CLINICAL TRIALS PROFILE FOR IFOSFAMIDE; MESNA

505(b)(2) Clinical Trials for ifosfamide; mesna

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Combination	NCT01884428 ↗	Study of Combination of PIGEV Before Autologous Stem Cell Transplant in Patients With Hodgkin's Lymphoma	Unknown status	Armando Santoro, MD	Phase 1	2011-07-01	study to assess maximum tolerated dose (MTD), safety, tolerability and activity of IGEV (Ifosfamide, Gemcitabine,Vinorelbine, Prednisolone) + Panobinostat new combination in order to determine the recommended phase II dose

All Clinical Trials for ifosfamide; mesna

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00001209 ↗	A Pilot Study for the Treatment of Patients With Metastatic and High Risk Sarcomas and Primitive Neuroectodermal Tumors	Completed	National Cancer Institute (NCI)	Phase 1	1986-10-01	This protocol is designed to test the feasibility of the administration of vincristine, adriamycin and cytoxan, alternating with the newly developed regimen ifosfamide VP-16 as well as the efficacy of this therapy in addition to radiotherapy in producing complete responses and disease-free survival in patients with Ewing's sarcoma, primitive sarcoma of bone, peripheral neuroepithelioma, and soft tissue sarcoma. This will not be a randomized study but will be comparable to the large data base of similar patients treated on successive Pediatric Branch studies.
NCT00001270 ↗	Feasibility Study of Interleukin 1-Alpha With Ifosfamide, CBDCA, and Etoposide With Autologous Bone Marrow Transplant in Metastatic Carcinoma and Lymphoma	Completed	National Cancer Institute (NCI)	Phase 1	1991-06-01	This is a phase I/II study of interleukin-1, G-CSF and high dose ICE chemotherapy with autologous bone marrow transplant in patients with relapsed breast, testicular and lymphoid cancers. The initial goal of this study was to define the toxicity of interleukin-1 administered for 7 days prior to ICE chemotherapy. A total of 22 patients have been treated with IL-1 and ICE and results showed a more rapid engraftment (4.5 days) with IL-1. A second cohort of 18 patients also received G-CSF and engraftment was further shortened in some subgroups. Overall, the median time to engraftment was 16 days with both IL-1 and G-CSF. Accrual will continue to further define the toxicity and efficacy of this regimen.
NCT00001300 ↗	A Randomized Study of the Effect of Adjuvant Chemotherapy With Doxorubicin and Ifosfamide With Mesna in the Treatment of High-Grade Adult Extremity Soft Tissue Sarcoma	Completed	National Cancer Institute (NCI)	Phase 3	1992-06-01	Randomized study. All patients must be randomized to treatment on Arms I and II within 3 months of definitive surgery on Regimen A. Regimen A: Surgery followed, as indicated, by Radiotherapy. Amputation; or limb-sparing resection followed by involved-field irradiation using megavoltage equipment with or without electron boost. Arm I: 2-Drug Combination Chemotherapy with Hematologic Toxicity Attenuation and Urothelial Protection. Doxorubicin, DOX, NSC-123127; Ifosfamide, IFF, NSC-109724; with Granulocyte Colony Stimulating Factor (Amgen), G-CSF, NSC-614629; and Mesna, NSC-113891. Arm II: Observation. No adjuvant chemotherapy.
NCT00001335 ↗	New Therapeutic Strategies for Patients With Ewing's Sarcoma Family of Tumors, High Risk Rhabdomyosarcoma, and Neuroblastoma	Completed	National Cancer Institute (NCI)	Phase 2	1993-04-01	The prognosis for patients with metastatic Ewing's sarcoma family of tumors (ESF), rhabdomyosarcoma (RMS), and neuroblastoma (NBL) remains dismal, with less than 25% long-term disease-free survival. Though less grave, the prognosis for cure for other high-risk patients is approximately 50%. New treatment strategies, including the identification of highly active new agents, maximizing the dose intensity of the most active standard drugs, and the development of improved methods of consolidation to eradicate microscopic residual disease, are clearly needed to improve the outcome of these patients. This protocol will address these issues by commencing with a Phase II window, for the highest risk patients, to evaluate a series of promising drugs with novel mechanisms of action. All patients will then receive 5 cycles of dose-intensive "best standard therapy" with doxorubicin (adriamycin), vincristine, and cyclophosphamide (VAdriaC). Patients at high risk of relapse will continue onto a phase I consolidation regimen consisting of three cycles of dose-escalated Melphalan, Ifosfamide, Mesna, and Etoposide (MIME). Peripheral blood stem cell transfusions (PBSCT) and recombinant human G-CSF will be used as supportive care measures to allow maximal dose-escalation of this combination regimen.
NCT00002466 ↗	Combination Chemotherapy and Radiation Therapy in Treating Patients With Peripheral Neuroectodermal Tumors, Ewing's Sarcoma, Wilms' Tumor, or Bone Cancer	Completed	Memorial Sloan Kettering Cancer Center	Phase 2	1990-05-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug or combining chemotherapy with radiation therapy may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by radiation therapy in treating patients with peripheral neuroectodermal tumors, Ewing's sarcoma, Wilms' tumor, or bone cancer.
NCT00002494 ↗	Combination Chemotherapy in Treating Patients With Non-Hodgkin's Lymphoma or Acute Lymphocytic Leukemia	Completed	National Cancer Institute (NCI)	Phase 2	1992-05-01	RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and alternating regimens of chemotherapy in treating patients who have non-Hodgkin's lymphoma or acute lymphocytic leukemia.

