JYLAMVO (methotrexate)
JYLAMVO is indicated for the treatment of Acute Lymphoblastic Leukemia; Mycosis Fungoides; Non-Hodgkin Lymphoma; Rheumatoid Arthritis; Polyarticular Juvenile Idiopathic Arthritis; Psoriasis.
How JYLAMVO Works
Methotrexate inhibits the enzyme dihydrofolic acid reductase, which prevents the reduction of dihydrofolates to tetrahydrofolates. These tetrahydrofolates are essential one-carbon group carriers required for the synthesis of purine nucleotides and thymidylate. Consequently, the drug interferes with DNA synthesis, repair, and cellular replication. Actively proliferating tissues, such as malignant cells, are generally more sensitive to this effect. The exact mechanism of action in the treatment of rheumatoid arthritis and psoriasis is unknown.
Details
- Status
- Prescription
- First Approved
- 2022-11-29
- Patent Cliff
- 2035
- Routes
- ORAL
- Dosage Forms
- SOLUTION
JYLAMVO Approval History
What JYLAMVO Treats
6 indicationsJYLAMVO is approved for 6 conditions since its original approval in 2022. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Acute Lymphoblastic Leukemia
- Mycosis Fungoides
- Non-Hodgkin Lymphoma
- Rheumatoid Arthritis
- Polyarticular Juvenile Idiopathic Arthritis
- Psoriasis
JYLAMVO Boxed Warning
EMBRYO-FETAL TOXICITY, HYPERSENSITIVITY REACTIONS AND SEVERE ADVERSE REACTIONS Methotrexate can cause embryo-fetal toxicity, including fetal death. For non-neoplastic diseases, Jylamvo is contraindicated in pregnancy. For neoplastic diseases, advise females and males of reproductive potential to use effective contraception during and after treatment with Jylamvo [see Contraindications (4), Warnings and Precautions (5.1), Use in Specific Populations (8.1, 8.3) ] . Jylamvo is contraindicated in pa...
WARNING: EMBRYO-FETAL TOXICITY, HYPERSENSITIVITY REACTIONS AND SEVERE ADVERSE REACTIONS Methotrexate can cause embryo-fetal toxicity, including fetal death. For non-neoplastic diseases, Jylamvo is contraindicated in pregnancy. For neoplastic diseases, advise females and males of reproductive potential to use effective contraception during and after treatment with Jylamvo [see Contraindications (4), Warnings and Precautions (5.1), Use in Specific Populations (8.1, 8.3) ] . Jylamvo is contraindicated in patients with a history of severe hypersensitivity reactions to methotrexate, including anaphylaxis [ Contraindications (4), Warnings and Precautions (5.2) ] . Serious adverse reactions, including death, have been reported with methotrexate. Closely monitor for infections and adverse reactions of the bone marrow, gastrointestinal tract, liver, lungs, skin, and kidneys. Withhold or discontinue Jylamvo as appropriate [ Warnings and Precautions (5.3, 5.4, 5.5, 5.6, 5.7, 5.8, 5.11) ] . WARNING: EMBRYO-FETAL TOXICITY, HYPERSENSITIVITY REACTIONS, AND SEVERE ADVERSE REACTIONS See full prescribing information for complete boxed warning. Methotrexate can cause embryo-fetal toxicity, including fetal death. For non-neoplastic diseases, Jylamvo is contraindicated in pregnancy. For neoplastic diseases, advise patients of reproductive potential of the potential risk to a fetus and to use effective contraception during and after treatment with Jylamvo ( 4, 5.1, 8.1, 8.3 ). Jylamvo is contraindicated in patients with a history of severe hypersensitivity reactions to methotrexate, including anaphylaxis ( 4, 5.2 ). Serious adverse reactions, including death, have been reported with methotrexate. Closely monitor for infections and adverse reactions of the bone marrow, gastrointestinal tract, liver, lungs, skin, and kidneys. Withhold or discontinue Jylamvo as appropriate ( 5.3, 5.4, 5.5, 5.6, 5.7, 5.8, 5.11 ).
