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 137 indications[4].[1]

Trexall is one of 1707 small molecule programs targeting Pompe Disease. It is currently in Approved.

137

Indications

1,198

Total Trials

Active Trials

1,706

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Pompe DiseaseUnknown status

LeukemiaCompleted

T-Cell Acute Lymphoblastic LeukemiaCompleted

Metabolic SyndromeActive, not recruiting

Temporal ArteritisApproved

Cardiovascular DiseaseApproved

Urinary Bladder CancerApproved

Sensorineural Hearing LossApproved

Non-Melanoma Skin CarcinomaApproved

Head and Neck Malignant NeoplasiaApproved

Pompe DiseaseApproved

Unknown status

LeukemiaPhase 3

Completed

T-Cell Acute Lymphoblastic LeukemiaPhase 3

Completed

Metabolic SyndromeApproved

Active, not recruiting

Temporal ArteritisApproved

Approved

Cardiovascular DiseaseApproved

Approved

Urinary Bladder CancerApproved

Approved

Sensorineural Hearing LossApproved

Approved

Non-Melanoma Skin CarcinomaApproved

Approved

Head and Neck Malignant NeoplasiaApproved

Approved

Showing 10 of 137 indications

Competition

Competitive Landscape

414 competitors in Non-Small Cell Lung Cancer

#DrugCompanyPhaseTrials

Trexall

Jazz Pharmaceuticals

Approved

2 2

Aumolertinib

Jiangsu Hansoh Pharmaceutical Co., Ltd.

Phase 3

6 3

Eftilagimod Alfa

IImmutep S.A.S.

Phase 3

1 4

Remeron

OOrganon and Co

Preclinical

1 5

Aqupla

Jiangsu Simcere Pharmaceutical Co., Ltd.

Preclinical

—6

Ftorafur

TThe First Affiliated Hospital with Nanjing Medical University

Preclinical

—7

Vibramycin

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

Treatment

1 9

PD-1 Inhibitors

BBioNTech US Inc.

Preclinical

2 10

Pyrotinib Maleate

AstraZeneca

Preclinical

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 3Recruiting

Acute Leukemia

NCT04314219

Post-ApprovalActive, not recruiting

Rheumatoid Arthritis

NCT05353829

Q3 2027

Post-ApprovalNot yet recruiting

Treatment

NCT07477691

Q4 2027

Post-ApprovalRecruiting

Alopecia Areata

NCT07381556

Phase 1Active, not recruiting

Central Nervous System Lymphoma

NCT03684980

Clinical

Trials by Indication[1]

Rheumatoid Arthritis31 trials

Study Of The Safety Of CE 224,545 And Methotrexate In Patients With Rheumatoid Arthritis

Completed· Pfizer logo

Pfizer·Phase 1·NCT00446784·20 enrolled

Safety, Tolerability, and Efficacy of GS-9876 in Participants With Active Rheumatoid Arthritis on Background Therapy With Methotrexate

Completed· Gilead logo

Gilead·Phase 2·NCT02885181·83 enrolled

Effects of Abatacept in Patients With Early Rheumatoid Arthritis

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT02504268·994 enrolled

Show 28 more trials

A Study to Determine the Effect of Methotrexate (MTX) Dose on Clinical Outcome and Ultrasonographic Signs in Subjects With Moderately to Severely Active Rheumatoid Arthritis (RA) Treated With Adalimumab (MUSICA)

Completed· AbbVie logo

AbbVie·Phase 4·NCT01185288·309 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

Methotrexate Combined With Tofacitinib in Rheumatoid Arthritis

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

Treatment of Early Aggressive Rheumatoid Arthritis (TEAR)

Completed·UUniversity of Alabama at Birmingham·Phase 4·NCT00259610·755 enrolled

A Study of Imatinib 400 mg Once Daily in Combination With Methotrexate in the Treatment of Rheumatoid Arthritis.

Completed· Novartis logo

Novartis·Phase 2·NCT00154336·50 enrolled

A Study of Effectiveness and Safety of CNTO 136 in Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy

Completed·CCentocor, Inc.·Phase 2·NCT00718718·187 enrolled

Efficacy and Safety of Resveratrol in Patients With Rheumatoid Arthritis.

Recruiting·—·N/A·NCT07089381·118 enrolled

Efficacy and Safety Study of Abatacept Subcutaneous Plus Methotrexate in Inducing Remission in Adults With Very Early Rheumatoid Arthritis

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT01142726·511 enrolled

A Study to Evaluate the Efficacy, Safety and Pharmacokinetics/Pharmacodynamics (PK/PD) of Ocrelizumab in Patients With Rheumatoid Arthritis

Terminated· Roche logo

Roche·Phase 2·NCT00779220·152 enrolled

An Efficacy and Safety Study of Infliximab in Participants With Rheumatoid Arthritis

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 4·NCT00896168·234 enrolled

Long-term Efficacy of Iguratimod Alone or Iguratimod in Combination With Methotrexate in Patients With Rheumatoid Arthritis

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

Jiangsu Simcere Pharmaceutical Co., Ltd.·Phase 4·NCT01548001·910 enrolled

A Study of RoActemra/Actemra (Tocilizumab) With or Without Methotrexate in Patients With Mild to Moderate Rheumatoid Arthritis With an Inadequate Response to Methotrexate