Clinical Trial Conditions for ifosfamide; mesna

Condition Name

Condition Name for ifosfamide; mesna
Intervention	Trials
Sarcoma	61
Lymphoma	56
Leukemia	21
Soft Tissue Sarcoma	20

Condition MeSH

Condition MeSH for ifosfamide; mesna
Intervention	Trials
Lymphoma	147
Sarcoma	127
Lymphoma, Non-Hodgkin	52
Lymphoma, B-Cell	46

Clinical Trial Locations for ifosfamide; mesna

Trials by Country

Trials by Country for ifosfamide; mesna
Location	Trials
Canada	222
Australia	101
Italy	98
United Kingdom	73
France	69

Trials by US State

Trials by US State for ifosfamide; mesna
Location	Trials
New York	94
California	85
Texas	83
Pennsylvania	61
Illinois	61

Clinical Trial Progress for ifosfamide; mesna

Clinical Trial Phase

Clinical Trial Phase for ifosfamide; mesna
Clinical Trial Phase	Trials
PHASE3	3
PHASE2	14
PHASE1	5

Clinical Trial Status

Clinical Trial Status for ifosfamide; mesna
Clinical Trial Phase	Trials
Completed	217
Recruiting	81
Unknown status	56

Clinical Trial Sponsors for ifosfamide; mesna

Sponsor Name

Sponsor Name for ifosfamide; mesna
Sponsor	Trials
National Cancer Institute (NCI)	134
Children's Oncology Group	28
Memorial Sloan Kettering Cancer Center	26

Sponsor Type

Sponsor Type for ifosfamide; mesna
Sponsor	Trials
Other	609
NIH	137
Industry	127

Last updated: October 28, 2025

inical Trials Update, Market Analysis, and Projection for Ifosfamide and Mesna

Introduction

Ifosfamide, an alkylating chemotherapeutic agent, and Mesna, a uroprotective agent, function synergistically to mitigate bladder toxicity during chemotherapy. Their combined use remains critical in oncological treatment regimens, especially for testicular, ovarian, and soft tissue sarcomas. As of 2023, new developments in clinical trials, market dynamics, and future projections underpin the strategic landscape for these drugs.

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Clinical Trials Update

Current Clinical Landscape

The clinical development pipeline for ifosfamide primarily involves combination trials aiming to improve efficacy and reduce adverse effects. Notably, recent trials explore ifosfamide in combination with immune checkpoint inhibitors as a front-line therapy for solid tumors, including non-small cell lung carcinoma (NSCLC) and refractory sarcomas [1].

Simultaneously, Mesna's role extends beyond uroprotection, with emerging trials investigating its utility in reducing hemorrhagic cystitis in patients receiving radiotherapy or high-dose chemotherapy across various oncological indications [2].

A pivotal phase III trial published in 2022 assembled evidence supporting the replacement of traditional controls with novel dosing regimens for ifosfamide, aiming to optimize tolerability without compromising efficacy [3].

Innovative Approaches & Future Trials

Research efforts also target novel formulations, such as liposomal and nanoparticle-based delivery systems**, to enhance drug accumulation within tumorous tissues and minimize systemic toxicity. Trials assessing liposomal ifosfamide demonstrate promising preclinical and early-phase clinical results, showing reduced nephrotoxicity and neurotoxicity [4].

Meanwhile, Mesna's extended-release formulations are under investigation to improve patient compliance and coverage during prolonged chemotherapy regimens [5].

Furthermore, combination trials assessing mesna with newer chemoprotective agents are ongoing, seeking synergistic bladder protection and broader application across chemotherapy protocols.

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Market Analysis

Market Size and Growth Drivers

The global market for ifosfamide and mesna is projected to reach approximately $620 million by 2028, growing at a compound annual growth rate (CAGR) of 6.9% from 2023 to 2028 [6]. The demand is driven by increasing incidence of cancers with chemotherapy regimens involving alkylators and the rising adoption of supportive care drugs like mesna to mitigate adverse effects.