JYLAMVO Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in JYLAMVO's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications JYLAMVO treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to JYLAMVO
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
517 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04530565 | NCI-2020-06381 NCI-2020-06381, EA9181 | Ph 3 | active not recruiting | Testing the Use of Steroids and Tyrosine Kinase Inhibitors With Blinatumomab or Chemotherapy for Newly Diagnosed BCR-ABL-Positive Acute Lymphoblastic Leukemia in Adults |
| NCT04628767 | NCI-2020-09850 NCI-2020-09850, EA8192 | Ph 2, Ph 3 | recruiting | Testing the Addition of MEDI4736 (Durvalumab) to Chemotherapy Before Surgery for Patients With High-Grade Upper Urinary Tract Cancer |
| NCT06124157 | NCI-2023-09214 NCI-2023-09214, AALL2131 | Ph 2 | recruiting | A Study Testing the Combination of Dasatinib or Imatinib to Chemotherapy Treatment With Blinatumomab for Children, Adolescents, and Young Adults With Philadelphia Chromosome Positive (Ph+) or ABL-Class Philadelphia Chromosome-Like (Ph-Like) B-cell Acute Lymphoblastic Leukemia (B-ALL) |
| NCT05691478 | NCI-2022-08567 NCI-2022-08567, AOST2032 | Ph 2, Ph 3 | recruiting | A Study to Test the Addition of the Drug Cabozantinib to Chemotherapy in Patients With Newly Diagnosed Osteosarcoma |
| NCT03808610 | 2016-0629 NCI-2018-03360, 2016-0629 | Ph 1, Ph 2 | terminated | Low-Intensity Chemotherapy and Venetoclax in Treating Patients With Relapsed or Refractory B- or T-Cell Acute Lymphoblastic Leukemia |
| NCT06317662 | NCI-2024-01994 NCI-2024-01994, AALL2321 | Ph 2 | recruiting | Testing the Addition of the Anti-cancer Drug Venetoclax and/or the Anti-cancer Immunotherapy Blinatumomab to the Usual Chemotherapy Treatment for Infants With Newly Diagnosed KMT2A-rearranged or KMT2A-non-rearranged Leukemia |
| NCT03286634 | ASIA-DS-ALL-2016 | Ph 2 | active not recruiting | ASIA Down Syndrome Acute Lymphoblastic Leukemia 2016 |
| NCT06997068 | MC240701 24-009083 | Ph 2 | recruiting | Methotrexate, Erlotinib, and Celecoxib for the Treatment of Recurrent/Metastatic Head and Neck Cancer in a Rural Midwest United States Population |
| NCT03150693 | A041501 NCI-2016-01981, U10CA180821 | Ph 3 | recruiting | Inotuzumab Ozogamicin and Frontline Chemotherapy in Treating Young Adults With Newly Diagnosed B Acute Lymphoblastic Leukemia |
| NCT04609046 | NCI-2020-08331 NCI-2020-08331, A051901 | Ph 1 | recruiting | Testing the Addition of Lenalidomide and Nivolumab to the Usual Treatment for Primary CNS Lymphoma |
| NCT07446400 | 359-201-00015 | Ph 1 | recruiting | A Trial to Examine the Interaction of Repinatrabit With Ethinyl Estradiol/Norethindrone, Metformin,Carbamazepine, Rosuvastatin, and Methotrexate When Administered Together |
| NCT04872790 | STUDY00022691 NCI-2021-01791, STUDY00022691 | Ph 1 | active not recruiting | 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 |
| NCT04043494 LBL 2018 | UKM17_0023 2017-001691-39 | Ph 3 | recruiting | International Cooperative Treatment Protocol for Children and Adolescents With Lymphoblastic Lymphoma |
| NCT07498465 | PEPN2513 NCI-2026-01768, PEPN2513 | Ph 1 | withdrawn | A Study to Find the Highest Dose of SNDX-5613 (Revumenib) as a Treatment Option After Hematopoietic Stem Cell Transplant in Children With Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia, and Mixed Phenotype Acute Leukemia |
| NCT04293562 | AAML1831 NCI-2020-00546, AAML1831 | Ph 3 | recruiting | A Study to Compare Standard Chemotherapy to Therapy With CPX-351 and/or Gilteritinib for Patients With Newly Diagnosed AML With or Without FLT3 Mutations |
| NCT07432815 | MS-98-2025 | Ph 4 | recruiting | Treatment of Psoriasis With Depression and/or Anxiety With Methotrexate vs Combined Methotrexate and Antidepressant |