Completed· Roche logo

Roche·Phase 3·NCT01587989·77 enrolled

Adalimumab in Combination With Methotrexate vs Methotrexate Alone in Early Rheumatoid Arthritis

Completed·AAbbott·Phase 3·NCT00234845·148 enrolled

A Study of Tocilizumab and Methotrexate Treatment Strategies (Adding Tocilizumab to Methotrexate Versus Switching to Tocilizumab) in Patients With Active Rheumatoid Arthritis With Inadequate Response to Prior Methotrexate Treatment

Completed· Roche logo

Roche·Phase 3·NCT00810199·556 enrolled

A Comparison of Methotrexate Alone or Combined to Infliximab or to Pulse Methylprednisolone in Early Rheumatoid Arthritis: A Magnetic Resonance Imaging Study

Completed·UUniversité Catholique de Louvain·Phase 4·NCT00396747·45 enrolled

Adalimumab Administered in Korean Rheumatoid Arthritis Subjects Treated With Methotrexate

Completed·AAbbott·Phase 3·NCT00235859·128 enrolled

Study Evaluating the Efficacy and Safety of Etanercept and Methotrexate in Japanese Subjects With Rheumatoid Arthritis

Completed· Pfizer logo

Pfizer·Phase 3·NCT00445770·550 enrolled

Study of Two Doses of ABX464 in Participants With Moderate to Severe Rheumatoid Arthritis

Completed·AAbivax S.A.·Phase 2·NCT03813199·60 enrolled

A Study of RoActemra/Actemra (Tocilizumab) in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Disease-Modifying Antirheumatic Drugs (DMARDs) (ALABASTER)

Completed· Roche logo

Roche·Phase 3·NCT01235507·71 enrolled

A Study of Safety and Effectiveness of Golimumab in Participants With Active Rheumatoid Arthritis Despite Methotrexate Therapy

Completed·CCentocor, Inc.·Phase 3·NCT00361335·643 enrolled

A Study to Assess the Safety and Efficacy of Tocilizumab in Patients With Active Rheumatoid Arthritis

Completed· Roche logo

Roche·Phase 3·NCT00109408·673 enrolled

Single Ascending Dose Study of Safety and Tolerability of Sarilumab and Methotrexate in Japanese Patients With Rheumatoid Arthritis

Completed· Sanofi logo

Sanofi·Phase 1·NCT01850680·61 enrolled

A Study to Assess the Effect of Tocilizumab + Methotrexate on Signs and Symptoms in Patients With Moderate to Severe Active Rheumatoid Arthritis Currently on Methotrexate Therapy

Completed· Roche logo

Roche·Phase 3·NCT00106522·499 enrolled

Effectiveness in Daily Practice of Different Treatment Strategies for Early Rheumatoid Arthritis.

Completed·PP. Verschueren·Phase 4·NCT01172639·400 enrolled

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Trial to Evaluate the Safety, Tolerability, and Efficacy of MK-8457 in Participants With Rheumatoid Arthritis (MK-8457-010)

Terminated· Merck & Co. logo

Merck & Co.·Phase 2·NCT01651936·56 enrolled

A Study of the EP4 Antagonist CR6086 in Combination With Methotrexate, in DMARD-naïve Patients With Early Rheumatoid Arthritis

Completed·RRottapharm Biotech·Phase 2·NCT03163966·248 enrolled

Psoriasis16 trials

Evaluate Whether Combination Therapy With Methotrexate and Raptiva in Psoriasis Patients is Safe and Increases Efficacy

Completed·UUniversity of California, Davis·Phase 1/2·NCT00368654·12 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

Bioavailability in Patient With Psoriasis: Metoject Prefilled Pen

Completed·Mmedac GmbH·Phase 1·NCT02097173·35 enrolled

Show 13 more trials

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

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

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

Completed·RRyszard Górecki··NCT03757364·32 enrolled

MAP Study: Methotrexate and Adalimumab in Psoriasis

Completed·JJeffrey J Crowley MD·Phase 2/3·NCT03217734·56 enrolled

Study Evaluating Etanercept and Methotrexate in Plaque Psoriasis

Completed· Pfizer logo

Pfizer·Phase 4·NCT00161655·60 enrolled

Comparative Effectiveness of Psoriasis Treatments on Systemic Inflammation

Completed·UUniversity Hospitals Cleveland Medical Center··NCT02330380·26 enrolled

Evaluation of the Effect of Narrowband UVB Versus Methotrexate on Serum Chitotriosidase Level in Psoriasis

Unknown status·—·Phase 4·NCT05427175·30 enrolled

Outcomes With Treatment and Withdraw of Ixekizumab in Patients With Plaque Psoriasis

Recruiting·SSingapore General Hospital·Phase 4·NCT04537689·40 enrolled

Mechanism of Action Study for Psoriasis

Completed·TTufts Medical Center·Phase 4·NCT00932113·33 enrolled

Comparison Study of Psoriasis Severity Assessment Tools

Completed·SSeoul National University Hospital·Phase 4·NCT02655705·34 enrolled

A Study Comparing the Safety and Efficacy of Risankizumab to Methotrexate in Subjects With Moderate to Severe Plaque Psoriasis

Completed· AbbVie logo

AbbVie·Phase 3·NCT03219437·104 enrolled

Dose Ranging Study to Compare the Efficacy and Safety of Methotrexate in Plaque Type Psoriasis