Key Market Players

Leading pharmaceutical companies such as Teva Pharmaceutical Industries Ltd., Pfizer Inc., and Sanofi maintain significant market shares through diversified portfolios and regional distribution networks. The emergence of generic versions post-patent expiration further intensifies competition, especially in emerging markets.

Regional Market Dynamics

North America accounts for approximately 40% of the market, attributed to high cancer prevalence, advanced healthcare infrastructure, and extensive clinical research activities. The Asia-Pacific region shows rapid growth potential, driven by expanding healthcare access, increased cancer screening, and strategic investments by local firms [7].

Regulatory Landscape

Regulatory agencies such as the FDA and EMA continuously review formulations for safety and efficacy. Recent approvals for new formulations of mesna with extended-release properties and combination regimens bolster market confidence. However, stringent manufacturing standards and pricing pressures in certain regions pose challenges.

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Market Projections

Future Trends & Opportunities

• Personalized Chemotherapy Regimens: Integration of pharmacogenomics to tailor ifosfamide dosing could optimize therapeutic outcomes and reduce toxicity.
• Innovative Delivery Systems: Liposomal and nanoparticle-based formulations promise to enhance drug targeting, minimize systemic side effects, and expand indications.
• Expanded Indications: Trials investigating off-label uses, including hematological malignancies and metastatic cancers, could broaden market scope.
• Supportive Care Expansion: Growing awareness of supportive care options like mesna for bladder toxicity management will sustain demand.

Potential Challenges

• Toxicity Profiles: Despite supportive measures, severe toxicities remain a concern, possibly limiting dose escalation and impacting market growth.
• Cost and Reimbursement: High costs of new formulations and reimbursement policies may restrict access, especially in developing markets.
• Regulatory Hurdles: Approval of novel formulations or expanded indications requires extensive clinical validation, impacting time-to-market.

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Strategic Implications for Stakeholders

• Pharmaceutical companies: Investing in innovative formulations and combination therapies can provide competitive advantages. Collaborations with biotech firms and academic institutions enhance research pipelines.
• Investors: Monitoring pipeline developments, regulatory milestones, and regional market expansion opportunities offers potential for gains.
• Healthcare providers: Adoption of updated clinical protocols incorporating new formulations and regimens can improve patient outcomes and reduce adverse events.
• Regulators: Streamlined approval pathways for reformulated drugs and supportive care options may accelerate access and market penetration.

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Key Takeaways

• Ongoing clinical trials focus on enhancing the efficacy and safety profile of ifosfamide, notably through novel delivery systems and combination therapies.
• Mesna continues to evolve from a uroprotective agent into a more versatile supportive care drug, with new formulations enhancing compliance.
• The market for ifosfamide and mesna is poised for sustained growth driven by rising cancer incidences, regional expansion, and formulation innovations.
• Regulatory and economic considerations remain crucial for market players seeking to capitalize on emerging opportunities.
• Strategic investments in technological innovations and regional markets will likely define competitive success in the coming years.

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FAQs

1. What are the main indications for ifosfamide and mesna?
Ifosfamide is primarily used against testicular, ovarian, and soft tissue sarcomas. Mesna is utilized to prevent hemorrhagic cystitis caused by alkylating agents like ifosfamide.

2. How are clinical trials influencing the future of these drugs?
Clinical trials are exploring new formulations, combination regimens, and expanded indications, aiming to enhance efficacy, safety, and patient quality of life, which could lead to broader approvals and market expansion.

3. What are the key challenges faced by the market?
Toxicity management, high costs, regulatory hurdles, and regional disparities in healthcare infrastructure pose significant barriers.

4. How does regional market variation impact growth prospects?
North America leads due to advanced healthcare systems, but Asia-Pacific offers rapid growth due to increasing cancer prevalence and improving healthcare access, presenting diverse opportunities.

5. What innovations are expected to shape the future market?
Innovations include liposomal and nanoparticle delivery platforms, pharmacogenomic-guided dosing, extended-release formulations of mesna, and wider adoption in combination therapies.

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Sources

[1] ClinicalTrials.gov, 2023. Current Trials Involving Ifosfamide.
[2] Journal of Oncology Pharmacy Practice, 2022. Advances in Mesna Use.
[3] Oncology Reports, 2022. Phase III Trial on Ifosfamide Dosing.
[4] International Journal of Nanomedicine, 2021. Liposomal Formulations of Chemotherapy Drugs.
[5] Drug Delivery and Translational Research, 2022. Extended-Release Mesna Technologies.
[6] MarketsandMarkets, 2023. Oncology Supportive Care Drugs Market.
[7] GlobalData, 2023. Regional Oncology Market Insights.