled

Metastatic Colorectal Cancer2 trials

Methotrexate in Metastatic Colorectal Cancer With MSH2 Deficiency

Terminated·RRoyal Marsden NHS Foundation Trust·Phase 2·NCT00952016·2 enrolled

Study to Investigate Outcome of Individualized Treatment in Patients With Metastatic Colorectal Cancer

Recruiting·OOslo University Hospital·Phase 2·NCT05725200·40 enrolled

Anaplastic Large Cell Lymphoma2 trials

Brentuximab Vedotin or Crizotinib and Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage II-IV Anaplastic Large Cell Lymphoma

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT01979536·137 enrolled

Ifosfamide, Carboplatin, Etoposide, and SGN-30 in Treating Young Patients With Recurrent Anaplastic Large Cell Lymphoma

Terminated·NNational Cancer Institute (NCI)·Phase 1/2·NCT00354107·5 enrolled

Juvenile Idiopathic Arthritis2 trials

A Study of the Safety and Efficacy of CNTO 148 (Golimumab) in Children With Juvenile Idiopathic Arthritis (JIA) and Multiple Joint Involvement Who Have Poor Response to Methotrexate (GO KIDS)

Terminated· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT01230827·173 enrolled

A Study to Evaluate the Pharmacokinetics, Efficacy and Safety of Intravenous Golimumab in Pediatric Participants With Active Polyarticular Course Juvenile Idiopathic Arthritis Despite Methotrexate Therapy

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT02277444·130 enrolled

Tocilizumab1 trial

Tocilizumab REMission in Early RA

Completed·UUniversity of Leeds·Phase 4·NCT04157010·20 enrolled

Adjuvant Treatment1 trial

Randomized Study Comparing Pre- and Postoperative vs. Conventional Adjuvant Treatment in Receptor-negative Patients

Completed·AAustrian Breast & Colorectal Cancer Study Group·Phase 3·NCT00309569·429 enrolled

Myelodysplastic Syndromes1 trial

Reduced-Intensity Regimen Before Donor Bone Marrow Transplant in Treating Patients With Myelodysplastic Syndromes

Completed·EEastern Cooperative Oncology Group·Phase 2·NCT00045305·17 enrolled

Hematologic Malignancy1 trial

Allo-HSCT With Alternative Donor in Treatment of Hematologic Malignancy

Completed·NNanfang Hospital, Southern Medical University·N/A·NCT02487069·876 enrolled

Lymphoid Malignancies1 trial

Natural Killer (NK) Cell Adback After Allogeneic Stem Cell Transplant With Campath-IH Plus Chemorx for Patients With Lymphoid Malignancies

Completed·MM.D. Anderson Cancer Center·Phase 2·NCT00536978·22 enrolled

Neuroblastoma1 trial

Allogeneic Hematopoietic Stem Cell Transplantation for 4/M Neuroblastoma

Not yet recruiting·SSun Yat-Sen Memorial Hospital of Sun Yat-Sen University·Phase 2·NCT05303727·64 enrolled

Hodgkin's Disease1 trial

Sequential Administration of Oral 6-Thioguanine (6-TG) After Methotrexate (MTX) in Patients With Relapsed Hodgkin's Disease (Phase II)

Completed·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT00587873·18 enrolled

Proliferative Vitreoretinopathy1 trial

Methotrexate For The Prevention and Treatment of Proliferative Vitreoretinopathy in Pediatric Patients

Withdrawn·SStanford University·Phase 1·NCT04830878

Newly Diagnosed1 trial

Pembrolizumab + Chemotherapy in Newly Diagnosed PCNSL

Recruiting·—·Phase 1·NCT06475235·15 enrolled

Atorvastatin1 trial

Randomized Study: Standard of Care With or Without Atorvastatin for Prevention of GVHD for Matched Unrelated Donor BMT

Withdrawn·LLoyola University·Phase 3·NCT03066466

Multiple Myeloma1 trial

Combination Chemotherapy and Donor Stem Cell Transplant Followed by Ixazomib Citrate Maintenance Therapy in Treating Patients With Relapsed High-Risk Multiple Myeloma

Completed·OOHSU Knight Cancer Institute·Phase 1·NCT02504359·11 enrolled

Adalimumab1 trial

Evaluate if Response to Infliximab or Adalimumab May be Regained With an Immunomodulator