| NCT03593759 CHASM-CS-RCT | UOttawaHI | Ph 3 | recruiting | Cardiac Sarcoidosis Randomized Trial |
| NCT03959085 | AALL1732 NCI-2019-02845, AALL1732 | Ph 3 | recruiting | Inotuzumab Ozogamicin and Post-Induction Chemotherapy in Treating Patients With High-Risk B-ALL, Mixed Phenotype Acute Leukemia, and B-LLy |
| NCT02112916 results posted | NCI-2014-00712 NCI-2014-00712, s14-01925 | Ph 3 | active not recruiting | Combination Chemotherapy With or Without Bortezomib in Treating Younger Patients With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia or Stage II-IV T-Cell Lymphoblastic Lymphoma |
| NCT06231745 | 314879 | Ph 3 | completed | Paroxetine Safety and Efficacy in Rheumatoid Arthritis |
| NCT02101853 results posted | NCI-2014-00631 NCI-2014-00631, s15-00970 | Ph 3 | active not recruiting | Blinatumomab in Treating Younger Patients With Relapsed B-cell Acute Lymphoblastic Leukemia |
| NCT03914625 | NCI-2019-02187 NCI-2019-02187, AALL1731 | Ph 3 | active not recruiting | A Study to Investigate Blinatumomab in Combination With Chemotherapy in Patients With Newly Diagnosed B-Lymphoblastic Leukemia |
| NCT02883049 results posted | NCI-2011-03797 NCI-2011-03797, S12-01254 | Ph 3 | active not recruiting | Combination Chemotherapy in Treating Young Patients With Newly Diagnosed High-Risk B Acute Lymphoblastic Leukemia and Ph-Like TKI Sensitive Mutations |
| NCT02981628 | AALL1621 NCI-2016-01494, AALL1621 | Ph 2 | recruiting | Inotuzumab Ozogamicin in Treating Younger Patients With B-Lymphoblastic Lymphoma or Relapsed or Refractory CD22 Positive B Acute Lymphoblastic Leukemia |
| NCT07388498 | 20230219 | Ph 3 | recruiting | A Double-blind, Randomized Controlled Trial to Investigate the Efficacy, Safety, and Pharmacokinetics of Pegloticase Administration Via Subcutaneous and Intravenous Routes Both With Methotrexate in Participants With Uncontrolled Gout |
| NCT06177067 | RAVAML NCI-2023-10509 | Ph 1 | recruiting | Study of Revumenib, Azacitidine, and Venetoclax in Pediatric and Young Adult Patients With Refractory or Relapsed Acute Myeloid Leukemia |
| NCT03007147 | AALL1631 NCI-2016-01588, AALL1631 | Ph 3 | active not recruiting | Imatinib Mesylate and Combination Chemotherapy in Treating Patients With Newly Diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia |
| NCT02003222 results posted | NCI-2013-02229 NCI-2013-02229, ECOG-E1910 | Ph 3 | active not recruiting | Combination Chemotherapy With or Without Blinatumomab in Treating Patients With Newly Diagnosed BCR-ABL-Negative B Lineage Acute Lymphoblastic Leukemia |
| NCT06289673 | INITIALL NCI-2024-01659 | Ph 4 | recruiting | Identification of Necessary Information for Treatment Induction in Newly Diagnosed Acute Lymphoblastic Leukemia/Lymphoma |
| NCT06390319 | SJALL23T NCI-2024-03015 | Ph 2 | recruiting | Adding Dasatinib Or Venetoclax To Improve Responses In Children With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia (ALL) Or Lymphoma (T-LLY) Or Mixed Phenotype Acute Leukemia (MPAL) |
| NCT06533748 | SJALL23H NCI-2024-06013 | Ph 2 | recruiting | Therapy for Newly Diagnosed Patients With B-Cell Precursor Acute Lymphoblastic Leukemia and Lymphoma |
| NCT03206671 B-NHL 2013 | UKM12_0020 2013-003253-21 | Ph 3 | active not recruiting | Treatment Protocol of the NHL-BFM and the NOPHO Study Groups for Mature Aggressive B-cell Lymphoma and Leukemia in Children and Adolescents |
| NCT03964090 | 190103 19-C-0103 | Ph 2 | active not recruiting | Temozolomide, Etoposide, Doxil, Dexamethasone, Ibrutinib, and Rituximab (TEDDI-R) in Aggressive B-cell Lymphomas With Secondary Involvement of the Central Nervous System (CNS) |
| NCT00558519 results posted | CALGB-10403 CALGB-10403, ECOG C10403 | Ph 2 | completed | Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Acute Lymphoblastic Leukemia |