Completed·PPost Graduate Institute of Medical Education and Research, Chandigarh·Phase 4·NCT01187264·100 enrolled

Methotrexate Versus Apremilast for Pruritus in Psoriasis

Not yet recruiting·ZZarmeen Khawar·Phase 4·NCT07432386·80 enrolled

National Psoriasis Foundation - Dendritic Cell-Specific Transmembrane Protein (DC-Stamp) Biomarker Study

Completed·UUniversity of Rochester··NCT01123265·22 enrolled

Acute Lymphoblastic Leukemia15 trials

Study of Imatinib-Combined Chemotherapy for BCR-ABL-Positive Acute Lymphoblastic Leukemia (ALL)

Completed·JJapan Adult Leukemia Study Group·Phase 2·NCT00130195·100 enrolled

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

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

Combination Chemotherapy and Imatinib Mesylate in Treating Children With Relapsed Acute Lymphoblastic Leukemia

Completed·NNational Cancer Institute (NCI)·N/A·NCT00049569·126 enrolled

Show 12 more trials

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

PETHEMA LAL-RI/96: Treatment for Patients With Standard Risk Acute Lymphoblastic Leukemia

Completed·PPETHEMA Foundation·Phase 4·NCT00494897·374 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

Trial for Treatment of Adult Patients With Standard Risk Acute Lymphoblastic Leukemia With Chemotherapy and Rituximab

Completed·JJohann Wolfgang Goethe University Hospital·Phase 4·NCT00199004·60 enrolled

Chemotherapy With or Without Imatinib and/or Peripheral Stem Cell Transplant in Acute Lymphoblastic Leukemia

Completed·GGruppo Italiano Malattie EMatologiche dell'Adulto·Phase 2·NCT00458848·470 enrolled

Combination Chemotherapy in Treating Young Patients With Acute Lymphoblastic Leukemia

Unknown status·UUniversitätsklinikum Hamburg-Eppendorf·N/A·NCT00343369·550 enrolled

Chemotherapy in Treating Patients With Acute Lymphoblastic Leukemia and Diffuse Non-Hodgkin's Lymphoma

Completed·NNational Institutes of Health Clinical Center (CC)·Phase 2·NCT00018954

Combination Chemotherapy in Treating Adult Patients With Newly Diagnosed Acute Lymphoblastic Leukemia

Unknown status·OOhio State University Comprehensive Cancer Center·Phase 2·NCT01005758·180 enrolled

Pediatric-inspired Regimen Combined With Venetoclax for Adolescent and Adult Patients With de Novo Philadelphia Chromosome-Negative Acute Lymphoblastic Leukemia

Recruiting·IInstitute of Hematology & Blood Diseases Hospital, China·Phase 2·NCT05660473·100 enrolled

Chemotherapy With or Without Total-Body Irradiation Prior to Bone Marrow Transplantation in Treating Children With Acute Lymphoblastic Leukemia

Terminated·—·Phase 3·NCT00002961·43 enrolled

Combination Chemotherapy Plus Steroid Therapy in Treating Children With Acute Lymphoblastic Leukemia or Lymphoblastic Non-Hodgkin's Lymphoma

Unknown status·EEuropean Organisation for Research and Treatment of Cancer - EORTC·Phase 3·NCT00003728·1,500 enrolled

Bone Marrow Transplantation10 trials

Bone Marrow Transplantation in Treating Patients With Hematologic Cancer

Completed·FFred Hutchinson Cancer Center·Phase 2·NCT00005854

Chemotherapy Plus Bone Marrow Transplantation in Treating Patients With Refractory Non-Hodgkin's Lymphoma, Hodgkin's Disease, or Multiple Myeloma

Completed·BBarbara Ann Karmanos Cancer Institute·Phase 2·NCT00002552·40 enrolled

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

Show 7 more trials

Combination Chemotherapy With or Without Bone Marrow Transplantation in Treating Children With Acute Myeloid Leukemia

Completed·MMedical Research Council·Phase 3·NCT00003436·2,000 enrolled

Bone Marrow Transplantation in Treating Patients With Leukemia, Myelodysplasia, or Lymphoblastic Lymphoma

Completed·VVirginia Commonwealth University·Phase 2/3·NCT00003187·19 enrolled

Monoclonal Antibody Followed by Bone Marrow Transplantation in Treating Patients With Acute Myelogenous Leukemia in Remission or First Relapse

Completed·FFred Hutchinson Cancer Center·Phase 2·NCT00002554·30 enrolled

Phase II Study of Bone Marrow Transplantation Using Related Donors in Patients With Aplastic Anemia

Completed·NNational Center for Research Resources (NCRR)·Phase 2·NCT00004323·10 enrolled

Bone Marrow Transplantation With Specially Treated Bone Marrow in Treating Patients With Hematologic Cancer That Have Not Responded to Previous Therapy

Completed·—·Phase 1·NCT00005988·5 enrolled

Combination Chemotherapy Followed by Bone Marrow Transplantation in Treating Patients With Advanced Hematologic Cancer

Completed·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT00014469

Removal of T Cells to Prevent Graft-Versus-Host Disease in Patients Undergoing Bone Marrow Transplantation

Terminated·HH. Lee Moffitt Cancer Center and Research Institute·Phase 2·NCT00005641