Terminated·IIndiana University·N/A·NCT02413047·3 enrolled

Heart Failure1 trial

METhotrexate Therapy Effects in the Physical Capacity of Patients With ISchemic Heart Failure (METIS Trial)

Completed·IInstituto de Cardiologia do Rio Grande do Sul·Phase 2/3·NCT00759811·50 enrolled

Myeloproliferative Disorder1 trial

Chemotherapy in Treating Children With Down Syndrome and Myeloproliferative Disorder, Acute Myelogenous Leukemia, or Myelodysplastic Syndrome

Completed·CChildren's Oncology Group·Phase 3·NCT00003593·254 enrolled

Chemotherapy1 trial

Low Dose Metronomic Poly-chemotherapy for Metastatic CRC

Completed·HHaEmek Medical Center, Israel·Phase 2·NCT02280694·45 enrolled

Relapsed/Refractory B-cell ALL1 trial

Phase I Study of Inotuzumab With Augmented BFM Re-Induction for Patients With Relapsed/Refractory B-cell ALL

Active, not recruiting·UUniversity of Virginia·Phase 1·NCT03962465·36 enrolled

Primitive Neuroectodermal Tumor1 trial

Combination Chemotherapy Followed By Peripheral Stem Cell Transplant in Treating Young Patients With Newly Diagnosed Supratentorial Primitive Neuroectodermal Tumors or High-Risk Medulloblastoma

Completed·CChildren's Oncology Group·Phase 3·NCT00336024·91 enrolled

Langerhans Cell Histiocytosis1 trial

LCH-IV, International Collaborative Treatment Protocol for Children and Adolescents With Langerhans Cell Histiocytosis

Recruiting·NNorth American Consortium for Histiocytosis·Phase 2/3·NCT02205762·1,400 enrolled

Medulloblastoma1 trial

Fourth Ventricular Administration of Immune Checkpoint Inhibitor (Nivolumab) and Methotrexate or 5-Azacytidine for Recurrent Medulloblastoma, Ependymoma, and Other CNS Malignancies

Withdrawn·JJeffrey Treiber·Phase 1·NCT06466798

Hematologic Malignancies1 trial

Venetoclax Basket Trial for High Risk Hematologic Malignancies

Recruiting·—·Phase 1·NCT05292664·30 enrolled

Plexiform Neurofibroma1 trial

Combination Chemotherapy in Treating Patients With Neurofibromatosis and Progressive Plexiform Neurofibromas

Completed·—·Phase 2·NCT00030264·23 enrolled

Pulmonary Sarcoidosis1 trial

Effectiveness of Methotrexate Versus Prednisone as First-line Therapy for Pulmonary Sarcoidosis

Active, not recruiting·EErasmus Medical Center·Phase 4·NCT04314193·138 enrolled

Transitional Cell Carcinoma1 trial

Comparison of Immediate and Delayed Adjuvant Chemotherapy in Treating Patients Who Have Undergone a Radical Cystectomy for Stage III or Stage IV Transitional Cell Carcinoma of the Bladder Urothelium

Completed·EEuropean Organisation for Research and Treatment of Cancer - EORTC·Phase 3·NCT00028756·285 enrolled

Severe Aplastic Anemia1 trial

Allogeneic Stem Cell Transplant for Patients With Severe Aplastic Anemia

Terminated·—·Phase 2·NCT00578903·22 enrolled

Hematological Malignancies1 trial

Pediatric Study of GVHD Ppx w/o Calcineurin Inhibitors After Day60 Post First Allo HSCT for Hematological Malignancies.

Terminated·SSt. Jude Children's Research Hospital·Phase 2·NCT05579769·3 enrolled

Recurrent1 trial

Fenretinide in Children With Recurrent/Resistant ALL, AML, and NHL

Terminated·SSouth Plains Oncology Consortium·Phase 1·NCT01187810·3 enrolled

Efficacy1 trial

The Clinical Efficacy of Immunomodulators in RA Patients

Recruiting·QQilu Hospital of Shandong University·Phase 4·NCT05626348·400 enrolled

Lymphoblastic Lymphoma1 trial

NHL16: Study For Newly Diagnosed Patients With Acute Lymphoblastic Lymphoma

Completed·SSt. Jude Children's Research Hospital·Phase 2·NCT01451515·23 enrolled

Interaction1 trial

A Drug Interaction Study of LY3871801 in Healthy Participants

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT05602675·39 enrolled

Completed·RRegimmune Corporation·Phase 1/2·NCT01379209·68 enrolled

Allogeneic Hematopoietic Cell Transplant1 trial

Allogeneic Hematopoietic Cell Transplantation for Patients With Busulfex-based Regimen

