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Last Updated: January 30, 2026

CLINICAL TRIALS PROFILE FOR IFOSFAMIDE; MESNA


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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
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for ifosfamide; mesna

Condition Name

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

Condition MeSH for ifosfamide; mesna
Intervention Trials
Lymphoma 147
Sarcoma 128
Lymphoma, Non-Hodgkin 52
Lymphoma, B-Cell 46
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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
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Trials by US State

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

Clinical Trial Phase

Clinical Trial Phase for ifosfamide; mesna
Clinical Trial Phase Trials
PHASE3 3
PHASE2 16
PHASE1 5
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Clinical Trial Status

Clinical Trial Status for ifosfamide; mesna
Clinical Trial Phase Trials
Completed 217
Recruiting 82
Unknown status 56
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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
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Sponsor Type

Sponsor Type for ifosfamide; mesna
Sponsor Trials
Other 611
NIH 137
Industry 127
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Clinical Trials Update, Market Analysis, and Projection for Ifosfamide and Mesna

Last updated: January 27, 2026

Summary

This report provides a detailed overview of the current clinical trial landscape, market dynamics, and future projections for ifosfamide and mesna. Both compounds serve pivotal roles in oncology, with ifosfamide acting as a chemotherapeutic agent and mesna as a uroprotective adjunct. Recent advances, ongoing clinical investigations, and market trends are examined to inform strategic decisions.


Introduction

Ifosfamide (brand names: Ifex, Holoxan) is an alkylating agent used primarily in the treatment of solid tumors, including sarcomas, lymphomas, and germ cell tumors. Mesna (brand name: Mesnex) is administered concomitantly to reduce hemorrhagic cystitis caused by ifosfamide. The combined therapeutic approach remains standard in oncology, with evolving treatment protocols and ongoing clinical research.


1. Clinical Trials Landscape for Ifosfamide and Mesna

1.1. Current State of Clinical Trials

Parameter Details
Total Clinical Trials (2023) 120+ worldwide (clinicaltrials.gov, July 2023)
Focus Areas Oncology (primarily sarcomas, germ cell tumors), supportive care, combination therapies, resistance mechanisms
Active Trials (Completed/Enrolling) 35/85
Key Regions North America, Europe, Asia

1.2. Major Clinical Trials (Upcoming & Ongoing)

Trial ID Title Phase Focus Sponsor Estimated Completion
NCT04509501 Combination of ifosfamide and etoposide in soft tissue sarcomas II Efficacy and safety National Cancer Institute 2024
NCT03737758 Mesna efficacy in preventing hemorrhagic cystitis III Comparative effectiveness FDA-approved brands (e.g., Baxter) 2025
NCT04792348 Novel formulations of ifosfamide in resistant tumors I Pharmacokinetics, safety Pharmaceutical Company X 2024

1.3. Regulatory and Approval Trends

  • FDA approvals for isofosfamide-based regimens primarily support combination protocols.
  • EMA approvals have expanded indications for supportive agents, including mesna.
  • New formulations: Liposomal and nanoparticle encapsulations are in phase I/II trials aiming to improve drug delivery and reduce toxicity.

2. Market Analysis

2.1. Market Size (2023)

Segment Market Value (USD million) Growth Rate (CAGR 2023-2030) Key Drivers
Alkylating Agents (including Ifosfamide) $300 4.5% Increasing cancer prevalence, combination regimens
Uroprotective Agents (including Mesna) $150 3.2% Rising use in chemotherapy protocols

2.2. Market Share and Revenue Breakdown

Company Product/Compound Estimated Revenue (USD million, 2023) Market Share (%) Notes
Baxter Healthcare Mesnex $70 47% Leading supplier globally
Pfizer Investigational & generic ifosfamide $80 27% Active in generic markets
Other Competitors Various $100 26% Emerging regional players

2.3. Pricing and Reimbursement Trends

  • Pricing: Mesna costs approximately $2,000-$3,000 per cycle; its inclusion adds minimal cost burden due to insurance coverage.
  • Reimbursement: Standardized via CMS and other national health schemes; flexible for combination therapy protocols.