Breast Cancer9 trials

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

Completed· Amgen logo

Amgen·Phase 2·NCT00124111

A Clinical Trial in Patients With Breast Cancer Susceptibility Gene (BRCA) Defective Tumours

Completed·UUniversity of Oxford·Phase 2·NCT01432145·74 enrolled

Combination Chemotherapy With or Without Epirubicin in Treating Women With Stage I or Stage II Breast Cancer

Completed·UUniversity Hospital Birmingham·Phase 3·NCT00003577·2,000 enrolled

Show 6 more trials

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

Tamoxifen Following Combination Chemotherapy in Treating Women With Operable Invasive Breast Cancer

Completed·SScottish Cancer Therapy Network·Phase 3·NCT00002579·2,000 enrolled

Combination Chemotherapy in Treating Women With Stage III Breast Cancer

Suspended·GGrupo Oncologico Cooperativo del Sur·Phase 3·NCT00002696

ELDA: Elderly Breast Cancer - Docetaxel in Adjuvant Treatment

Completed·NNational Cancer Institute, Naples·Phase 3·NCT00331097·300 enrolled

A Pilot Trial of Sequential Chemotherapy With Antimetabolite Induction, High-Dose Alkylating Agent Consolidation With Peripheral Blood Progenitor Cell Support, and Intensification With Paclitaxel and Doxorubicin for Patients With High-Risk Breast Cancer

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT00001498·55 enrolled

Standard Chemotherapy Compared With High-Dose Chemotherapy Plus Peripheral Stem Cell Transplant in Treating Women With Advanced or Inflammatory Breast Cancer

Unknown status·SScottish Cancer Therapy Network·Phase 3·NCT00003680·300 enrolled

74 more indications

Lymphoma8 trials

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

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

Methotrexate, Cyclophosphamide, and Etoposide Phosphate Given With Osmotic Blood-Brain Barrier Disruption Plus Dexamethasone and Cytarabine in Treating Patients With Primary CNS Lymphoma

Completed·OOHSU Knight Cancer Institute·Phase 2·NCT00074178·22 enrolled

High-Dose Chemotherapy Given Together With Peripheral Blood Stem Cell Transplant in Treating Patients With Intestinal T-Cell Lymphoma

Unknown status·CCancer Research UK·Phase 2·NCT00669812·60 enrolled

Show 5 more trials

Combination Chemotherapy in Treating Children With Non-Hodgkin's Lymphoma

Completed·UUNICANCER·Phase 3·NCT00003650·179 enrolled

Association of L-asparaginase-Methotrexate-Dexamethasone for Nasal and Nasal-type Natural Killer (NK)-T-cell Lymphoma

Completed·UUniversity Hospital, Limoges·Phase 2·NCT00283985·40 enrolled

A Phase III Randomized Trial of Low-Dose Versus Standard-Dose mBACOD Chemotherapy With rGM-CSF for Treatment of AIDS-Associated Non-Hodgkin's Lymphoma

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 3·NCT00000658·250 enrolled

Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Newly Diagnosed Aggressive Non-Hodgkin's Lymphoma

Completed·SSwiss Cancer Institute·Phase 3·NCT00003215·400 enrolled

Combination Chemotherapy in Treating Pediatric Patients With Advanced-Stage Large Cell Lymphoma

Completed·CChildren's Oncology Group·Phase 3·NCT00002618·242 enrolled

Methotrexate8 trials

Methotrexate Infusion Into Fourth Ventricle in Children With Recurrent Malignant Fourth Ventricular Brain Tumors

Completed·TThe University of Texas Health Science Center, Houston·Phase 1·NCT02458339·7 enrolled

Treatment of Early RA: Minocycline in Combination With Methotrexate vs Methotrexate Alone

Completed·UUniversity of Nebraska·Phase 3·NCT00579644·91 enrolled

A 30-month Follow-up of MERINO Participants to Evaluate Long-term Effects of Methotrexate in Erosive Hand OA.

Enrolling by invitation·—··NCT06281184·108 enrolled

Show 5 more trials

Comparison of Tofacitinib and Methotrexate in Takayasu's Arteritis

Recruiting·SShanghai Zhongshan Hospital·Phase 4·NCT05102448·76 enrolled

A Study to Investigate BMS-986165 and Methotrexate in Healthy Male Patients

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT03402087·30 enrolled

GLPG0259 Multiple Ascending Dose and Methotrexate Drug-drug Interaction (DDI) in Healthy Subjects

Completed·GGalapagos NV·Phase 1·NCT00989703·24 enrolled

Study of the Response and Cardiorespiratory Endurance in Early RA Patients Treated With Tocilizumab or Methotrexate

Completed·PPatrick Durez·N/A·NCT01245452·30 enrolled

Comparison of Disease Modifying Antirheumatic Drugs Therapy in Patients With RA Failing Methotrexate Monotherapy

Terminated·JJawaharlal Institute of Postgraduate Medical Education & Research·Phase 3·NCT02930343·136 enrolled

Leukemia5 trials

Radiolabeled BC8 Antibody, Busulfan, Cyclophosphamide Followed by Donor Stem Cell Transplant in Treating Patients With Acute Myelogenous Leukemia in First Remission

Completed·FFred Hutchinson Cancer Center·Phase 2·NCT00005940·18 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

Show 2 more trials

Combination Chemotherapy in Treating Patients With Acute B-Lymphoblastic Leukemia or Non-Hodgkin's Lymphoma