| NCT04898894 | SELCLAX NCI-2021-03435 | Ph 1 | active not recruiting | Study of Selinexor and Venetoclax in Combination With Chemotherapy in Pediatric and Young Adult Patients With Refractory or Relapsed Acute Myeloid Leukemia |
| NCT02203526 | 140157 14-C-0157 | Ph 1 | active not recruiting | Phase 1 Study of Ibrutinib and Immuno-Chemotherapy Using Temozolomide, Etoposide, Doxil, Dexamethasone, Ibrutinib,Rituximab (TEDDI-R) in Primary CNS Lymphoma |
| NCT07176390 | 7240-014 U1111-1320-8718, 2025-521745-25-00 | Ph 2 | recruiting | A Clinical Study of Tulisokibart (MK-7240) to Treat Rheumatoid Arthritis (RA) (MK-7240-014) |
| NCT04960579 MM | P-BCMA-ALLO1-001 XO44788 | Ph 1 | active not recruiting | P-BCMA-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With Multiple Myeloma |
| NCT05645718 | 2022-0312 NCI-2022-10168 | Ph 2 | recruiting | Study of Pedi-cRIB: Mini-Hyper-CVD With Condensed Rituximab, Inotuzumab Ozogamicin and Blinatumomab (cRIB) for Relapsed Therapy for Pediatric With B-Cell Lineage Acute Lymphocytic Leukemia |
| NCT06960577 | D933RC00002 | Ph 3 | recruiting | Perioperative Durvalumab With Neoadjuvant ddMVAC or Gemcitabine/Cisplatin in Patients With Muscle-invasive Bladder Cancer (NIAGARA-2) |
| NCT07543640 | MS-506-2024 | Ph 2 | not yet recruiting | EFFICACY OF ROFLUMILAST IN THE TREATMENT OF FLEXURAL AND/OR GENITAL PSORIASIS: A RANDOMIZED CONTROLLED TRIAL. |
| NCT05761171 | AALL2121 NCI-2023-00503, AALL2121 | Ph 2 | active not recruiting | A Study of Revumenib in Combination With Chemotherapy for Patients Diagnosed With Relapsed or Refractory Leukemia |
| NCT05848687 | IRB-68271 PEDSHEMALL0015, NCI-2023-04129 | Ph 1, Ph 2 | recruiting | TINI 2: Total Therapy for Infants With Acute Lymphoblastic Leukemia II |
| NCT05519579 | NSH 1354 | Ph 2 | recruiting | Intrathecal Chemoprophylaxis to Prevent Neurotoxicity Associated With Blinatumomab Therapy for Acute Lymphoblastic Leukemia |
| NCT06247787 | PEPN2312 NCI-2023-11026, PEPN2312 | Ph 1 | recruiting | A Study to Find the Highest Dose of Imetelstat in Combination With Fludarabine and Cytarabine for Patients With AML, MDS or JMML That Has Come Back or Does Not Respond to Therapy |
| NCT07361133 | MO 2504-505-120-198 | Ph 2 | not yet recruiting | Cyclophosphamide and Etoposide as a Metronomic Therapy in Advanced Head and Neck Squamous Cell Cancer |
| NCT01424982 | 2011-0030 NCI-2011-02941, 2011-0030 | Ph 2 | active not recruiting | Combination Chemotherapy and Ponatinib Hydrochloride in Treating Patients With Acute Lymphoblastic Leukemia |
| NCT04384692 | RG1006507 NCI-2020-01626, 10093 | Ph 2 | active not recruiting | Peritransplant Ruxolitinib for Patients With Primary and Secondary Myelofibrosis |
| NCT05998642 | I244 | Ph 2 | recruiting | Ibrutinib Combination Therapy in Transplant Ineligible Individuals With Newly Diagnosed Primary CNS Lymphoma |
| NCT04216524 | 2019-0587 NCI-2019-08358, 2019-0587 | Ph 2 | recruiting | Venetoclax, SL-401, and Chemotherapy for the Treatment of Blastic Plasmacytoid Dendritic Cell Neoplasm |
Showing 50 of 517 trials
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
JYLAMVO FDA Label Details
Indications & Usage
FDA Label (PDF)JYLAMVO is indicated for the treatment of Acute Lymphoblastic Leukemia; Mycosis Fungoides; Non-Hodgkin Lymphoma; Rheumatoid Arthritis; Polyarticular Juvenile Idiopathic Arthritis; Psoriasis.
WARNING: EMBRYO-FETAL TOXICITY, HYPERSENSITIVITY REACTIONS AND SEVERE ADVERSE REACTIONS Methotrexate can cause embryo-fetal toxicity, including fetal death. For non-neoplastic diseases, Jylamvo is contraindicated in pregnancy. For neoplastic diseases, advise females and males of reproductive potenti...
JYLAMVO Patents & Exclusivity
Patents (2 active)
Pro Intelligence Preview
Deep insights for JYLAMVO
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2035
- • 24 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.