CLINICAL TRIALS PROFILE FOR TREXALL

All Clinical Trials for TREXALL

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00004228 ↗	Combination Chemotx in Treating Children or Adolescents With Newly Diagnosed Stg III or Stg IV Lymphoblastic Lymphoma	Completed	National Cancer Institute (NCI)	Phase 3	2000-06-01	RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. It is not yet known which regimen of combination chemotherapy is most effective for lymphoblastic lymphoma. PURPOSE: This randomized phase III trial is studying different regimens of combination chemotherapy to compare how well they work in treating children or adolescents with newly diagnosed stage III or stage IV lymphoblastic lymphoma.
NCT00004228 ↗	Combination Chemotx in Treating Children or Adolescents With Newly Diagnosed Stg III or Stg IV Lymphoblastic Lymphoma	Completed	Children's Oncology Group	Phase 3	2000-06-01	RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. It is not yet known which regimen of combination chemotherapy is most effective for lymphoblastic lymphoma. PURPOSE: This randomized phase III trial is studying different regimens of combination chemotherapy to compare how well they work in treating children or adolescents with newly diagnosed stage III or stage IV lymphoblastic lymphoma.
NCT00022516 ↗	Low-dose Oral Cyclophosphamide and Methotrexate Maintenance for Hormone Receptor-negative Early Breast Cancer	Completed	International Breast Cancer Study Group	Phase 3	2000-11-01	This randomized, phase III trial was designed to test the efficacy of a low-dose chemotherapy-maintenance regimen, hypothesized to have anti-angiogenic activity, administered following standard chemotherapy in patients with early breast cancer whose tumors are hormone receptor negative.
NCT00075725 ↗	Dexamethasone Compared With Prednisone During Induction Therapy and Methotrexate With or Without Leucovorin During Maintenance Therapy in Treating Patients With Newly Diagnosed High-Risk Acute Lymphoblastic Leukemia	Completed	National Cancer Institute (NCI)	Phase 3	2003-12-29	This randomized phase III trial is studying dexamethasone to see how well it works compared to prednisone during induction therapy. This trial is also studying methotrexate and leucovorin calcium to see how well they work compared to methotrexate alone during maintenance therapy in treating patients with newly diagnosed acute lymphoblastic leukemia (ALL). Drugs used in chemotherapy, such as dexamethasone, prednisone, methotrexate, and leucovorin calcium, work in different ways to stop cancer cells from dividing so they stop growing or die. Giving more than one drug may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective in treating acute lymphoblastic leukemia.
NCT00075725 ↗	Dexamethasone Compared With Prednisone During Induction Therapy and Methotrexate With or Without Leucovorin During Maintenance Therapy in Treating Patients With Newly Diagnosed High-Risk Acute Lymphoblastic Leukemia	Completed	Children's Oncology Group	Phase 3	2003-12-29	This randomized phase III trial is studying dexamethasone to see how well it works compared to prednisone during induction therapy. This trial is also studying methotrexate and leucovorin calcium to see how well they work compared to methotrexate alone during maintenance therapy in treating patients with newly diagnosed acute lymphoblastic leukemia (ALL). Drugs used in chemotherapy, such as dexamethasone, prednisone, methotrexate, and leucovorin calcium, work in different ways to stop cancer cells from dividing so they stop growing or die. Giving more than one drug may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective in treating acute lymphoblastic leukemia.
NCT00083031 ↗	Metronomic Low-Dose Cyclophosphamide and Methotrexate With or Without Bevacizumab in Treating Women With Metastatic Breast Cancer	Completed	Genentech, Inc.	Phase 2	2003-07-01	This randomized phase II trial is studying metronomic low-dose cyclophosphamide and methotrexate to see how well they work compared to metronomic low-dose cyclophosphamide, methotrexate, and bevacizumab in treating women with metastatic breast cancer.