Completed·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT00002471

Combination Chemotherapy in Treating Patients With Relapsed or Refractory Acute Lymphocytic Leukemia

Unknown status·HHannover Medical School·Phase 2·NCT00002532

Treatment5 trials

PETHEMA LAL-07FRAIL: All Treatment In Fragile Patients Ph' Negative Over 55 Years

Unknown status·PPETHEMA Foundation·Phase 4·NCT01358201·100 enrolled

a Retrospective Study on the Systemic Treatment of LPP and FFA

Completed·EErasmus Medical Center··NCT06512766·315 enrolled

LAL-BR/2001: Study Treatment to Low Risk ALL

Completed·PPETHEMA Foundation·Phase 4·NCT00526175·150 enrolled

Show 2 more trials

Immune Modulation During Palynziq® Treatment in Adults (IMPALA)

Not yet recruiting· BioMarin Pharmaceutical logo

BioMarin Pharmaceutical·Phase 4·NCT07477691·12 enrolled

Treatments Against RA and Effect on FDG-PET/CT

Completed·—·Phase 4·NCT02374021·159 enrolled

Stem Cell Transplant5 trials

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

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

Busulfan and Fludarabine Before Donor Stem Cell Transplant in Treating Patients With Hematologic Cancer

Withdrawn·UUniversity of California, San Francisco·Phase 2·NCT00301912

Total-Body Irradiation and Cyclophosphamide in Treating Patients Who Are Undergoing Donor Stem Cell Transplant for Hematologic Cancer and Other Diseases

Completed·FFred Hutchinson Cancer Center·Phase 2·NCT00317785·50 enrolled

Show 2 more trials

Donor Stem Cell Transplant Followed By Donor White Blood Cell Infusions in Treating Young Patients With Hematologic Cancer

Terminated·UUniversity of California, San Francisco·N/A·NCT00301860·8 enrolled

Alemtuzumab, Fludarabine, and Busulfan Followed By Donor Stem Cell Transplant in Treating Young Patients With Hematologic Disorders

Completed·UUniversity of California, San Francisco·Phase 2·NCT00301834·35 enrolled

Central Nervous System Lymphoma5 trials

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

Show 2 more trials

Rituximab, Methotrexate, Vincristine Sulfate, Procarbazine Hydrochloride, and Cytarabine With or Without Radiation Therapy in Treating Patients With Primary Central Nervous System Lymphoma

Completed· Radiation Therapy Oncology Group logo

Radiation Therapy Oncology Group·Phase 2·NCT01399372·91 enrolled

LTA Pilot Study of Glucarpidase in Patients With Central Nervous System Lymphoma

Active, not recruiting·MMemorial Sloan Kettering Cancer Center·Phase 1·NCT03684980·58 enrolled

Pregnancy4 trials

Comparison of the Effectiveness of Single-Dose Methotrexate Protocol With Letrozole + Single-Dose Methotrexate in the Medical Treatment of Patients Diagnosed With Ectopic Pregnancy

Completed·YYuzuncu Yil University·N/A·NCT06504082·60 enrolled

Assessment of the Efficacy of Letrozole in the Treatment of Ectopic Pregnancy

Unknown status·TTehran University of Medical Sciences·Phase 1/2·NCT05918718·150 enrolled

Sequential Letrozole and Methotrexate Therapy Role in Treatment of Tubal Ectopic Pregnancy

Completed·ZZagazig University·N/A·NCT06426979·200 enrolled

Show 1 more trial

RCT for Women With a Persisting Pregnancy of Unknown Location

Terminated·UUniversity of Pennsylvania·Phase 1/2·NCT01800162·2 enrolled

Graft Versus Host Disease4 trials

Calcineurin Inhibitor-Free Interventions BMT CTN 1301 for Prevention of Graft-versus-Host Disease (BMT CTN 1301)

Completed·NNational Heart, Lung, and Blood Institute (NHLBI)·Phase 3·NCT02345850·346 enrolled

Bortezomib Plus Tacrolimus and Methotrexate to Prevent Graft Versus Host Disease (GVHD) After Mismatched Allogeneic Non-Myeloablative Blood Stem Cell Transplantation

Completed·—·Phase 1/2·NCT00369226·45 enrolled

Prevention of Graft-Versus-Host Disease in Patients With Hematologic Malignancies Who Are Receiving a Bone Marrow Transplant

Withdrawn·FFred Hutchinson Cancer Center·Phase 1/2·NCT00002790

Show 1 more 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

Bladder Cancer3 trials

S1314, Co-expression Extrapolation (COXEN) Program to Predict Chemotherapy Response in Patients With Bladder Cancer

Completed·SSWOG Cancer Research Network·Phase 2·NCT02177695·237 enrolled

Drug Screening Using IMD in Bladder Cancer

Unknown status·—·Phase 1·NCT06204614·18 enrolled

Combination Chemotherapy in Treating Patients With Bladder Cancer

Completed·EEastern Cooperative Oncology Group·Phase 3·NCT00003701·490 enrolled

Arthritis2 trials

Psoriatic Oligoarthritis Intervention With Symptomatic thErapy

Completed·UUniversity of Oxford·Phase 4·NCT03797872·1 enrolled

Multicenter Randomized Prospective Trial Comparing Methotrexate Alone or in Combination With Adalimumab in Early Arthritis