Completed·UUNC Lineberger Comprehensive Cancer Center·Phase 1/2·NCT00448357·54 enrolled

Relapse1 trial

Trial of Nelarabine, Etoposide and Cyclophosphamide in Relapsed T-cell ALL and T-cell LL

Terminated·TTherapeutic Advances in Childhood Leukemia Consortium·Phase 1/2·NCT00981799·23 enrolled

Graft Vs Host Disease1 trial

Vorinostat for Graft vs Host Disease Prevention in Children, Adolescents and Young Adults Undergoing Allogeneic Blood and Marrow Transplantation

Active, not recruiting·UUniversity of Michigan Rogel Cancer Center·Phase 1/2·NCT03842696·43 enrolled

Acute Leukemia of Ambiguous Lineage1 trial

Efficacy of Acute Lymphoblastic Leukemia-Based Therapy in Treating Patients With Acute Leukemia of Ambiguous Lineage

Recruiting·IInstitute of Hematology & Blood Diseases Hospital, China·Phase 2·NCT04440267·50 enrolled

Chronic Lymphocytic Leukemia1 trial

Fludarabine and Cyclophosphamide in Treating Patients Who Are Undergoing Donor Stem Cell Transplant for Chronic Lymphocytic Leukemia or Waldenstrom's Macroglobulinemia

Completed·GGerman CLL Study Group·Phase 1/2·NCT00281983·100 enrolled

T-cell acute lymphoblastic leukemia1 trial

Low-Intensity Chemotherapy and Venetoclax in Treating Patients With Relapsed or Refractory B- or T-Cell Acute Lymphoblastic Leukemia

Active, not recruiting·MM.D. Anderson Cancer Center·Phase 1/2·NCT03808610·50 enrolled

Non-Small Cell Lung Cancer1 trial

Regorafenib and Methotrexate in Treating Participants With Recurrent or Metastatic KRAS Mutated Non-Small Cell Lung Cancer

Completed·SStanford University·Phase 2·NCT03520842·22 enrolled

Juvenile Myelomonocytic Leukemia1 trial

Cytosine Arabinoside and Mitoxantrone for Patients With Juvenile Myelomonocytic Leukemia Receiving Repeat Stem Cell Transplantation

Terminated·MMasonic Cancer Center, University of Minnesota·Phase 1/2·NCT00609739·1 enrolled

Chidamide1 trial

Precision Diagnosis Directing HDACi Chidamide Target Therapy for Adult ETP-ALL

Unknown status·NNanfang Hospital, Southern Medical University·Phase 2/3·NCT03553238·70 enrolled

Acute Myeloid Leukemia1 trial

Peginterferon Alfa-2a to Enhance Anti-leukemic Responses After Allogeneic Transplantation in Acute Myeloid Leukemia

Completed·UUniversity of Michigan Rogel Cancer Center·Phase 1/2·NCT02328755·37 enrolled

Myelofibrosis1 trial

JAK Inhibitor Before Donor Stem Cell Transplant in Treating Patients With Primary or Secondary Myelofibrosis

Active, not recruiting·FFred Hutchinson Cancer Center·Phase 2·NCT02251821·61 enrolled

MDS/AML1 trial

GVAX vs. Placebo for MDS/AML After Allo HSCT

Terminated·—·Phase 2·NCT01773395·123 enrolled

Advanced Head and Neck Cancer1 trial

Methotrexate Compared With Paclitaxel in Treating Patients With Advanced Head and Neck Cancer

Completed·EEastern Cooperative Oncology Group·Phase 3·NCT00003592·230 enrolled

TACE1 trial

Abatacept Post-marketing Clinical Study in Japan

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 4·NCT01758198·405 enrolled

Advanced Cancer1 trial

Two-Drug Combination Chemotherapy Compared With Four-Drug Combination Chemotherapy in Treating Patients With Advanced Cancer of the Urothelium

Completed·EEastern Cooperative Oncology Group·Phase 3·NCT00003376·330 enrolled

Ankylosing Spondylitis1 trial

Methotrexate in Ankylosing Spondylitis (MTX in AS)