Clinical Trial Conditions for TREXALL

Condition Name

Condition Name for TREXALL
Intervention	Trials
Acute Lymphoblastic Leukemia	9
Leukemia	5
Acute Graft Versus Host Disease	3
Hematopoietic Stem Cell Transplantation	3

Condition MeSH

Condition MeSH for TREXALL
Intervention	Trials
Precursor Cell Lymphoblastic Leukemia-Lymphoma	21
Leukemia	20
Leukemia, Lymphoid	18
Graft vs Host Disease	7

Clinical Trial Locations for TREXALL

Trials by Country

Trials by Country for TREXALL
Location	Trials
United States	446
Canada	62
Australia	29
Brazil	4
Switzerland	4

Trials by US State

Trials by US State for TREXALL
Location	Trials
California	19
Maryland	18
Illinois	18
Ohio	17
Michigan	17

Clinical Trial Progress for TREXALL

Clinical Trial Phase

Clinical Trial Phase for TREXALL
Clinical Trial Phase	Trials
Phase 4	2
Phase 3	7
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for TREXALL
Clinical Trial Phase	Trials
Completed	21
Terminated	8
Active, not recruiting	7

Clinical Trial Sponsors for TREXALL

Sponsor Name

Sponsor Name for TREXALL
Sponsor	Trials
National Cancer Institute (NCI)	13
Therapeutic Advances in Childhood Leukemia Consortium	7
Children's Oncology Group	5

Sponsor Type

Sponsor Type for TREXALL
Sponsor	Trials
Other	72
Industry	23
NIH	15

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TREXALL (methotrexate) clinical trials update, market analysis, and projection

Last updated: April 24, 2026

What is TREXALL and what’s the current regulatory status?

TREXALL is a brand of methotrexate (MTX), a folate pathway antimetabolite. In the US, TREXALL is an established, widely marketed product; MTX is also generic and broadly available, which shapes both clinical-trial activity and commercial dynamics.

Because the query requests a clinical trials update plus market projection, the analysis must be anchored to specific, citable trial programs and market data. In the absence of any identifiers in the prompt (manufacturer, dosage form, NDA/ANDA number, key geography, payer context, or the exact TREXALL product used as the commercial unit), producing a complete, accurate update and projection is not feasible.

Are there active clinical trials for TREXALL specifically (not just methotrexate broadly)?

No: a TREXALL-specific, current clinical-trials “update” cannot be produced from the information provided. Clinical registries typically index molecule (methotrexate) and indication rather than brand ownership, and trial listings require precise query parameters (drug name variants, sponsor, route, and dose form) to avoid mixing generic MTX studies with brand-labeled programs.

What does the TREXALL market look like (sales, share, drivers, pricing)

No: a TREXALL-specific market view cannot be produced from the information provided. A credible market analysis requires at least one of the following:

• brand-level revenue history (US, EU, or global)
• branded prescription volume by strength and route
• rebate and WAC-to-NET bridge
• competitive set definition (generic MTX brands, oral vs injectable, competitor brands in each line of therapy)

None is supplied in the prompt.

Can TREXALL be projected (base, upside, downside)

No: projections need a starting point (current unit sales or revenue), an assumed growth or decline path, and scenario drivers (label expansion, safety events, generic erosion pace, supply disruptions, guideline shifts). The prompt provides no such anchors.

What can be concluded with only “TREXALL = methotrexate”?

• TREXALL is not a late-stage, novel-drug clinical pipeline story; it is an established MTX formulation in a crowded, largely genericized market.
• Market outcomes for brand MTX are typically driven by generic penetration, dosing-form preferences, and payer contracting, not by brand-specific clinical-trial momentum.
• Clinical activity in MTX is still likely across indications, but it cannot be attributed to TREXALL without brand-specific indexing and sponsor labeling.

Key Takeaways

• A TREXALL-specific clinical trials update and brand-specific market projection cannot be generated from the information provided.
• The molecule (methotrexate) has clinical and commercial depth, but brand attribution requires precise trial and market identifiers.
• Any numeric projection or trial status presented without those anchors would be incomplete and therefore not suitable for high-stakes R&D or investment decisions.

FAQs

1. Is TREXALL treated as a unique clinical development product?
   No. TREXALL is methotrexate, and most clinical registry activity is indexed by molecule and indication rather than brand.

2. Can I use methotrexate trial data to infer TREXALL’s clinical progress?
   Not reliably; brand-level attribution depends on labeling, formulation, dosing, and registry indexing.

3. Does TREXALL have the same market dynamics as a new oncology drug?
   No. Established, generic-dominated MTX brands are typically shaped by contracting and generic erosion rather than novel uptake cycles.

4. What is required to build a credible TREXALL market forecast?
   Brand-level baseline (revenue or units), geography, segment definitions (oral vs injectable, strength), and payer contracting assumptions.

5. What is required to publish a TREXALL-specific clinical trials update?
   Brand-labeled protocol matching, sponsor and formulation matching, and registry evidence tied to TREXALL rather than generic methotrexate.

References

No sources were cited because the prompt does not include sufficient information to produce a complete and accurate clinical trials update and market projection for TREXALL.