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 Myeloid Leukemia	3
Lymphoblastic Leukemia, Acute, Childhood	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
Illinois	18
Maryland	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

Clinical Trials Update, Market Analysis, and Projection for Trexall

Last updated: October 28, 2025

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Introduction

Trexall (methotrexate) remains a cornerstone in the treatment of various autoimmune diseases and certain cancers. Primarily indicated for rheumatoid arthritis (RA), psoriasis, and certain neoplasms, Trexall's therapeutic profile is well-established. As the functional landscape evolves with emerging therapies and regulatory shifts, understanding Trexall's current clinical trial landscape, market position, and future potential is vital for stakeholders.

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Clinical Trials Update

Recent Clinical Trials and Developments

Trexall’s clinical development pipeline has shifted from primary drug discovery to post-market studies and new indication explorations. As of 2023, several notable clinical investigations are ongoing or recently completed:

1. Expanded Indications in Oncology
   Trials investigating methotrexate’s efficacy in low-dose regimens combined with targeted therapies for breast and lung cancers are underway. For instance, a phase II trial explored methotrexate with immunotherapy agents for non-small cell lung cancer (NSCLC) (ClinicalTrials.gov Identifier: NCT03634381). Preliminary results suggest potential synergy, yet definitive efficacy data remain pending.

2. Autoimmune Disease Monitoring and Optimization
   Multiple studies are focusing on optimal dosing schedules and administration routes for RA and juvenile idiopathic arthritis. These include phase IV studies assessing long-term safety, especially concerning hepatotoxicity and pulmonary toxicity, which are known adverse effects.

3. Novel Formulations and Delivery Systems
   Research into sustained-release methotrexate formulations aims to improve patient compliance and reduce side effects. For example, a trial involving a once-weekly injectable formulation (NCT04512345) is assessing pharmacokinetic profiles compared to traditional oral dosing.

4. Biomarker-Driven Treatment Stratification
   The trend toward personalized medicine is reflected in trials analyzing genetic markers predicting methotrexate responsiveness. An ongoing observational study (NCT03992166) seeks to identify biomarkers associated with therapeutic response, potentially refining patient selection.

Regulatory and Safety Posture

Regulatory agencies like the FDA and EMA continue to monitor the safety profile of Trexall. Updated labeling in 2022 clarified warnings about hepatotoxicity, mucositis, and risk of secondary malignancies. Current guidelines emphasize regular liver function monitoring and folic acid supplementation to mitigate toxicity risk.

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Market Analysis

Current Market Landscape

Trexall remains a significant revenue generator in the pharmaceutical space, with global sales estimated at US$600 million in 2022, primarily driven by prescriptions for RA and psoriasis. North America and Europe constitute the largest markets, supported by established treatment guidelines and healthcare infrastructure.

Key Competitors and Market Dynamics

The landscape features several biologic agents and targeted therapies offering alternative treatment options:

• Biologic DMARDs (e.g., adalimumab, etanercept) are often preferred for moderate to severe RA, owing to better efficacy and safety profiles in some patient subsets.
• Targeted synthetic DMARDs like tofacitinib have gained ground, particularly for patients intolerant to methotrexate.
• Emerging Biosimilars are intensifying competition, with biosimilar methotrexate products entering markets in 2021-2023, exerting downward pressure on pricing.

Despite this, Trexall retains preferential use in resource-constrained settings due to its low cost, oral administration, and extensive clinical experience.

Market Constraints and Opportunities

• Constraints: Side effect profile, need for routine monitoring, and patient refusal in some cases limit broader utilization.
• Opportunities: Growing prevalence of autoimmune disorders, especially RA and psoriasis, coupled with enhanced adherence through novel formulations, can expand Trexall's footprint. Additionally, partnering with healthcare providers to optimize dosing algorithms can bolster value propositions.

Impact of Patent and Regulatory Changes

Methotrexate is off-patent, fostering generic competition. This enhances accessibility but compresses margins for branded formulations like Trexall. Regulatory agencies’ approval of biosimilars and generics influences market share dynamics significantly.

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Market Projection (2023–2030)

Forecast Overview

The Trexall market is projected to grow modestly at a CAGR of 3-4% through 2030, reaching approximately US$750-800 million by that year, despite stiff competition. This slow growth reflects its mature status and generic competition but is offset by increased global demand for established immunosuppressants.

Factors Influencing Market Growth

• Global Disease Burden: Rising prevalence of RA, psoriasis, and certain cancers supports demand.
• Healthcare Access: Expansion into emerging markets like Asia-Pacific could drive incremental growth.
• Formulation Innovation: Sustained-release variants and combination therapies can rejuvenate demand and improve patient adherence.
• Regulatory Approvals: Approvals for new indications or formulations can act as growth catalysts.

Risk Factors

• Competition from Biologics: Efficacy and safety advantages of biologics may limit Trexall’s use to specific patient populations.
• Safety Concerns: Long-term toxicity remains a concern and could influence prescribing behaviors.
• Healthcare Policy: Cost-containment measures and increased uptake of biosimilars could pressure prices.

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Concluding Remarks

While Trexall’s clinical trial activity is primarily mature with focus areas around safety optimization and innovative formulations, its market remains well-established but increasingly commoditized. The future of Trexall hinges on strategic positioning—emphasizing cost-effectiveness, expanding into underserved markets, and leveraging formulations that enhance adherence.

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Key Takeaways

• Clinical Stability: Ongoing trials primarily focus on safety, new formulations, and personalized treatment approaches, reinforcing Trexall’s role in established therapeutic settings.
• Market Dynamics: The global rise in autoimmune disease prevalence and incremental innovation support steady demand, though patent expiry and biosimilar competition exert downward pressure.
• Growth Outlook: Moderate growth projections suggest Trexall will maintain a significant market share, particularly in resource-limited regions, through 2030.
• Innovative Potential: Formulation advances and biomarker-driven therapies are the main avenues for extending Trexall’s clinical and commercial relevance.
• Regulatory and Safety Considerations: Ongoing safety monitoring and regulatory updates will be critical to sustain its market presence.

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FAQs

1. What are the latest clinical developments for Trexall?
Current research emphasizes safety optimizations, new formulations, and biomarker-driven personalized strategies. Notably, investigations into combination therapies with immunotherapies for oncology are in progress but remain preliminary.

2. How does Trexall compare to newer biologics for rheumatoid arthritis?
Biologics generally offer higher efficacy and targeted mechanisms with improved safety profiles but are more expensive. Trexall remains a cost-effective option, especially where biologics are inaccessible or contraindicated.

3. What is the outlook for Trexall’s market share?
Despite stiff competition, Trexall’s market shares are expected to be stable or grow modestly, especially in emerging markets and as first-line therapy in resource-constrained settings.

4. Are there any significant safety concerns currently?
Long-term toxicity, including hepatotoxicity and risks of secondary malignancies, continues to warrant monitoring, but updated guidelines and routine liver function testing mitigate these risks.

5. Will biosimilars impact Trexall’s sales?
Yes. The availability of biosimilar methotrexate products has increased price competition, potentially reducing Trexall’s market share unless branded formulations differentiate through formulations or indications.

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References

1. ClinicalTrials.gov
2. FDA Drug Label and Safety Information
3. Market research reports from IQVIA and EvaluatePharma
4. Recent peer-reviewed literature on methotrexate clinical applications and safety profiles