Unknown status·—·Phase 2·NCT00243750·20 enrolled

Drug1 trial

To Evaluate The Effect Of SAR153191 (REGN88) Added To Other RA Drugs In Patients With RA Who Are Not Responding To Or Intolerant Of Anti-TNF Therapy (SARIL-RA-TARGET)

Completed· Sanofi logo

Sanofi·Phase 3·NCT01709578·546 enrolled

Primary Biliary Cirrhosis1 trial

Ursodiol-Methotrexate for Primary Biliary Cirrhosis

Completed·NNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)·Phase 3·NCT00006168

Neoadjuvant Chemotherapy1 trial

Neoadjuvant Chemotherapy With Methotrexate, Vinblastine, Adriamycin and Cisplatin (M-VAC) Plus Avastin in Patients With Urothelial Cancer

Completed·MM.D. Anderson Cancer Center·Phase 2·NCT00506155·60 enrolled

Mucous Membrane Pemphigoid1 trial

Baricitinib for the Treatment of Ocular Mucous Membrane Pemphigoid

Terminated·WWashington University School of Medicine·Phase 2·NCT05263505·2 enrolled

Immunotherapy1 trial

Pilot Study of MGd + High-dose MTX-Based Chemoimmunotherapy + RT for Newly Dx PCNSL

Withdrawn·NNorthwestern University·Phase 1·NCT00734773

Interstitial Lung Disease1 trial

Effects of Tofacitinib vs Methotrexate on Rheumatoid Arthritis Interstitial Lung Disease

Terminated·VVastra Gotaland Region·Phase 4·NCT04311567·3 enrolled

Transplantation1 trial

Study Testing Two Conditioning Regimen With a Single Prophylaxis of GVHD by Cyclophosphamide and Methotrexate Post-transplant in Patients Eligible for Matched-donor Allograft Transplantation

Recruiting·NNantes University Hospital·Phase 2·NCT06252870·82 enrolled

Bone Marrow Transplantation1 trial

Chemotherapy and Bone Marrow Transplantation in Treating Patients Acute Myeloid With Leukemia or Myelodysplastic Syndrome

Completed·BBarbara Ann Karmanos Cancer Institute·Phase 2·NCT00002547·280 enrolled

Ovarian Reserve1 trial

The Impact of Salpingectomy and Single Dose Systemic Methotrexate Treatments on Ovarian Reserve in Ectopic Pregnancy

Completed·—·N/A·NCT02714998·131 enrolled

Chronic Myelogenous Leukemia1 trial

Combination Chemotherapy and Interferon Alfa in Treating Patients With Chronic Myelogenous Leukemia

Completed·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT00002598·30 enrolled

Primary Sjögren's Syndrome (pSS)1 trial

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), Proof of Mechanism of GSK2618960 in Primary Sjögren's Syndrome (pSS)

Withdrawn· GSK logo

GSK·Phase 2·NCT03239600

Graft Versus Host Disease1 trial

TAC/MTX vs. TAC/MMF/PTCY for Prevention of Graft-versus-Host Disease and Microbiome and Immune Reconstitution Study (BMT CTN 1703/1801)

Completed·MMedical College of Wisconsin·Phase 3·NCT03959241·431 enrolled

Efficacy and Safety1 trial

Efficacy and Safety Study of ATG for Prophylaxis of aGVHD in Matched Sibling Donor PBSCT

Completed·—·Phase 4·NCT02677181·100 enrolled

Cancer of the Head and Neck1 trial

A Study of the Combination of Cetuximab and Methotrexate in Recurrent or Metastatic Cancer of the Head and Neck

Unknown status·RRadboud University Medical Center·Phase 1/2·NCT02054442·52 enrolled

Regulatory

FDA Approval Timeline[5]

Jan 1, 1982

METHOTREXATE SODIUM

NDA NDA008085

Mar 31, 1982

METHOTREXATE LPF

NDA NDA011719

Jun 3, 2002

TREXALL

NDA ANDA040385

Jun 3, 2002

TREXALL

NDA ANDA040385

Jul 9, 2002

TREXALL

NDA ANDA040385

Jul 10, 2014

RASUVO

NDA NDA205776

Nov 7, 2014

OTREXUP

NDA NDA204824

Dec 20, 2016

TREXALL

NDA ANDA040385

Dec 20, 2016

TREXALL

NDA ANDA040385

Apr 25, 2017

XATMEP

NDA NDA208400

Nov 27, 2019

REDITREX

NDA NDA210737

Aug 24, 2020

METHOTREXATE

NDA NDA214121

Jun 14, 2021

TREXALL

NDA ANDA040385

Nov 29, 2022

JYLAMVO

NDA NDA212479

May 27, 2026

TREXALL

NDA ANDA040385

Sources

References

[1]
ClinicalTrials.gov — 1190 trial records for Methotrexate. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Trexall drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Methotrexate compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Methotrexate. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA ANDA040385). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Trexall. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Jazz Pharmaceuticals company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Dihydrofolate Reductase Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: Jazz Pharmaceuticals