Unknown status·GGoupe d'Etudes et de Recherche Clinique En Rhumatologie·Phase 4·NCT00291915·80 enrolled

Advanced Head and Neck Cancer2 trials

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

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

Radiation Therapy With or Without Chemotherapy in Treating Patients With Advanced Head and Neck Cancer

Completed·CCancer Research UK·Phase 3·NCT00002476

Chronic Myelogenous Leukemia2 trials

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

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

Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Chronic Myelogenous Leukemia or Myelodysplastic Syndrome

Completed·FFred Hutchinson Cancer Center·Phase 2·NCT00027924

Primary Biliary Cirrhosis2 trials

Phase III Randomized Study of Ursodiol With Vs Without Methotrexate for Primary Biliary Cirrhosis

Completed·NNational Center for Research Resources (NCRR)·Phase 3·NCT00004784·315 enrolled

Ursodiol-Methotrexate for Primary Biliary Cirrhosis

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

Juvenile Idiopathic Arthritis2 trials

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

Juvenile Idiopathic Arthritis (JIA) Registry

Completed· AbbVie logo

AbbVie··NCT00783510·849 enrolled

Acute Leukemia2 trials

Comparing Post-Transplant Cyclophosphamide As GVHD Prophylaxis to Standard of Care for Acute Leukemia Patients

Recruiting·KKing Faisal Specialist Hospital & Research Center·Phase 3·NCT04314219·264 enrolled

Filgrastim-Treated Donor Peripheral Stem Cell Transplantation in Treating Patients With Acute Leukemia</p>

Completed·FFred Hutchinson Cancer Center·Phase 2·NCT00025545

Osteoarthritis1 trial

Erosive Osteoarthritis of the Hands: Treatment by Methotrexate Versus Placebo

Unknown status·—·Phase 3·NCT01068405·64 enrolled

Dermatomyositis1 trial

Understanding the Pathogenesis and Treatment of Childhood Onset Dermatomyositis

Terminated·—·Phase 2/3·NCT00035958·75 enrolled

Schizophrenia1 trial

RCT of Methotrexate Added to Treatment As Usual in Schizophrenia

Completed·PPakistan Institute of Living and Learning·Phase 1·NCT02074319·92 enrolled

Langerhans Cell Histiocytosis1 trial

Combination Chemotherapy in Treating Young Patients With Langerhans Cell Histiocytosis

Completed·HHistiocyte Society·N/A·NCT00276757·376 enrolled

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

Tocilizumab1 trial

Study to Describe Real World Drug Retention Rate of the Tocilizumab at One Year

Completed· Roche logo

Roche··NCT02608112·291 enrolled

Head and Neck Squamous Cell Cancer1 trial

LUX-Head&Neck 1: A Phase III Trial of Afatinib (BIBW2992) Versus Methotrexate for the Treatment of Recurrent and/or Metastatic (R/M) Head and Neck Squamous Cell Cancer After Platinum Based Chemotherapy

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 3·NCT01345682·483 enrolled

Giant Cell Arteritis1 trial

Phase II Randomized Study of Glucocorticoids With or Without Methotrexate for Treatment of Giant Cell Arteritis

Completed·TThe Cleveland Clinic·Phase 2·NCT00004686·300 enrolled

Acute Myeloid Leukemia1 trial

Gemtuzumab Ozogamicin in Treating Young Patients With Newly Diagnosed Acute Myeloid Leukemia Undergoing Remission Induction and Intensification Therapy

Completed·CChildren's Oncology Group·Phase 2·NCT00070174·350 enrolled

Immunotherapy1 trial

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

Withdrawn·NNorthwestern University·Phase 1·NCT00734773

Ankylosing Spondylitis1 trial

Methotrexate in Ankylosing Spondylitis (MTX in AS)

Unknown status·—·Phase 2·NCT00243750·20 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

TACE1 trial

Abatacept Post-marketing Clinical Study in Japan

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 4·NCT01758198·405 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

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

Allogeneic Stem Cell Transplantation1 trial

Planned Donor Lymphocyte Infusion (DLI) After Allogeneic Stem Cell Transplantation (SCT)

Terminated·MM.D. Anderson Cancer Center·Phase 2·NCT01518153·16 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

Interstitial Lung Disease1 trial

Effects of Tofacitinib vs Methotrexate on Rheumatoid Arthritis Interstitial Lung Disease

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

Uveitis1 trial

The Efficacy and Safety of Adalimumab in Non-infectious Anterior Pediatric Uveitis With Peripheral Vascular Leakage

Unknown status·PPeking Union Medical College Hospital·Phase 4·NCT05015335·50 enrolled

Blood Disease1 trial

Donor Peripheral Stem Cell Transplant and Donor Natural Killer Cell Transplant After Total-Body Irradiation, Thiotepa, Fludarabine, and Muromonab-CD3 in Treating Patients With Leukemia or Other Blood Diseases

Terminated·FFred Hutchinson Cancer Center·Phase 2·NCT00450983·1 enrolled

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

Mantle Cell Lymphoma1 trial

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

Myelodysplastic Syndrome1 trial

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

Asthma1 trial

Low-dose Methotrexate for Change in Global Initiative for Asthma Step 5 Medications in Chronic Severe Asthma

Unknown status·UUniversita degli Studi di Catania·Phase 3·NCT02124226·102 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