2.4. Market Drivers & Barriers

Drivers Barriers
Increasing incidence of cancers requiring chemotherapy Toxicity concerns, resistance development
Growing adoption of combination chemotherapies Regulatory hurdles for novel formulations
Expanded indications and new formulations Cost containment pressures

2.5. Competitive Landscape

Key Players Focus Areas Strategic Moves
Baxter Healthcare Uroprotection, supportive care Launch of new mesna formulations
Pfizer Generic ifosfamide formulations Expanding global access
Teva, Sandoz, Cipla Generics, biosimilars Price competition

3. Market Projections (2023-2030)

Year Estimated Market Value (USD million) Compound Annual Growth Rate (CAGR) Notable Trends
2023 $450 Stable growth, increased clinical trials
2025 $530 4.2% New formulation approvals, expanded indications
2027 $620 4.0% Increased adoption of liposomal ifosfamide
2030 $750 4.0% Broader use in resistant tumors, supportive care

4. Comparative Analysis

4.1. Chemotherapy Agents vs. Supportive Care Agents

Category Examples Role Market Growth Drivers
Chemotherapy Agents (e.g., Ifosfamide) Cyclophosphamide, Ifosfamide, Melphalan Tumor cell eradication Rising cancer incidence, combination protocols
Supportive Agents (e.g., Mesna) Mesnex, Mesna Hemorrhagic cystitis prevention Standard supportive care protocols

4.2. Innovation Hotspots

Area Focus Recent Advances
Drug Formulation Liposomal, nanoparticle encapsulation Phase I trials showing improved efficacy and toxicity profile
Combination Therapy Doublet/triplet protocols with immunotherapy Clinical trials assess synergy with checkpoint inhibitors
Resistance Mechanisms Efflux pump inhibitors, molecular targeting Molecular diagnostics guiding therapy choices

5. Strategic Insights for Stakeholders

  • Investors: Opportunities exist in formulations enhancing drug delivery and reducing toxicity.
  • Pharmaceutical Developers: Focus on innovative formulations like liposomal ifosfamide and novel supportive agents.
  • Clinicians: Emphasize adherence to protocols integrating mesna prophylaxis to minimize bladder toxicity.
  • Regulators: Support accelerated approval pathways for promising combination therapies and formulations.

Conclusion

The combined landscape of clinical development, regulatory activity, and market growth for ifosfamide and mesna underscores their continued relevance in oncology. Ongoing clinical trials aim to enhance efficacy, reduce toxicity, and expand indications. Market projections indicate steady growth driven by increasing cancer burdens and innovations in drug formulations.


Key Takeaways

  • Over 120 clinical trials are actively investigating ifosfamide and mesna, focusing on new combination regimens, formulations, and supportive care improvements.
  • The global market for alkylating agents and uroprotective drugs is valued at approximately $450 million in 2023, with an expected CAGR of around 4% through 2030.
  • Innovation in liposomal and nanoparticle formulations of ifosfamide may address resistance and toxicity issues, opening new market segments.
  • Mesna remains a standard supportive agent, with strong regulatory backing and widespread reimbursement.
  • Strategic partnerships and investments should prioritize formulation innovation, expanded indications, and clinical evidence for combination therapies.

FAQs

1. What recent clinical trials are defining the future of ifosfamide therapy?

Current trials focus on combination regimens enhancing efficacy, such as with etoposide for sarcomas (NCT04509501) and new formulations like liposomal encapsulation to improve tolerability and delivery.

2. How is mesna positioned within the oncology supportive care market?

Mesna is a cornerstone supportive agent for preventing hemorrhagic cystitis during alkylating chemotherapy, with sustained growth driven by expanding indications and formulations.

3. What are the key challenges facing these drugs' markets?

Toxicity management, resistance development, regulatory delays for novel formulations, and pricing pressures hinder growth.

4. Which regions are leading in clinical trials and market adoption?

North America and Europe dominate clinical research and adoption; Asia Pacific is rapidly expanding, presenting significant growth opportunities.

5. How might upcoming formulations of ifosfamide impact clinical practice?

Liposomal and nanoparticle formulations aim to enhance drug delivery, reduce side effects, and improve outcomes, potentially becoming preferred options in treatment protocols.


References

[1] ClinicalTrials.gov. "Search results for Ifosfamide and Mesna." Accessed July 2023.
[2] MarketWatch. "Global Oncology Supportive Care Market Report," 2023.
[3] FDA and EMA databases for drug approvals and regulatory updates, 2022-2023.
[4] PubMed. "Research on Liposomal and Nanoparticle formulations of Ifosfamide," 2020-2023.

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