Patent Landscape[6]

Patent Cliff

Oct 4, 2026

Earliest patent expiration — generic entry possible after this date

Patent #Expires

9629959Jan 24, 2026

11446441Jan 24, 2026

8562564Jan 24, 2026

9533102Jan 24, 2026

8021335Oct 4, 2026

21 more patents

10709844Mar 10, 2029

9867949Mar 10, 2029

11684723Mar 10, 2029

8664231Jun 1, 2029

8480631Mar 19, 2030

8579865Mar 19, 2030

8945063Mar 19, 2030

9421333Mar 19, 2030

11497753Mar 19, 2030

12357642Mar 19, 2030

8814834May 27, 2031

11969503Jan 2, 2033

11116724Jan 2, 2033

10610485Jan 2, 2033

12396947Jan 2, 2033

9855215Jan 2, 2033

9259427Jan 2, 2033

10231927Jan 2, 2033

11771701Oct 29, 2034

12605385Oct 25, 2035

11129833Oct 28, 2035

Trexall

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2027

Trials by Indication[1]

Rheumatoid Arthritis40 trials

Acute Lymphoblastic Leukemia29 trials

Lymphoma11 trials

Central Nervous System Lymphoma7 trials

Leukemia6 trials

Breast Cancer6 trials

Myelodysplastic Syndrome5 trials

Stem Cell Transplant5 trials

Treatment4 trials

Psoriasis4 trials

Methotrexate3 trials

Uveitis2 trials

Psoriatic Arthritis2 trials

Stem Cell Transplantation2 trials

Bladder Cancer2 trials

Mantle Cell Lymphoma2 trials

Osteosarcoma2 trials

Metastatic Colorectal Cancer2 trials

Anaplastic Large Cell Lymphoma2 trials

Juvenile Idiopathic Arthritis2 trials

Tocilizumab1 trial

Adjuvant Treatment1 trial

Myelodysplastic Syndromes1 trial

Hematologic Malignancy1 trial

Lymphoid Malignancies1 trial

Neuroblastoma1 trial

Hodgkin's Disease1 trial

Proliferative Vitreoretinopathy1 trial

Newly Diagnosed1 trial

Atorvastatin1 trial

Multiple Myeloma1 trial

Adalimumab1 trial

Heart Failure1 trial

Myeloproliferative Disorder1 trial

Chemotherapy1 trial

Relapsed/Refractory B-cell ALL1 trial

Primitive Neuroectodermal Tumor1 trial

Langerhans Cell Histiocytosis1 trial

Medulloblastoma1 trial

Hematologic Malignancies1 trial

Plexiform Neurofibroma1 trial

Pulmonary Sarcoidosis1 trial

Transitional Cell Carcinoma1 trial

Severe Aplastic Anemia1 trial

Hematological Malignancies1 trial

Recurrent1 trial

Efficacy1 trial

Lymphoblastic Lymphoma1 trial

Interaction1 trial

Pleural Mesothelioma1 trial

Pediatric ALL1 trial

Hematopoietic Stem Cell Transplantation1 trial

Allogeneic Hematopoietic Cell Transplant1 trial

Relapse1 trial

Graft Vs Host Disease1 trial

Acute Leukemia of Ambiguous Lineage1 trial

Chronic Lymphocytic Leukemia1 trial

T-cell acute lymphoblastic leukemia1 trial

Non-Small Cell Lung Cancer1 trial

Juvenile Myelomonocytic Leukemia1 trial

Chidamide1 trial

Acute Myeloid Leukemia1 trial

Myelofibrosis1 trial

MDS/AML1 trial

Advanced Head and Neck Cancer1 trial

TACE1 trial

Advanced Cancer1 trial

Ankylosing Spondylitis1 trial

Drug1 trial

Primary Biliary Cirrhosis1 trial

Neoadjuvant Chemotherapy1 trial

Mucous Membrane Pemphigoid1 trial

Immunotherapy1 trial