Atopic Dermatitis1 trial

Study of Methotrexate Efficacy Versus Cyclosporine in Moderate to Severe Atopic Dermatitis Patients

Completed·HHospices Civils de Lyon·Phase 3·NCT00809172·100 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

Combination Therapy1 trial

Disease-Modifying Antirheumatic Drugs Cycle Combination Therapy Research

Unknown status·SShanxi Medical University·N/A·NCT01617590·500 enrolled

Chidamide1 trial

Precision Diagnosis Directing HDACi Chidamide Target Therapy for Adult T-LBL/ALL

Unknown status·NNanfang Hospital, Southern Medical University·Phase 2/3·NCT03564704·80 enrolled

Primitive Neuroectodermal Tumor1 trial

Radiation Therapy and Combination Chemotherapy in Treating Young Patients With Medulloblastoma, Supratentorial Primitive Neuroectodermal Tumor, or Ependymoma

Completed·UUniversitätsklinikum Hamburg-Eppendorf·N/A·NCT00303810·567 enrolled

Urothelial Cancer1 trial

Gemcitabine Hydrochloride and Cisplatin or High-Dose Methotrexate, Vinblastine, Doxorubicin Hydrochloride, and Cisplatin in Treating Patients With Urothelial Cancer

Withdrawn·UUniversity of Southern California·Phase 2·NCT01639521

Ulcerative Colitis1 trial

Methotrexate in Induction and Maintenance of Steroid Free Remission in Ulcerative Colitis

Completed·UUniversity of North Carolina, Chapel Hill·Phase 2·NCT01393405·179 enrolled

Myeloproliferative Disorder1 trial

Combination Chemotherapy Plus Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Myeloproliferative Disorders

Completed·FFred Hutchinson Cancer Center·Phase 2·NCT00002792·20 enrolled

Myeloid1 trial

Myeloid-Derived Suppressor Cells and Checkpoint Immune Regulators' Expression in Allogeneic SCT Using FluBuATG

Completed·—·Phase 1·NCT02916979·20 enrolled

T-cell non-Hodgkin lymphoma1 trial

Combination Chemotherapy and Denileukin Diftitox in Treating Patients With Newly Diagnosed T-Cell Non-Hodgkin Lymphoma

Withdrawn·UUniversity of Miami·N/A·NCT00513188

Lichen Planopilaris1 trial

The Effectiveness of Hydroxychloroquine Versus Methotrexate in the Treatment of Lichen Planopilaris in Routine Clinical Care: a Patient Preference Trial

Recruiting·EErasmus Medical Center··NCT06512753·56 enrolled

Newly Diagnosed1 trial

PD-1 Inhibitor Combined With Rituximab, Methotrexate, and Orelabrutinib (PD-1i+RMO) for Newly Diagnosed PCNSL and SCNSL.

Recruiting·TThe First Affiliated Hospital with Nanjing Medical University·Phase 2·NCT07410520·50 enrolled

Refractory Solid Tumors1 trial

Donor Stem Cell Transplant in Treating Young Patients With Relapsed or Refractory Solid Tumors

Completed·MMilton S. Hershey Medical Center·Phase 1·NCT00112645·10 enrolled

Anemia1 trial

Cyclophosphamide in Treating Patients Who Are Undergoing a Donor Bone Marrow Transplant for Fanconi's Anemia

Completed·FFred Hutchinson Cancer Center·Phase 1·NCT00317876·25 enrolled

Anaplastic Large Cell Lymphoma1 trial

Combination Chemotherapy in Treating Children With Anaplastic Large Cell Lymphoma (ALCL 99)

Completed·GGustave Roussy, Cancer Campus, Grand Paris·Phase 3·NCT00006455·885 enrolled

Precursor B-Cell Acute Lymphoblastic Leukemia1 trial

Therapy for Pediatric Relapsed or Refractory Precursor B-Cell Acute Lymphoblastic Leukemia and Lymphoma

Completed·SSt. Jude Children's Research Hospital·Phase 2·NCT01700946·80 enrolled

Skin Cancer1 trial

Intralesional Versus Intramuscular Methotrexate for Non-melanoma Skin Cancers

Completed·ZZagazig University·Phase 2·NCT05315128·60 enrolled

Bone Marrow Transplant1 trial

G-CSF-Treated Donor Bone Marrow Transplant in Treating Patients With Hematologic Disorders

Terminated·OOHSU Knight Cancer Institute·N/A·NCT00253552·4 enrolled

Multiple Myeloma1 trial

Melphalan and Busulfan Followed By Donor Peripheral Stem Cell Transplant, Tacrolimus, and Methotrexate in Treating Patients With Multiple Myeloma

Completed·FFred Hutchinson Cancer Center·Phase 2·NCT00313625·20 enrolled

Alopecia Areata1 trial

Cyclosporine Or Methotrexate for Pediatric Alopecia Areata: Routine Clinical Care Effectiveness Study

Recruiting·EErasmus Medical Center·Phase 4·NCT07381556·50 enrolled

T-cell acute lymphoblastic leukemia1 trial

Adding Targeted Drugs to Usual Chemotherapy for Adults With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia (T-ALL) and T-Cell Lymphoblastic Lymphoma (T-LBL)

Withdrawn·NNational Cancer Institute (NCI)·Phase 2·NCT06210750

Ovarian Cancer1 trial

Methotrexate Plus Dipyridamole in Treating Patients With Advanced Ovarian Cancer

Unknown status·OOttawa Regional Cancer Centre·Phase 2·NCT00002487

Multiple Sclerosis1 trial

Combination Therapy With Avonex and BiMonthly High Dose Intravenous Methotrexate in Multiple Sclerosis

Completed·MMidAmerica Neuroscience Research Foundation at Rowe Neurology Institute·Phase 4·NCT00037102·16 enrolled

Vasculitis1 trial

The Effect of Some Drugs Used in Treatment of Vasculitis on the Complement System in Children

Unknown status·—·Phase 3·NCT03692416·70 enrolled

Intermediate Uveitis1 trial

Randomized, Controlled Trial to Test the Efficacy of Interferon Beta in the Treatment of Intermediate Uveitis

Completed·HHeidelberg University·Phase 3·NCT00344253·19 enrolled

Acute Graft Versus Host Disease1 trial

Methotrexate and Glucocorticoids in Treating Patients With Newly Diagnosed Acute Graft-Versus-Host Disease After Donor Stem Cell Transplant

Completed·FFred Hutchinson Cancer Center·Phase 2·NCT00357084·53 enrolled

Cervical Cancer1 trial

Radiation Therapy With or Without Chemotherapy After Surgery in Treating Patients With Stage IB or Stage IIA Cervical Cancer

Completed·EEuropean Organisation for Research and Treatment of Cancer - EORTC·Phase 3·NCT00003209·700 enrolled

Osteosarcoma1 trial

A Study of Bevacizumab in Combination With Chemotherapy for Treatment of Osteosarcoma

Completed·SSt. Jude Children's Research Hospital·Phase 2·NCT00667342·43 enrolled

Crohn's Disease1 trial

Reduce Risk for Crohn's Disease Patients

Completed·PPIBD-Net·Phase 4·NCT02852694·192 enrolled

ESS1 trial

IL-7 and IL-7R Expression in RA Patients With Active vs. Inactive Disease Treated With DMARD or CIMZIA

Completed·UUniversity of Illinois at Chicago·Phase 4·NCT02451748·32 enrolled

Unspecified2 trials

4 x Epirubicin, Cyclophosphamide, Followed by 4 x Docetaxel Versus 6 x CMF / 6 x CEF

Completed·WWest German Study Group·Phase 3·NCT02115204·2,011 enrolled

Genetic Variation in TRAF3IP2 (rs13190932)

Recruiting·SSouth Valley University·N/A·NCT07086924·50 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 — 1198 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

Mar 10, 2029

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

Q3 2027

Q4 2027

Trials by Indication[1]

Rheumatoid Arthritis31 trials

Psoriasis16 trials

Acute Lymphoblastic Leukemia15 trials

Bone Marrow Transplantation10 trials

Breast Cancer9 trials

Lymphoma8 trials

Methotrexate8 trials

Leukemia5 trials

Treatment5 trials

Stem Cell Transplant5 trials

Central Nervous System Lymphoma5 trials

Pregnancy4 trials

Graft Versus Host Disease4 trials

Bladder Cancer3 trials

Arthritis2 trials

Advanced Head and Neck Cancer2 trials

Chronic Myelogenous Leukemia2 trials

Primary Biliary Cirrhosis2 trials

Juvenile Idiopathic Arthritis2 trials

Acute Leukemia2 trials

Osteoarthritis1 trial

Dermatomyositis1 trial

Schizophrenia1 trial

Langerhans Cell Histiocytosis1 trial

Neoadjuvant Chemotherapy1 trial

Tocilizumab1 trial

Head and Neck Squamous Cell Cancer1 trial

Giant Cell Arteritis1 trial

Acute Myeloid Leukemia1 trial

Immunotherapy1 trial

Ankylosing Spondylitis1 trial

Transplantation1 trial

TACE1 trial

Ovarian Reserve1 trial

Advanced Cancer1 trial

Allogeneic Stem Cell Transplantation1 trial

Efficacy and Safety1 trial

Interstitial Lung Disease1 trial

Cancer of the Head and Neck1 trial

Uveitis1 trial

Blood Disease1 trial

Acute Promyelocytic Leukemia1 trial

Glioma1 trial

Mucous Membrane Pemphigoid1 trial

Mantle Cell Lymphoma1 trial

Myelodysplastic Syndrome1 trial

Asthma1 trial

Primary Sjögren's Syndrome (pSS)1 trial

Atopic Dermatitis1 trial

Drug1 trial

Combination Therapy1 trial

Chidamide1 trial

Primitive Neuroectodermal Tumor1 trial

Urothelial Cancer1 trial

Ulcerative Colitis1 trial

Myeloproliferative Disorder1 trial

Myeloid1 trial

T-cell non-Hodgkin lymphoma1 trial

Lichen Planopilaris1 trial

Newly Diagnosed1 trial

Refractory Solid Tumors1 trial

Anemia1 trial

Anaplastic Large Cell Lymphoma1 trial

Precursor B-Cell Acute Lymphoblastic Leukemia1 trial

Skin Cancer1 trial

Bone Marrow Transplant1 trial

Multiple Myeloma1 trial

Alopecia Areata1 trial

T-cell acute lymphoblastic leukemia1 trial

Ovarian Cancer1 trial

Multiple Sclerosis1 trial

Vasculitis1 trial